CUMULATIVE 

SUPPLEMENT 12 

December 2023 

APPROVED 

DRUG PRODUCTS 

WITH 

THERAPEUTIC EQUIVALENCE EVALUATIONS 

43rd EDITION 

Department of Health and Human Services 

Food and Drug Administration 

Office of Medical Products and Tobacco 

Center for Drug Evaluation and Research 

Office of Generic Drugs 

Office of Generic Drug Policy 

2023 
Prepared By 

Food and Drug Administration 

Office of Medical Products and Tobacco 

Center for Drug Evaluation and Research 

Office of Generic Drugs 

Office of Generic Drug Policy 
 

 

 

 

 

 

 

APPROVED DRUG PRODUCTS 

with 

THERAPEUTIC EQUIVALENCE EVALUATIONS 

43rd EDITION 

Cumulative Supplement 12

December 2023 

CONTENTS 

PAGE 

Contents 

1.0 INTRODUCTION.............................................................................................................................. v 

1.1 HOW TO USE THE CUMULATIVE SUPPLEMENT........................................................................vi 

1.2 CUMULATIVE SUPPLEMENT CONTENT......................................................................................vi 

1.3 APPLICANT NAME CHANGES......................................................................................................vii 

1.4 LEVOTHYROXINE SODIUM ...........................................................................................................ix 

1.5 AVAILABILITY OF THE EDITION.................................................................................................... x 

1.6 REPORT OF COUNTS FOR THE PRESCRIPTION DRUG PRODUCT LIST................................xi 

1.7 CUMULATIVE SUPPLEMENT LEGEND........................................................................................xii 

DRUG PRODUCT LISTS 

Prescription Drug Product List ................................................................................ 1-1 

Drug Products with Approval under Section 505 of the Act Administered by the Center for 

Drug Products Which Must Demonstrate in vivo Bioavailability Only if Product Fails to 

OTC Drug Product List ........................................................................................................... 2-1 

Biologics Evaluation and Research List ............................................................... 3-1 

Orphan Products Designations and Approvals List .................................................... 4-1 

Achieve Adequate Dissolution ............................................................................ 5-1 

PATENT AND EXCLUSIVITY INFORMATION ADDENDUM 

A. Patent and Exclusivity Lists ............................................................................................. A-1 

B. Patent and Exclusivity Terms ............................................................................ B-1 

iv 
 

 

 

 

 

 

APPROVED DRUG PRODUCTS 

with 

THERAPEUTIC EQUIVALENCE EVALUATIONS 

43rd EDITION 

CUMULATIVE SUPPLEMENT 12 

December 2023 

1.0 INTRODUCTION 

This Cumulative Supplement is one of a series of monthly updates to the 

Approved Drug Products with Therapeutic Equivalence Evaluations (the 

List, commonly known as the Orange Book). The List is composed of four 

parts: approved prescription drug products with therapeutic equivalence 

evaluations; approved over-the-counter (OTC) drug products for those 

drugs that may not be marketed without NDAs or ANDAs because they are not 

covered under existing OTC monographs; drug products with approval under 

Section 505 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) 

administered by the Center for Biologics Evaluation and Research; and 

approved products that have never been marketed, are for exportation, are 

for military use, have been discontinued from marketing and we have not 

determined that they were withdrawn for safety or effectiveness reasons, 

or that have had their approvals withdrawn for other than safety or 

efficacy reasons. 

The Cumulative Supplement provides, among other things, information on 

newly approved drugs and, if necessary, revised therapeutic equivalence 

evaluations and updated patent and exclusivity data. The Addendum 

contains appropriate drug patent and exclusivity information required of 

the Agency by the "Drug Price Competition and Patent Term Restoration Act 

of 1984" for the Prescription, OTC, Discontinued Drug Product, and Drug 

Products with Approval under Section 505 of the Act Administered by the 

Center for Biologics Evaluation and Research Lists. 

Because all parts of the publication are subject to changes, additions, 

or deletions, the List must be used in conjunction with the most current 

Cumulative Supplement. Users may wish to mark to the left of the 

ingredient(s) in the List to indicate that changes to that entry appear 

in the Cumulative Supplement. Drug product information is provided in 

each Cumulative Supplement for completeness to assist in locating the 

proper place in the List for the revision. 

The presence of any therapeutic equivalence code indicates that the drug 

product is multisource; the deletion of a therapeutic equivalence code 

indicates that the drug product has become single source. (An infrequent 

exception exists when a therapeutic equivalence code is revised. In that 

case, the deletion of the therapeutic equivalence code is followed 

immediately by the addition of the revised one.) 

Products that have never been marketed, are for exportation, are for 

military use, have been discontinued from marketing and we have not 

determined that they were withdrawn for safety or effectiveness reasons 

or that have had their approvals withdrawn for other than safety or 

efficacy reasons, will be flagged in this Cumulative Supplement with the 

"@" symbol to designate their non-marketed status. All products having a 

v 
 

 

 

 

 

 

 

 

 

 

 

"@" symbol in the 12th Cumulative Supplement of this Edition List will 

then be added to the "Discontinued Drug Product List" appearing in the 

next Edition. The current Annual Edition Section 2., How To Use The Drug 

Product Lists, describes the layout and usage of the List. 

1.1 HOW TO USE THE CUMULATIVE SUPPLEMENT 

New additions to the Prescription Drug Product List and OTC Drug Product 

List are indicated by the symbol >A>. The Patent and Exclusivity List new 

additions are indicated by the symbol >A> to the left of Patent Number or 

Exclusivity Code. The >A> symbol is then dropped in subsequent Cumulative 

Supplements for that item. 

New deletions to the Prescription Drug Product List and OTC Drug Product 

List are indicated by the symbol >D> (DELETE) to the left of the line. 

The information line with the >D> symbol is dropped in subsequent 

Cumulative Supplements for that item. 

The Patent and Exclusivity List is arranged in alphabetical order by 

active ingredient name(s) and trade name. The trade name will follow the 

active ingredient name separated by a dash symbol. Also shown is the 

application number and product number (FDA's internal file number) for 

reference purposes. All patents with their expiration dates are 

displayed for each application number. Drug substance and drug product 

patents are indicated as such with DS or DP in the Patent codes column. 

Use patents are indicated with the symbol "U" followed by a number 

representing a specific use. Exclusivity information for a specific drug 

is indicated by an abbreviation followed by the date upon which the 

exclusivity expires. Refer to the Exclusivity Terms, Section B, in the 

Patent and Exclusivity Information Addendum for an explanation of all 

codes and abbreviations. Refer to Section 1.3 for internet access to the 

most current list of Patent and Exclusivity terms. 

1.2 CUMULATIVE SUPPLEMENT CONTENT 

Since February 2005, we have been providing daily Electronic Orange Book 

(EOB) product information for new generic drug approvals. Daily generic 

updates provide the consumer with the current list of approved generic 

products which is important for substitution purposes. Previously, a 

first-time-generic product approved early in the month would not be 

published in the Cumulative Supplement (CS) for several weeks. 

The CS monthly update publish goal is by the end of the following month’s 

second work week (e.g., November’s supplement will be updated by the end 

of the second full work week in December). 

Currently, the monthly PDF CS includes: 

• Generic product ANDA (Abbreviated New Drug Approval) approvals as of 

the date of publication. 

• All product changes received and processed as of the date of 

publication. 

o Refer to CS Section 1.7 Cumulative Supplement Legend for 

types of changes 

vi 
 

 

 

 

 

 

 

• New Drug Application (NDA) approvals appear in the CS month they 

were approved. 

• Patent information, also updated daily in the EOB, is current to 

the date of publication. 

• Exclusivity information is updated monthly and is current as of the 

date of publication. 

Every effort is made to ensure the Cumulative Supplement is 

accurate. Applicant holders are requested to inform the FDA Division of 

Orange Book Publication and Regulatory Assessment (DOBPRA) of any changes 

or corrections. The DOBPRA can be contacted by email at 

orangebook@fda.hhs.gov. 

1.3 APPLICANT NAME CHANGES 

It is not practical to identify in the Cumulative Supplement each product 

involved when an applicant transfers its entire line of approved drug 

products to another applicant, or when an applicant changes its name. 

Therefore, the cumulation of these transfers and name changes will be 

identified in this section only. Where only partial lines of approved 

products are transferred between applicants, each approved product 

involved will appear as an applicant name change entry in the Cumulative 

Supplement. 

It is also not practical to identify each, and every product involved 

when an applicant name is changed to meet internal publication standards 

(e.g., MSD or Zenith [Former Abbreviated Names] are changed, respectively 

to Merck Sharp Dohme or Zenith Labs [New Abbreviated Names]). When this 

occurs, each product involved (either currently in the Cumulative 

Supplement or in the following year's edition) will reflect the new 

abbreviated name. Consequently, it will not appear as an applicant name 

change entry in the Cumulative Supplement nor will the cumulation of 

these name changes appear in this section. The Electronic Orange Book 

Query, updated monthly, will contain the most current applicant holder 

name. 

FORMER APPLICANT NAME NEW APPLICANT NAME 

(FORMER ABBREVIATED NAME) (NEW ABBREVIATED NAME) 

AKORN OPERATING CO LLC EPIC PHARMA LLC 

(AKORN) (EPIC PHARMA LLC) 

AKORN OPERATING CO LLC HIKMA PHARMACEUTICALS USA INC 

(AKORN) (HIKMA) 

AKORN OPERATING CO LLC RISING PHARMA HOLDINGS INC 

(AKORN) (RISING) 

ALEOR DERMACEUTICALS LTD ALEMBIC PHARMACEUTICALS LTD 

(ALEOR DERMACEUTICALS) (ALEMBIC) 

ALLERGAN ABBVIE INC 

(ALLERGAN) (ABBVIE) 

vii 
 

ALLERGAN HOLDINGS UNLTD CO 

(ALLERGAN HOLDINGS) 

ALLERGAN INC 

(ALLERGAN) 

ALLERGAN SALES LLC 

(ALLERGAN) 

ALLERGAN SALES LLC 

(ALLERGAN) 

EMCURE PHARMACEUTICALS LTD 

(EMCURE PHARMS) 

EMCURE PHARMACEUTICALS LTD 

(EMCURE PHARMS LTD) 

EPIC PHARMA INC 

(EPIC PHARMA) 

EPIC PHARMA INC 

(EPIC PHARMA INC) 

HERITAGE PHARMA LABS INC 

(HERITAGE PHARMA) 

HERITAGE PHARMA LABS INC DBA 

AVET PHARMACEUTICALS LABS INC 

(HERITAGE PHARMA AVET) 

MAYNE PHARMA INC 

(MAYNE PHARMA INC) 

MAYNE PHARMA INTERNATIONAL PTY 

LTD 

(MAYNE PHARMA) 

MAYNE PHARMA INTERNATIONAL PTY 

LTD 

(MAYNE PHARMA INTL) 

MAYNE PHARMA LLC 

(MAYNE PHARMA) 

NEXUS PHARMACEUTICALS INC 

(NEXUS PHARMS) 

STRIDES PHARMA GLOBAL PTE LTD 

(STRIDES PHARMA) 

TARO PHARMACEUTICALS USA INC 

(TARO) 

TORRENT PHARMA INC 

(TORRENT) 

ABBVIE INC 

(ABBVIE) 

ABBVIE INC 

(ABBVIE) 

ABBVIE 

(ABBVIE) 

ABBVIE INC 

(ABBVIE) 

AVET LIFESCIENCES LTD 

(AVET LIFESCIENCES) 

AVET LIFESCIENCES LTD 

(AVET LIFESCIENCES) 

EPIC PHARMA LLC 

(EPIC PHARMA LLC) 

EPIC PHARMA LLC 

(EPIC PHARMA LLC) 

CHARTWELL RX SCIENCES LLC 

(CHARTWELL RX) 

CHARTWELL RX SCIENCES LLC 

(CHARTWELL RX) 

DR REDDYS LABORATORIES SA 

(DR REDDYS LABS SA) 

DR REDDYS LABORATORIES SA 

(DR REDDYS LABS SA) 

DR REDDYS LABORATORIES SA 

(DR REDDYS LABS SA) 

DR REDDYS LABORATORIES SA 

(DR REDDYS LABS SA) 

NEXUS PHARMACEUTICALS LLC 

(NEXUS) 

CHARTWELL RX SCIENCES LLC 

(CHARTWELL RX) 

TARO PHARMACEUTICALS INC 

(TARO) 

APOZEAL PHARMACEUTICALS INC 

(APOZEAL PHARMS) 

viii 
 

 

 

 

1.4 LEVOTHYROXINE SODIUM1 

Because there are multiple reference listed drugs for levothyroxine 

sodium tablets and some reference listed drugs' sponsors have conducted 

studies to establish their drugs' therapeutic equivalence to other 

reference listed drugs, FDA has determined that its usual practice of 

assigning two or three character therapeutic equivalence codes may be 

potentially confusing and inadequate for these drug products. Looking at 

the Orange Book listing alone for a product identified as a reference 

listed drug or reference standard, it may be difficult to determine to 

which therapeutic equivalence code the reference listed drugs and/or 

reference standard designation corresponds. For example, Unithroid 0.3 mg 

strength has been assigned the therapeutic equivalence codes AB1, AB2, 

and AB3 and it is identified as the reference listed drug and reference 

standard, but it is unclear that the reference listed drug and reference 

standard designations are associated with the AB1 therapeutic equivalence 

code. 

Accordingly, FDA provides the following chart, which identifies (1) a 

reference listed drug for each therapeutic equivalence code in the Orange 

Book and (2) and the reference standard products in the Active Section of 

the Orange Book.2 

• Therapeutic equivalence has been established between products that have 

the same AB+number therapeutic equivalence code (i.e. AB1, AB2, AB3 or 

AB4). 

• More than one therapeutic equivalence code may apply to some products. 

One common therapeutic equivalence code indicates therapeutic 

equivalence between products. For example, Unithroid has been assigned 

therapeutic equivalence codes AB1, AB2, and AB3 therefore Unithroid 

tablets are considered therapeutically equivalent to other 

levothyroxine sodium products of the same strength with these 

therapeutic equivalence codes. 

TE Code Proprietary Name Applicant Strength Appl 

No 

RLD RS 

AB1 UNITHROID STEVENS J 

ABBVIE 

KING 

PHARMS 

ALVOGEN 

INC 

0.3MG 

0.3MG 

0.2MG 

0.3MG 

N021210 

N021402 

N021301 

N021116 

RLD 

RLD 

RLD 

RLD 

RS 

RS 

RS 

−

AB2 SYNTHROID 

AB3 LEVOXYL 

AB4 THYRO-TABS 

1 In previous editions of the Orange Book, FDA provided a chart outlining therapeutic equivalence 

codes for all .025 mg levothyroxine sodium drug products in the Active Section of the Orange

Book. FDA has decided, for ease of review, to revise the chart to identify the NDAs for the 

reference listed drugs for each therapeutic equivalence code (i.e., AB1, AB2, AB3, and AB4), and

their corresponding reference standards, which are identified in 0.2 and 0.3 mg strengths.

2 Please consult the Active Section of the Orange Book for information on other strengths. 

ix 
 

 

 

 

AB4 LEVOTHYROXINE SODIUM3 MYLAN 0.3MG A076187 − RS 

1.5 AVAILABILITY OF THE EDITION 

Since 1997, the Electronic Orange Book Query (EOBQ) 

http://www.accessdata.fda.gov/scripts/cder/ob/default.cfm, has been 

available on the internet and has become the updated-every-month Orange 

Book. The Query provides searching of the approved drug list by active 

ingredient, proprietary name, applicant holder, applicant number or patent 

number. Product search categories are: prescription, over-the-counter, 

discontinued drugs. There are links to patent and exclusivity information 

that may be applicable to each product. 

Commencing with the 25th edition, the Annual Edition and monthly 

Cumulative Supplements have been provided in downloadable Portable 

Document Format (PDF) at the EOB home page by clicking on Publications. 

The PDF annual and cumulative supplements duplicate previous paper 

versions. Over time, there will be an archive for the annuals and each 

year's December Cumulative Supplement. 

The downloaded Annual Edition and Cumulative Supplements are also 

available in a paper version (Approved Drug Products with Therapeutic 

Equivalence Evaluations, ADP) from the U.S. Government Printing 

Office: http://bookstore.gpo.gov; toll free 866-512-1800. 

There are historical lists of Orange Book cumulative supplement product 

monthly changes at 

http://www.fda.gov/Drugs/InformationOnDrugs/ucm086229.htm. There are 

ASCII text files of the Orange Book drug product, patent, and exclusivity 

data at http://www.fda.gov/Drugs/InformationOnDrugs/ucm129689.htm. The 

drug product text files are provided in eobzip.zip format. The files are 

updated concurrently with the monthly cumulative supplements. The annual 

Orange Book Edition Appendices A, B, and C in PDF format are updated 

quarterly. 

Effective August 18, 2003, patent submissions for publication in the Orange 

Book and Docket *95S-0117 need to be submitted on form FDA-3542 which may 

be downloaded from the FDA Forms List, 

Effective August 18, 2003, patent submissions for publication in the Orange 

Book and Docket *95S-0117 need to be submitted on form FDA-3542 which may 

be downloaded from the FDA Forms List, 

https://www.fda.gov/about-fda/reports-manuals-forms/forms. 

3 Lloyd’s Thyro-Tabs tablets (NDA 021116) (previously known as Levothroid) previously was listed 

in the Discontinued Drug Product List section of the Orange Book. It is the RLD for therapeutic

equivalents identified with the AB4 code. During this time, Mylan’s levothyroxine product (ANDA 

076187) was selected as the reference standard for ANDA applicants to use to establish

bioequivalence to Thyro-Tabs. It remains the reference standard for ANDA applicants to use to 

establish bioequivalence to Thyro-Tabs. If an ANDA that uses Mylan’s levothyroxine product as

its reference standard is approved, the ANDA will receive an AB4 rating. The ANDA applicant also 

may obtain an AB rating for its product to the other reference listed drugs (i.e., Unithroid,

Synthroid, and Levoxyl) by submitting supplements that demonstrate that the generic product is 

bioequivalent to these other reference listed drugs and satisfies all other therapeutic

equivalence criteria with respect to these reference listed drugs. See Letter from Janet 

Woodcock, M.D., Director, Center for Drug Evaluation and Research, FDA to Teri Nataline,

Principal Consultant, Lachman Consultant Services, Inc., Docket No. FDA-2015-P-0403 (May 27, 

2016). 

x 
 

 

The current listing of the Orphan Product Designations and Approvals is 

available at https://www.fda.gov/industry/developing-products-rarediseases-conditions/designating-orphan-product-drugs-and-biologicalproducts. 

1.6 REPORT OF COUNTS FOR THE PRESCRIPTION DRUG PRODUCT LIST 

DESCRIPTION OF REPORT 

This report provides summary counts derived from the product information 

in the Prescription Drug Product List and the current Cumulative 

Supplement. Products included in the counts are domestically marketed 

drug products approved for both safety and effectiveness under section 505 

of the Federal Food, Drug, and Cosmetic Act. Excluded are approved drug 

products marketed by distributors; those marketed solely abroad; and those 

now regarded as medical devices, biologics or foods. 

The baseline column (December of the previous Annual Edition) refers to 

the products in the Prescription Drug Product List. For each three-month 

period, a column of quarterly data is added which incorporates counts of 

product activity from the previous quarter(s) with those in the baseline 

count. 

DEFINITIONS 

Drug Product 

For this report, a drug product is the representation in the Prescription 

Drug Product List of an active moiety (molecular entity and its salts, 

esters and derivatives) either as a single ingredient or as a combination 

product provided in a specific dosage form and strength for a given route 

of administration with approval for marketing by a firm under a particular 

generic or trade name. 

New Molecular Entity 

A new molecular entity is considered an active moiety that has not 

previously been approved (either as the parent compound or as a salt, 

ester or derivative of the parent compound) in the United States for use 

in a drug product either as a single ingredient or as part of a 

combination. 

REPORT OF COUNTS FOR THE PRESCRIPTION DRUG PRODUCT LIST 

COUNTS CUMULATIVE BY QUARTER 

CATEGORIES DEC MAR JUN SEP DEC 

COUNTED 2022 2023 2023 2023 2023 

DRUG PRODUCTS 21983 22398 22632 22925 23099 

LISTED SINGLE 2718 2759 2779 2771 2784 

SOURCE (12.4%) (12.3%) (12.3%) (12.1%) (12.1%) 

MULTISOURCE 19265 19639 19853 20154 20315 

(87.6%) (87.7%) (87.7%) (87.9%) (87.9%) 

THERAPEUTICALLY 19165 19554 19781 20083 20252 

EQUIVALENT (87.2%) (87.3%) (87.4%) (87.6%) (87.7%) 

xi 
 

NOT 

THERAPEUTICALLY 

EQUIVALENT 

100 

(0.5%) 

85 

(0.4%) 

72 

(0.3%) 

71 

(0.3%) 

63 

(0.3%) 

EXCEPTIONS4 46 46 46 46 46 

(0.2%) (0.2%) (0.2%) (0.2%) (0.2%) 

NEW MOLECULAR 

ENTITIES 8 19 11 20 32 

APPROVED 

NUMBER OF 

APPLICANTS 1211 1222 1217 1216 1214 

1.7 CUMULATIVE SUPPLEMENT LEGEND 

The List is sorted by Ingredient(s) and, within each grouping, by the 

Dosage Form; Route of Administration and then by trade name (or 

established name of the active ingredient, if no trade name exists). 

The individual product record contains the Therapeutic Equivalence Code, 

Reference Listed Drug symbol, Reference Standard symbol, applicant 

holder, strength(s), New Drug Application number, product number, and 

approval date. The application number preceded by “N” is a New Drug 

Application (NDA or innovator). The application number preceded by an “A” 

is an Abbreviated New Drug Application (ANDA or generic). The last two 

columns describe the action. The Action Month is the CS month the action 

occurred. The OB Action is the type of change that has occurred. 

New ingredient(s), new dosage form, new route(s) of administration, new 

trade names, and new product additions are preceded by >A> during the 

action month. The change month is the current CS month; the change code 

for new approvals is NEWA. Following months will display the same 

information without the >A>. 

Changes to currently listed products will list two records. The deleted 

product record will be proceeded by >D>. The product record change 

addition being made will be preceded by >A>. Following months will 

display only the >A> record without the >A>. All changes that occur to 

the product through the Annual year will be listed. The change month and 

change code will document the change. 

The change code and description: 

NEWA New drug product approval 

NFTG New first-time generic approval 

CAHN5 Applicant holder firm name has changed 

CAIN Change. There has been a change in the Ingredient(s) name. 

All products will be deleted under the old name and all 

products will be added under the changed ingredient(s) name. 

CDFR Change. Dosage Form; Route of Administration 

CFTG Change. A TE Code is added when a first time generic for an 

innovator is approved. 

4 Amino acid containing products of varying composition (see Introduction, page xx of the List). 5 The Cumulative Supplement (CS) currently displays a condensed 20 character collapsed applicant

holder firm name and the Electronic Orange Book (EOB) query may display up to a 250-character 

full applicant holder firm name. An applicant holder firm name change usually changes both the

collapsed name and long name. On occasion, only the long name is changed resulting in the CS 

displaying only the collapsed name for the >D> and >A> action. The new firm long name will

display in the EOB query. 

xii 
 

 

 

 

CMFD Change. The product is moved from the Discontinued Section 

due to a change in marketing status. 

CMKT Change. RX to OTC marketing status switch. 

CMS1 Change. Miscellaneous addition to list. 

CMS2 Change. Miscellaneous deletion from list. 

CPOT Change. Potency amount/unit. 

CRLD Change. Reference Listed Drug 

CHRS Change. Reference Standard 

CTEC Change. Therapeutic Equivalence Code. 

CTNA Change. Trade Name. 

DISC Discontinued. The Rx or OTC listed product is not 

being marketed and will appear in the discontinued 

section in the next edition. 

xiii 
PRESCRIPTION DRUG PRODUCT LIST - 43RD EDITION

RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - December 2023 1-1

ABACAVIR SULFATE

TABLET;ORAL

ABACAVIR SULFATE

>D>

>A>

>D>

AB

AB !

HETERO LABS LTD III

ZIAGEN

EQ 300MG BASE

EQ 300MG BASE

A091560

A091560

001 Sep 13, 2013

001 Sep 13, 2013

Dec CHRS

Dec CHRS

>D>

>A>

AB +!

+ @

VIIV HLTHCARE EQ 300MG BASE

EQ 300MG BASE

N020977

N020977

001 Dec 17, 1998

001 Dec 17, 1998

Dec DISC

Dec DISC

ABACAVIR SULFATE; LAMIVUDINE

>A>

>A>

TABLET, FOR SUSPENSION;ORAL

ABACAVIR SULFATE AND LAMIVUDINE

>A> +! MYLAN LABS LTD EQ 60MG BASE;30MG N204311 001 Dec 22, 2023 Dec NEWA

ABACAVIR SULFATE; LAMIVUDINE; ZIDOVUDINE

TABLET;ORAL

ABACAVIR SULFATE, LAMIVUDINE AND ZIDOVUDINE

>D>

>A>

>D>

AB

!

LUPIN LTD

TRIZIVIR

EQ 300MG BASE;150MG;300MG

EQ 300MG BASE;150MG;300MG

A202912

A202912

001 Dec 05, 2013

001 Dec 05, 2013

Dec CHRS

Dec CHRS

>D>

>A>

AB +!

+ @

VIIV HLTHCARE EQ 300MG BASE;150MG;300MG

EQ 300MG BASE;150MG;300MG

N021205

N021205

001 Nov 14, 2000

001 Nov 14, 2000

Dec DISC

Dec DISC

ABIRATERONE ACETATE

TABLET;ORAL

ABIRATERONE ACETATE

AB

AB

AB

DR REDDYS

FLORIDA

TEVA PHARMS USA

500MG

500MG

500MG

A208416

A215086

A210726

002 Sep 01, 2023

001 Mar 23, 2023

001 Jan 26, 2023

Aug NEWA

Mar NEWA

Jan NEWA

ABIRATERONE ACETATE; NIRAPARIB TOSYLATE

TABLET;ORAL

AKEEGA

+

+!

JANSSEN BIOTECH 500MG;EQ 50MG BASE

500MG;EQ 100MG BASE

N216793

N216793

001 Aug 11, 2023

002 Aug 11, 2023

Aug NEWA

Aug NEWA

ACARBOSE

TABLET;ORAL

ACARBOSE

@

@

@

DASH PHARMS 25MG

50MG

100MG

A091053

A091053

A091053

001 Jan 06, 2011

002 Jan 06, 2011

003 Jan 06, 2011

Feb CAHN

Feb CAHN

Feb CAHN

ACETAMINOPHEN

SOLUTION;INTRAVENOUS

ACETAMINOPHEN

AP

AP

AP

@

HQ SPCLT PHARMA

INFORLIFE

WOCKHARDT BIO AG

ZYDUS PHARMS

1GM/100ML (10MG/ML)

1GM/100ML (10MG/ML)

1GM/100ML (10MG/ML)

1GM/100ML (10MG/ML)

A215403

A215403

A205746

A216467

001 May 03, 2023

001 May 03, 2023

001 Apr 18, 2023

001 Oct 25, 2022

Apr NEWA

Nov CAHN

Apr NEWA

Mar DISC

ACETAMINOPHEN; BENZHYDROCODONE HYDROCHLORIDE

TABLET;ORAL

APADAZ

+ @

+ @

+ @

+ @

+ @

+ @

KVK TECH INC

ZEVRA THERAP

325MG;EQ 4.08MG BASE

325MG;EQ 6.12MG BASE

325MG;EQ 8.16MG BASE

325MG;EQ 4.08MG BASE

325MG;EQ 6.12MG BASE

325MG;EQ 8.16MG BASE

N208653

N208653

N208653

N208653

N208653

N208653

002 Jan 04, 2019

001 Feb 23, 2018

003 Jan 04, 2019

002 Jan 04, 2019

001 Feb 23, 2018

003 Jan 04, 2019

Mar DISC

Mar DISC

Mar DISC

Jun CAHN

Jun CAHN

Jun CAHN

ACETAMINOPHEN; BUTALBITAL

TABLET;ORAL

BUTALBITAL AND ACETAMINOPHEN

AA

AA

AA

AA

@ ALVOGEN

NE RX PHARMA

SENORES PHARMS

300MG;50MG

300MG;50MG

300MG;50MG

325MG;25MG

325MG;50MG

A207635

A214955

A214088

A214088

A214088

001 Jun 05, 2017

001 Aug 16, 2022

001 Apr 07, 2022

002 Apr 07, 2022

003 Apr 07, 2022

Aug DISC

Sep CAHN

Jan CAHN

Jan CAHN

Jan CAHN
RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - December 2023 1-2

ACETAMINOPHEN; BUTALBITAL; CAFFEINE

AA

AA

CAPSULE;ORAL

BUTALBITAL, ACETAMINOPHEN AND CAFFEINE

RISE PHARMA 300MG;50MG;40MG

325MG;50MG;40MG

A214087

A214087

001

002

Aug 13, 2021

Aug 13, 2021

Sep CAHN

Sep CAHN

ACETAMINOPHEN; CAFFEINE; DIHYDROCODEINE BITARTRATE

TABLET;ORAL

ACETAMINOPHEN, CAFFEINE AND DIHYDROCODEINE BITARTRATE

@ LARKEN LABS INC 325MG;30MG;16MG A204209 001 Sep 30, 2016 Oct DISC

ACETAMINOPHEN; CODEINE PHOSPHATE

SOLUTION;ORAL

ACETAMINOPHEN AND CODEINE PHOSPHATE

AA ! GENUS LIFESCIENCES 120MG/5ML;12MG/5ML

TABLET;ORAL

ACETAMINOPHEN AND CODEINE PHOSPHATE

A087508 001 Sep CAHN

>D>

>D>

>D>

>A>

>A>

>A>

AA

AA

AA

AA

AA

AA

@

@

+ @

EYWA

NOSTRUM LABS INC

WES PHARMA INC

300MG;15MG

300MG;30MG

300MG;60MG

300MG;15MG

300MG;30MG

300MG;60MG

300MG;15MG

300MG;30MG

300MG;60MG

A211610

A211610

A211610

A088629

A088629

A088629

A211610

A211610

A211610

001

002

003

002

003

001

001

002

003

Jun 27, 2019

Jun 27, 2019

Jun 27, 2019

Mar 06, 1985

Mar 06, 1985

Mar 06, 1985

Jun 27, 2019

Jun 27, 2019

Jun 27, 2019

Dec CAHN

Dec CAHN

Dec CAHN

Apr DISC

Apr DISC

Apr DISC

Dec CAHN

Dec CAHN

Dec CAHN

ACETAMINOPHEN; HYDROCODONE BITARTRATE

SOLUTION;ORAL

HYDROCODONE BITARTRATE AND ACETAMINOPHEN

>D>

>A>

AA

AA

EYWA 325MG/15ML;7.5MG/15ML

@ GENUS 325MG/15ML;7.5MG/15ML

@ VISTAPHARM 325MG/15ML;7.5MG/15ML

WES PHARMA INC 325MG/15ML;7.5MG/15ML

TABLET;ORAL

HYDROCODONE BITARTRATE AND ACETAMINOPHEN

A211023

A200343

A200343

A211023

001

001

001

001

Mar 08, 2019

Jan 25, 2012

Jan 25, 2012

Mar 08, 2019

Dec CAHN

Nov CAHN

Aug DISC

Dec CAHN

@

@

@

@

@

@

@

@

@

NOVEL LABS INC

SUN PHARM INDS INC

300MG;5MG

300MG;7.5MG

300MG;10MG

325MG;5MG

325MG;7.5MG

325MG;10MG

325MG;5MG

325MG;7.5MG

325MG;10MG

A206142

A206142

A206142

A206245

A206245

A206245

A090118

A090118

A090118

001

002

003

001

002

003

001

002

003

Nov 14, 2016

Nov 14, 2016

Nov 14, 2016

Dec 01, 2016

Dec 01, 2016

Dec 01, 2016

Dec 23, 2008

Dec 23, 2008

Dec 23, 2008

Nov DISC

Nov DISC

Nov DISC

Nov DISC

Nov DISC

Nov DISC

Jun DISC

Jun DISC

Jun DISC

ACETAMINOPHEN; IBUPROFEN

TABLET;ORAL

COMBOGESIC

+ @

+!

AFT PHARMS LTD 325MG;97.5MG

325MG;97.5MG

N209471

N209471

001

001

Mar 01, 2023

Mar 01, 2023

Aug DISC

Mar NEWA

ACETAMINOPHEN; IBUPROFEN SODIUM

SOLUTION;INTRAVENOUS

COMBOGESIC IV

+!

+!

AFT PHARMS LTD

HIKMA

1GM/100ML (10MG/ML);EQ 300MG

BASE/100ML (EQ 3MG BASE/ML)

1GM/100ML (10MG/ML);EQ 300MG

BASE/100ML (EQ 3MG BASE/ML)

N215320

N215320

001

001

Oct 17, 2023

Oct 17, 2023

Oct NEWA

Oct CAHN

ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE

TABLET;ORAL

OXYCODONE AND ACETAMINOPHEN

>D>

>A>

>D>

>A>

>D>

>A>

>D>

AA

AA

AA

AA

@

@

@

@

@

DR REDDYS LABS SA

SUN PHARM INDS INC

500MG;7.5MG

650MG;10MG

325MG;2.5MG

325MG;2.5MG

325MG;5MG

325MG;5MG

325MG;7.5MG

325MG;7.5MG

325MG;10MG

A090177

A090177

A090535

A090535

A090535

A090535

A090535

A090535

A090535

005

006

001

001

002

002

003

003

004

Oct 20, 2008

Oct 20, 2008

Dec 26, 2013

Dec 26, 2013

Dec 26, 2013

Dec 26, 2013

Dec 26, 2013

Dec 26, 2013

Dec 26, 2013

Apr CAHN

Apr CAHN

Dec DISC

Dec DISC

Dec DISC

Dec DISC

Dec DISC

Dec DISC

Dec DISC
RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - December 2023 1-3

>A>

TABLET;ORAL

OXYCODONE AND ACETAMINOPHEN

@ 325MG;10MG A090535 004 Dec 26, 2013 Dec DISC

AB

ACETAMINOPHEN; TRAMADOL HYDROCHLORIDE

TABLET;ORAL

TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN

! AMNEAL PHARMS 325MG;37.5MG

@ CHARTWELL RX 325MG;37.5MG

A090485

A076475

001 Dec 09, 2009

001 Apr 21, 2005

Mar CHRS

Oct CAHN

ACETAZOLAMIDE

AB

AB

AB

AB

AB

AB

AB

AB

AB

CAPSULE, EXTENDED RELEASE;ORAL

ACETAZOLAMIDE

INDICUS PHARMA 500MG

TABLET;ORAL

ACETAZOLAMIDE

AARKISH PHARMS NJ 125MG

250MG

AJANTA PHARMA LTD 125MG

250MG

@ BRECKENRIDGE 125MG

@ 250MG

NE RX PHARMA 125MG

250MG

ZYDUS 125MG

250MG

A090779

A217197

A217197

A211151

A211151

A207503

A207503

A217197

A217197

A211069

A211069

001 Jul 14, 2011

001 May 09, 2023

002 May 09, 2023

001 Sep 11, 2023

002 Sep 11, 2023

001 Apr 30, 2020

002 Apr 30, 2020

001 May 09, 2023

002 May 09, 2023

001 Apr 04, 2023

002 Apr 04, 2023

Feb CMFD

Apr NEWA

Apr NEWA

Sep NEWA

Sep NEWA

Jan DISC

Jan DISC

Sep CAHN

Sep CAHN

Mar NEWA

Mar NEWA

AT

ACETIC ACID, GLACIAL

SOLUTION/DROPS;OTIC

ACETIC ACID

@ CHARTWELL RX

VOSOL

! HIKMA

2%

2%

A040166

N012179

001 Jul 26, 1996

001

Jan CAHN

Sep CAHN

>D>

>A> AT

AT

AT

AT

ACETIC ACID, GLACIAL; HYDROCORTISONE

SOLUTION/DROPS;OTIC

HYDROCORTISONE AND ACETIC ACID

@ COSETTE 2%;1%

2%;1%

@ 2%;1%

+! TARO 2%;1%

+ 2%;1%

VOSOL HC

+! SAPTALIS PHARMS 2%;1%

A040609

A040609

A040609

A088759

A088759

N012770

001 Feb 06, 2006

001 Feb 06, 2006

001 Feb 06, 2006

001 Mar 04, 1985

001 Mar 04, 1985

001

Dec CMFD

Dec CMFD

Jun DISC

Jun CHRS

Jun CRLD

Oct CAHN

ACETYLCYSTEINE

AP

AN

INJECTABLE;INTRAVENOUS

ACETYLCYSTEINE

STERISCIENCE

SOLUTION;INHALATION, ORAL

ACETYLCYSTEINE

EXELA PHARMA

6GM/30ML (200MG/ML)

20%

A217182

A205643

001 Apr 19, 2023

001 Nov 01, 2023

Apr NEWA

Oct NEWA

ACYCLOVIR

AB

AB

AB

AB

AB

AB

AB

CAPSULE;ORAL

ACYCLOVIR

@ AUROBINDO PHARMA USA

INDOCO

CREAM;TOPICAL

ACYCLOVIR

ALEMBIC

ZYDUS LIFESCIENCES

SUSPENSION;ORAL

ACYCLOVIR

AUROBINDO PHARMA

CHARTWELL RX

MSN

! NOVITIUM PHARMA

@ VISTAPHARM

ZOVIRAX

+ @ MYLAN

200MG

200MG

5%

5%

200MG/5ML

200MG/5ML

200MG/5ML

200MG/5ML

200MG/5ML

200MG/5ML

A074727

A075090

A212361

A206770

A216331

A212718

A217393

A212252

A213951

N019909

001 Apr 22, 1997

001 Jan 26, 1999

001 Nov 21, 2023

001 Feb 28, 2023

001 Mar 31, 2022

001 Apr 23, 2020

001 Mar 09, 2023

001 Jul 10, 2020

001 Jan 11, 2021

001 Dec 22, 1989

May CAHN

Sep CAHN

Nov NEWA

Feb NEWA

Oct CMFD

Aug CAHN

Mar NEWA

May CHRS

Oct DISC

May DISC
RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - December 2023 1-4

TABLET;BUCCAL

SITAVIG

+! LNHC

TABLET;ORAL

ACYCLOVIR

50MG N203791 001 Apr 12, 2013 Sep CAHN

@ AUROBINDO PHARMA USA

@

400MG

800MG

A075211

A075211

001 Sep 28, 1998

002 Sep 28, 1998

Apr CAHN

Apr CAHN

ACYCLOVIR SODIUM

INJECTABLE;INJECTION

ACYCLOVIR SODIUM

>A> AP HAINAN POLY EQ 50MG BASE/ML A218111 001 Jan 08, 2024 Dec NEWA

ADAPALENE

GEL;TOPICAL

ADAPALENE

AB ENCUBE ETHICALS 0.3% A200298 001 Jun 14, 2012 Apr CMFD

ADAPALENE; BENZOYL PEROXIDE

GEL;TOPICAL

ADAPALENE AND BENZOYL PEROXIDE

AB ENCUBE 0.1%;2.5% A206164 001 May 23, 2018 Aug CMFD

ADAPALENE; BENZOYL PEROXIDE; CLINDAMYCIN PHOSPHATE

GEL;TOPICAL

CABTREO

+! BAUSCH 0.15%;3.1%;1.2% N216632 001 Oct 20, 2023 Oct NEWA

ADENOSINE

SOLUTION;INTRAVENOUS

ADENOSINE

>D> AP

AP

>D> AP

AP

>A> AP

>A> AP

!

!

!

!

!

!

HONG KONG

MEITHEAL

60MG/20ML (3MG/ML)

60MG/20ML (3MG/ML)

90MG/30ML (3MG/ML)

90MG/30ML (3MG/ML)

60MG/20ML (3MG/ML)

90MG/30ML (3MG/ML)

A077425

A077425

A077425

A077425

A077425

A077425

001 Aug 29, 2013

001 Aug 29, 2013

002 Aug 29, 2013

002 Aug 29, 2013

001 Aug 29, 2013

002 Aug 29, 2013

Dec CAHN

Sep CAHN

Dec CAHN

Sep CAHN

Dec CAHN

Dec CAHN

ALBENDAZOLE

TABLET;ORAL

ALBENDAZOLE

@

@

CHARTWELL RX

CIPLA LTD

200MG

200MG

A211636

A210434

001 Jun 10, 2020

001 Sep 21, 2018

May CAHN

Sep DISC

ALBUTEROL SULFATE

SOLUTION;INHALATION

ALBUTEROL SULFATE

AN

AN

! RITEDOSE CORP

SENTISS

TABLET;ORAL

ALBUTEROL SULFATE

EQ 0.021% BASE

EQ 0.5% BASE

A214531

A074543

001 Dec 28, 2021

001 Jan 15, 1998

Jun CHRS

Jul CAHN

AB

AB !

DASH PHARMS NATCO EQ 2MG BASE

EQ 4MG BASE

A072894

A072894

002 Jan 17, 1991

001 Jan 17, 1991

Feb CAHN

Feb CAHN

ALBUTEROL SULFATE; BUDESONIDE

AEROSOL, METERED;INHALATION

AIRSUPRA

+!

+!

ASTRAZENECA

BOND

EQ 90MCG BASE/INH;80MCG/INH

EQ 90MCG BASE/INH;80MCG/INH

N214070

N214070

001 Jan 10, 2023

001 Jan 10, 2023

Feb CAHN

Jan NEWA

ALENDRONATE SODIUM

SOLUTION;ORAL

ALENDRONATE SODIUM

AA

AA

! HIKMA

NOVITIUM PHARMA

TABLET;ORAL

ALENDRONATE SODIUM

EQ 70MG BASE/75ML

EQ 70MG BASE/75ML

A090520

A214512

001 Feb 25, 2013

001 May 11, 2023

May CTEC

May NEWA

@ ANDA REPOSITORY

@

@

@

EQ 5MG BASE

EQ 10MG BASE

EQ 35MG BASE

EQ 70MG BASE

A079049

A079049

A079049

A079049

003 Aug 04, 2008

004 Aug 04, 2008

001 Aug 04, 2008

002 Aug 04, 2008

Sep CAHN

Sep CAHN

Sep CAHN

Sep CAHN
RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - December 2023 1-5

TABLET;ORAL

ALENDRONATE SODIUM

@ CHARTWELL RX

@

@

@

TABLET, EFFERVESCENT;ORAL

BINOSTO

EQ 5MG BASE

EQ 10MG BASE

EQ 35MG BASE

EQ 70MG BASE

A079049

A079049

A079049

A079049

003 Aug 04, 2008

004 Aug 04, 2008

001 Aug 04, 2008

002 Aug 04, 2008

Nov CAHN

Nov CAHN

Nov CAHN

Nov CAHN

+! RADIUS EQ 70MG BASE N202344 001 Mar 12, 2012 Oct CAHN

ALFENTANIL HYDROCHLORIDE

INJECTABLE;INJECTION

ALFENTA

AP +! RISING EQ 0.5MG BASE/ML N019353 001 Dec 29, 1986 Sep CAHN

ALLOPURINOL

TABLET;ORAL

ALLOPURINOL

>A>

>D>

>A>

>A>

AB

AB

AB

AB

AB

AB !

@

@

ACCORD HLTHCARE

AIPING PHARM INC

FOSUN PHARMA

HETERO LABS LTD V

LUPIN LTD

UNICHEM

300MG

100MG

100MG

100MG

300MG

100MG

300MG

300MG

A203154

A070268

A070268

A217748

A217748

A211807

A211807

A211820

002 May 06, 2013

001 Dec 31, 1985

001 Dec 31, 1985

001 Aug 03, 2023

002 Aug 03, 2023

001 Dec 14, 2023

002 Dec 14, 2023

002 Mar 12, 2019

Jul CHRS

Dec CAHN

Dec CAHN

Jul NEWA

Jul NEWA

Dec NEWA

Dec NEWA

Jul CHRS

ALOSETRON HYDROCHLORIDE

TABLET;ORAL

ALOSETRON HYDROCHLORIDE

>D>

>A>

>D>

>A>

AB

AB

@

@

HIKMA EQ 0.5MG BASE

EQ 0.5MG BASE

EQ 1MG BASE

EQ 1MG BASE

A200652

A200652

A200652

A200652

001 May 04, 2015

001 May 04, 2015

002 May 04, 2015

002 May 04, 2015

Dec DISC

Dec DISC

Dec DISC

Dec DISC

ALPROSTADIL

INJECTABLE;INJECTION

ALPROSTADIL

>D>

>A>

AP

AP

AP

HONG KONG

MEITHEAL

0.5MG/ML

0.5MG/ML

0.5MG/ML

A075196

A075196

A075196

001 Apr 30, 1999

001 Apr 30, 1999

001 Apr 30, 1999

Dec CAHN

Sep CAHN

Dec CAHN

ALVIMOPAN

CAPSULE;ORAL

ALVIMOPAN

AB

AB

AB !

HIKMA

PAR PHARM

WATSON LABS TEVA

ENTEREG

12MG

12MG

12MG

A217753

A216843

A208295

001 Aug 31, 2023

001 Jan 24, 2023

001 Dec 19, 2019

Aug NEWA

Jan NEWA

Jun CHRS

+ @ CUBIST PHARMS 12MG N021775 001 May 20, 2008 Jun DISC

AMANTADINE HYDROCHLORIDE

CAPSULE;ORAL

AMANTADINE HYDROCHLORIDE

AB

AB

RISING 100MG

STRIDES PHARMA 100MG

SYRUP;ORAL

AMANTADINE HYDROCHLORIDE

A210129

A209047

001 Mar 02, 2020

001 Jun 07, 2017

Sep CAHN

Feb CTEC

AA

AA

! AUROBINDO PHARMA USA 50MG/5ML

ELYSIUM 50MG/5ML

TABLET;ORAL

AMANTADINE HYDROCHLORIDE

A074170

A214178

001 Oct 28, 1994

001 Aug 20, 2021

Jul CAHN

Sep CAHN

AB

AB

ATHEM

STRIDES PHARMA

100MG

100MG

A210215

A209035

001 Mar 10, 2020

001 Jun 09, 2017

Sep CAHN

Feb CTEC

AMIFOSTINE

INJECTABLE;INJECTION

AMIFOSTINE

@ SUN PHARM

ETHYOL

500MG/VIAL A077126 001 Mar 14, 2008 Jul DISC

+! CLINIGEN 500MG/VIAL N020221 001 Dec 08, 1995 Jul CTEC
RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - December 2023 1-6

AMIKACIN SULFATE

>D>

>D>

>A>

>A>

AP

AP

AP

INJECTABLE;INJECTION

AMIKACIN SULFATE

! HIKMA

@ HONG KONG

@

@ MEITHEAL

EQ 50MG BASE/ML

EQ 50MG BASE/ML

EQ 50MG BASE/ML

EQ 250MG BASE/ML

EQ 250MG BASE/ML

EQ 50MG BASE/ML

EQ 250MG BASE/ML

A063313

A064045

A064045

A064045

A064045

A064045

A064045

001

001

001

002

002

001

002

Apr 11, 1994

Sep 28, 1993

Sep 28, 1993

Sep 28, 1993

Sep 28, 1993

Sep 28, 1993

Sep 28, 1993

Feb CTEC

Dec CAHN

Sep CAHN

Dec CAHN

Sep CAHN

Dec CAHN

Dec CAHN

AMINOCAPROIC ACID

>A>

AA

AA

AA

AA

AB

AB

AB

SOLUTION;ORAL

AMICAR

+! HIKMA

AMINOCAPROIC ACID

SUNNY

TARO

TARO PHARMS

@ VISTAPHARM

TABLET;ORAL

AMICAR

+ HIKMA

+

AMINOCAPROIC ACID

MSN

0.25GM/ML

0.25GM/ML

0.25GM/ML

0.25GM/ML

0.25GM/ML

500MG

1GM

1GM

N015230

A213213

A214458

A214458

A212814

N015197

N015197

A212938

002

001

001

001

001

001

002

002

Dec 27, 2023

Mar 24, 2023

Mar 24, 2023

Feb 26, 2020

Jun 24, 2004

Sep 13, 2023

Sep CAHN

Dec NEWA

May CAHN

Mar NEWA

Mar DISC

Sep CAHN

Sep CAHN

Sep NEWA

AMINOPHYLLINE

TABLET;ORAL

AMINOPHYLLINE

@ CHARTWELL MOLECULAR

@

100MG

200MG

A084588

A084588

001

002

Jul CAHN

Jul CAHN

AMIODARONE HYDROCHLORIDE

AB

AB

AB

TABLET;ORAL

AMIODARONE HYDROCHLORIDE

CHARTWELL RX 100MG

200MG

400MG

A077069

A077069

A077069

003

001

002

Oct 04, 2016

Apr 08, 2005

Apr 08, 2005

Jun CAHN

Jun CAHN

Jun CAHN

AMITRIPTYLINE HYDROCHLORIDE

AB

AB

AB

AB

AB

AB

AB

AB

AB

AB

AB

AB

AB

AB

AB

AB

AB

AB

AB

AB

AB

AB

AB

AB

TABLET;ORAL

AMITRIPTYLINE HYDROCHLORIDE

CHEMISTRY HLTH 10MG

25MG

50MG

75MG

100MG

150MG

GRAVITI PHARMS 10MG

25MG

50MG

75MG

100MG

150MG

RISING 10MG

25MG

50MG

75MG

100MG

150MG

RUBICON 10MG

25MG

50MG

75MG

100MG

150MG

A216243

A216243

A216243

A216243

A216243

A216243

A217411

A217411

A217411

A217411

A217411

A217411

A217411

A217411

A217411

A217411

A217411

A217411

A215376

A215376

A215376

A215376

A215376

A215376

001

002

003

004

005

006

001

002

003

004

005

006

001

002

003

004

005

006

001

002

003

004

005

006

Jun 06, 2022

Jun 06, 2022

Jun 06, 2022

Jun 06, 2022

Jun 06, 2022

Jun 06, 2022

May 19, 2023

May 19, 2023

May 19, 2023

May 19, 2023

May 19, 2023

May 19, 2023

May 19, 2023

May 19, 2023

May 19, 2023

May 19, 2023

May 19, 2023

May 19, 2023

May 01, 2023

May 01, 2023

May 01, 2023

May 01, 2023

May 01, 2023

May 01, 2023

Sep CAHN

Sep CAHN

Sep CAHN

Sep CAHN

Sep CAHN

Sep CAHN

May NEWA

May NEWA

May NEWA

May NEWA

May NEWA

May NEWA

Aug CAHN

Aug CAHN

Aug CAHN

Aug CAHN

Aug CAHN

Aug CAHN

Apr NEWA

Apr NEWA

Apr NEWA

Apr NEWA

Apr NEWA

Apr NEWA
RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - December 2023 1-7

AMITRIPTYLINE HYDROCHLORIDE; CHLORDIAZEPOXIDE

TABLET;ORAL

CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDE

+

+

@ ANDA REPOSITORY

@

LIMBITROL

@ CHARTWELL RX

LIMBITROL DS

@ CHARTWELL RX

EQ 12.5MG BASE;5MG

EQ 25MG BASE;10MG

EQ 12.5MG BASE;5MG

EQ 25MG BASE;10MG

A070765

A070766

N016949

N016949

001

001

001

002

Dec 10, 1986

Dec 10, 1986

Sep CAHN

Sep CAHN

Mar CAHN

Mar CAHN

AMLODIPINE BENZOATE

AB

AB

SUSPENSION;ORAL

AMLODIPINE BENZOATE

@ AMNEAL

KATERZIA

+! AZURITY

+!

EQ 1MG BASE/ML

EQ 1MG BASE/ML

EQ 1MG BASE/ML

EQ 1MG BASE/ML

A215035

A215035

N211340

N211340

001

001

001

001

Jun 13, 2023

Jun 13, 2023

Jul 08, 2019

Jul 08, 2019

Jun DISC

Jun NFTG

Jun CTEC

Jun CFTG

AMLODIPINE BESYLATE

AB

AB

AB

TABLET;ORAL

AMLODIPINE BESYLATE

COREPHARMA EQ 2.5MG BASE

EQ 5MG BASE

EQ 10MG BASE

A076719

A076719

A076719

001

002

003

May 23, 2007

May 23, 2007

May 23, 2007

Feb CAHN

Feb CAHN

Feb CAHN

AB

AB

AB

AB

AB

AB

AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE

CAPSULE;ORAL

LOTREL

+ SANDOZ EQ 2.5MG BASE;10MG

+ EQ 5MG BASE;10MG

+ EQ 5MG BASE;20MG

+ EQ 5MG BASE;40MG

+ EQ 10MG BASE;20MG

+! EQ 10MG BASE;40MG

N020364

N020364

N020364

N020364

N020364

N020364

002

003

004

007

005

006

Mar 03, 1995

Mar 03, 1995

Mar 03, 1995

Apr 11, 2006

Jun 20, 2002

Apr 11, 2006

Sep CAHN

Sep CAHN

Sep CAHN

Sep CAHN

Sep CAHN

Sep CAHN

AMMONIA N-13

>D>

>A>

AP

INJECTABLE;INTRAVENOUS

AMMONIA N 13

SHERTECH LABS LLC

@

@ SOFIE

3.75mCi-260mCi/ML

3.75mCi-260mCi/ML

18.8mCi-188mCi/5ML (3.75-

37.5mCi/ML)

A204366

A204366

A204667

001

001

001

Sep 19, 2014

Sep 19, 2014

Apr 22, 2015

Dec DISC

Dec DISC

May DISC

AMOXICILLIN

FOR SUSPENSION;ORAL

AMOXICILLIN

@ CHARTWELL RX

@

125MG/5ML

250MG/5ML

A062059

A062059

001

002

Jan CAHN

Jan CAHN

AMOXICILLIN; CLARITHROMYCIN; VONOPRAZAN FUMARATE

CAPSULE, TABLET, TABLET;ORAL

VOQUEZNA TRIPLE PAK

+! PHATHOM 500MG;500MG;EQ 20MG BASE N215152 001 May 03, 2022 Nov CMFD

>A>

>A>

AB

AB

AB

AB

AB

AB

AMOXICILLIN; CLAVULANATE POTASSIUM

FOR SUSPENSION;ORAL

AMOXICILLIN AND CLAVULANATE POTASSIUM

DEVA HOLDING AS 250MG/5ML;EQ 62.5MG BASE/5ML

400MG/5ML;EQ 57MG BASE/5ML

600MG/5ML;EQ 42.9MG BASE/5ML

MICRO LABS 600MG/5ML;EQ 42.9MG BASE/5ML

TABLET;ORAL

AMOXICILLIN AND CLAVULANATE POTASSIUM

DEVA HOLDING AS 500MG;EQ 125MG BASE

875MG;EQ 125MG BASE

A210374

A210416

A209351

A217805

A209992

A209991

001

001

001

001

001

001

Nov 29, 2023

Dec 11, 2023

Sep 13, 2023

Dec 08, 2023

Sep 15, 2023

Sep 15, 2023

Nov NEWA

Dec NEWA

Sep NEWA

Dec NEWA

Sep NEWA

Sep NEWA
RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - December 2023 1-8

AMOXICILLIN; VONOPRAZAN FUMARATE

CAPSULE, TABLET;ORAL

VOQUEZNA DUAL PAK

+! PHATHOM 500MG;EQ 20MG BASE N215153 001 May 03, 2022 Nov CMFD

AMPHETAMINE

TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE;ORAL

ADZENYS XR-ODT

>D> AB + NEOS THERAPS EQ 3.1MG BASE N204326 001 Jan 27, 2016 Dec CTEC

>A> + EQ 3.1MG BASE N204326 001 Jan 27, 2016 Dec CTEC

AB + EQ 3.1MG BASE N204326 001 Jan 27, 2016 Jun CFTG

>D> AB + EQ 6.3MG BASE N204326 002 Jan 27, 2016 Dec CTEC

>A> + EQ 6.3MG BASE N204326 002 Jan 27, 2016 Dec CTEC

AB + EQ 6.3MG BASE N204326 002 Jan 27, 2016 Jun CFTG

>D> AB + EQ 9.4MG BASE N204326 003 Jan 27, 2016 Dec CTEC

>A> + EQ 9.4MG BASE N204326 003 Jan 27, 2016 Dec CTEC

AB + EQ 9.4MG BASE N204326 003 Jan 27, 2016 Jun CFTG

>D> AB + EQ 12.5MG BASE N204326 004 Jan 27, 2016 Dec CTEC

>A> + EQ 12.5MG BASE N204326 004 Jan 27, 2016 Dec CTEC

AB + EQ 12.5MG BASE N204326 004 Jan 27, 2016 Jun CFTG

>D> AB + EQ 15.7MG BASE N204326 005 Jan 27, 2016 Dec CTEC

>A> + EQ 15.7MG BASE N204326 005 Jan 27, 2016 Dec CTEC

AB + EQ 15.7MG BASE N204326 005 Jan 27, 2016 Jun CFTG

>D> AB +! EQ 18.8MG BASE N204326 006 Jan 27, 2016 Dec CTEC

>A> +! EQ 18.8MG BASE N204326 006 Jan 27, 2016 Dec CTEC

AB +! EQ 18.8MG BASE N204326 006 Jan 27, 2016 Jun CFTG

>D> AMPHETAMINE

>D> AB ACTAVIS LABS FL INC EQ 3.1MG BASE A209253 001 Jun 22, 2023 Dec DISC

>A> @ EQ 3.1MG BASE A209253 001 Jun 22, 2023 Dec DISC

AB EQ 3.1MG BASE A209253 001 Jun 22, 2023 Jun NFTG

>D> AB EQ 6.3MG BASE A209253 002 Jun 22, 2023 Dec DISC

>A> @ EQ 6.3MG BASE A209253 002 Jun 22, 2023 Dec DISC

AB EQ 6.3MG BASE A209253 002 Jun 22, 2023 Jun NFTG

>D> AB EQ 9.4MG BASE A209253 003 Jun 22, 2023 Dec DISC

>A> @ EQ 9.4MG BASE A209253 003 Jun 22, 2023 Dec DISC

AB EQ 9.4MG BASE A209253 003 Jun 22, 2023 Jun NFTG

>D> AB EQ 12.5MG BASE A209253 004 Jun 22, 2023 Dec DISC

>A> @ EQ 12.5MG BASE A209253 004 Jun 22, 2023 Dec DISC

AB EQ 12.5MG BASE A209253 004 Jun 22, 2023 Jun NFTG

>D> AB EQ 15.7MG BASE A209253 005 Jun 22, 2023 Dec DISC

>A> @ EQ 15.7MG BASE A209253 005 Jun 22, 2023 Dec DISC

AB EQ 15.7MG BASE A209253 005 Jun 22, 2023 Jun NFTG

>D> AB EQ 18.8MG BASE A209253 006 Jun 22, 2023 Dec DISC

>A> @ EQ 18.8MG BASE A209253 006 Jun 22, 2023 Dec DISC

AB EQ 18.8MG BASE A209253 006 Jun 22, 2023 Jun NFTG

AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE

CAPSULE, EXTENDED RELEASE;ORAL

DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE

AB ANI PHARMS 2.5MG;2.5MG;2.5MG;2.5MG A205401 002 Jan 22, 2019 Feb CMFD

AB ASCENT PHARMS INC 1.25MG;1.25MG;1.25MG;1.25MG A214959 001 Sep 29, 2021 Feb CTNA

AB 2.5MG;2.5MG;2.5MG;2.5MG A214959 002 Sep 29, 2021 Feb CTNA

AB 3.75MG;3.75MG;3.75MG;3.75MG A214959 003 Sep 29, 2021 Feb CTNA

AB 5MG;5MG;5MG;5MG A214959 004 Sep 29, 2021 Feb CTNA

AB 6.25MG;6.25MG;6.25MG;6.25MG A214959 005 Sep 29, 2021 Feb CTNA

AB 7.5MG;7.5MG;7.5MG;7.5MG A214959 006 Sep 29, 2021 Feb CTNA

AB GRANULES 1.25MG;1.25MG;1.25MG;1.25MG A217027 001 Jan 23, 2023 Feb CTNA

AB 1.25MG;1.25MG;1.25MG;1.25MG A217027 001 Jan 23, 2023 Jan NEWA

AB 2.5MG;2.5MG;2.5MG;2.5MG A217027 002 Jan 23, 2023 Feb CTNA

AB 2.5MG;2.5MG;2.5MG;2.5MG A217027 002 Jan 23, 2023 Jan NEWA

AB 3.75MG;3.75MG;3.75MG;3.75MG A217027 003 Jan 23, 2023 Feb CTNA

AB 3.75MG;3.75MG;3.75MG;3.75MG A217027 003 Jan 23, 2023 Jan NEWA

AB 5MG;5MG;5MG;5MG A217027 004 Jan 23, 2023 Feb CTNA

AB 5MG;5MG;5MG;5MG A217027 004 Jan 23, 2023 Jan NEWA

AB 6.25MG;6.25MG;6.25MG;6.25MG A217027 005 Jan 23, 2023 Feb CTNA

AB 6.25MG;6.25MG;6.25MG;6.25MG A217027 005 Jan 23, 2023 Jan NEWA

AB 7.5MG;7.5MG;7.5MG;7.5MG A217027 006 Jan 23, 2023 Jan NEWA

AB LANNETT CO INC 1.25MG;1.25MG;1.25MG;1.25MG A214403 001 Nov 26, 2021 Feb CMFD

@ 1.25MG;1.25MG;1.25MG;1.25MG A214403 001 Nov 26, 2021 Feb CTNA

AB 2.5MG;2.5MG;2.5MG;2.5MG A214403 002 Nov 26, 2021 Feb CMFD

@ 2.5MG;2.5MG;2.5MG;2.5MG A214403 002 Nov 26, 2021 Feb CTNA

AB 3.75MG;3.75MG;3.75MG;3.75MG A214403 003 Nov 26, 2021 Feb CMFD
RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - December 2023 1-9

CAPSULE, EXTENDED RELEASE;ORAL

DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE

@ 3.75MG;3.75MG;3.75MG;3.75MG A214403 003

AB 5MG;5MG;5MG;5MG A214403 004

@ 5MG;5MG;5MG;5MG A214403 004

AB 6.25MG;6.25MG;6.25MG;6.25MG A214403 005

@ 6.25MG;6.25MG;6.25MG;6.25MG A214403 005

AB 7.5MG;7.5MG;7.5MG;7.5MG A214403 006

@ 7.5MG;7.5MG;7.5MG;7.5MG A214403 006

AB SPECGX LLC 3.125MG;3.125MG;3.125MG;3.125MG A211546 001

AB 6.25MG;6.25MG;6.25MG;6.25MG A211546 002

AB 9.375MG;9.375MG;9.375MG;9.375MG A211546 003

AB 12.5MG;12.5MG;12.5MG;12.5MG A211546 004

AB SUN PHARM INDS INC 3.125MG;3.125MG;3.125MG;3.125MG A215997 001

AB 6.25MG;6.25MG;6.25MG;6.25MG A215997 002

AB 9.375MG;9.375MG;9.375MG;9.375MG A215997 003

AB 12.5MG;12.5MG;12.5MG;12.5MG A215997 004

AB TEVA PHARMS USA 3.125MG;3.125MG;3.125MG;3.125MG A210876 001

AB 6.25MG;6.25MG;6.25MG;6.25MG A210876 002

AB 9.375MG;9.375MG;9.375MG;9.375MG A210876 003

AB 12.5MG;12.5MG;12.5MG;12.5MG A210876 004

MYDAYIS

AB + TAKEDA PHARMS USA 3.125MG;3.125MG;3.125MG;3.125MG N022063 001

AB + 6.25MG;6.25MG;6.25MG;6.25MG N022063 002

AB + 9.375MG;9.375MG;9.375MG;9.375MG N022063 003

AB +! 12.5MG;12.5MG;12.5MG;12.5MG N022063 004

TABLET;ORAL

DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE

AB ALKEM LABS LTD 1.25MG;1.25MG;1.25MG;1.25MG A217787 001

AB 1.875MG;1.875MG;1.875MG;1.875MG A217787 002

AB 2.5MG;2.5MG;2.5MG;2.5MG A217787 003

AB 3.125MG;3.125MG;3.125MG;3.125MG A217787 004

AB 3.75MG;3.75MG;3.75MG;3.75MG A217787 005

AB 5MG;5MG;5MG;5MG A217787 006

AB 7.5MG;7.5MG;7.5MG;7.5MG A217787 007

AB LANNETT CO INC 1.25MG;1.25MG;1.25MG;1.25MG A215565 001

AB 1.875MG;1.875MG;1.875MG;1.875MG A215565 002

AB 2.5MG;2.5MG;2.5MG;2.5MG A215565 003

AB 3.125MG;3.125MG;3.125MG;3.125MG A215565 004

AB 3.75MG;3.75MG;3.75MG;3.75MG A215565 005

AB 5MG;5MG;5MG;5MG A215565 006

AB 7.5MG;7.5MG;7.5MG;7.5MG A215565 007

AMPICILLIN SODIUM

INJECTABLE;INJECTION

AMPICILLIN SODIUM

@ STERISCIENCE EQ 250MG BASE/VIAL A201025 001

@ EQ 500MG BASE/VIAL A201025 002

AP EQ 1GM BASE/VIAL A201025 003

AP EQ 2GM BASE/VIAL A201025 004

AP EQ 10GM BASE/VIAL A202198 001

AMPICILLIN SODIUM; SULBACTAM SODIUM

INJECTABLE;INJECTION

AMPICILLIN AND SULBACTAM

AP STERISCIENCE EQ 1GM BASE/VIAL;EQ 500MG A201024 001

BASE/VIAL

AP EQ 2GM BASE/VIAL;EQ 1GM BASE/VIAL A201024 002

AP EQ 10GM BASE/VIAL;EQ 5GM BASE/VIAL A202197 001

UNASYN

>D> AP ! PFIZER EQ 2GM BASE/VIAL;EQ 1GM BASE/VIAL A062901 002

>A> @ EQ 2GM BASE/VIAL;EQ 1GM BASE/VIAL A062901 002

>D> AP ! EQ 1GM BASE/VIAL;EQ 500MG A062901 001

BASE/VIAL

>A> @ EQ 1GM BASE/VIAL;EQ 500MG A062901 001

BASE/VIAL

AMPICILLIN/AMPICILLIN TRIHYDRATE

CAPSULE;ORAL

AMPICILLIN TRIHYDRATE

AUROBINDO PHARMA EQ 250MG BASE A216554 001

AB EQ 500MG BASE A216554 002

AB ! SANDOZ EQ 500MG BASE A064082 002

Nov 26, 2021

Nov 26, 2021

Nov 26, 2021

Nov 26, 2021

Nov 26, 2021

Nov 26, 2021

Nov 26, 2021

Aug 31, 2023

Aug 31, 2023

Aug 31, 2023

Aug 31, 2023

Sep 27, 2023

Sep 27, 2023

Sep 27, 2023

Sep 27, 2023

Jan 31, 2022

Jan 31, 2022

Jan 31, 2022

Jan 31, 2022

Jun 20, 2017

Jun 20, 2017

Jun 20, 2017

Jun 20, 2017

Oct 06, 2023

Oct 06, 2023

Oct 06, 2023

Oct 06, 2023

Oct 06, 2023

Oct 06, 2023

Oct 06, 2023

Jul 08, 2022

Jul 08, 2022

Jul 08, 2022

Jul 08, 2022

Jul 08, 2022

Jul 08, 2022

Jul 08, 2022

Apr 09, 2014

Apr 09, 2014

Apr 09, 2014

Apr 09, 2014

Apr 07, 2014

Apr 07, 2014

Apr 07, 2014

Apr 07, 2014

Feb 27, 1992

Feb 27, 1992

Nov 23, 1988

Nov 23, 1988

Oct 31, 2023

Oct 31, 2023

Aug 29, 1995

Feb CTNA

Feb CMFD

Feb CTNA

Feb CMFD

Feb CTNA

Feb CMFD

Feb CTNA

Aug NEWA

Aug NEWA

Aug NEWA

Aug NEWA

Sep NEWA

Sep NEWA

Sep NEWA

Sep NEWA

Sep CMFD

Sep CMFD

Sep CMFD

Sep CMFD

Aug CTEC

Aug CTEC

Aug CTEC

Aug CTEC

Sep NEWA

Sep NEWA

Sep NEWA

Sep NEWA

Sep NEWA

Sep NEWA

Sep NEWA

Feb CMFD

Feb CMFD

Feb CMFD

Feb CMFD

Feb CMFD

Feb CMFD

Feb CMFD

Jan CAHN

Jan CAHN

Jan CAHN

Jan CAHN

Jan CAHN

Jan CAHN

Jan CAHN

Jan CAHN

Dec DISC

Dec DISC

Dec DISC

Dec DISC

Oct NEWA

Oct NEWA

Oct CTEC
RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - December 2023 1-10

CAPSULE;ORAL

PRINCIPEN '250'

+ @ APOTHECON

PRINCIPEN '500'

EQ 250MG BASE N050056 001 Jul CRLD

+ @ APOTHECON EQ 500MG BASE N050056 002 Jul CRLD

ANAGRELIDE HYDROCHLORIDE

CAPSULE;ORAL

ANAGRELIDE HYDROCHLORIDE

@

@

NATCO PHARMA USA EQ 0.5MG BASE

EQ 1MG BASE

A076811

A076811

001 Apr 18, 2005

002 Apr 18, 2005

Aug CAHN

Aug CAHN

ANASTROZOLE

TABLET;ORAL

ANASTROZOLE

@

@

ANDA REPOSITORY

CHARTWELL RX

1MG

1MG

A090732

A090732

001 Jun 28, 2010

001 Jun 28, 2010

Sep CAHN

Nov CAHN

APALUTAMIDE

TABLET;ORAL

ERLEADA

+

+!

JANSSEN BIOTECH 60MG

240MG

N210951

N210951

001 Feb 14, 2018

002 Feb 17, 2023

Feb CHRS

Feb NEWA

APIXABAN

TABLET;ORAL

APIXABAN

AB

AB

AB

AB

AB

AB

@

@

@

@

AUROBINDO PHARMA LTD

HETERO LABS LTD V

ZYDUS PHARMS

2.5MG

2.5MG

5MG

5MG

2.5MG

5MG

2.5MG

2.5MG

5MG

5MG

A210026

A210026

A210026

A210026

A210066

A210066

A210185

A210185

A210185

A210185

001 May 26, 2023

001 May 26, 2023

002 May 26, 2023

002 May 26, 2023

001 Nov 21, 2023

002 Nov 21, 2023

001 Feb 27, 2023

001 Feb 27, 2023

002 Feb 27, 2023

002 Feb 27, 2023

Jun DISC

May NEWA

Jun DISC

May NEWA

Nov NEWA

Nov NEWA

Jul DISC

Feb NEWA

Jul DISC

Feb NEWA

APOMORPHINE HYDROCHLORIDE

FILM;SUBLINGUAL

KYNMOBI

+

+

+

+

+

+

+

+

+

+

@

@

@

@

@

@

@

@

@

@

SUMITOMO PHARMA AM

SUNOVION PHARMS INC

10MG

15MG

20MG

25MG

30MG

10MG

15MG

20MG

25MG

30MG

N210875

N210875

N210875

N210875

N210875

N210875

N210875

N210875

N210875

N210875

001 May 21, 2020

002 May 21, 2020

003 May 21, 2020

004 May 21, 2020

005 May 21, 2020

001 May 21, 2020

002 May 21, 2020

003 May 21, 2020

004 May 21, 2020

005 May 21, 2020

Jul CAHN

Jul CAHN

Jul CAHN

Jul CAHN

Jul CAHN

Jul DISC

Jul DISC

Jul DISC

Jul DISC

Jul DISC

APRACLONIDINE HYDROCHLORIDE

SOLUTION/DROPS;OPHTHALMIC

IOPIDINE

AT +!

+!

HARROW EYE EQ 0.5% BASE

EQ 1% BASE

N020258

N019779

001 Jul 30, 1993

001 Dec 31, 1987

May CAHN

May CAHN

APREMILAST

TABLET;ORAL

APREMILAST

AB

AB

AB

AB

AB

AB

AB

@

@

@

@

ANNORA

AUROBINDO PHARMA LTD

DR REDDYS

10MG

20MG

30MG

10MG

10MG

20MG

20MG

30MG

30MG

10MG

10MG

A211878

A211878

A211878

A211716

A211716

A211716

A211716

A211716

A211716

A211756

A211756

001 Jul 26, 2023

002 Jul 26, 2023

003 Jul 26, 2023

001 Jul 19, 2023

001 Jul 19, 2023

002 Jul 19, 2023

002 Jul 19, 2023

003 Jul 19, 2023

003 Jul 19, 2023

001 Jul 14, 2023

001 Jul 14, 2023

Jul NEWA

Jul NEWA

Jul NEWA

Aug DISC

Jul NEWA

Aug DISC

Jul NEWA

Aug DISC

Jul NEWA

Oct DISC

Jul NEWA
RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - December 2023 1-11

TABLET;ORAL

APREMILAST

AB

AB

AB

AB

AB

AB

AB

AB

@

@

@

@

@

GLENMARK PHARMS LTD

SHILPA

TEVA PHARMS USA INC

20MG

20MG

30MG

30MG

10MG

20MG

30MG

10MG

20MG

30MG

10MG

20MG

30MG

A211756

A211756

A211756

A211756

A211674

A211674

A211674

A211774

A211774

A211774

A211897

A211897

A211897

002

002

003

003

001

002

003

001

002

003

001

002

003

Jul 14, 2023

Jul 14, 2023

Jul 14, 2023

Jul 14, 2023

Oct 16, 2023

Oct 16, 2023

Oct 16, 2023

Apr 07, 2023

Apr 07, 2023

Apr 07, 2023

Aug 18, 2022

Aug 18, 2022

Aug 18, 2022

Oct DISC

Jul NEWA

Oct DISC

Jul NEWA

Oct NEWA

Oct NEWA

Oct NEWA

Mar NEWA

Mar NEWA

Mar NEWA

Feb DISC

Feb DISC

Feb DISC

ARFORMOTEROL TARTRATE

SOLUTION;INHALATION

ARFORMOTEROL TARTRATE

AN RITEDOSE CORP EQ 0.015MG BASE/2ML A214736 001 Mar 02, 2022 Feb CMFD

ARGATROBAN

INJECTABLE;INJECTION

ARGATROBAN

AP

AP

AP

!

+ @

+!

GLAND PHARMA LTD

HOSPIRA

SANDOZ

50MG/50ML (1MG/ML)

250MG/2.5ML (100MG/ML)

250MG/2.5ML (100MG/ML)

250MG/2.5ML (100MG/ML)

A217848

A204120

N020883

N020883

001

001

001

001

Jul 31, 2023

Sep 21, 2016

Jun 30, 2000

Jun 30, 2000

Jul NEWA

Sep CHRS

Sep DISC

May CAHN

ARIPIPRAZOLE

SOLUTION;ORAL

ARIPIPRAZOLE

AA

AA

CHARTWELL RX 1MG/ML

HETERO LABS LTD III 1MG/ML

SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR

ABILIFY ASIMTUFII

A215595

A216150

001

001

Oct 25, 2022

Nov 01, 2023

May CAHN

Oct NEWA

+ OTSUKA

+!

TABLET;ORAL

ARIPIPRAZOLE

720MG/2.4ML (300MG/ML)

960MG/3.2ML (300MG/ML)

N217006

N217006

001

002

Apr 27, 2023

Apr 27, 2023

Apr NEWA

Apr NEWA

AB

AB

AB

AB

AB

AB

AB

AB

AB

BRECKENRIDGE

SUNSHINE

2MG

5MG

10MG

15MG

20MG

30MG

2MG

5MG

10MG

A091279

A091279

A091279

A091279

A091279

A091279

A213037

A213037

A213037

001

002

003

004

005

006

001

002

003

Jan 09, 2017

Jan 09, 2017

Jan 09, 2017

Jan 09, 2017

Jan 09, 2017

Jan 09, 2017

Oct 02, 2023

Oct 02, 2023

Oct 02, 2023

Sep CAHN

Sep CAHN

Sep CAHN

Sep CAHN

Sep CAHN

Sep CAHN

Sep NEWA

Sep NEWA

Sep NEWA

ARMODAFINIL

TABLET;ORAL

ARMODAFINIL

@

@

@

COREPHARMA 50MG

150MG

250MG

A201514

A201514

A201514

001

002

003

Mar 25, 2019

Mar 25, 2019

Mar 25, 2019

Feb CAHN

Feb CAHN

Feb CAHN

ARSENIC TRIOXIDE

INJECTABLE;INJECTION

ARSENIC TRIOXIDE

AP

AP

AP

ORBICULAR

PENN LIFE

1MG/ML

2MG/ML

1MG/ML

A217413

A217413

A209873

001

002

001

Apr 20, 2023

Apr 20, 2023

May 06, 2019

Apr NEWA

Apr NEWA

May CAHN

ASPIRIN

CAPSULE, EXTENDED RELEASE;ORAL

DURLAZA

+

+

@

@

ESPERO

HESP

162.5MG

162.5MG

N200671

N200671

001

001

Sep 04, 2015

Sep 04, 2015

Aug DISC

Oct CAHN
RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - December 2023 1-12

ASPIRIN; CARISOPRODOL

TABLET;ORAL

CARISOPRODOL AND ASPIRIN

@ CHARTWELL RX 325MG;200MG A089594 001 Mar 31, 1989 Mar CAHN

ASPIRIN; METHOCARBAMOL

TABLET;ORAL

ROBAXISAL

+ @ ROBINS AH 325MG;400MG N012281 001 Mar CRLD

ATAZANAVIR SULFATE

CAPSULE;ORAL

ATAZANAVIR SULFATE

@ CIPLA

@

@

@

EQ 100MG BASE

EQ 150MG BASE

EQ 200MG BASE

EQ 300MG BASE

A200626

A200626

A200626

A200626

001

002

003

004

Aug 09, 2018

Aug 09, 2018

Aug 09, 2018

Aug 09, 2018

Aug DISC

Aug DISC

Aug DISC

Aug DISC

ATENOLOL

AB

AB

AB

AB

AB

AB

TABLET;ORAL

ATENOLOL

TWI PHARMS

TENORMIN

+ TWI PHARMS

+

+!

25MG

50MG

100MG

25MG

50MG

100MG

A072304

A072304

A072304

N018240

N018240

N018240

002

003

001

004

001

002

Jul 31, 1992

Jul 18, 1988

Jul 15, 1988

Apr 09, 1990

Nov CAHN

Nov CAHN

Nov CAHN

Nov CAHN

Nov CAHN

Nov CAHN

AB

AB

AB

AB

ATENOLOL; CHLORTHALIDONE

TABLET;ORAL

ATENOLOL AND CHLORTHALIDONE

@ AUROBINDO PHARMA USA 50MG;25MG

@ 100MG;25MG

TWI PHARMS 50MG;25MG

100MG;25MG

TENORETIC 100

+! TWI PHARMS 100MG;25MG

TENORETIC 50

+ TWI PHARMS 50MG;25MG

A074203

A074203

A072302

A072302

N018760

N018760

001

002

002

001

001

002

Oct 31, 1993

Oct 31, 1993

May 31, 1990

May 31, 1990

Jun 08, 1984

Jun 08, 1984

Apr CAHN

Apr CAHN

Nov CAHN

Nov CAHN

Nov CAHN

Nov CAHN

ATOMOXETINE HYDROCHLORIDE

AB

CAPSULE;ORAL

ATOMOXETINE HYDROCHLORIDE

ZYDUS PHARMS USA INC 10MG A079017 007 Apr 05, 2023 Mar NEWA

ATORVASTATIN CALCIUM

>A>

>A>

>A>

>A>

AB

AB

AB

AB

AB

AB

AB

AB

AB

AB

AB

AB

AB

AB

AB

SUSPENSION;ORAL

ATORVALIQ

+! CMP DEV LLC

TABLET;ORAL

ATORVASTATIN CALCIUM

ACI

BIOCON PHARMA

@

@

@

@

CADILA PHARMS LTD

HETERO LABS LTD V

20MG/5ML

EQ 10MG BASE

EQ 20MG BASE

EQ 40MG BASE

EQ 80MG BASE

EQ 10MG BASE

EQ 10MG BASE

EQ 20MG BASE

EQ 20MG BASE

EQ 40MG BASE

EQ 40MG BASE

EQ 80MG BASE

EQ 80MG BASE

EQ 10MG BASE

EQ 20MG BASE

EQ 40MG BASE

EQ 80MG BASE

EQ 10MG BASE

EQ 20MG BASE

EQ 40MG BASE

N213260

A217634

A217634

A217634

A217634

A216436

A216436

A216436

A216436

A216436

A216436

A216436

A216436

A212103

A212103

A212103

A212103

A214344

A214344

A214344

001

001

002

003

004

001

001

002

002

003

003

004

004

001

002

003

004

001

002

003

Feb 01, 2023

Dec 21, 2023

Dec 21, 2023

Dec 21, 2023

Dec 21, 2023

Nov 23, 2022

Nov 23, 2022

Nov 23, 2022

Nov 23, 2022

Nov 23, 2022

Nov 23, 2022

Nov 23, 2022

Nov 23, 2022

Oct 16, 2023

Oct 16, 2023

Oct 16, 2023

Oct 16, 2023

Sep 12, 2023

Sep 12, 2023

Sep 12, 2023

Feb NEWA

Dec NEWA

Dec NEWA

Dec NEWA

Dec NEWA

Sep CMFD

May DISC

Sep CMFD

May DISC

Sep CMFD

May DISC

Sep CMFD

May DISC

Oct NEWA

Oct NEWA

Oct NEWA

Oct NEWA

Sep NEWA

Sep NEWA

Sep NEWA
RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - December 2023 1-13

TABLET;ORAL

ATORVASTATIN CALCIUM

>A>

>A>

>A>

>A>

AB

AB

AB

AB

AB

@

@

@

@

LEPU PHARM

MANKIND PHARMA

EQ 80MG BASE

EQ 10MG BASE

EQ 20MG BASE

EQ 40MG BASE

EQ 80MG BASE

EQ 10MG BASE

EQ 20MG BASE

EQ 40MG BASE

EQ 80MG BASE

A214344

A216848

A216848

A216848

A216848

A217081

A217081

A217081

A217081

004 Sep 12, 2023

001 Nov 03, 2022

002 Nov 03, 2022

003 Nov 03, 2022

004 Nov 03, 2022

001 Jan 05, 2024

002 Jan 05, 2024

003 Jan 05, 2024

004 Jan 05, 2024

Sep NEWA

Apr DISC

Apr DISC

Apr DISC

Apr DISC

Dec NEWA

Dec NEWA

Dec NEWA

Dec NEWA

>A>

>A>

>A>

>A>

>D>

>D>

>D>

>D>

ATORVASTATIN CALCIUM; EZETIMIBE

TABLET;ORAL

LYPQOZET

ALTHERA PHARMS EQ 10MG BASE;10MG

EQ 20MG BASE;10MG

EQ 40MG BASE;10MG

! EQ 80MG BASE;10MG

SCOV3 EQ 10MG BASE;10MG

EQ 20MG BASE;10MG

EQ 40MG BASE;10MG

! EQ 80MG BASE;10MG

A206084

A206084

A206084

A206084

A206084

A206084

A206084

A206084

001 Apr 26, 2017

002 Apr 26, 2017

003 Apr 26, 2017

004 Apr 26, 2017

001 Apr 26, 2017

002 Apr 26, 2017

003 Apr 26, 2017

004 Apr 26, 2017

Dec CAHN

Dec CAHN

Dec CAHN

Dec CAHN

Dec CAHN

Dec CAHN

Dec CAHN

Dec CAHN

ATROPINE

SOLUTION;INTRAMUSCULAR

ATROPEN

+

+

+

+

@

@

@

@

MMT EQ 0.25MG SULFATE/0.3ML

EQ 0.5MG SULFATE/0.7ML

EQ 1MG SULFATE/0.7ML

EQ 2MG SULFATE/0.7ML

N017106

N017106

N017106

N017106

004 Sep 17, 2004

003 Jun 19, 2003

002 Jun 19, 2003

001

May DISC

May DISC

May DISC

May DISC

ATROPINE SULFATE

SOLUTION;INTRAVENOUS

ATROPINE SULFATE

AP AMNEAL

SOLUTION/DROPS;OPHTHALMIC

ATROPINE SULFATE

1MG/10ML (0.1MG/ML) A215342 002 Oct 25, 2023 Oct NEWA

>A>

AT

AT

AT

AT

+

!

+

AKORN

AMNEAL

MANKIND PHARMA

RISING

1%

1%

1%

1%

N206289

A214752

A218148

N206289

001 Jul 18, 2014

001 Jul 14, 2022

001 Jan 08, 2024

001 Jul 18, 2014

Jul CHRS

Jul CHRS

Dec NEWA

Sep CAHN

ATROPINE SULFATE; DIPHENOXYLATE HYDROCHLORIDE

TABLET;ORAL

DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE

@ UPSHER SMITH LABS 0.025MG;2.5MG A210571 001 Aug 31, 2018 Jun DISC

AZACITIDINE

POWDER;INTRAVENOUS, SUBCUTANEOUS

AZACITIDINE

AP JIANGSU HANSOH PHARM 100MG/VIAL A215905 001 Jun 28, 2023 Jun NEWA

AZELAIC ACID

AEROSOL, FOAM;TOPICAL

FINACEA

+! LEO PHARMA AS 15% N207071 001 Jul 29, 2015 Feb CTEC

AZELASTINE HYDROCHLORIDE

SPRAY, METERED;NASAL

AZELASTINE HYDROCHLORIDE

AB BIONPHARMA 0.137MG/SPRAY A090176 001 Jul 28, 2015 Jun CAHN

AZELASTINE HYDROCHLORIDE; FLUTICASONE PROPIONATE

SPRAY, METERED;NASAL

AZELASTINE HYDROCHLORIDE AND FLUTICASONE PROPIONATE

>D>

>A>

AB

AB !

APOTEX

DYMISTA

0.137MG/SPRAY;0.05MG/SPRAY

0.137MG/SPRAY;0.05MG/SPRAY

A207712

A207712

001 Apr 28, 2017

001 Apr 28, 2017

Dec CHRS

Dec CHRS

>D>

>A>

AB

AB

+!

+

MYLAN SPECIALITY LP 0.137MG/SPRAY;0.05MG/SPRAY

0.137MG/SPRAY;0.05MG/SPRAY

N202236

N202236

001 May 01, 2012

001 May 01, 2012

Dec CHRS

Dec CHRS
RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - December 2023 1-14

AZITHROMYCIN

FOR SUSPENSION;ORAL

AZITHROMYCIN

AB

AB

HAINAN POLY

INJECTABLE;INJECTION

AZITHROMYCIN

EQ 100MG BASE/5ML

EQ 200MG BASE/5ML

A217036

A217036

001

002

Jul 27, 2023

Jul 27, 2023

Jul NEWA

Jul NEWA

AP SLATE RUN PHARMA

TABLET;ORAL

AZITHROMYCIN

EQ 500MG BASE/VIAL A203412 001 Oct 09, 2018 Sep CAHN

>D>

>A>

>D>

>A>

AB

AB

AB

AB

@ ACI

@

@

@

@ AUROBINDO PHARMA USA

@ ZYDUS PHARMS

@

EQ 250MG BASE

EQ 250MG BASE

EQ 250MG BASE

EQ 500MG BASE

EQ 500MG BASE

EQ 500MG BASE

EQ 600MG BASE

EQ 250MG BASE

EQ 250MG BASE

EQ 500MG BASE

EQ 500MG BASE

A215772

A215772

A215772

A215773

A215773

A215773

A065360

A213275

A213275

A213056

A213056

001

001

001

001

001

001

001

001

001

001

001

Jul 15, 2022

Jul 15, 2022

Jul 15, 2022

Jul 12, 2022

Jul 12, 2022

Jul 12, 2022

Jan 08, 2007

Apr 11, 2023

Apr 11, 2023

Apr 07, 2023

Apr 07, 2023

Dec CMFD

Dec CMFD

Jan DISC

Dec CMFD

Dec CMFD

Jan DISC

May CAHN

Aug DISC

Mar NEWA

Aug DISC

Mar NEWA

BACITRACIN ZINC; HYDROCORTISONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE

OINTMENT;OPHTHALMIC

NEOMYCIN AND POLYMYXIN B SULFATES, BACITRACIN ZINC AND HYDROCORTISONE

@ AKORN 400 UNITS/GM;1%;EQ 3.5MG A065213 001

BASE/GM;10,000 UNITS/GM

! BAUSCH AND LOMB 400 UNITS/GM;1%;EQ 3.5MG A064068 001

BASE/GM;10,000 UNITS/GM

Jul 25, 2012

Oct 30, 1995

Jan DISC

Jan CTEC

BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE

OINTMENT;OPHTHALMIC

NEOMYCIN AND POLYMYXIN B SULFATES AND BACITRACIN ZINC

@ AKORN 400 UNITS/GM;EQ 3.5MG

BASE/GM;10,000 UNITS/GM

A065088 001 Feb 06, 2004 Jan DISC

BACLOFEN

INJECTABLE;INTRATHECAL

BACLOFEN

AP

AP

AP

AP

AP

ACIC PHARMS

RUBICON

SOLUTION;ORAL

OZOBAX

0.5MG/ML

2MG/ML

0.5MG/ML

1MG/ML

2MG/ML

A216309

A216309

A217324

A217324

A217324

001

002

001

002

003

Aug 10, 2023

Aug 10, 2023

Feb 22, 2023

Feb 22, 2023

Feb 22, 2023

Aug NEWA

Aug NEWA

Feb NEWA

Feb NEWA

Feb NEWA

+ @ METACEL PHARMS LLC

OZOBAX DS

5MG/5ML N208193 001 Sep 18, 2019 Nov DISC

+! METACEL PHARMS LLC

SUSPENSION;ORAL

BACLOFEN

10MG/5ML N208193 002 Oct 12, 2023 Nov NEWA

AB

AB

AB

ANI PHARMS

SLAYBACK PHARMA LLC

FLEQSUVY

+! AZURITY

TABLET;ORAL

BACLOFEN

25MG/5ML

25MG/5ML

25MG/5ML

A217252

A217252

N215602

001

001

001

Jun 08, 2023

Jun 08, 2023

Feb 04, 2022

Aug CAHN

Jun NFTG

Jun CFTG

>A>

>A>

AB

AB

AB

AB

AB

AB

AB

AB

AB

AB

AB

@ APPCO

@

BEXIMCO PHARMS USA

GRAVITI PHARMS

MICRO LABS

RISING

! RUBICON

UNICHEM

@ UPSHER SMITH LABS

@

10MG

20MG

5MG

10MG

20MG

5MG

10MG

20MG

5MG

10MG

20MG

5MG

5MG

10MG

20MG

A090334

A090334

A214114

A217788

A217788

A217687

A217687

A217687

A214374

A214374

A214374

A209102

A212067

A090334

A090334

001

002

003

001

002

001

002

003

001

002

003

001

003

001

002

Feb 18, 2010

Feb 18, 2010

Sep 19, 2023

Jan 10, 2024

Jan 10, 2024

Nov 08, 2023

Nov 08, 2023

Nov 08, 2023

Mar 05, 2021

Mar 05, 2021

Mar 05, 2021

Nov 28, 2017

Mar 09, 2023

Feb 18, 2010

Feb 18, 2010

Nov CAHN

Nov CAHN

Sep NEWA

Dec NEWA

Dec NEWA

Nov NEWA

Nov NEWA

Nov NEWA

Oct CAHN

Oct CAHN

Oct CAHN

Nov CHRS

Mar NEWA

Sep CAHN

Sep CAHN
RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - December 2023 1-15

BALOXAVIR MARBOXIL

TABLET;ORAL

XOFLUZA

+ @

+

+!

GENENTECH INC 20MG

40MG

80MG

N210854

N210854

N210854

001

002

003

Oct 24, 2018

Oct 24, 2018

Mar 18, 2021

Jun DISC

Jun CHRS

Jun CHRS

BALSALAZIDE DISODIUM

CAPSULE;ORAL

BALSALAZIDE DISODIUM

AB

@ DASH PHARMS NATCO

ZYDUS

750MG

750MG

A077807

A217592

001

001

Dec 28, 2007

Jun 08, 2023

Feb CAHN

Jun NEWA

BECLOMETHASONE DIPROPIONATE MONOHYDRATE

SPRAY, METERED;NASAL

BECONASE AQ

+ @ GLAXOSMITHKLINE EQ 0.042MG DIPROP/SPRAY N019389 001 Jul 27, 1987 Nov DISC

BENAZEPRIL HYDROCHLORIDE

TABLET;ORAL

BENAZEPRIL HYDROCHLORIDE

>D>

>A>

>D>

>A>

>D>

>A>

>D>

>A>

AB

AB

AB

AB

AB

AB

AB

AB

@

@

@

@

ANI PHARMS

COREPHARMA

5MG

5MG

10MG

10MG

20MG

20MG

40MG

40MG

5MG

10MG

20MG

40MG

A076333

A076333

A076333

A076333

A076333

A076333

A076333

A076333

A077128

A077128

A077128

A077128

001

001

002

002

003

003

004

004

001

002

003

004

Feb 11, 2004

Feb 11, 2004

Feb 11, 2004

Feb 11, 2004

Feb 11, 2004

Feb 11, 2004

Feb 11, 2004

Feb 11, 2004

Mar 08, 2006

Mar 08, 2006

Mar 08, 2006

Mar 08, 2006

Dec CMFD

Dec CMFD

Dec CMFD

Dec CMFD

Dec CMFD

Dec CMFD

Dec CMFD

Dec CMFD

Mar CAHN

Mar CAHN

Mar CAHN

Mar CAHN

BENAZEPRIL HYDROCHLORIDE; HYDROCHLOROTHIAZIDE

TABLET;ORAL

BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE

AB

AB

AB

AB

APOTEX 5MG;6.25MG

10MG;12.5MG

20MG;12.5MG

20MG;25MG

A078794

A078794

A078794

A078794

001

002

003

004

Aug 21, 2014

Aug 21, 2014

Aug 21, 2014

Aug 21, 2014

May CMFD

May CMFD

May CMFD

May CMFD

BENDAMUSTINE HYDROCHLORIDE

POWDER;IV (INFUSION)

BENDAMUSTINE HYDROCHLORIDE

AP

AP

AP

AP

AP

AP

AP

AP

AP

AP

AP

AP

APOTEX

BRECKENRIDGE

EUGIA PHARMA

KINDOS

@ MYLAN LABS LTD

@

@ NANG KUANG PHARM CO

@

SOLUTION;INTRAVENOUS

BELRAPZO

25MG/VIAL

100MG/VIAL

25MG/VIAL

100MG/VIAL

25MG/VIAL

100MG/VIAL

25MG/VIAL

100MG/VIAL

25MG/VIAL

25MG/VIAL

100MG/VIAL

100MG/VIAL

25MG/VIAL

25MG/VIAL

100MG/VIAL

100MG/VIAL

A204230

A204230

A205447

A205447

A214739

A214739

A211001

A211001

A204104

A204104

A204104

A204104

A206554

A206554

A206554

A206554

001

002

001

002

001

002

001

002

001

001

002

002

001

001

002

002

Jun 05, 2023

Jun 05, 2023

Feb 14, 2023

Feb 14, 2023

Jun 05, 2023

Jun 05, 2023

Jun 05, 2023

Jun 05, 2023

Apr 28, 2023

Apr 28, 2023

Apr 28, 2023

Apr 28, 2023

Jun 07, 2023

Jun 07, 2023

Jun 07, 2023

Jun 07, 2023

May NEWA

May NEWA

Feb NEWA

Feb NEWA

May NEWA

May NEWA

May NEWA

May NEWA

May DISC

Apr NEWA

May DISC

Apr NEWA

Nov DISC

May NEWA

Nov DISC

May NEWA

AP +! EAGLE PHARMS 100MG/4ML (25MG/ML)

BENDAMUSTINE HYDROCHLORIDE

N205580 001 May 15, 2018 Aug CDFR

AP

AP

+!

+!

+ @

+ @

+ @

APOTEX

BAXTER HLTHCARE CORP

HOSPIRA

100MG/4ML (25MG/ML)

100MG/4ML (25MG/ML)

25MG/ML (25MG/ML)

100MG/4ML (25MG/ML)

200MG/8ML (25MG/ML)

N215033

N216078

N211530

N211530

N211530

001

001

001

002

003

Dec 07, 2022

Dec 15, 2022

Dec 15, 2022

Dec 15, 2022

Dec 15, 2022

Aug CTEC

Sep CTEC

Jan DISC

Jan DISC

Jan DISC
RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - December 2023 1-16

AP

AA

AA

AA

AA

AA

AA

SOLUTION;IV (INFUSION)

BELRAPZO

+! EAGLE PHARMS

BENZONATATE

CAPSULE;ORAL

BENZONATATE

ASCENT PHARMS INC

CHARTWELL RX

@

@

@

HERITAGE PHARMS LABS

! PURACAP PHARM LLC

!

@ THEPHARMANETWORK LLC

@

@

100MG/4ML (25MG/ML)

150MG

100MG

100MG

150MG

200MG

200MG

100MG

200MG

100MG

200MG

100MG

150MG

200MG

AB

AB

BENZOYL PEROXIDE; CLINDAMYCIN PHOSPHATE

GEL;TOPICAL

BENZACLIN

+ @ BAUSCH 5%;EQ 1% BASE

CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE

@ CHARTWELL RX 5%;1.2%

! GLENMARK PHARMS 5%;EQ 1% BASE

ONEXTON

+! BAUSCH 3.75%;EQ 1.2% BASE

>A> AA

BENZTROPINE MESYLATE

TABLET;ORAL

BENZTROPINE MESYLATE

CHARTWELL RX 0.5MG

AT

BEPOTASTINE BESILATE

SOLUTION/DROPS;OPHTHALMIC

BEPOTASTINE BESILATE

ALEMBIC 1.5%

>D>

>A>

AB

BETAMETHASONE ACETATE; BETAMETHASONE SODIUM PHOSPHATE

INJECTABLE;INJECTION

BETAMETHASONE ACETATE AND BETAMETHASONE SODIUM PHOSPHATE

HIKMA 3MG/ML;EQ 3MG BASE/ML

BETAMETHASONE DIPROPIONATE

LOTION;TOPICAL

BETAMETHASONE DIPROPIONATE

@ SHREE HARI INTL EQ 0.05% BASE

LOTION, AUGMENTED;TOPICAL

BETAMETHASONE DIPROPIONATE

@ PAI HOLDINGS PHARM EQ 0.05% BASE

@ EQ 0.05% BASE

@ VERTICE EQ 0.05% BASE

AB

AB

AB

BETAMETHASONE DIPROPIONATE; CALCIPOTRIENE

AEROSOL, FOAM;TOPICAL

CALCIPOTRIENE AND BETAMETHASONE DIPROPIONATE

GLENMARK PHARMS LTD 0.064%;0.005%

ENSTILAR

+! LEO PHARMA AS 0.064%;0.005%

OINTMENT;TOPICAL

CALCIPOTRIENE AND BETAMETHASONE DIPROPIONATE

@ CHARTWELL RX 0.064%;0.005%

@ TOLMAR 0.064%;0.005%

SUSPENSION;TOPICAL

CALCIPOTRIENE AND BETAMETHASONE DIPROPIONATE

COSETTE 0.064%;0.005%

N205580

A211518

A040682

A210562

A210562

A040682

A210562

A040682

A040682

A206948

A206948

A040627

A040627

A040627

N050756

A203688

A209252

N050819

A081265

A214588

A077838

A070274

A206389

A206389

A206389

A214688

N207589

A201615

A201615

A210765

001

002

001

001

002

002

003

001

002

001

002

001

003

002

001

001

001

002

003

001

001

001

001

001

001

001

001

001

001

001

May 15, 2018 Aug CTEC

Feb 22, 2019 Oct CTEC

Jul 30, 2007 Feb CAHN

Nov 09, 2018 Oct DISC

Nov 09, 2018 Oct DISC

Jul 30, 2007 Feb CAHN

Nov 09, 2018 Oct DISC

Jul 30, 2007 Aug CAHN

Jul 30, 2007 Aug CAHN

Dec 19, 2018 Aug CHRS

Dec 19, 2018 Aug CHRS

Mar 30, 2007 Aug DISC

Sep 24, 2014 Aug DISC

Jul 25, 2007 Aug DISC

Dec 21, 2000 Feb DISC

Aug 25, 2016 Nov CAHN

Mar 14, 2019 Feb CHRS

Nov 24, 2014 Aug CTEC

Nov 29, 2023 Dec NEWA

Apr 05, 2023 Mar NEWA

Jan 17, 2023 Jan NEWA

Aug 12, 1985 Sep CAHN

Feb 13, 2018 Dec CAHN

Feb 13, 2018 May DISC

Feb 13, 2018 Dec CAHN

Mar 21, 2023 Mar NFTG

Oct 16, 2015 Mar CFTG

Jan 14, 2013 Oct CAHN

Jan 14, 2013 Feb DISC

May 11, 2020 Feb CAHN
RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - December 2023 1-17

BETAMETHASONE DIPROPIONATE; CLOTRIMAZOLE

CREAM;TOPICAL

CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE

AB ! TARO EQ 0.05% BASE;1% A075673 001 May 29, 2001

LOTRISONE

+ @ ORGANON EQ 0.05% BASE;1% N018827 001 Jul 10, 1984

BETAMETHASONE VALERATE

AEROSOL, FOAM;TOPICAL

BETAMETHASONE VALERATE

AB ! TARO 0.12% A208204 001 May 24, 2017

AB XIROMED 0.12% A210639 001 Apr 18, 2023

LUXIQ

+ @ MYLAN 0.12% N020934 001 Feb 28, 1999

BETAXOLOL HYDROCHLORIDE

SOLUTION/DROPS;OPHTHALMIC

BETAXOLOL HYDROCHLORIDE

@ AKORN EQ 0.5% BASE A075386 001 Jun 30, 2000

BETHANECHOL CHLORIDE

TABLET;ORAL

BETHANECHOL CHLORIDE

AA CHARTWELL RX 5MG A040728 002 Oct 26, 2007

AA 10MG A040728 003 Oct 26, 2007

AA 25MG A040728 004 Oct 26, 2007

AA 50MG A040728 001 Oct 26, 2007

BEXAGLIFLOZIN

TABLET;ORAL

BRENZAVVY

+! THERACOSBIO 20MG N214373 001 Jan 20, 2023

BICALUTAMIDE

TABLET;ORAL

BICALUTAMIDE

AB ADAPTIS 50MG A079089 001 Jul 06, 2009

AB BRECKENRIDGE 50MG A091011 001 Jun 10, 2015

AB PINNACLE LIFE SCI 50MG A079089 001 Jul 06, 2009

BIMATOPROST

IMPLANT;OPHTHALMIC

DURYSTA

+! ABBVIE 10MCG N211911 001 Mar 04, 2020

SOLUTION/DROPS;OPHTHALMIC

LUMIGAN

+! ABBVIE 0.01% N022184 001 Aug 31, 2010

+ @ 0.03% N021275 001 Mar 16, 2001

>A> BIRCH TRITERPENES

>A> GEL;TOPICAL

>A> FILSUVEZ

>A> +! AMRYT 10% N215064 001 Dec 18, 2023

BISMUTH SUBCITRATE POTASSIUM; METRONIDAZOLE; TETRACYCLINE HYDROCHLORIDE

CAPSULE;ORAL

BISMUTH SUBCITRATE POTASSIUM, METRONIDAZOLE AND TETRACYCLINE HYDROCHLORIDE

AB PAR PHARM 140MG;125MG;125MG A205770 001 Mar 06, 2023

AB RICONPHARMA LLC 140MG;125MG;125MG A217511 001 Jul 03, 2023

PYLERA

AB +! ABBVIE 140MG;125MG;125MG N050786 001 Sep 28, 2006

AB +! ALLERGAN 140MG;125MG;125MG N050786 001 Sep 28, 2006

AB +! LABS JUVISE 140MG;125MG;125MG N050786 001 Sep 28, 2006

BISMUTH SUBSALICYLATE; METRONIDAZOLE; TETRACYCLINE HYDROCHLORIDE

TABLET, CHEWABLE, TABLET, CAPSULE;ORAL

BISMUTH SUBSALICYLATE, METRONIDAZOLE AND TETRACYCLINE HYDROCHLORIDE

! NOSTRUM LABS INC 262.4MG, N/A, N/A;N/A, 250MG, A202584 001 Nov 30, 2018

N/A;N/A, N/A, 500MG

May CHRS

May DISC

Aug CHRS

Apr NEWA

Aug DISC

Feb DISC

May CAHN

May CAHN

May CAHN

May CAHN

Jan NEWA

Sep CAHN

Sep CAHN

Jan CAHN

Jan CAHN

Jul CAHN

Jul CAHN

Dec NEWA

Feb NFTG

Jun NEWA

Mar CAHN

Feb CFTG

Sep CAHN

Aug CAHN
RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - December 2023 1-18

BISOPROLOL FUMARATE

TABLET;ORAL

BISOPROLOL FUMARATE

AB

AB

AB

AB

@

@

ALEMBIC

DASH PHARMS NATCO

PRINSTON INC

5MG

10MG

5MG

10MG

5MG

10MG

A204891

A204891

A075831

A075831

A217368

A217368

001

002

001

002

001

002

Jan 11, 2017

Jan 11, 2017

Dec 14, 2005

Dec 14, 2005

Jul 14, 2023

Jul 14, 2023

Feb CAHN

Feb CAHN

Feb CAHN

Feb CAHN

Jul NEWA

Jul NEWA

BIVALIRUDIN

INJECTABLE;INTRAVENOUS

BIVALIRUDIN

AP SLATE RUN PHARMA 250MG/VIAL A213078 001 May 28, 2021 Sep CAHN

BORTEZOMIB

INJECTABLE;INTRAVENOUS, SUBCUTANEOUS

BORTEZOMIB

AP

@ ACCORD HLTHCARE

@ SCINOPHARM TAIWAN

POWDER;INTRAVENOUS

BORTEZOMIB

3.5MG/VIAL

3.5MG/VIAL

3.5MG/VIAL

A204405

A216912

A216912

001

001

001

Jul 26, 2022

Sep 26, 2023

Sep 26, 2023

Feb DISC

Nov DISC

Sep NEWA

@ DR REDDYS

@ FRESENIUS KABI USA

SOLUTION;INTRAVENOUS

BORTEZOMIB

3.5MG/VIAL

3.5MG/VIAL

N206927

N205004

001

001

Oct 04, 2019

Nov 06, 2017

May DISC

May DISC

+ @ MAIA PHARMS INC 3.5MG/1.4ML (2.5MG/ML) N215331 002 Jul 27, 2022 Oct DISC

BOSENTAN

TABLET;ORAL

BOSENTAN

@

@

@

@

HIKMA

PAR PHARM INC

62.5MG

125MG

62.5MG

125MG

A208695

A208695

A205699

A205699

001

002

001

002

Apr 26, 2019

Apr 26, 2019

Apr 26, 2019

Apr 26, 2019

Oct DISC

Oct DISC

Apr DISC

Apr DISC

BOSUTINIB MONOHYDRATE

CAPSULE;ORAL

BOSULIF

+

+!

+!

+

PF PRISM CV EQ 50MG BASE

EQ 50MG BASE

EQ 100MG BASE

EQ 100MG BASE

N217729

N217729

N217729

N217729

001

001

002

002

Sep 26, 2023

Sep 26, 2023

Sep 26, 2023

Sep 26, 2023

Oct CHRS

Sep NEWA

Oct CHRS

Sep NEWA

BRETYLIUM TOSYLATE

INJECTABLE;INJECTION

BRETYLIUM TOSYLATE

@ BRECKENRIDGE 50MG/ML A204386 001 Dec 21, 2018 Feb DISC

BREXPIPRAZOLE

TABLET;ORAL

BREXPIPRAZOLE

AB

AB

AB

AB

AB

AB

AB

AB

AB

AB

AB

AB

@

@

@

@

@

@

AJANTA PHARMA LTD

ALKEM LABS LTD

0.25MG

0.25MG

0.5MG

0.5MG

1MG

1MG

2MG

2MG

3MG

3MG

4MG

4MG

0.25MG

0.5MG

1MG

2MG

3MG

4MG

A213718

A213718

A213718

A213718

A213718

A213718

A213718

A213718

A213718

A213718

A213718

A213718

A213782

A213782

A213782

A213782

A213782

A213782

001

001

002

002

003

003

004

004

005

005

006

006

001

002

003

004

005

006

Feb 03, 2023

Feb 03, 2023

Feb 03, 2023

Feb 03, 2023

Feb 03, 2023

Feb 03, 2023

Feb 03, 2023

Feb 03, 2023

Feb 03, 2023

Feb 03, 2023

Feb 03, 2023

Feb 03, 2023

Nov 28, 2023

Nov 28, 2023

Nov 28, 2023

Nov 28, 2023

Nov 28, 2023

Nov 28, 2023

Aug DISC

Jan NEWA

Aug DISC

Jan NEWA

Aug DISC

Jan NEWA

Aug DISC

Jan NEWA

Aug DISC

Jan NEWA

Aug DISC

Jan NEWA

Nov NEWA

Nov NEWA

Nov NEWA

Nov NEWA

Nov NEWA

Nov NEWA
RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - December 2023 1-19

TABLET;ORAL

BREXPIPRAZOLE

AB

AB

AB

AB

AB

AB

AB

AB

AB

AB

AB

AB

AB

AB

AB

AB

AB

AB

AB

AB

AB

AB

AB

AB

AB

AB

AB

AB

AB

AB

@ AMNEAL

@

@

@

@

@

@ AUROBINDO PHARMA LTD

@

@

@

@

@

HETERO LABS LTD V

@ LUPIN LTD

@

@

@

@

@

OPTIMUS

@ TEVA PHARMS USA INC

@

@

@

@

@

@ ZYDUS PHARMS

@

@

@

@

@

REXULTI

0.25MG

0.25MG

0.5MG

0.5MG

1MG

1MG

2MG

2MG

3MG

3MG

4MG

4MG

0.25MG

0.25MG

0.5MG

0.5MG

1MG

1MG

2MG

2MG

3MG

3MG

4MG

4MG

0.25MG

0.5MG

1MG

2MG

3MG

4MG

0.25MG

0.25MG

0.5MG

0.5MG

1MG

1MG

2MG

2MG

3MG

3MG

4MG

4MG

0.25MG

0.5MG

1MG

2MG

3MG

4MG

0.25MG

0.5MG

1MG

2MG

3MG

4MG

0.25MG

0.5MG

1MG

2MG

3MG

4MG

A213562

A213562

A213562

A213562

A213562

A213562

A213562

A213562

A213562

A213562

A213562

A213562

A213659

A213659

A213659

A213659

A213659

A213659

A213659

A213659

A213659

A213659

A213659

A213659

A213669

A213669

A213669

A213669

A213669

A213669

A213512

A213512

A213512

A213512

A213512

A213512

A213512

A213512

A213512

A213512

A213512

A213512

A213758

A213758

A213758

A213758

A213758

A213758

A213692

A213692

A213692

A213692

A213692

A213692

A213660

A213660

A213660

A213660

A213660

A213660

001

001

002

002

003

003

004

004

005

005

006

006

001

001

002

002

003

003

004

004

005

005

006

006

001

002

003

004

005

006

001

001

002

002

003

003

004

004

005

005

006

006

001

002

003

004

005

006

001

002

003

004

005

006

001

002

003

004

005

006

Jan 31, 2023

Jan 31, 2023

Jan 31, 2023

Jan 31, 2023

Jan 31, 2023

Jan 31, 2023

Jan 31, 2023

Jan 31, 2023

Jan 31, 2023

Jan 31, 2023

Jan 31, 2023

Jan 31, 2023

Nov 02, 2023

Nov 02, 2023

Nov 02, 2023

Nov 02, 2023

Nov 02, 2023

Nov 02, 2023

Nov 02, 2023

Nov 02, 2023

Nov 02, 2023

Nov 02, 2023

Nov 02, 2023

Nov 02, 2023

Nov 20, 2023

Nov 20, 2023

Nov 20, 2023

Nov 20, 2023

Nov 20, 2023

Nov 20, 2023

Mar 17, 2023

Mar 17, 2023

Mar 17, 2023

Mar 17, 2023

Mar 17, 2023

Mar 17, 2023

Mar 17, 2023

Mar 17, 2023

Mar 17, 2023

Mar 17, 2023

Mar 17, 2023

Mar 17, 2023

Oct 25, 2023

Oct 25, 2023

Oct 25, 2023

Oct 25, 2023

Oct 25, 2023

Oct 25, 2023

Aug 11, 2022

Aug 11, 2022

Aug 11, 2022

Aug 11, 2022

Aug 11, 2022

Aug 11, 2022

Jan 10, 2023

Jan 10, 2023

Jan 10, 2023

Jan 10, 2023

Jan 10, 2023

Jan 10, 2023

Mar DISC

Jan NEWA

Mar DISC

Jan NEWA

Mar DISC

Jan NEWA

Mar DISC

Jan NEWA

Mar DISC

Jan NEWA

Mar DISC

Jan NEWA

Nov DISC

Oct NEWA

Nov DISC

Oct NEWA

Nov DISC

Oct NEWA

Nov DISC

Oct NEWA

Nov DISC

Oct NEWA

Nov DISC

Oct NEWA

Nov NEWA

Nov NEWA

Nov NEWA

Nov NEWA

Nov NEWA

Nov NEWA

May DISC

Mar NEWA

May DISC

Mar NEWA

May DISC

Mar NEWA

May DISC

Mar NEWA

May DISC

Mar NEWA

May DISC

Mar NEWA

Oct NEWA

Oct NEWA

Oct NEWA

Oct NEWA

Oct NEWA

Oct NEWA

Feb DISC

Feb DISC

Feb DISC

Feb DISC

Feb DISC

Feb DISC

Jun DISC

Jun DISC

Jun DISC

Jun DISC

Jun DISC

Jun DISC

AB

AB

AB

AB

AB

AB

+

+

+

+

+

+

+!

+!

+

+

+

OTSUKA 0.25MG

0.25MG

0.5MG

0.5MG

1MG

1MG

2MG

2MG

3MG

3MG

4MG

N205422

N205422

N205422

N205422

N205422

N205422

N205422

N205422

N205422

N205422

N205422

001

001

002

002

003

003

004

004

005

005

006

Jul 10, 2015

Jul 10, 2015

Jul 10, 2015

Jul 10, 2015

Jul 10, 2015

Jul 10, 2015

Jul 10, 2015

Jul 10, 2015

Jul 10, 2015

Jul 10, 2015

Jul 10, 2015

Oct CTEC

Aug CTEC

Oct CTEC

Aug CTEC

Oct CTEC

Aug CTEC

Oct CTEC

Aug CTEC

Oct CTEC

Aug CTEC

Oct CTEC
RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - December 2023 1-20

TABLET;ORAL

REXULTI

+ 4MG N205422 006 Jul 10, 2015 Aug CTEC

BRIMONIDINE TARTRATE

AB

AT

AT

SOLUTION/DROPS;OPHTHALMIC

BRIMONIDINE TARTRATE

ALEMBIC

MICRO LABS

0.1%

0.15%

0.2%

A216909

A215225

A217846

001 Aug 01, 2023

001 Mar 29, 2023

001 Nov 22, 2023

Jul NEWA

Mar NEWA

Nov NEWA

AB

AB

AB

BRIMONIDINE TARTRATE; TIMOLOL MALEATE

SOLUTION/DROPS;OPHTHALMIC

BRIMONIDINE TARTRATE AND TIMOLOL MALEATE

ALEMBIC 0.2%;EQ 0.5% BASE

FLORIDA 0.2%;EQ 0.5% BASE

SENTISS 0.2%;EQ 0.5% BASE

A215230

A201949

A091086

001 Aug 25, 2023

001 Oct 04, 2022

001 Oct 31, 2022

Aug NEWA

Nov CAHN

Jul CAHN

BRINZOLAMIDE

AB

AB

SUSPENSION/DROPS;OPHTHALMIC

AZOPT

+! SANDOZ 1%

BRINZOLAMIDE

PADAGIS US 1%

N020816

A211914

001 Apr 01, 1998

001 Jul 28, 2023

Sep CAHN

Jul NEWA

BRIVARACETAM

TABLET;ORAL

BRIVARACETAM

@ AUROBINDO PHARMA LTD

@

@ LUPIN LTD

@

@

@

@

BRIVIACT

+ UCB INC

+

+

+

+!

50MG

100MG

10MG

25MG

50MG

75MG

100MG

10MG

25MG

50MG

75MG

100MG

A214848

A214848

A214918

A214918

A214918

A214918

A214918

N205836

N205836

N205836

N205836

N205836

001 Jan 06, 2023

002 Jan 06, 2023

001 Dec 20, 2022

002 Dec 20, 2022

003 Dec 20, 2022

004 Dec 20, 2022

005 Dec 20, 2022

001 May 12, 2016

002 May 12, 2016

003 May 12, 2016

004 May 12, 2016

005 May 12, 2016

Mar DISC

Mar DISC

Mar DISC

Mar DISC

Mar DISC

Mar DISC

Mar DISC

Mar CTEC

Mar CTEC

Mar CTEC

Mar CTEC

Mar CTEC

BROMFENAC SODIUM

AT2

AT2

AB

AT2

AT2

AB

SOLUTION/DROPS;OPHTHALMIC

BROMFENAC SODIUM

AKORN

! ALEMBIC

LUPIN LTD

SENTISS

PROLENSA

+! BAUSCH AND LOMB

EQ 0.09% ACID

EQ 0.09% ACID

EQ 0.07% ACID

EQ 0.09% ACID

EQ 0.09% ACID

EQ 0.07% ACID

A203395

A210560

A206027

A202903

A203395

N203168

001 Jan 22, 2014

001 Jun 21, 2019

001 Nov 22, 2023

001 Aug 15, 2023

001 Jan 22, 2014

001 Apr 05, 2013

Jun CHRS

Jun CHRS

Nov NFTG

Aug NEWA

Jul CAHN

Nov CFTG

BROMOCRIPTINE MESYLATE

>A>

>D>

>A>

>D>

AB

AB

AB

AB

CAPSULE;ORAL

PARLODEL

+ SS PHARMA

+ VALIDUS PHARMS

TABLET;ORAL

BROMOCRIPTINE MESYLATE

@ AUROBINDO PHARMA USA

PARLODEL

+ SS PHARMA

+ VALIDUS PHARMS

EQ 5MG BASE

EQ 5MG BASE

EQ 2.5MG BASE

EQ 2.5MG BASE

EQ 2.5MG BASE

N017962

N017962

A076962

N017962

N017962

002 Mar 01, 1982

002 Mar 01, 1982

001 Sep 24, 2004

001

001

Dec CAHN

Dec CAHN

Apr CAHN

Dec CAHN

Dec CAHN

BROMPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PSEUDOEPHEDRINE HYDROCHLORIDE

SYRUP;ORAL

BROMFED-DM

AA + WOCKHARDT BIO AG 2MG/5ML;10MG/5ML;30MG/5ML A088811 001 Jun 07, 1985 Jun CHRS

AA +! 2MG/5ML;10MG/5ML;30MG/5ML A088811 001 Jun 07, 1985 Jun CRLD
RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - December 2023 1-21

SYRUP;ORAL

BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE

>D>

>A>

AA

AA

AA

!

@

@

BIONPHARMA

BRECKENRIDGE

EYWA

PADAGIS US

WES PHARMA INC

2MG/5ML;10MG/5ML;30MG/5ML

2MG/5ML;10MG/5ML;30MG/5ML

2MG/5ML;10MG/5ML;30MG/5ML

2MG/5ML;10MG/5ML;30MG/5ML

2MG/5ML;10MG/5ML;30MG/5ML

A203997

A203997

A211170

A205292

A211170

001

001

001

001

001

Sep 30, 2020

Sep 30, 2020

Jun 16, 2020

Jul 15, 2014

Jun 16, 2020

Jun CAHN

Jan DISC

Dec CAHN

Jun CHRS

Dec CAHN

BUDESONIDE

AB

AB

AN

AEROSOL, FOAM;RECTAL

BUDESONIDE

PADAGIS ISRAEL 2MG/ACTUATION

UCERIS

+! SALIX 2MG/ACTUATION

CAPSULE, DELAYED RELEASE;ORAL

ORTIKOS

+ @ SUN PHARM INDS INC 6MG

+ @ 9MG

SUSPENSION;INHALATION

BUDESONIDE

EUGIA PHARMA 0.5MG/2ML

A215328

N205613

N211929

N211929

A216667

001

001

001

002

001

Apr 12, 2023

Oct 07, 2014

Jun 13, 2019

Jun 13, 2019

Nov 29, 2023

Mar NFTG

Mar CFTG

Oct DISC

Oct DISC

Nov NEWA

BUDESONIDE; FORMOTEROL FUMARATE

AEROSOL, METERED;INHALATION

SYMBICORT AEROSPHERE

+! ASTRAZENECA 0.16MG/INH;0.0048MG/INH N216579 001 Apr 28, 2023 Apr NEWA

BUMETANIDE

AP

AB

AB

AB

INJECTABLE;INJECTION

BUMETANIDE

SAGENT

TABLET;ORAL

BUMETANIDE

TARO

0.25MG/ML

0.5MG

1MG

2MG

A074441

A213458

A213458

A213458

001

001

002

003

Jan 27, 1995

Jul 24, 2023

Jul 24, 2023

Jul 24, 2023

Aug CAHN

Jul NEWA

Jul NEWA

Jul NEWA

BUPIVACAINE HYDROCHLORIDE

>A>

>A>

>A>

AP

AP

AP

AP

AP

AP

AP

AP

AP

AP

AP

AP

INJECTABLE;INJECTION

BUPIVACAINE HYDROCHLORIDE

KINDOS 0.25%

0.25%

0.5%

0.5%

0.75%

SOMERSET 0.25%

0.5%

STERISCIENCE 0.25%

0.5%

BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE

STERISCIENCE 0.25%

0.5%

0.75%

INJECTABLE;SPINAL

BUPIVACAINE HYDROCHLORIDE

@ BAXTER HLTHCARE CORP 0.75%

A216039

A216040

A216039

A216040

A216040

A217792

A217792

A091503

A091503

A091487

A091487

A091487

A207266

001

001

002

002

003

001

002

001

002

002

001

003

001

Jun 23, 2023

Dec 27, 2023

Jun 23, 2023

Dec 27, 2023

Dec 27, 2023

Nov 20, 2023

Nov 20, 2023

Oct 18, 2011

Oct 18, 2011

Oct 18, 2011

Oct 18, 2011

Oct 18, 2011

Jul 25, 2016

Jun NEWA

Dec NEWA

Jun NEWA

Dec NEWA

Dec NEWA

Nov NEWA

Nov NEWA

Jun CMFD

Jun CMFD

Jun CMFD

Jun CMFD

Jun CMFD

Aug DISC

BUPRENORPHINE

AB

FILM, EXTENDED RELEASE;TRANSDERMAL

BUPRENORPHINE

@ ALVOGEN 7.5MCG/HR

7.5MCG/HR

SOLUTION, EXTENDED RELEASE;SUBCUTANEOUS

BRIXADI

+ BRAEBURN 8MG/0.16ML (50MG/ML)

+ 16MG/0.32ML (50MG/ML)

+ 24MG/0.48ML (50MG/ML)

+ 32MG/0.64ML (50MG/ML)

+ 64MG/0.18ML (356MG/ML)

+ 96MG/0.27ML (356MG/ML)

+! 128MG/0.36ML (356MG/ML)

A207490

A207490

N210136

N210136

N210136

N210136

N210136

N210136

N210136

005

005

001

002

003

004

005

006

007

Mar 21, 2023

Mar 21, 2023

May 23, 2023

May 23, 2023

May 23, 2023

May 23, 2023

May 23, 2023

May 23, 2023

May 23, 2023

Sep DISC

Mar NEWA

May NEWA

May NEWA

May NEWA

May NEWA

May NEWA

May NEWA

May NEWA
RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - December 2023 1-22

BUPRENORPHINE HYDROCHLORIDE

INJECTABLE;INJECTION

BUPRENORPHINE HYDROCHLORIDE

AP ! PAR STERILE PRODUCTS EQ 0.3MG BASE/ML A206586 001 Jul 28, 2015 Jul CHRS

BUPROPION HYDROCHLORIDE

TABLET, EXTENDED RELEASE;ORAL

BUPROPION HYDROCHLORIDE

>D>

>A>

>D>

>A>

AB3

AB1

AB1

AB1

AB3

AB3

AB1

@ ANCHEN PHARMS

@

ANNORA PHARMA

SCINOPHARM TAIWAN

SUN PHARM

@

FORFIVO XL

150MG

300MG

300MG

100MG

150MG

200MG

150MG

300MG

100MG

100MG

A077284

A077284

A077284

A216800

A216800

A216800

A210081

A210081

A078866

A078866

001

002

002

001

002

003

001

002

001

001

Dec 14, 2006

Dec 14, 2006

Dec 14, 2006

May 31, 2023

May 31, 2023

May 31, 2023

Nov 03, 2017

Nov 03, 2017

Apr 06, 2010

Apr 06, 2010

Sep DISC

Dec DISC

Dec DISC

May NEWA

May NEWA

May NEWA

Sep CAHN

Sep CAHN

Dec DISC

Dec DISC

+! TWI PHARMS 450MG N022497 001 Nov 10, 2011 Nov CAHN

BUSPIRONE HYDROCHLORIDE

TABLET;ORAL

BUSPIRONE HYDROCHLORIDE

AB

@

@

@

@

@

@

GRAVITI PHARMS

RISING

ZYDUS PHARMS

5MG

10MG

15MG

5MG

10MG

15MG

7.5MG

A075413

A075413

A075413

A075413

A075413

A075413

A078888

001

002

003

001

002

003

005

Mar 19, 2002

Mar 19, 2002

Mar 19, 2002

Mar 19, 2002

Mar 19, 2002

Mar 19, 2002

Mar 21, 2023

Feb CAHN

Feb CAHN

Feb CAHN

Aug CAHN

Aug CAHN

Aug CAHN

Mar NEWA

BUSULFAN

INJECTABLE;INJECTION

BUSULFAN

@ AM REGENT

@ ARTHUR GRP

TABLET;ORAL

MYLERAN

6MG/ML

6MG/ML

A202259

A205106

001

001

Dec 22, 2015

Sep 21, 2018

Jan DISC

Mar DISC

+! WAYLIS THERAP 2MG N009386 001 Sep CAHN

BUTENAFINE HYDROCHLORIDE

CREAM;TOPICAL

MENTAX

+ @ MYLAN 1% N020524 001 Oct 18, 1996 Jul DISC

CABAZITAXEL

SOLUTION;INTRAVENOUS

CABAZITAXEL

AP

AP

AP

+!

@

@

ACCORD HLTHCARE

APOTEX

DR REDDYS

MYLAN LABS LTD

60MG/3ML (20MG/ML)

60MG/1.5ML (40MG/ML)

60MG/1.5ML (40MG/ML)

60MG/1.5ML (40MG/ML)

60MG/1.5ML (40MG/ML)

60MG/1.5ML (40MG/ML)

N207949

A207736

A207736

A207718

A207381

A207381

001

001

001

001

001

001

Dec 29, 2021

Feb 10, 2023

Feb 10, 2023

Feb 10, 2023

Jul 05, 2023

Jul 05, 2023

Feb CMFD

Aug DISC

Feb NEWA

Feb NEWA

Jul DISC

Jun NEWA

CABOZANTINIB S-MALATE

CAPSULE;ORAL

COMETRIQ

+ EXELIXIS

+!

EQ 20MG BASE

EQ 80MG BASE

N203756

N203756

001

002

Nov 29, 2012

Nov 29, 2012

Jun CHRS

Jun CHRS

CALCIPOTRIENE

CREAM;TOPICAL

CALCIPOTRIENE

@ CHARTWELL RX

@ TOLMAR

SOLUTION;TOPICAL

CALCIPOTRIENE

0.005%

0.005%

A200935

A200935

001

001

May 30, 2012

May 30, 2012

Oct CAHN

Feb DISC

AT

AT !

CHARTWELL RX

COSETTE

0.005%

0.005%

A207163

A078468

001

001

Dec 26, 2017

Mar 24, 2011

Jul CAHN

Feb CHRS
RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - December 2023 1-23

CALCITRIOL

CAPSULE;ORAL

CALCITRIOL

AB ! STRIDES PHARMA

ROCALTROL

0.5MCG A091356 002 Dec 12, 2014 May CHRS

>A> AB + SS PHARMA 0.25MCG N018044 001 Dec CAHN

>A> AB + 0.5MCG N018044 002 Dec CAHN

>D> AB + VALIDUS PHARMS 0.25MCG N018044 001 Dec CAHN

>D> AB + 0.5MCG N018044 002 Dec CAHN

AB +

INJECTABLE;INJECTION

CALCITRIOL

0.5MCG N018044 002 May CHRS

AP ! LONG GROVE PHARMS

@

SOLUTION;ORAL

CALCITRIOL

0.001MG/ML

0.002MG/ML

A078066

A078066

001

002

Jan 29, 2008

Jan 29, 2008

Aug CAHN

Aug CAHN

AA

AA

PATRIN

RISING

ROCALTROL

1MCG/ML

1MCG/ML

A203973

A209798

001

001

Jul 28, 2023

Nov 21, 2018

Jul NEWA

Jul CAHN

>A>

>D>

AA

AA

+!

+!

SS PHARMA

VALIDUS PHARMS

1MCG/ML

1MCG/ML

N021068

N021068

001

001

Nov 20, 1998

Nov 20, 1998

Dec CAHN

Dec CAHN

CALCIUM ACETATE

CAPSULE;ORAL

CALCIUM ACETATE

>D>

>A> AB

AB

@

@

SQUARE PHARMS 667MG

667MG

667MG

667MG

A217205

A217205

A217205

A217205

001

001

001

001

Mar 13, 2023

Mar 13, 2023

Mar 13, 2023

Mar 13, 2023

Dec CMFD

Dec CMFD

Sep DISC

Mar NEWA

SOLUTION;ORAL

PHOSLYRA

+ @ FRESENIUS MEDCL 667MG/5ML N022581 001 Apr 18, 2011 Jun DISC

CALCIUM GLUCONATE

SOLUTION;INTRAVENOUS

CALCIUM GLUCONATE

AP

AP

AP

AP

AP

AP

B BRAUN MEDICAL INC 10GM/100ML (100MG/ML)

+! FRESENIUS KABI USA 5GM/50ML (100MG/ML)

+! 10GM/100ML (100MG/ML)

NIVAGEN PHARMS INC 5GM/50ML (100MG/ML)

SOMERSET 5GM/50ML (100MG/ML)

10GM/100ML (100MG/ML)

CALCIUM GLUCONATE IN SODIUM CHLORIDE

A216541

N208418

N208418

A213071

A217689

A217689

001

002

003

002

001

002

Aug 21, 2023

Jun 15, 2017

Jun 15, 2017

Oct 19, 2023

Oct 19, 2023

Oct 19, 2023

Aug NFTG

Oct CFTG

Aug CFTG

Oct NFTG

Oct NFTG

Oct NEWA

AP

AP

AP

AP

+!

+!

AMNEAL

FRESENIUS KABI USA

1GM/50ML (20MG/ML)

2GM/100ML (20MG/ML)

1GM/50ML (20MG/ML)

2GM/100ML (20MG/ML)

A217174

A217174

N208418

N208418

001

002

004

005

Sep 05, 2023

Sep 05, 2023

Jun 17, 2021

Jun 17, 2021

Aug NFTG

Aug NFTG

Aug CFTG

Aug CFTG

CANDESARTAN CILEXETIL

TABLET;ORAL

CANDESARTAN CILEXETIL

AB

AB

AB

AB

AB

AB

AB

PRINSTON INC

ZYDUS LIFESCIENCES

8MG

16MG

32MG

4MG

8MG

16MG

32MG

A206233

A206233

A206233

A091390

A091390

A091390

A091390

001

002

003

001

002

003

004

Aug 21, 2023

Aug 21, 2023

Aug 21, 2023

Aug 23, 2017

Aug 23, 2017

Aug 23, 2017

Aug 23, 2017

Aug NEWA

Aug NEWA

Aug NEWA

May CAHN

May CAHN

May CAHN

May CAHN

CANDESARTAN CILEXETIL; HYDROCHLOROTHIAZIDE

TABLET;ORAL

CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE

AB

AB

AB

ZYDUS LIFESCIENCES 16MG;12.5MG

32MG;12.5MG

32MG;25MG

A203466

A203466

A203466

001

002

003

Nov 27, 2017

Nov 27, 2017

Nov 27, 2017

May CAHN

May CAHN

May CAHN
RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - December 2023 1-24

CANNABIDIOL

SOLUTION;ORAL

EPIDIOLEX

>D>

>A>

+!

+!

GW RES LTD

JAZZ PHARMS RES

100MG/ML

100MG/ML

N210365

N210365

001

001

Sep 28, 2018

Sep 28, 2018

Dec CAHN

Dec CAHN

CANTHARIDIN

SOLUTION;TOPICAL

YCANTH

+! VERRICA PHARMS 0.7% N212905 001 Jul 21, 2023 Jul NEWA

CAPECITABINE

TABLET;ORAL

CAPECITABINE

AB

AB

TEYRO LABS

XELODA

150MG

500MG

A217237

A217237

001

002

Oct 23, 2023

Oct 23, 2023

Oct NEWA

Oct NEWA

AB

AB

+

+!

CHEPLAPHARM 150MG

500MG

N020896

N020896

001

002

Apr 30, 1998

Apr 30, 1998

Apr CAHN

Apr CAHN

CAPIVASERTIB

TABLET;ORAL

TRUQAP

+ ASTRAZENECA

+!

160MG

200MG

N218197

N218197

001

002

Nov 16, 2023

Nov 16, 2023

Nov NEWA

Nov NEWA

CAPTOPRIL

TABLET;ORAL

CAPTOPRIL

AB

AB

AB

AB

AB

AB

AB

AB

AB

AB

AB

AB

@

@

@

@

AUROBINDO PHARMA USA

CHANGZHOU PHARM

COREPHARMA

KENTON

12.5MG

25MG

50MG

100MG

12.5MG

25MG

50MG

100MG

12.5MG

25MG

50MG

100MG

12.5MG

25MG

50MG

100MG

A074434

A074434

A074434

A074434

A214442

A214442

A214442

A214442

A074737

A074737

A074737

A074737

A074677

A074677

A074677

A074677

001

002

003

004

001

002

003

004

001

002

003

004

004

002

001

003

Feb 13, 1996

Feb 13, 1996

Feb 13, 1996

Feb 13, 1996

Jan 27, 2023

Jan 27, 2023

Jan 27, 2023

Jan 27, 2023

Oct 28, 1998

Oct 28, 1998

Oct 28, 1998

Oct 28, 1998

May 30, 1997

May 30, 1997

May 30, 1997

May 30, 1997

May CAHN

May CAHN

May CAHN

May CAHN

Jan NEWA

Jan NEWA

Jan NEWA

Jan NEWA

Mar CAHN

Mar CAHN

Mar CAHN

Mar CAHN

Sep CAHN

Sep CAHN

Sep CAHN

Sep CAHN

CAPTOPRIL; HYDROCHLOROTHIAZIDE

TABLET;ORAL

CAPTOPRIL AND HYDROCHLOROTHIAZIDE

!

!

RISING 25MG;15MG

25MG;25MG

50MG;15MG

50MG;25MG

A074896

A074896

A074896

A074896

001

002

004

003

Dec 29, 1997

Dec 29, 1997

Dec 29, 1997

Dec 29, 1997

May CMFD

May CMFD

May CMFD

May CMFD

CARBAMAZEPINE

SUSPENSION;ORAL

CARBAMAZEPINE

AB CHARTWELL RX

TABLET;ORAL

CARBAMAZEPINE

100MG/5ML A075714 001 Jun 05, 2002 Jan CAHN

@ RK PHARMA 200MG

TABLET, EXTENDED RELEASE;ORAL

CARBAMAZEPINE

A214328 001 Aug 16, 2021 Jun CAHN

AB

AB

AB

AB

AB

@

@

@

AJANTA PHARMA LTD

AMNEAL PHARMS

100MG

100MG

200MG

200MG

400MG

400MG

100MG

200MG

A216193

A216193

A216193

A216193

A216193

A216193

A212704

A212704

001

001

002

002

003

003

001

002

Mar 24, 2023

Mar 24, 2023

Mar 24, 2023

Mar 24, 2023

Mar 24, 2023

Mar 24, 2023

Sep 22, 2023

Sep 22, 2023

Sep DISC

Mar NEWA

Sep DISC

Mar NEWA

Sep DISC

Mar NEWA

Sep NEWA

Sep NEWA
RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - December 2023 1-25

TABLET, EXTENDED RELEASE;ORAL

CARBAMAZEPINE

AB

AB

AB

AB

AB

AB

AB

RICONPHARMA LLC

SCIECURE PHARMA INC

400MG

100MG

200MG

400MG

100MG

200MG

400MG

A212704

A216404

A216404

A216404

A216235

A216235

A216235

003 Sep 22, 2023

001 Dec 02, 2022

002 Dec 02, 2022

003 Dec 02, 2022

001 Mar 02, 2023

002 Mar 02, 2023

003 Mar 02, 2023

Sep NEWA

Jun CMFD

Jun CMFD

Jun CMFD

Feb NEWA

Feb NEWA

Feb NEWA

CARBIDOPA

TABLET;ORAL

CARBIDOPA

>A> AB BEXIMCO PHARMS USA 25MG A217961 001 Dec 11, 2023 Dec NEWA

CARBIDOPA; LEVODOPA

TABLET;ORAL

CARBIDOPA AND LEVODOPA

AB

AB

AB

@ ZYDUS PHARMS 10MG;100MG

10MG;100MG

@ 25MG;100MG

25MG;100MG

@ 25MG;250MG

25MG;250MG

TABLET, EXTENDED RELEASE;ORAL

CARBIDOPA AND LEVODOPA

A215999

A215999

A215999

A215999

A215999

A215999

001 Apr 04, 2023

001 Apr 04, 2023

002 Apr 04, 2023

002 Apr 04, 2023

003 Apr 04, 2023

003 Apr 04, 2023

Aug DISC

Mar NEWA

Aug DISC

Mar NEWA

Aug DISC

Mar NEWA

AB

AB

! SCIEGEN PHARMS INC 50MG;200MG

SUN PHARM INDS 50MG;200MG

TABLET, ORALLY DISINTEGRATING;ORAL

CARBIDOPA AND LEVODOPA

A214091

A077828

002 Oct 05, 2021

002 Aug 23, 2007

May CHRS

May CHRS

SUN PHARM 10MG;100MG

25MG;100MG

A078690

A078690

001 Jul 31, 2009

002 Jul 31, 2009

Apr CTEC

Apr CTEC

CARBINOXAMINE MALEATE

SOLUTION;ORAL

CARBINOXAMINE MALEATE

! GENUS

TABLET;ORAL

CARBINOXAMINE MALEATE

4MG/5ML A040458 001 Apr 25, 2003 Sep CAHN

AA ! GENUS 4MG A040442 001 Mar 19, 2003 Sep CAHN

CARBOPLATIN

INJECTABLE;INJECTION

CARBOPLATIN

>D>

>D>

>D>

>A>

>A>

>A>

@ MYLAN LABS LTD

@

@

@ NATCO PHARMA USA

@

@

INJECTABLE;INTRAVENOUS

CARBOPLATIN

50MG/VIAL

150MG/VIAL

450MG/VIAL

50MG/VIAL

150MG/VIAL

450MG/VIAL

A091510

A091510

A091510

A091510

A091510

A091510

001 May 29, 2012

002 May 29, 2012

003 May 29, 2012

001 May 29, 2012

002 May 29, 2012

003 May 29, 2012

Dec CAHN

Dec CAHN

Dec CAHN

Dec CAHN

Dec CAHN

Dec CAHN

AP

AP

AP

EPIC PHARMA LLC

NOVAST LABS

600MG/60ML (10MG/ML)

450MG/45ML (10MG/ML)

600MG/60ML (10MG/ML)

A091268

A208487

A208487

002 Jul 28, 2010

003 Apr 26, 2017

004 Apr 26, 2017

Oct CAHN

May CMFD

May CMFD

CARBOPROST TROMETHAMINE

INJECTABLE;INJECTION

CARBOPROST TROMETHAMINE

AP

AP

AP

AP

AP

AP

AP

ALEMBIC

CAPLIN

EUGIA PHARMA

GLAND PHARMA LTD

SOLA PHARMS

STERISCIENCE

WELDING

EQ 0.25MG BASE/ML

EQ 0.25MG BASE/ML

EQ 0.25MG BASE/ML

EQ 0.25MG BASE/ML

EQ 0.25MG BASE/ML

EQ 0.25MG BASE/ML

EQ 0.25MG BASE/ML

A217198

A216882

A216939

A217657

A216824

A216897

A216824

001 Jun 15, 2023

001 Feb 13, 2023

001 May 25, 2023

001 Aug 07, 2023

001 May 19, 2023

001 Jul 25, 2023

001 May 19, 2023

Jun NEWA

Feb NEWA

May NEWA

Jul NEWA

Jun CAHN

Jul NEWA

May NEWA
RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - December 2023 1-26

CARFILZOMIB

POWDER;INTRAVENOUS

KYPROLIS

AP

+

+

+!

ONYX PHARMS AMGEN 10MG/VIAL

30MG/VIAL

60MG/VIAL

N202714

N202714

N202714

003

002

001

Jun 07, 2018

Jun 03, 2016

Jul 20, 2012

Jun CAHN

Jun CAHN

Jun CAHN

CARIPRAZINE HYDROCHLORIDE

CAPSULE;ORAL

CARIPRAZINE HYDROCHLORIDE

@ ZYDUS

@

@

@

VRAYLAR

EQ 1.5MG BASE

EQ 3MG BASE

EQ 4.5MG BASE

EQ 6MG BASE

A213984

A213984

A213984

A213984

001

002

003

004

Sep 09, 2022

Sep 09, 2022

Sep 09, 2022

Sep 09, 2022

May CAHN

May CAHN

May CAHN

May CAHN

+!

+

+

+

ABBVIE EQ 1.5MG BASE

EQ 3MG BASE

EQ 4.5MG BASE

EQ 6MG BASE

N204370

N204370

N204370

N204370

001

002

003

004

Sep 17, 2015

Sep 17, 2015

Sep 17, 2015

Sep 17, 2015

Jan CAHN

Jan CAHN

Jan CAHN

Jan CAHN

CARMUSTINE

INJECTABLE;INJECTION

CARMUSTINE

AP

AP

AP

AP

AP

@

@

ACCORD HLTHCARE

ALEMBIC

MSN

MYLAN LABS LTD

PENN LIFE

100MG/VIAL

100MG/VIAL

100MG/VIAL

100MG/VIAL

100MG/VIAL

100MG/VIAL

100MG/VIAL

A214117

A214117

A215730

A214814

A215368

A215368

A209278

001

001

001

001

001

001

001

Dec 27, 2022

Dec 27, 2022

Oct 20, 2023

May 11, 2023

Mar 03, 2023

Mar 03, 2023

Apr 02, 2019

Jul DISC

Mar CTNA

Oct NEWA

May NEWA

Mar DISC

Feb NEWA

May CAHN

CEFACLOR

CAPSULE;ORAL

CEFACLOR

>D>

>A>

>D>

>A>

>D>

>A>

>D>

>A>

AB

AB

AB

AB

!

!

@

@

HIKMA

YUNG SHIN PHARM

EQ 250MG BASE

EQ 250MG BASE

EQ 500MG BASE

EQ 500MG BASE

EQ 250MG BASE

EQ 250MG BASE

EQ 500MG BASE

EQ 500MG BASE

A065350

A065350

A065350

A065350

A065146

A065146

A065146

A065146

001

001

002

002

001

001

002

002

Apr 03, 2007

Apr 03, 2007

Apr 03, 2007

Apr 03, 2007

Jan 22, 2004

Jan 22, 2004

Jan 22, 2004

Jan 22, 2004

Dec DISC

Dec DISC

Dec DISC

Dec DISC

Dec CTEC

Dec CTEC

Dec CTEC

Dec CTEC

CEFADROXIL/CEFADROXIL HEMIHYDRATE

CAPSULE;ORAL

CEFADROXIL

>D>

>A>

AB HIKMA

@

FOR SUSPENSION;ORAL

CEFADROXIL

EQ 500MG BASE

EQ 500MG BASE

A065311

A065311

001

001

Feb 07, 2006

Feb 07, 2006

Dec DISC

Dec DISC

>D>

>A>

>D>

>A>

AB

AB

HIKMA PHARMS

@

@

TABLET;ORAL

CEFADROXIL

EQ 250MG BASE/5ML

EQ 250MG BASE/5ML

EQ 500MG BASE/5ML

EQ 500MG BASE/5ML

A091036

A091036

A091036

A091036

001

001

002

002

Nov 28, 2012

Nov 28, 2012

Nov 28, 2012

Nov 28, 2012

Dec DISC

Dec DISC

Dec DISC

Dec DISC

>D>

>A>

>D>

>A>

AB

AB !

!

@

HIKMA

TEVA PHARMS

EQ 1GM BASE

EQ 1GM BASE

EQ 1GM BASE

EQ 1GM BASE

A065260

A065260

A062774

A062774

001

001

001

001

Mar 30, 2006

Mar 30, 2006

Apr 08, 1987

Apr 08, 1987

Dec DISC

Dec DISC

Dec CTEC

Dec CTEC

CEFAZOLIN SODIUM

INJECTABLE;INJECTION

ANCEF IN PLASTIC CONTAINER

@ BAXTER HLTHCARE

POWDER;INTRAVENOUS

CEFAZOLIN SODIUM

EQ 20MG BASE/ML A063002 002 Mar 28, 1991 Oct DISC

+! HQ SPCLT PHARMA EQ 2GM BASE/VIAL N211413 001 May 08, 2023 May NEWA
RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - December 2023 1-27

CEFDINIR

CAPSULE;ORAL

CEFDINIR

AB ANDA REPOSITORY

FOR SUSPENSION;ORAL

CEFDINIR

300MG A065418 001 Jul 18, 2007 Sep CAHN

AB

AB

ANDA REPOSITORY 125MG/5ML

250MG/5ML

A065429

A065429

001

002

Jul 18, 2007

Jul 18, 2007

Sep CAHN

Sep CAHN

CEFEPIME HYDROCHLORIDE

INJECTABLE;INJECTION

CEFEPIME HYDROCHLORIDE

>D>

>A>

>D>

>A>

>D>

>A>

AP

AP

AP

AP

AP

!

!

!

QILU

MAXIPIME

EQ 500MG BASE/VIAL

EQ 500MG BASE/VIAL

EQ 1GM BASE/VIAL

EQ 1GM BASE/VIAL

EQ 2GM BASE/VIAL

EQ 2GM BASE/VIAL

A203704

A203704

A203704

A203704

A203704

A203704

001

001

002

002

003

003

Feb 01, 2016

Feb 01, 2016

Feb 01, 2016

Feb 01, 2016

Feb 01, 2016

Feb 01, 2016

Dec CTEC

Dec CTEC

Dec CHRS

Dec CHRS

Dec CHRS

Dec CHRS

>D>

>A>

>D>

>A>

>D>

>A>

AP

AP

AP

+!

+ @

+!

+ @

+!

+ @

HOSPIRA INC EQ 500MG BASE/VIAL

EQ 500MG BASE/VIAL

EQ 1GM BASE/VIAL

EQ 1GM BASE/VIAL

EQ 2GM BASE/VIAL

EQ 2GM BASE/VIAL

N050679

N050679

N050679

N050679

N050679

N050679

001

001

002

002

003

003

Jan 18, 1996

Jan 18, 1996

Jan 18, 1996

Jan 18, 1996

Jan 18, 1996

Jan 18, 1996

Dec DISC

Dec DISC

Dec DISC

Dec DISC

Dec DISC

Dec DISC

CEFOTAXIME SODIUM

INJECTABLE;INJECTION

CEFOTAXIME

@

@

@

@

HIKMA EQ 500MG BASE/VIAL

EQ 1GM BASE/VIAL

EQ 2GM BASE/VIAL

EQ 10GM BASE/VIAL

A065072

A065072

A065072

A065071

001

002

003

001

Nov 20, 2002

Nov 20, 2002

Nov 20, 2002

Nov 20, 2002

Mar DISC

Mar DISC

Mar DISC

Mar DISC

CEFOTETAN DISODIUM

INJECTABLE;INJECTION

CEFOTAN

+

+

@ PAI HOLDINGS PHARM

@

CEFOTETAN

EQ 1GM BASE/VIAL

EQ 2GM BASE/VIAL

N050588

N050588

001

002

Dec 27, 1985

Dec 27, 1985

May DISC

May DISC

!

!

FRESENIUS KABI USA EQ 1GM BASE/VIAL

EQ 2GM BASE/VIAL

A065374

A065374

001

002

Aug 09, 2007

Aug 09, 2007

May CTEC

May CTEC

CEFPODOXIME PROXETIL

TABLET;ORAL

CEFPODOXIME PROXETIL

AB

AB

ANDA REPOSITORY EQ 100MG BASE

EQ 200MG BASE

A065388

A065388

001

002

Nov 14, 2007

Nov 14, 2007

Sep CAHN

Sep CAHN

CEFTAROLINE FOSAMIL

POWDER;INTRAVENOUS

TEFLARO

+!

+!

ABBVIE 400MG/VIAL

600MG/VIAL

N200327

N200327

001

002

Oct 29, 2010

Oct 29, 2010

May CAHN

May CAHN

CEFTAZIDIME

INJECTABLE;INJECTION

CEFTAZIDIME

AP

AP

AP

!

!

!

ACS DOBFAR

FORTAZ

1GM/VIAL

2GM/VIAL

6GM/VIAL

A062640

A062640

A062640

002

003

004

Nov 20, 1985

Nov 20, 1985

Feb 03, 1992

May CHRS

May CHRS

May CHRS

+

+

+

+

@ PAI HOLDINGS PHARM

@

@

@

TAZICEF

500MG/VIAL

1GM/VIAL

2GM/VIAL

6GM/VIAL

N050578

N050578

N050578

N050578

001

002

003

004

Jul 19, 1985

Jul 19, 1985

Jul 19, 1985

Jul 19, 1985

May DISC

May DISC

May DISC

May DISC

@ HOSPIRA 500MG/VIAL

500MG/VIAL

A062662

A062662

001

001

Mar 06, 1986

Mar 06, 1986

May DISC

May CTEC
RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - December 2023 1-28

CEFTRIAXONE SODIUM

INJECTABLE;INJECTION

CEFTRIAXONE SODIUM

AP ANDA REPOSITORY EQ 10GM BASE/VIAL A091117 001 Jan 20, 2017 Sep CAHN

CEFUROXIME AXETIL

TABLET;ORAL

CEFUROXIME AXETIL

AB

AB

AB

ANDA REPOSITORY EQ 125MG BASE

EQ 250MG BASE

EQ 500MG BASE

A065359

A065359

A065359

001

002

003

Feb 15, 2008

Feb 15, 2008

Feb 15, 2008

Sep CAHN

Sep CAHN

Sep CAHN

CEFUROXIME SODIUM

INJECTABLE;INJECTION

CEFUROXIME AND DEXTROSE IN DUPLEX CONTAINER

+ @ B BRAUN

+!

+ @

CEFUROXIME SODIUM

EQ 750MG BASE/VIAL

EQ 750MG BASE/VIAL

EQ 1.5GM BASE/VIAL

N050780

N050780

N050780

001

001

002

Feb 21, 2001

Feb 21, 2001

Feb 21, 2001

Jun DISC

May CTEC

Jun DISC

AP

@ ACS DOBFAR SPA

! HIKMA

@

ZINACEF

EQ 7.5GM BASE/VIAL

EQ 1.5GM BASE/VIAL

EQ 7.5GM BASE/VIAL

A064124

A065048

A065046

001

002

001

May 30, 1997

Jan 09, 2004

Jan 09, 2004

Jun DISC

Jun CHRS

Jun DISC

+ @ PAI HOLDINGS PHARM EQ 1.5GM BASE/VIAL

+ @ EQ 7.5GM BASE/VIAL

INJECTABLE;INTRAMUSCULAR, INTRAVENOUS

CEFUROXIME SODIUM

N050558

N050558

003

004

Oct 19, 1983

Oct 23, 1986

Jun DISC

Jun DISC

AB ! HIKMA

ZINACEF

EQ 750MG BASE/VIAL A065048 001 Jan 09, 2004 Jun CHRS

+ @ PAI HOLDINGS PHARM EQ 750MG BASE/VIAL N050558 002 Oct 19, 1983 Jun DISC

CELECOXIB

CAPSULE;ORAL

CELECOXIB

AB

AB

AB

@ MYLAN

@

@

@

@ YABAO PHARM

@

@

SOLUTION;ORAL

ELYXYB

50MG

100MG

200MG

400MG

100MG

100MG

200MG

200MG

400MG

400MG

A078857

A078857

A078857

A078857

A212564

A212564

A212564

A212564

A212564

A212564

001

002

003

004

001

001

002

002

003

003

May 30, 2014

Feb 11, 2015

Feb 11, 2015

Feb 11, 2015

Apr 10, 2023

Apr 10, 2023

Apr 10, 2023

Apr 10, 2023

Apr 10, 2023

Apr 10, 2023

Jun DISC

Mar DISC

Jun DISC

Jun DISC

Sep DISC

Mar NEWA

Sep DISC

Mar NEWA

Sep DISC

Mar NEWA

+! SCILEX HLDG

+ @

25MG/ML

25MG/ML

N212157

N212157

001

001

May 05, 2020

May 05, 2020

Nov CMFD

Feb CAHN

CEPHALEXIN

CAPSULE;ORAL

CEPHALEXIN

>D>

>A>

>D>

>A>

AB

AB

AB

AB

AB

AB

!

@

@

ALKEM LABS LTD

ANDA REPOSITORY

AUROBINDO PHARMA

HIKMA

EQ 750MG BASE

EQ 250MG BASE

EQ 500MG BASE

EQ 750MG BASE

EQ 250MG BASE

EQ 250MG BASE

EQ 500MG BASE

EQ 500MG BASE

A090836

A065248

A065248

A065253

A065215

A065215

A065215

A065215

004

001

002

003

001

001

002

002

Mar 29, 2013

Jun 28, 2005

Jun 28, 2005

Dec 06, 2023

Jan 24, 2006

Jan 24, 2006

Jan 24, 2006

Jan 24, 2006

Nov CTEC

Sep CAHN

Sep CAHN

Nov NEWA

Dec DISC

Dec DISC

Dec DISC

Dec DISC

CETIRIZINE HYDROCHLORIDE

SOLUTION/DROPS;OPHTHALMIC

ZERVIATE

+! HARROW EYE EQ 0.24% BASE

SYRUP;ORAL

CETIRIZINE HYDROCHLORIDE

N208694 001 May 30, 2017 Oct CAHN

AA BIONPHARMA 5MG/5ML A078488 001 Oct 06, 2008 Jun CAHN
RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - December 2023 1-29

CETRORELIX ACETATE

POWDER;SUBCUTANEOUS

CETRORELIX ACETATE

AP TEVA PHARMS INC EQ 0.25MG BASE/VIAL A215737 001 Aug 12, 2022 Jul CAHN

CEVIMELINE HYDROCHLORIDE

CAPSULE;ORAL

CEVIMELINE HYDROCHLORIDE

AB

AB

AB

AUROBINDO PHARMA

BIONPHARMA

RUBICON

30MG

30MG

30MG

A215056

A218290

A216682

001

001

001

Apr 18, 2023

Nov 08, 2023

Apr 06, 2023

Apr NEWA

Nov NEWA

Mar NEWA

CHLORAMBUCIL

TABLET;ORAL

LEUKERAN

+! WAYLIS THERAP 2MG N010669 002 Sep CAHN

CHLORDIAZEPOXIDE HYDROCHLORIDE; CLIDINIUM BROMIDE

CAPSULE;ORAL

CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE

>A>

AB

AB

@

ALEMBIC

AUROBINDO PHARMA LTD

TORRENT

5MG;2.5MG

5MG;2.5MG

5MG;2.5MG

A216969

A216419

A217385

001

001

001

Sep 15, 2023

Sep 14, 2023

Dec 14, 2023

Sep NEWA

Sep NEWA

Dec DISC

CHLORHEXIDINE GLUCONATE

SOLUTION;DENTAL

CHLORHEXIDINE GLUCONATE

AT CHARTWELL RX 0.12% A075006 001 Mar 03, 2004 Jan CAHN

CHLOROPROCAINE HYDROCHLORIDE

SOLUTION;INTRATHECAL

CLOROTEKAL

+ @ B BRAUN MEDICAL INC 50MG/5ML (10MG/ML) N208791 001 Sep 26, 2017 Sep DISC

CHLOROTHIAZIDE

TABLET;ORAL

DIURIL

+

+

@

@

RISING 250MG

500MG

N011145

N011145

004

002

Sep CAHN

Sep CAHN

CHLOROTHIAZIDE SODIUM

INJECTABLE;INJECTION

CHLOROTHIAZIDE SODIUM

>D>

>A>

>D>

AP

AP !

SAGENT PHARMS INC

DIURIL

EQ 500MG BASE/VIAL

EQ 500MG BASE/VIAL

A202462

A202462

001

001

May 29, 2015

May 29, 2015

Dec CHRS

Dec CHRS

>D>

>A>

AP

AP

+!

+ @

+!

RISING EQ 500MG BASE/VIAL

EQ 500MG BASE/VIAL

EQ 500MG BASE/VIAL

N011145

N011145

N011145

005

005

005

Dec DISC

Dec DISC

Sep CAHN

CHLORPROMAZINE HYDROCHLORIDE

TABLET;ORAL

CHLORPROMAZINE HYDROCHLORIDE

AB

AB

AB

AB

AB

AB

AB

AB

AB

AB

AB

AB

AB

AB

AB

AB

AB

AB

ALEMBIC

AMNEAL PHARMS CO

APPCO

CHARTWELL RX

10MG

25MG

50MG

100MG

200MG

10MG

25MG

50MG

100MG

200MG

10MG

25MG

50MG

100MG

200MG

10MG

25MG

50MG

A217350

A217350

A217350

A217350

A217350

A209755

A209755

A209755

A209755

A209755

A213590

A213590

A213590

A213590

A213590

A212630

A212630

A212630

001

002

003

004

005

001

002

003

004

005

001

002

003

004

005

001

002

003

Jul 18, 2023

Jul 18, 2023

Jul 18, 2023

Jul 18, 2023

Jul 18, 2023

Sep 10, 2018

Sep 10, 2018

Sep 10, 2018

Sep 10, 2018

Sep 10, 2018

Aug 31, 2020

Aug 31, 2020

Aug 31, 2020

Aug 31, 2020

Aug 31, 2020

Nov 29, 2021

Nov 29, 2021

Nov 29, 2021

Jul NEWA

Jul NEWA

Jul NEWA

Jul NEWA

Jul NEWA

Apr CTEC

Apr CTEC

Apr CTEC

Apr CTEC

Apr CTEC

Jul CMFD

Jul CMFD

Jul CMFD

Jul CMFD

Jul CMFD

Sep CAHN

Sep CAHN

Sep CAHN
RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - December 2023 1-30

TABLET;ORAL

CHLORPROMAZINE HYDROCHLORIDE

AB

AB

AB

AB

AB

AB

AB

LUPIN

100MG

200MG

10MG

25MG

50MG

100MG

200MG

A212630

A212630

A213327

A213327

A213327

A213327

A213327

004

005

001

002

003

004

005

Nov 29, 2021

Nov 29, 2021

Jul 13, 2023

Jul 13, 2023

Jul 13, 2023

Jul 13, 2023

Jul 13, 2023

Sep CAHN

Sep CAHN

Jul NEWA

Jul NEWA

Jul NEWA

Jul NEWA

Jul NEWA

CHLORZOXAZONE

TABLET;ORAL

CHLORZOXAZONE

AA

AB

AB

AB

AB

AB

AB

AA

AA

AA

AA

AB

AB

@ ACME LABS

APPCO

APTAPHARMA INC

AUROBINDO PHARMA LTD

BELCHER

COREPHARMA

GRAVITI PHARMS

RISE PHARMA

UPSHER SMITH LABS

500MG

500MG

375MG

750MG

375MG

750MG

375MG

750MG

250MG

250MG

250MG

250MG

375MG

750MG

A214365

A214365

A212047

A212047

A212053

A212053

A089853

A089853

A215540

A214702

A216925

A215158

A212047

A212047

001

001

001

002

001

002

002

003

001

001

001

001

001

002

Apr 27, 2023

Apr 27, 2023

Jan 27, 2023

Jan 27, 2023

Sep 14, 2020

Sep 14, 2020

Aug 17, 2023

Aug 17, 2023

Jan 24, 2023

Apr 10, 2023

Aug 09, 2023

Jul 29, 2021

Jan 27, 2023

Jan 27, 2023

Nov DISC

Apr NEWA

Jan NEWA

Jan NEWA

Sep CAHN

Sep CAHN

Aug NEWA

Aug NEWA

Jan NEWA

Mar NEWA

Jul NEWA

Sep CAHN

Sep CAHN

Sep CAHN

CHOLESTYRAMINE

POWDER;ORAL

CHOLESTYRAMINE

@

@

ANI PHARMS EQ 4GM RESIN/PACKET

EQ 4GM RESIN/SCOOPFUL

A074554

A074554

001

002

Oct 02, 1996

Oct 02, 1996

Aug DISC

Aug DISC

CHOLIC ACID

CAPSULE;ORAL

CHOLBAM

+

+!

MIRUM 50MG

250MG

N205750

N205750

001

002

Mar 17, 2015

Mar 17, 2015

Sep CAHN

Sep CAHN

CHOLINE FENOFIBRATE

CAPSULE, DELAYED RELEASE;ORAL

FENOFIBRIC ACID

AB

AB

SCINOPHARM TAIWAN EQ 45MG FENOFIBRIC ACID

EQ 135MG FENOFIBRIC ACID

A210469

A210469

001

002

Jul 05, 2019

Jul 05, 2019

Sep CAHN

Sep CAHN

CICLOPIROX

SHAMPOO;TOPICAL

CICLOPIROX

>D>

>A>

@ PAI HOLDINGS PHARM

@

@ VERTICE

SOLUTION;TOPICAL

CICLOPIROX

1%

1%

1%

A209975

A209975

A209975

001

001

001

Apr 05, 2018

Apr 05, 2018

Apr 05, 2018

Dec CAHN

May DISC

Dec CAHN

AT

AT !

ENCUBE

PADAGIS US

8%

8%

A077687

A077623

001

001

Sep 18, 2007

Sep 18, 2007

Oct CMFD

Jan CHRS

CILOSTAZOL

TABLET;ORAL

CILOSTAZOL

AB

AB

@

@

@

@

AUROBINDO PHARMA USA

CASI PHARMS INC

EPIC PHARMA LLC

50MG

100MG

50MG

100MG

50MG

100MG

A077019

A077019

A077310

A077021

A077022

A077022

001

002

001

001

002

001

Nov 23, 2004

Nov 23, 2004

Nov 08, 2005

Nov 23, 2004

Mar 11, 2005

Nov 23, 2004

Apr CAHN

Apr CAHN

Nov DISC

Nov DISC

Jun CMFD

Jun CMFD
RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - December 2023 1-31

CIMETIDINE

TABLET;ORAL

CIMETIDINE

@ PLIVA 800MG A074566 001 Feb 27, 1997 Sep DISC

CIMETIDINE HYDROCHLORIDE

AA

AA

SOLUTION;ORAL

CIMETIDINE HYDROCHLORIDE

! PAI HOLDINGS PHARM EQ 300MG BASE/5ML

@ PHARMOBEDIENT CNSLTG EQ 300MG BASE/5ML

@ XTTRIUM LABS INC EQ 300MG BASE/5ML

EQ 300MG BASE/5ML

A074664

A074757

A074757

A074757

001

001

001

001

Oct 28, 1997

Oct 17, 1997

Oct 17, 1997

Oct 17, 1997

Oct CAHN

Sep CAHN

Jul DISC

Mar CAHN

CINACALCET HYDROCHLORIDE

>D>

>D>

>D>

>A>

>A>

>A>

AB

AB

AB

AB

AB

AB

TABLET;ORAL

CINACALCET HYDROCHLORIDE

@ AMNEAL PHARMS 30MG

@ 60MG

@ 90MG

CHARTWELL RX EQ 30MG BASE

EQ 60MG BASE

EQ 90MG BASE

SLATE RUN PHARMA EQ 30MG BASE

EQ 60MG BASE

EQ 90MG BASE

@ STEVENS J 30MG

@ 60MG

@ 90MG

A204364

A204364

A204364

A213325

A213325

A213325

A210207

A210207

A210207

A204364

A204364

A204364

001

002

003

001

002

003

001

002

003

001

002

003

Dec 02, 2021

Dec 02, 2021

Dec 02, 2021

May 18, 2020

May 18, 2020

May 18, 2020

Aug 01, 2018

Aug 01, 2018

Aug 01, 2018

Dec 02, 2021

Dec 02, 2021

Dec 02, 2021

Dec CAHN

Dec CAHN

Dec CAHN

Jun CAHN

Jun CAHN

Jun CAHN

Sep CAHN

Sep CAHN

Sep CAHN

Dec CAHN

Dec CAHN

Dec CAHN

CIPROFLOXACIN

AB

AB

AB

AB

FOR SUSPENSION;ORAL

CIPRO

+ BAYER HLTHCARE 250MG/5ML

+! 500MG/5ML

CIPROFLOXACIN

CHARTWELL 250MG/5ML

500MG/5ML

INJECTABLE, SUSPENSION;OTIC

OTIPRIO

+ @ ALK ABELLO 6% (60MG/ML)

N020780

N020780

A200563

A200563

N207986

001

002

001

002

001

Sep 26, 1997

Sep 26, 1997

Mar 05, 2014

Mar 05, 2014

Dec 10, 2015

May CTEC

May CTEC

May CMFD

May CMFD

Jan DISC

CIPROFLOXACIN HYDROCHLORIDE

AT

AT

AB

AB

AB

OINTMENT;OPHTHALMIC

CILOXAN

+! SANDOZ EQ 0.3% BASE

SOLUTION/DROPS;OPHTHALMIC

CILOXAN

+! SANDOZ EQ 0.3% BASE

CIPROFLOXACIN HYDROCHLORIDE

@ AKORN EQ 0.3% BASE

@ PAI HOLDINGS PHARM EQ 0.3% BASE

RUBICON EQ 0.3% BASE

TABLET;ORAL

CIPROFLOXACIN HYDROCHLORIDE

AMNEAL EQ 250MG BASE

EQ 500MG BASE

EQ 750MG BASE

@ TARO EQ 250MG BASE

@ EQ 500MG BASE

@ EQ 750MG BASE

N020369

N019992

A076555

A076754

A075928

A075939

A075939

A075939

A076912

A076912

A076912

001

001

001

001

001

002

003

004

002

003

004

Mar 30, 1998

Dec 31, 1990

Dec 11, 2008

Jun 09, 2004

Jun 09, 2004

Jun 09, 2004

Jun 09, 2004

Jun 09, 2004

Oct 06, 2004

Oct 06, 2004

Oct 06, 2004

Sep CAHN

Sep CAHN

Feb DISC

Aug DISC

Aug CMFD

Jun CMFD

Jun CMFD

Jun CMFD

Aug DISC

Aug DISC

Aug DISC

CIPROFLOXACIN HYDROCHLORIDE; HYDROCORTISONE

SUSPENSION/DROPS;OTIC

CIPRO HC

+! SANDOZ EQ 0.2% BASE;1% N020805 001 Feb 10, 1998 Sep CAHN
RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - December 2023 1-32

CIPROFLOXACIN; CIPROFLOXACIN HYDROCHLORIDE

TABLET, EXTENDED RELEASE;ORAL

CIPROFLOXACIN EXTENDED RELEASE

@

@

RISING 212.6MG;EQ 287.5MG BASE

425.2MG;EQ 574.9MG BASE

A078183

A078183

001

002

Mar 22, 2007

Mar 22, 2007

Jun CAHN

Jun CAHN

CIPROFLOXACIN; DEXAMETHASONE

SUSPENSION/DROPS;OTIC

CIPRODEX

AB +! SANDOZ 0.3%;0.1%

CIPROFLOXACIN AND DEXAMETHASONE

N021537 001 Jul 18, 2003 Sep CAHN

AB

AB

AKORN

SENTISS

0.3%;0.1%

0.3%;0.1%

A215768

A215768

001

001

Jun 09, 2023

Jun 09, 2023

Jun NEWA

Aug CAHN

CISATRACURIUM BESYLATE

INJECTABLE;INJECTION

CISATRACURIUM BESYLATE

>A>

>D>

>A>

AP

AP

AP

AP

AP

AP

CAPLIN

HIKMA

EQ 2MG BASE/ML

EQ 10MG BASE/ML

EQ 2MG BASE/ML

EQ 2MG BASE/ML

EQ 10MG BASE/ML

EQ 10MG BASE/ML

A217725

A217725

A203078

A203079

A203078

A203078

001

002

001

001

001

002

Jun 09, 2023

Jun 09, 2023

Jun 28, 2022

Apr 19, 2023

Jun 28, 2022

Dec 18, 2023

Jun NEWA

Jun NEWA

Dec CPOT

Apr NEWA

Dec CPOT

Dec NEWA

CITALOPRAM HYDROBROMIDE

TABLET;ORAL

CELEXA

AB

AB

AB

+

+

+!

@

ABBVIE EQ 10MG BASE

EQ 20MG BASE

EQ 40MG BASE

EQ 60MG BASE

N020822

N020822

N020822

N020822

001

002

003

004

Apr 27, 2000

Jul 17, 1998

Jul 17, 1998

Jul 17, 1998

Feb CAHN

Feb CAHN

Feb CAHN

Feb CAHN

CLARITHROMYCIN

FOR SUSPENSION;ORAL

CLARITHROMYCIN

SANDOZ

!

TABLET;ORAL

CLARITHROMYCIN

125MG/5ML

250MG/5ML

A065283

A065283

002

003

Sep 04, 2007

Sep 04, 2007

May CTEC

May CTEC

@ TEVA 250MG

@ 500MG

TABLET, EXTENDED RELEASE;ORAL

CLARITHROMYCIN

A065155

A065155

001

002

May 31, 2005

May 31, 2005

Sep DISC

Sep DISC

AB NOSTRUM LABS INC 500MG A203243 001 Feb 29, 2016 Sep CMFD

CLINDAMYCIN HYDROCHLORIDE

CAPSULE;ORAL

CLINDAMYCIN HYDROCHLORIDE

AB

AB

AB

GLENMARK PHARMS LTD EQ 75MG BASE

EQ 150MG BASE

EQ 300MG BASE

A216957

A216957

A216957

001

002

003

Mar 10, 2023

Mar 10, 2023

Mar 10, 2023

Mar NEWA

Mar NEWA

Mar NEWA

CLINDAMYCIN PALMITATE HYDROCHLORIDE

FOR SOLUTION;ORAL

CLINDAMYCIN PALMITATE HYDROCHLORIDE

AA CHARTWELL RX EQ 75MG BASE/5ML A206958 001 May 05, 2017 Feb CAHN

CLINDAMYCIN PHOSPHATE

AEROSOL, FOAM;TOPICAL

CLINDAMYCIN PHOSPHATE

AT ! PADAGIS ISRAEL

EVOCLIN

1% A090785 001 Mar 31, 2010 Jun CHRS

+ @ MYLAN

GEL;TOPICAL

CLINDAMYCIN PHOSPHATE

1% N050801 001 Oct 22, 2004 Jun DISC

AB1 ZYDUS LIFESCIENCES EQ 1% BASE

INJECTABLE;INJECTION

CLINDAMYCIN PHOSPHATE IN DEXTROSE 5%

A216587 001 Sep 19, 2023 Sep NEWA

AP

AP

HIKMA EQ 6MG BASE/ML

EQ 12MG BASE/ML

A214401

A214401

001

002

Apr 05, 2023

Apr 05, 2023

Mar NEWA

Mar NEWA
RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - December 2023 1-33

INJECTABLE;INJECTION

CLINDAMYCIN PHOSPHATE IN DEXTROSE 5%

AP

SOLUTION;TOPICAL

CLINDAMYCIN PHOSPHATE

EQ 18MG BASE/ML A214401 003 Apr 05, 2023 Mar NEWA

AT CHARTWELL RX

@ PAI HOLDINGS PHARM

@ XTTRIUM LABS INC

EQ 1% BASE

EQ 1% BASE

EQ 1% BASE

A209846

A206945

A063304

001 Feb 08, 2018

001 Dec 30, 2016

001 Jul 15, 1997

May CAHN

Aug DISC

Jan CAHN

CLINDAMYCIN PHOSPHATE; TRETINOIN

GEL;TOPICAL

CLINDAMYCIN PHOSPHATE AND TRETINOIN

AB2 ENCUBE 1.2%;0.025% A216943 001 Sep 01, 2023 Aug NEWA

CLOBAZAM

SUSPENSION;ORAL

CLOBAZAM

@

@

@

@

ACCORD HLTHCARE

MYLAN

UPSHER SMITH LABS

VISTAPHARM

2.5MG/ML

2.5MG/ML

2.5MG/ML

2.5MG/ML

A216008

A211259

A210569

A210746

001 Sep 06, 2022

001 Oct 22, 2018

001 Oct 22, 2018

001 Jul 10, 2019

Mar DISC

Nov DISC

Mar DISC

Oct DISC

CLOBETASOL PROPIONATE

AEROSOL, FOAM;TOPICAL

CLOBETASOL PROPIONATE

AB2

AB1

!

!

@ NOVAST LABS

PADAGIS ISRAEL

TARO

OLUX

0.05%

0.05%

0.05%

A206805

A201402

A208779

001 Jul 31, 2017

001 Aug 14, 2012

001 Oct 04, 2018

Sep CAHN

Nov CHRS

Nov CHRS

+ @ MYLAN

OLUX E

0.05% N021142 001 May 26, 2000 Nov DISC

+ @ MYLAN

CREAM;TOPICAL

CLOBETASOL PROPIONATE

0.05% N022013 001 Jan 12, 2007 Nov DISC

AB1

@ CHARTWELL RX 0.05%

! ENCUBE 0.05%

@ PAI HOLDINGS PHARM 0.05%

@ TORRENT 0.05%

CLOBETASOL PROPIONATE (EMOLLIENT)

@ ANI PHARMS 0.05%

@ PAI HOLDINGS PHARM 0.05%

GEL;TOPICAL

CLOBETASOL PROPIONATE

A211207

A212982

A209974

A211836

A075733

A209411

001 Mar 26, 2021

001 Aug 28, 2020

001 Apr 17, 2018

001 Dec 30, 2019

001 Aug 22, 2001

001 Aug 21, 2017

May CAHN

Jun CHRS

Aug DISC

Feb DISC

Apr DISC

Aug DISC

@ PAI HOLDINGS PHARM

LOTION;TOPICAL

CLOBETASOL PROPIONATE

0.05% A208881 001 Mar 06, 2017 Aug DISC

@ PAI HOLDINGS PHARM

IMPEKLO

0.05% A208667 001 Nov 29, 2016 Aug DISC

+ @ MYLAN

OINTMENT;TOPICAL

CLOBETASOL PROPIONATE

0.05% N213691 001 May 19, 2020 Sep DISC

>A> AB MACLEODS PHARMS LTD

@ PAI HOLDINGS PHARM

SHAMPOO;TOPICAL

CLOBETASOL PROPIONATE

0.05%

0.05%

A215990

A208589

001 Dec 28, 2023

001 Jan 23, 2019

Dec NEWA

Aug DISC

@ ACTAVIS MID ATLANTIC

SOLUTION;TOPICAL

CLOBETASOL PROPIONATE

0.05% A078854 001 Jun 07, 2011 Sep DISC

AT ! TARO 0.05% A075224 001 Nov 16, 1998 Aug CHRS

CLOFARABINE

SOLUTION;INTRAVENOUS

CLOFARABINE

@ EUGIA PHARMA 20MG/20ML (1MG/ML) A212457 001 Oct 03, 2022 Mar DISC

CLOMIPRAMINE HYDROCHLORIDE

CAPSULE;ORAL

CLOMIPRAMINE HYDROCHLORIDE

AB AUROBINDO PHARMA 25MG A216440 001 Mar 20, 2023 Mar NEWA

AB 50MG A216440 002 Mar 20, 2023 Mar NEWA

AB 75MG A216440 003 Mar 20, 2023 Mar NEWA
RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - December 2023 1-34

CAPSULE;ORAL

CLOMIPRAMINE HYDROCHLORIDE

AB

AB

AB

AB

AB

AB

CHEMISTRY HLTH

RK PHARMA

25MG

50MG

75MG

25MG

50MG

75MG

A211364

A211364

A211364

A213221

A213221

A213221

001 Feb 07, 2020

002 Feb 07, 2020

003 Feb 07, 2020

001 Jun 22, 2020

002 Jun 22, 2020

003 Jun 22, 2020

Sep CAHN

Sep CAHN

Sep CAHN

Jun CAHN

Jun CAHN

Jun CAHN

CLONAZEPAM

TABLET;ORAL

CLONAZEPAM

AB

AB

AB

@

@

@

AUROBINDO PHARMA USA

CHARTWELL RX

0.5MG

1MG

2MG

0.5MG

1MG

2MG

A075150

A075150

A075150

A074925

A074925

A074925

001 Oct 05, 1998

002 Oct 05, 1998

003 Oct 05, 1998

001 Sep 30, 1997

002 Sep 30, 1997

003 Sep 30, 1997

Jan CMFD

Jan CMFD

Jan CMFD

Sep CAHN

Sep CAHN

Sep CAHN

CLONIDINE HYDROCHLORIDE

TABLET, EXTENDED RELEASE;ORAL

CLONIDINE HYDROCHLORIDE

>D>

>A>

>D>

>A>

>D>

AB2

AB1

AB1 !

ACTAVIS ELIZABETH

@

AJANTA PHARMA LTD

@ AMNEAL PHARMS NY

KAPVAY

0.1MG

0.1MG

0.1MG

0.1MG

0.1MG

A202792

A202792

A209686

A209686

A210052

001 May 15, 2015

001 May 15, 2015

001 Nov 20, 2017

001 Nov 20, 2017

001 Nov 20, 2017

Dec DISC

Dec DISC

Dec CHRS

Dec CHRS

Oct DISC

>D>

>A>

AB1 +!

+ @

CONCORDIA PHARMS INC 0.1MG

0.1MG

N022331

N022331

003 Sep 28, 2010

003 Sep 28, 2010

Dec DISC

Dec DISC

CLOPIDOGREL BISULFATE

TABLET;ORAL

CLOPIDOGREL BISULFATE

>A> AB

AB

AB

AB

@

@

@

ALKEM LABS LTD

CHARTWELL RX

HETERO LABS LTD V

RISING

SUN PHARM

EQ 75MG BASE

EQ 75MG BASE

EQ 300MG BASE

EQ 75MG BASE

EQ 300MG BASE

EQ 75MG BASE

EQ 75MG BASE

A203632

A202266

A202266

A205345

A205345

A204359

A090494

001 Dec 08, 2023

001 Aug 14, 2012

002 Nov 20, 2012

001 Aug 04, 2023

002 Aug 04, 2023

001 Feb 02, 2017

001 May 17, 2012

Dec NEWA

Jun CAHN

Jun CAHN

Aug NEWA

Aug NEWA

Aug CAHN

Sep DISC

CLORAZEPATE DIPOTASSIUM

CAPSULE;ORAL

CLORAZEPATE DIPOTASSIUM

@ DASH PHARMS

@

@

TRANXENE

3.75MG

7.5MG

15MG

A071509

A071510

A071511

001 Oct 19, 1987

001 Oct 19, 1987

001 Oct 19, 1987

Feb CAHN

Feb CAHN

Feb CAHN

>A>

>A>

>A>

>D>

>D>

>D>

+ @ AJENAT PHARMS

+ @

+ @

+ @ KEY THERAP

+ @

+ @

TABLET;ORAL

TRANXENE

3.75MG

7.5MG

15MG

3.75MG

7.5MG

15MG

N017105

N017105

N017105

N017105

N017105

N017105

001

002

003

001

002

003

Dec CAHN

Dec CAHN

Dec CAHN

Dec CAHN

Dec CAHN

Dec CAHN

>A>

>A> AB

+ @ AJENAT PHARMS

+

3.75MG

7.5MG

N017105

N017105

006

007

Dec CAHN

Dec CAHN

>A>

>D>

>D> AB

+ @

+ @ KEY THERAP

+

15MG

3.75MG

7.5MG

N017105

N017105

N017105

008

006

007

Dec CAHN

Dec CAHN

Dec CAHN

>D> + @

TRANXENE SD

15MG N017105 008 Dec CAHN

>A>

>A>

>D>

>D>

+ @ AJENAT PHARMS

+ @

+ @ KEY THERAP

+ @

11.25MG

22.5MG

11.25MG

22.5MG

N017105

N017105

N017105

N017105

005

004

005

004

Dec CAHN

Dec CAHN

Dec CAHN

Dec CAHN
RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - December 2023 1-35

CLOTRIMAZOLE

CREAM;TOPICAL

LOTRIMIN

+ @ SCHERING PLOUGH 1% N017619 001 Sep CRLD

SOLUTION;TOPICAL

CLOTRIMAZOLE

AT SCIEGEN PHARMS INC 1% A216569 001 Oct 16, 2023 Oct NEWA

CLOZAPINE

TABLET;ORAL

CLOZAPINE

@ DR REDDYS LABS SA 25MG A203807 001 Sep 17, 2015 Apr CAHN

@ 50MG A203807 003 Aug 22, 2017 Apr CAHN

@ 100MG A203807 002 Sep 17, 2015 Apr CAHN

@ 200MG A203807 004 Aug 22, 2017 Apr CAHN

@ MAYNE PHARMA 25MG A203807 001 Sep 17, 2015 Apr DISC

@ 50MG A203807 003 Aug 22, 2017 Apr DISC

@ 100MG A203807 002 Sep 17, 2015 Apr DISC

@ 200MG A203807 004 Aug 22, 2017 Apr DISC

TABLET, ORALLY DISINTEGRATING;ORAL

CLOZAPINE

AB MYLAN 150MG A201824 004 Aug 07, 2023 Jul NEWA

AB 200MG A201824 005 Aug 07, 2023 Jul NEWA

AB TEVA PHARMS USA 150MG A203039 001 Nov 25, 2015 Jul CTEC

AB 200MG A203039 002 Nov 25, 2015 Jul CTEC

COCAINE HYDROCHLORIDE

SOLUTION;NASAL

NUMBRINO

+! OMNIVIUM PHARMS 4% N209575 001 Jan 10, 2020 Aug CAHN

CODEINE PHOSPHATE; PROMETHAZINE HYDROCHLORIDE

SYRUP;ORAL

PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE

+ @ ACTAVIS MID ATLANTIC 10MG/5ML;6.25MG/5ML A088763 001 Oct 31, 1984 Sep DISC

AA ! TRIS PHARMA INC 10MG/5ML;6.25MG/5ML A200386 001 Jun 29, 2012 Sep CHRS

CODEINE PHOSPHATE; PSEUDOEPHEDRINE HYDROCHLORIDE; TRIPROLIDINE HYDROCHLORIDE

SYRUP;ORAL

TRIACIN-C

! ANIMA 10MG/5ML;30MG/5ML;1.25MG/5ML A088704 001 Mar 22, 1985 Mar CAHN

COLCHICINE

CAPSULE;ORAL

COLCHICINE

AB PAR PHARM INC 0.6MG A208678 001 Nov 29, 2018 Jun CMFD

MITIGARE

AB +! HIKMA INTL PHARMS 0.6MG N204820 001 Sep 26, 2014 Jun CTEC

TABLET;ORAL

LODOCO

+! AGEPHA PHARMA FZ 0.5MG N215727 001 Jun 16, 2023 Jun NEWA

COLCHICINE; PROBENECID

TABLET;ORAL

PROBENECID AND COLCHICINE

AB RISING 0.5MG;500MG A217030 001 Oct 24, 2023 Oct NEWA

COLESEVELAM HYDROCHLORIDE

FOR SUSPENSION;ORAL

COLESEVELAM HYDROCHLORIDE

AB IMPAX 3.75GM/PACKET A212886 001 Jan 18, 2023 Jan NEWA

TABLET;ORAL

COLESEVELAM HYDROCHLORIDE

@ CHARTWELL RX 625MG A201354 001 Dec 17, 2020 May CAHN

@ UNITED RES LABS 625MG A213456 001 Jan 21, 2022 Sep DISC

AB 625MG A213456 001 Jan 21, 2022 Sep CAHN
RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - December 2023 1-36

COLESTIPOL HYDROCHLORIDE

TABLET;ORAL

COLESTIPOL HYDROCHLORIDE

AB

AB

ANI PHARMS

PRAXGEN

1GM

1GM

A216517

A216517

001

001

Mar 10, 2023

Mar 10, 2023

Apr CAHN

Mar NEWA

>D> COPANLISIB DIHYDROCHLORIDE

>D>

>D>

>D>

>A>

POWDER;INTRAVENOUS

ALIQOPA

+! BAYER HEALTHCARE

+ @

60MG/VIAL

60MG/VIAL

N209936

N209936

001

001

Sep 14, 2017

Sep 14, 2017

Dec DISC

Dec DISC

CORTISONE ACETATE

TABLET;ORAL

CORTISONE ACETATE

@ HIKMA INTL PHARMS 25MG A080776 002 Jul DISC

CRIZOTINIB

CAPSULE, PELLETS;ORAL

XALKORI

+

+

+!

PF PRISM CV 20MG

50MG

150MG

N217581

N217581

N217581

001

002

003

Sep 07, 2023

Sep 07, 2023

Sep 07, 2023

Sep NEWA

Sep NEWA

Sep NEWA

CROMOLYN SODIUM

SOLUTION;INHALATION

CROMOLYN SODIUM

AN

@ EUGIA PHARMA

VIRTUS

SOLUTION/DROPS;OPHTHALMIC

CROMOLYN SODIUM

10MG/ML

10MG/ML

A074209

A075437

001

001

Apr 26, 1994

Apr 21, 2000

May CAHN

Apr CAHN

AT

@ AKORN

! SANDOZ

! SANDOZ INC

4%

4%

4%

A074706

A075282

A075282

001

001

001

Apr 29, 1998

Jun 16, 1999

Jun 16, 1999

Feb DISC

Feb CTEC

Feb CHRS

CROTAMITON

LOTION;TOPICAL

CROTAN

>A>

>D>

AT

AT

LEGACY PHARMA

MARNEL PHARMS

10%

10%

A087204

A087204

001

001

Dec CAHN

Dec CAHN

CYANOCOBALAMIN

SPRAY, METERED;NASAL

CYANOCOBALAMIN

AB

AB

LUPIN

PADAGIS ISRAEL

NASCOBAL

0.5MG/SPRAY

0.5MG/SPRAY

A210629

A212458

001

001

Jun 30, 2023

Sep 09, 2020

Jun NEWA

Nov CMFD

AB +! ENDO PHARMS INC 0.5MG/SPRAY N021642 001 Jan 31, 2005 Jun CTEC

CYCLOBENZAPRINE HYDROCHLORIDE

CAPSULE, EXTENDED RELEASE;ORAL

CYCLOBENZAPRINE HYDROCHLORIDE

@ APOTEX 15MG

@ 30MG

TABLET;ORAL

CYCLOBENZAPRINE HYDROCHLORIDE

A206703

A206703

001

002

Jul 24, 2018

Jul 24, 2018

Mar DISC

Mar DISC

AB

AB

AB

CHARTWELL RX 5MG

7.5MG

10MG

A078218

A078218

A078218

002

003

001

Jun 19, 2015

Nov 03, 2020

Apr 18, 2008

Feb CAHN

Feb CAHN

Feb CAHN

CYCLOPENTOLATE HYDROCHLORIDE

SOLUTION/DROPS;OPHTHALMIC

CYCLOGYL

+! ALCON LABS INC 0.5%

CYCLOPENTOLATE HYDROCHLORIDE

A084109 001 Feb CTEC

@ AKORN 0.5% A205937 001 Dec 09, 2015 Feb DISC
RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - December 2023 1-37

CYCLOPHOSPHAMIDE

CAPSULE;ORAL

CYCLOPHOSPHAMIDE

>A>

>A>

AB

AB

ZYDUS LIFESCIENCES

INJECTABLE;INJECTION

CYCLOPHOSPHAMIDE

25MG

50MG

A211552

A211552

001

002

Dec 13, 2023

Dec 13, 2023

Dec CAHN

Dec CAHN

>A>

>A>

>A>

AP

AP

AP

AP

AP

AP

AP

AP

AP

AP

AP

AP

RK PHARMA

SAGENT PHARMS INC

SUNNY

XGEN PHARMS

SOLUTION;INTRAVENOUS

CYCLOPHOSPHAMIDE

500MG/VIAL

1GM/VIAL

2GM/VIAL

500MG/VIAL

1GM/VIAL

2GM/VIAL

500MG/VIAL

1GM/VIAL

2GM/VIAL

500MG/VIAL

1GM/VIAL

2GM/VIAL

A216958

A216958

A216958

A214529

A214529

A214529

A215089

A215089

A215089

A211757

A211757

A211757

001

002

003

001

002

003

001

002

003

001

002

003

Dec 18, 2023

Dec 18, 2023

Dec 18, 2023

Jul 17, 2023

Jul 17, 2023

Jul 17, 2023

Oct 26, 2023

Oct 26, 2023

Oct 26, 2023

Oct 18, 2022

Oct 18, 2022

Oct 18, 2022

Dec NEWA

Dec NEWA

Dec NEWA

Jul NEWA

Jul NEWA

Jul NEWA

Oct NEWA

Oct NEWA

Oct NEWA

May CAHN

May CAHN

May CAHN

+! DR REDDYS

+!

+!

+! EUGIA PHARMA SPECLTS

+ @ NEVAKAR INJECTABLES

+!

+ @

+!

+! SANDOZ

+!

+!

500MG/ML (500MG/ML)

1GM/2ML (500MG/ML)

2GM/4ML (500MG/ML)

2GM/10ML (200MG/ML)

500MG/2.5ML (200MG/ML)

500MG/2.5ML (200MG/ML)

1GM/5ML (200MG/ML)

1GM/5ML (200MG/ML)

500MG/5ML (100MG/ML)

1GM/10ML (100MG/ML)

2GM/20ML (100MG/ML)

N210852

N210852

N210852

N210735

N217651

N217651

N217651

N217651

N217150

N217150

N217150

001

002

003

003

001

001

002

002

001

002

003

Jun 07, 2023

Jun 07, 2023

Jun 07, 2023

Nov 20, 2023

Jun 28, 2023

Jun 28, 2023

Jun 28, 2023

Jun 28, 2023

Sep 12, 2023

Sep 12, 2023

Sep 12, 2023

Jun NEWA

Jun NEWA

Jun NEWA

Nov NEWA

Aug DISC

Jun NEWA

Aug DISC

Jun NEWA

Sep NEWA

Sep NEWA

Sep NEWA

CYCLOSPORINE

EMULSION;OPHTHALMIC

CYCLOSPORINE

>A>

AB

AB

APOTEX

TEVA PHARMS USA INC

VERKAZIA

0.05%

0.05%

A207606

A203880

001

001

Jan 12, 2023

Dec 14, 2023

Jan NEWA

Dec NEWA

+! HARROW EYE

SOLUTION;OPHTHALMIC

VEVYE

0.1% N214965 001 Jun 23, 2021 Oct CAHN

+! HARROW EYE

+! NOVALIQ GMBH

SOLUTION;ORAL

CYCLOSPORINE

0.1%

0.1%

N217469

N217469

001

001

May 30, 2023

May 30, 2023

Sep CAHN

May NEWA

AB2

@ PHARMOBEDIENT CNSLTG

@ XTTRIUM LABS INC

SANDIMMUNE

100MG/ML

100MG/ML

100MG/ML

A065133

A065133

A065133

001

001

001

Sep 17, 2004

Sep 17, 2004

Sep 17, 2004

Sep CAHN

Jul DISC

Jan CAHN

+! NOVARTIS 100MG/ML N050574 001 Nov 14, 1983 Jul CTEC

CYPROHEPTADINE HYDROCHLORIDE

SYRUP;ORAL

CYPROHEPTADINE HYDROCHLORIDE

AA PATRIN 2MG/5ML

TABLET;ORAL

CYPROHEPTADINE HYDROCHLORIDE

A204823 001 Dec 27, 2016 Sep CAHN

AA

AA

AA

AA

+

!

@

@

CHARTWELL RX

HERITAGE PHARMA

KENTON

RISING

ZYDUS PHARMS

4MG

4MG

4MG

4MG

4MG

4MG

A088212

A087056

A040644

A207555

A207783

A208938

001

001

001

001

001

001

May 26, 1983

May 30, 2006

Jan 31, 2017

Dec 29, 2016

May 19, 2017

Mar CMFD

Nov DISC

Sep CAHN

Aug CAHN

May DISC

Nov CHRS

CYSTEINE HYDROCHLORIDE

SOLUTION;INTRAVENOUS

ELCYS

>A> +! EXELA PHARMA 2500MG/50ML (50MG/ML) N210660 002 Dec 04, 2023 Dec NEWA
RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - December 2023 1-38

DABIGATRAN ETEXILATE MESYLATE

CAPSULE;ORAL

DABIGATRAN ETEXILATE MESYLATE

>A>

>A>

>A>

AB

AB

AB

APOTEX

PRADAXA

EQ 75MG BASE

EQ 110MG BASE

EQ 150MG BASE

A208070

A208070

A208070

001

002

003

Dec 15, 2023

Dec 15, 2023

Dec 15, 2023

Dec NEWA

Dec NFTG

Dec NEWA

>D>

>A> AB

+

+

BOEHRINGER INGELHEIM EQ 110MG BASE

EQ 110MG BASE

N022512

N022512

003

003

Nov 20, 2015

Nov 20, 2015

Dec CFTG

Dec CFTG

DABRAFENIB MESYLATE

TABLET, FOR SUSPENSION;ORAL

TAFINLAR

+! NOVARTIS EQ 10MG BASE N217514 001 Mar 16, 2023 Mar NEWA

DACARBAZINE

INJECTABLE;INJECTION

DACARBAZINE

>D>

>D>

>A>

>A>

AP

AP

AP

AP

AP

AP

!

!

!

HONG KONG

MEITHEAL

200MG/VIAL

200MG/VIAL

500MG/VIAL

500MG/VIAL

200MG/VIAL

500MG/VIAL

A075259

A075259

A075259

A075259

A075259

A075259

002

002

001

001

002

001

Aug 27, 1998

Aug 27, 1998

Sep 22, 2000

Sep 22, 2000

Aug 27, 1998

Sep 22, 2000

Dec CAHN

Nov CAHN

Dec CAHN

Nov CAHN

Dec CAHN

Dec CAHN

DALBAVANCIN HYDROCHLORIDE

POWDER;INTRAVENOUS

DALVANCE

+! ABBVIE EQ 500MG BASE/VIAL N021883 001 May 23, 2014 Jun CAHN

DAPRODUSTAT

TABLET;ORAL

JESDUVROQ

+ GLAXOSMITHKLINE

+

+

+

+!

1MG

2MG

4MG

6MG

8MG

N216951

N216951

N216951

N216951

N216951

001

002

003

004

005

Feb 01, 2023

Feb 01, 2023

Feb 01, 2023

Feb 01, 2023

Feb 01, 2023

Feb NEWA

Feb NEWA

Feb NEWA

Feb NEWA

Feb NEWA

DAPSONE

GEL;TOPICAL

ACZONE

AB +! ABBVIE

DAPSONE

5% N021794 001 Jul 07, 2005 Jun CAHN

AB

AB

AB

AB

AB

AB

AB

AB

ACRUX DDS

ALEMBIC

AMNEAL

BELOTECA

ENCUBE

PADAGIS ISRAEL

TABLET;ORAL

DAPSONE

5%

7.5%

5%

7.5%

5%

5%

5%

7.5%

A213907

A215718

A209890

A212701

A213907

A212383

A215087

A212657

001

001

001

001

001

001

001

001

Jun 06, 2023

Oct 27, 2023

Oct 19, 2023

May 31, 2023

Jun 06, 2023

Oct 13, 2023

Oct 31, 2023

Nov 01, 2023

May NEWA

Oct NEWA

Oct NEWA

May NEWA

Sep CAHN

Oct NEWA

Oct NEWA

Oct NEWA

>D>

>A>

>D>

>A>

AB

AB

AB

ALVOGEN

@

@

@ CHARTWELL RX

@

+ EVEREST LIFE SCI

25MG

25MG

100MG

100MG

25MG

100MG

100MG

A205429

A205429

A205429

A205429

A204074

A204074

A086842

001

001

002

002

001

002

001

Jan 07, 2016

Jan 07, 2016

Jan 07, 2016

Jan 07, 2016

May 10, 2016

May 10, 2016

Dec DISC

Dec DISC

Dec DISC

Dec DISC

Sep CAHN

Sep CAHN

Jun CHRS

AB

AB

! NOVITIUM PHARMA

RISING

@ VIRTUS

@

100MG

25MG

25MG

100MG

A206505

A207165

A204074

A204074

002

002

001

002

Dec 01, 2016

Jul 20, 2023

May 10, 2016

May 10, 2016

Jun CHRS

Jul NEWA

Sep CAHN

Sep CAHN
RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - December 2023 1-39

DAPTOMYCIN

POWDER;INTRAVENOUS

DAPTOMYCIN

>D>

>A>

AP

AP

AP

AP

HAINAN POLY PHARM 500MG/VIAL

@ 500MG/VIAL

@ HISUN PHARM HANGZHOU 500MG/VIAL

500MG/VIAL

MYLAN 500MG/VIAL

! QILU PHARM HAINAN 500MG/VIAL

+! XELLIA PHARMS APS 350MG/VIAL

+! 500MG/VIAL

SOLUTION;INTRAVENOUS

DAPTOMYCIN IN 0.9% SODIUM CHLORIDE

A215890

A215890

A212250

A212250

A213966

A215316

N217415

N217415

001

001

001

001

001

001

001

002

Aug 18, 2022

Aug 18, 2022

Apr 21, 2021

Apr 21, 2021

Aug 07, 2023

Aug 24, 2021

Jan 30, 2023

Jan 30, 2023

Sep CMFD

Feb DISC

Dec CMFD

Dec CMFD

Jul NEWA

May CHRS

Jan NEWA

Jan NEWA

+!

+!

+!

+!

BAXTER HLTHCARE CORP 350MG/50ML (7MG/ML)

500MG/50ML (10MG/ML)

700MG/100ML (7MG/ML)

1GM/100ML (10MG/ML)

N213645

N213645

N213645

N213645

002

003

004

005

Feb 27, 2023

Feb 27, 2023

Feb 27, 2023

Feb 27, 2023

Mar NEWA

Mar NEWA

Mar NEWA

Mar NEWA

DARUNAVIR

TABLET;ORAL

DARUNAVIR

>A>

>A>

>A>

>A>

AB

AB

AB

AB

AB

AB

AB

AB

AB

AB

AB

AB

AB

AMNEAL

AUROBINDO PHARMA LTD

CIPLA

DR REDDYS

HETERO LABS LTD III

MSN

ZYDUS PHARMS

600MG

800MG

600MG

800MG

600MG

800MG

600MG

800MG

400MG

600MG

600MG

800MG

600MG

800MG

A212493

A212493

A210677

A210677

A206288

A206288

A211578

A211578

A202083

A202083

A215389

A215389

A214085

A214085

001

002

001

002

001

002

001

002

001

002

001

002

001

002

Dec 08, 2023

Dec 08, 2023

Nov 28, 2023

Nov 28, 2023

Nov 28, 2023

Nov 28, 2023

Nov 28, 2023

Nov 28, 2023

Sep 14, 2023

Sep 14, 2023

Nov 28, 2023

Nov 28, 2023

Dec 13, 2023

Dec 13, 2023

Dec NEWA

Dec NEWA

Nov NEWA

Nov NEWA

Nov NEWA

Nov NEWA

Nov NEWA

Nov NEWA

Sep NEWA

Sep NEWA

Nov NEWA

Nov NEWA

Dec NEWA

Dec NEWA

DASATINIB

>A>

TABLET;ORAL

PHYRAGO

>A>

>A>

>A>

>A>

>A>

>A>

+

+

+

+

+!

+

NANOCOPOEIA 20MG

50MG

70MG

80MG

100MG

140MG

N216099

N216099

N216099

N216099

N216099

N216099

001

002

003

004

005

006

Dec 05, 2023

Dec 05, 2023

Dec 05, 2023

Dec 05, 2023

Dec 05, 2023

Dec 05, 2023

Dec NEWA

Dec NEWA

Dec NEWA

Dec NEWA

Dec NEWA

Dec NEWA

DAUNORUBICIN HYDROCHLORIDE

INJECTABLE;INJECTION

DAUNORUBICIN HYDROCHLORIDE

>D>

>A>

AP

AP

AP

HONG KONG

MEITHEAL

EQ 5MG BASE/ML

EQ 5MG BASE/ML

EQ 5MG BASE/ML

A065035

A065035

A065035

001

001

001

Jan 24, 2000

Jan 24, 2000

Jan 24, 2000

Dec CAHN

Oct CAHN

Dec CAHN

DEFERASIROX

GRANULE;ORAL

DEFERASIROX

AB ANNORA PHARMA

TABLET;ORAL

DEFERASIROX

90MG A216229 003 Mar 16, 2023 Mar NEWA

>D>

>D>

>D>

>A>

AB

AB

AB

AB

AB

AB

@ AMNEAL

@

@

AUROBINDO PHARMA LTD

CHARTWELL RX

@ CIPLA

@

@

@ STEVENS J

90MG

180MG

360MG

90MG

180MG

360MG

90MG

180MG

360MG

90MG

180MG

360MG

90MG

A210727

A210727

A210727

A214474

A214474

A214474

A212669

A212669

A212669

A211852

A211852

A211852

A210727

001

003

002

001

002

003

001

002

003

001

003

002

001

Dec 27, 2019

Jun 15, 2020

Dec 27, 2019

Oct 16, 2023

Oct 16, 2023

Oct 16, 2023

May 27, 2021

May 27, 2021

May 27, 2021

Feb 11, 2020

Jun 15, 2020

Feb 11, 2020

Dec 27, 2019

Dec CAHN

Dec CAHN

Dec CAHN

Oct NEWA

Oct NEWA

Oct NEWA

Mar CAHN

Mar CAHN

Mar CAHN

Mar DISC

Mar DISC

Mar DISC

Dec CAHN
RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - December 2023 1-40

TABLET;ORAL

DEFERASIROX

>A>

>A>

@

@

180MG

360MG

A210727

A210727

003 Jun 15, 2020

002 Dec 27, 2019

Dec CAHN

Dec CAHN

TABLET, FOR SUSPENSION;ORAL

DEFERASIROX

@

@

@

TEVA PHARMS USA 125MG

250MG

500MG

A207124

A207124

A207124

001 Sep 23, 2022

002 Sep 23, 2022

003 Sep 23, 2022

Mar DISC

Mar DISC

Mar DISC

DEFERIPRONE

TABLET;ORAL

DEFERIPRONE

AB

AB

! HIKMA

TARO

FERRIPROX

1GM

1GM

A213239

A208800

002 Feb 08, 2022

002 Nov 22, 2023

May CHRS

Nov NEWA

AB + CHIESI 1GM N021825 002 Jul 25, 2019 May CHRS

DESIPRAMINE HYDROCHLORIDE

TABLET;ORAL

DESIPRAMINE HYDROCHLORIDE

AB

AB

AB

AB

AB

SANDOZ 10MG

25MG

50MG

75MG

150MG

A072103

A072103

A072103

A072103

A072103

002 May 24, 1988

003 May 24, 1988

004 May 24, 1988

005 Jun 20, 1988

006 Jun 20, 1988

Oct CMS1

Oct CMS1

Oct CMS1

Oct CMS1

Oct CMS1

DESLORATADINE

TABLET;ORAL

DESLORATADINE

@ DASH PHARMS 5MG A078351 001 Feb 10, 2012 Feb CAHN

DESMOPRESSIN ACETATE

INJECTABLE;INJECTION

DESMOPRESSIN ACETATE

>D>

>A>

AP

AP

AP

AP

AB

@ AM REGENT 0.004MG/ML

GLAND 0.004MG/ML

HONG KONG 0.004MG/ML

0.004MG/ML

MEITHEAL 0.004MG/ML

SPRAY, METERED;NASAL

DESMOPRESSIN ACETATE (NEEDS NO REFRIGERATION)

! APOTEX 0.01MG/SPRAY

@ SUN PHARM 0.01MG/SPRAY

TABLET;ORAL

DESMOPRESSIN ACETATE

A091374

A216904

A074888

A074888

A074888

A076703

A078271

001 Feb 14, 2019

001 Mar 20, 2023

001 Oct 15, 1997

001 Oct 15, 1997

001 Oct 15, 1997

001 Jan 27, 2005

001 Dec 23, 2013

Oct DISC

Mar NEWA

Dec CAHN

Sep CAHN

Dec CAHN

Aug CHRS

Aug DISC

>D>

>D>

>A>

>A>

@

@

@

@

MYLAN

NATCO PHARMA USA

0.1MG

0.2MG

0.1MG

0.2MG

A200653

A200653

A200653

A200653

001 Jun 27, 2014

002 Jun 27, 2014

001 Jun 27, 2014

002 Jun 27, 2014

Dec CAHN

Dec CAHN

Dec CAHN

Dec CAHN

TABLET;SUBLINGUAL

NOCDURNA

+

+

@

@

FERRING PHARMS INC 0.0277MG

0.0553MG

N022517

N022517

001 Jun 21, 2018

002 Jun 21, 2018

Oct DISC

Oct DISC

DESONIDE

AEROSOL, FOAM;TOPICAL

VERDESO

+ @ ALMIRALL

LOTION;TOPICAL

DESONIDE

0.05% N021978 001 Sep 19, 2006 Sep DISC

@ PAI HOLDINGS PHARM

OINTMENT;TOPICAL

DESONIDE

0.05% A207855 001 Sep 28, 2017 May DISC

@ PAI HOLDINGS PHARM 0.05% A212002 001 Mar 12, 2019 Aug DISC
RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - December 2023 1-41

DESOXIMETASONE

OINTMENT;TOPICAL

DESOXIMETASONE

@ PAI HOLDINGS PHARM 0.25% A208101 001 Feb 25, 2016 Aug DISC

DESVENLAFAXINE SUCCINATE

TABLET, EXTENDED RELEASE;ORAL

DESVENLAFAXINE SUCCINATE

>A> AB RUBICON EQ 25MG BASE A204028 003 Dec 07, 2023 Dec NEWA

DEUTETRABENAZINE

TABLET, EXTENDED RELEASE;ORAL

AUSTEDO XR

+

+

+!

TEVA 6MG

12MG

24MG

N216354

N216354

N216354

001

002

003

Feb 17, 2023

Feb 17, 2023

Feb 17, 2023

Feb NEWA

Feb NEWA

Feb NEWA

DEXAMETHASONE

ELIXIR;ORAL

DEXAMETHASONE

+ @ PHARMOBEDIENT CNSLTG 0.5MG/5ML

+ @ XTTRIUM LABS INC 0.5MG/5ML

SUSPENSION/DROPS;OPHTHALMIC

MAXIDEX

A088254

A088254

001

001

Jul 27, 1983

Jul 27, 1983

Sep CAHN

Jan CAHN

+! HARROW EYE

TABLET;ORAL

DEXAMETHASONE

0.1% N013422 001 May CAHN

AB

AB

AB

BP

AB

BP

AB

BP

AB

AB

AB

AB

AB

AB

AB

AB +

ALVOGEN

APOTEX

BIONPHARMA

HIKMA

4MG

6MG

0.5MG

0.5MG

0.75MG

0.75MG

1MG

1MG

1.5MG

2MG

4MG

6MG

2MG

4MG

6MG

0.5MG

A088481

A088481

A217695

A217695

A217695

A217695

A217695

A217695

A217695

A217695

A217695

A217695

A217538

A217001

A217001

A084611

004

001

001

001

002

002

003

003

004

005

006

007

001

001

002

001

Apr 28, 1983

Nov 28, 1983

Aug 23, 2023

Aug 23, 2023

Aug 23, 2023

Aug 23, 2023

Aug 23, 2023

Aug 23, 2023

Aug 23, 2023

Aug 23, 2023

Aug 23, 2023

Aug 23, 2023

Apr 26, 2023

Apr 19, 2023

Apr 19, 2023

Apr CTEC

Apr CTEC

Nov CTEC

Aug NEWA

Nov CTEC

Aug NEWA

Nov CTEC

Aug NEWA

Aug NEWA

Aug NEWA

Aug NEWA

Aug NEWA

Apr NEWA

Apr NEWA

Apr NEWA

Nov CTEC

AB + 0.75MG A084613 001 Nov CTEC

AB

AB

AB

AB

AB

+!

@

NOVITIUM PHARMA

PRASCO

1MG

0.5MG

0.75MG

2MG

4MG

4MG

A088306

A215604

A215604

A217696

A080399

A080399

001

004

005

001

002

002

Sep 15, 1983

Oct 05, 2023

Oct 05, 2023

May 09, 2023

Apr 20, 2022

Apr 20, 2022

Nov CTEC

Nov NEWA

Nov NEWA

Apr NEWA

Apr CMFD

Feb DISC

DEXAMETHASONE SODIUM PHOSPHATE

INJECTABLE;INJECTION

DEXAMETHASONE SODIUM PHOSPHATE

AP

AP

AP

GENEYORK PHARMS

GLAND PHARMA LTD

HIKMA

EQ 10MG PHOSPHATE/ML

EQ 10MG PHOSPHATE/ML

EQ 4MG PHOSPHATE/ML

A214890

A215654

A211451

001

002

001

Jul 07, 2023

Sep 25, 2023

Aug 01, 2023

Jun NEWA

Sep NEWA

Jul NEWA

DEXAMETHASONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE

OINTMENT;OPHTHALMIC

MAXITROL

AT +! SANDOZ 0.1%;EQ 3.5MG BASE/GM;10,000

UNITS/GM

SUSPENSION/DROPS;OPHTHALMIC

MAXITROL

N050065 002 Sep CAHN

AT +! HARROW EYE 0.1%;EQ 3.5MG BASE/ML;10,000

UNITS/ML

N050023 002 May CAHN
RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - December 2023 1-42

DEXAMETHASONE; TOBRAMYCIN

SUSPENSION/DROPS;OPHTHALMIC

TOBRADEX

AB +! SANDOZ 0.1%;0.3% N050592 001 Aug 18, 1988 Sep CAHN

TOBRADEX ST

+! HARROW EYE 0.05%;0.3% N050818 001 Feb 13, 2009 Oct CAHN

TOBRAMYCIN AND DEXAMETHASONE

@ AMNEAL 0.1%;0.3% A212991 001 Jul 15, 2021 Jun DISC

DEXMEDETOMIDINE HYDROCHLORIDE

INJECTABLE;INJECTION

DEXMEDETOMIDINE HYDROCHLORIDE

AP AMNEAL EQ 200MCG BASE/50ML (EQ 4MCG A216604 001 May 15, 2023 May NEWA

BASE/ML)

AP EQ 400MCG BASE/100ML (EQ 4MCG A216604 002 May 15, 2023 May NEWA

BASE/ML)

AP MILLA PHARMS EQ 200MCG BASE/50ML (EQ 4MCG A217308 001 Jun 07, 2023 May NEWA

BASE/ML)

AP EQ 400MCG BASE/100ML (EQ 4MCG A217308 002 Jun 07, 2023 May NEWA

BASE/ML)

DEXMETHYLPHENIDATE HYDROCHLORIDE

CAPSULE, EXTENDED RELEASE;ORAL

FOCALIN XR

AB + SANDOZ 5MG N021802 001 May 26, 2005 Sep CAHN

AB + 10MG N021802 002 May 26, 2005 Sep CAHN

AB + 15MG N021802 004 Aug 01, 2006 Sep CAHN

AB + 20MG N021802 003 May 26, 2005 Sep CAHN

AB + 25MG N021802 008 Apr 21, 2011 Sep CAHN

AB + 30MG N021802 005 Oct 23, 2009 Sep CAHN

AB + 35MG N021802 007 Apr 21, 2011 Sep CAHN

AB +! 40MG N021802 006 Aug 11, 2010 Sep CAHN

TABLET;ORAL

FOCALIN

AB + SANDOZ 2.5MG N021278 001 Nov 13, 2001 Sep CAHN

AB + 5MG N021278 002 Nov 13, 2001 Sep CAHN

AB +! 10MG N021278 003 Nov 13, 2001 Sep CAHN

DEXTROAMPHETAMINE SULFATE

SOLUTION;ORAL

DEXTROAMPHETAMINE SULFATE

AA ! PRASCO 5MG/5ML A040776 001 Jan 29, 2008 Mar CAHN

TABLET;ORAL

DEXTROAMPHETAMINE SULFATE

AA ARBOR PHARMS LLC 2.5MG A090533 001 Oct 25, 2011 Jan CTEC

AA 7.5MG A090533 003 Oct 25, 2011 Jan CTEC

AA 15MG A090533 005 Oct 25, 2011 Jan CTEC

AA 20MG A090533 006 Oct 25, 2011 Jan CTEC

AA 30MG A090533 007 Oct 25, 2011 Jan CTEC

AA WINDER LABS LLC 2.5MG A212160 001 Jun 07, 2021 Jan CMFD

AA 5MG A212160 002 Jun 07, 2021 Jan CMFD

AA 7.5MG A212160 003 Jun 07, 2021 Jan CMFD

AA 10MG A212160 004 Jun 07, 2021 Jan CMFD

AA 15MG A212160 005 Jun 07, 2021 Jan CMFD

AA 20MG A212160 006 Jun 07, 2021 Jan CMFD

AA 30MG A212160 007 Jun 07, 2021 Jan CMFD

DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE

INJECTABLE;INJECTION

POTASSIUM CHLORIDE 10MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.225% IN PLASTIC CONTAINER

AP FRESENIUS KABI USA 5GM/100ML;149MG/100ML;225MG/100ML A212348 001 Jul 30, 2021 Mar CMFD

POTASSIUM CHLORIDE 10MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45%

AP FRESENIUS KABI USA 5GM/100ML;74.5MG/100ML;450MG/100ML A213523 001 Mar 09, 2021 Mar CMFD

POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.225% IN PLASTIC CONTAINER

AP FRESENIUS KABI USA 5GM/100ML;149MG/100ML;225MG/100ML A212348 002 Jul 30, 2021 Mar CMFD

AP +! ICU MEDICAL INC 5GM/100ML;149MG/100ML;225MG/100ML N018365 001 Mar CHRS

AP + 5GM/100ML;149MG/100ML;225MG/100ML N018365 001 Mar CTEC

POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45%

AP FRESENIUS KABI USA 5GM/100ML;149MG/100ML;450MG/100ML A213523 002 Mar 09, 2021 Mar CMFD

POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9%

AP FRESENIUS KABI USA 5GM/100ML;149MG/100ML;900MG/100ML A213445 001 Mar 09, 2021 Mar CMFD
RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - December 2023

AP

AP

AP

INJECTABLE;INJECTION

POTASSIUM CHLORIDE 30MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45%

FRESENIUS KABI USA 5GM/100ML;224MG/100ML;450MG/100ML A213523

POTASSIUM CHLORIDE 40MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45%

FRESENIUS KABI USA 5GM/100ML;298MG/100ML;450MG/100ML A213523

POTASSIUM CHLORIDE 40MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9%

FRESENIUS KABI USA 5GM/100ML;298MG/100ML;900MG/100ML A213445

003

004

002

DIATRIZOATE MEGLUMINE; DIATRIZOATE SODIUM

SOLUTION;ORAL, RECTAL

DIATRIZOATE MEGLUMINE AND DIATRIZOATE SODIUM

AA

AA

ANDA REPOSITORY 66%;10% A214201

ANNORA PHARMA 66%;10% A215049

001

001

DIAZEPAM

GEL;RECTAL

DIASTAT ACUDIAL

AB

AB

+! BAUSCH 10MG/2ML (5MG/ML) N020648

+! 20MG/4ML (5MG/ML) N020648

DIAZEPAM

007

006

AB

AB

NOVEL LABS INC 10MG/2ML (5MG/ML) A091076

20MG/4ML (5MG/ML) A091076

TABLET;ORAL

DIAZEPAM

001

002

>D>

>D>

>D>

>A> AB

@ AIPING PHARM INC 2MG A070302

@ 2MG A070302

@ 5MG A070303

@ 5MG A070303

@ 10MG A070304

@ 10MG A070304

AUROBINDO PHARMA LTD 2MG A217843

001

001

001

001

001

001

001

>A> AB 5MG A217843 002

>A> AB 10MG A217843 003

>A>

>A>

>A>

AB

@ CHARTWELL RX 2MG A070302

@ 5MG A070303

@ 10MG A070304

NUVO PHARM 10MG A070464

001

001

001

001

DICLOFENAC EPOLAMINE

SYSTEM;TOPICAL

FLECTOR

+! IBSA 1.3% N021234 001

DICLOFENAC POTASSIUM

TABLET;ORAL

DICLOFENAC POTASSIUM

AB

@ CHARTWELL RX 50MG A075582

SENORES PHARMS 25MG A215787

001

002

AB 50MG A215787 001

DICLOFENAC SODIUM

GEL;TOPICAL

DICLOFENAC SODIUM

AB AMNEAL 3% A200936 001

SOLUTION;TOPICAL

DICLOFENAC SODIUM

AB AUROLIFE PHARMA LLC 2% A213040 001

@ PAI HOLDINGS PHARM 1.5% A202769

SOLUTION/DROPS;OPHTHALMIC

DICLOFENAC SODIUM

001

AT RUBICON 0.1% A077600 001

TABLET, DELAYED RELEASE;ORAL

DICLOFENAC SODIUM

AB RUBICON 25MG A216548 001

AB 50MG A216548 002

AB 75MG A216548 003

TABLET, EXTENDED RELEASE;ORAL

DICLOFENAC SODIUM

@ AUROBINDO PHARMA USA 100MG A076152 001

1-43

Mar 09, 2021 Mar CMFD

Mar 09, 2021 Mar CMFD

Mar 09, 2021 Mar CMFD

Jun 27, 2022 Sep CAHN

Nov 17, 2023 Nov NEWA

Sep 15, 2005 May CFTG

Sep 15, 2005 May CFTG

May 30, 2023 May NFTG

May 30, 2023 May NFTG

Dec 20, 1985 Dec CAHN

Dec 20, 1985 Oct CAHN

Dec 20, 1985 Dec CAHN

Dec 20, 1985 Oct CAHN

Dec 20, 1985 Dec CAHN

Dec 20, 1985 Oct CAHN

Dec 14, 2023 Dec NEWA

Dec 14, 2023 Dec NEWA

Dec 14, 2023 Dec NEWA

Dec 20, 1985 Dec CAHN

Dec 20, 1985 Dec CAHN

Dec 20, 1985 Dec CAHN

Feb 25, 1986 Nov CMFD

Jan 31, 2007 Aug CAHN

Feb 23, 2001 May CAHN

Nov 09, 2023 Nov NEWA

Mar 15, 2023 Mar NEWA

Oct 28, 2013 Feb CAHN

Feb 03, 2023 Jan NEWA

Jul 08, 2015 Aug DISC

Nov 13, 2008 Aug CMFD

May 11, 2023 May NEWA

May 11, 2023 May NEWA

May 11, 2023 May NEWA

Dec 13, 2001 Apr CAHN
RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - December 2023 1-44

DICLOFENAC SODIUM; MISOPROSTOL

TABLET, DELAYED RELEASE;ORAL

DICLOFENAC SODIUM AND MISOPROSTOL

AB

AB

@

@

ZYDUS PHARMS 50MG;0.2MG

50MG;0.2MG

75MG;0.2MG

75MG;0.2MG

A206771

A206771

A206771

A206771

001

001

002

002

Jun 12, 2023

Jun 12, 2023

Jun 12, 2023

Jun 12, 2023

Oct DISC

Jun NEWA

Oct DISC

Jun NEWA

DICYCLOMINE HYDROCHLORIDE

CAPSULE;ORAL

DICYCLOMINE HYDROCHLORIDE

AB

AB

COREPHARMA

PRINSTON INC

INJECTABLE;INJECTION

BENTYL

10MG

10MG

A216639

A217531

001

001

Mar 24, 2023

Aug 30, 2023

Mar NEWA

Aug NEWA

AP +! ABBVIE 10MG/ML

BENTYL PRESERVATIVE FREE

N008370 001 Oct 15, 1984 Feb CAHN

AP +! ABBVIE 10MG/ML

DICYCLOMINE HYDROCHLORIDE

N008370 002 Oct 15, 1984 Feb CAHN

AP

AP

OAK TREE PHARMA 10MG/ML

@ PRAXGEN PHARMS 10MG/ML

@ RENEW PHARMS 10MG/ML

10MG/ML

TABLET;ORAL

DICYCLOMINE HYDROCHLORIDE

A207084

A212058

A207084

A207084

001

001

001

001

May 04, 2018

Apr 26, 2019

May 04, 2018

May 04, 2018

Aug CAHN

Jul CAHN

Sep DISC

Aug CAHN

AB

AB

AB

AUROBINDO PHARMA USA

BIONPHARMA

TWI PHARMS

20MG

20MG

20MG

A040317

A217916

A216782

001

001

001

Sep 07, 1999

Aug 04, 2023

Jun 01, 2023

Feb CMFD

Jul NEWA

May NEWA

DIETHYLPROPION HYDROCHLORIDE

TABLET, EXTENDED RELEASE;ORAL

DIETHYLPROPION HYDROCHLORIDE

! LANNETT CO INC 75MG A091680 001 Oct 24, 2011 Feb CTEC

DIFLORASONE DIACETATE

CREAM;TOPICAL

DIFLORASONE DIACETATE

@ AVONDALE PHARMS

OINTMENT;TOPICAL

DIFLORASONE DIACETATE

0.05% A075187 001 Mar 30, 1998 May CAHN

AB AVONDALE PHARMS 0.05% A075374 001 Apr 27, 1999 May CAHN

DIFLUPREDNATE

EMULSION;OPHTHALMIC

DUREZOL

AB +! SANDOZ 0.05% N022212 001 Jun 23, 2008 Sep CAHN

DIHYDROERGOTAMINE MESYLATE

INJECTABLE;INJECTION

DIHYDROERGOTAMINE MESYLATE

AP GLAND PHARMA LTD 1MG/ML

SPRAY, METERED;NASAL

DIHYDROERGOTAMINE MESYLATE

A215623 001 Aug 18, 2023 Aug NEWA

AB

AB

AMNEAL

RUBICON

0.5MG/SPRAY

0.5MG/SPRAY

A214105

A216881

001

001

Jan 04, 2022

Jun 22, 2023

Apr CMFD

Jun NEWA

DILTIAZEM HYDROCHLORIDE

CAPSULE, EXTENDED RELEASE;ORAL

DILTIAZEM HYDROCHLORIDE

AB1

AB1

AB1

TWI PHARMS 60MG

90MG

120MG

A217377

A217377

A217377

001

002

003

Mar 01, 2023

Mar 01, 2023

Mar 01, 2023

Feb NEWA

Feb NEWA

Feb NEWA

INJECTABLE;INJECTION

DILTIAZEM HYDROCHLORIDE

AP

AP

EUGIA PHARMA

! SAGENT

TABLET;ORAL

DILTIAZEM HYDROCHLORIDE

5MG/ML

5MG/ML

A216552

A074617

001

001

Mar 29, 2023

Feb 28, 1996

Mar NEWA

Aug CAHN

@ EDENBRIDGE PHARMS

@

30MG

60MG

A211596

A211596

001

002

Nov 18, 2019

Nov 18, 2019

Aug DISC

Aug DISC
RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - December 2023 1-45

TABLET;ORAL

DILTIAZEM HYDROCHLORIDE

@ 90MG

@ 120MG

TABLET, EXTENDED RELEASE;ORAL

DILTIAZEM HYDROCHLORIDE

A211596

A211596

003 Nov 18, 2019

004 Nov 18, 2019

Aug DISC

Aug DISC

AB

AB

AB

AB

AB

AB

AB

AB

AB

AB

AB

AB

AMTA

SCIEGEN PHARMS INC

120MG

180MG

240MG

300MG

360MG

420MG

120MG

180MG

240MG

300MG

360MG

420MG

A216439

A216439

A216439

A216439

A216439

A216439

A216327

A216327

A216327

A216327

A216327

A216327

001 Mar 07, 2023

002 Mar 07, 2023

003 Mar 07, 2023

004 Mar 07, 2023

005 Mar 07, 2023

006 Mar 07, 2023

001 Apr 06, 2023

002 Apr 06, 2023

003 Apr 06, 2023

004 Apr 06, 2023

005 Apr 06, 2023

006 Apr 06, 2023

Feb NEWA

Feb NEWA

Feb NEWA

Feb NEWA

Feb NEWA

Feb NEWA

Mar NEWA

Mar NEWA

Mar NEWA

Mar NEWA

Mar NEWA

Mar NEWA

DIMERCAPROL

INJECTABLE;INJECTION

BAL

+! PROVEPHARM SAS 10% N005939 001 Aug CAHN

DIMETHYL FUMARATE

CAPSULE, DELAYED RELEASE;ORAL

DIMETHYL FUMARATE

AB

AB

SOLA PHARMS 120MG

240MG

A210436

A210436

001 Mar 26, 2021

002 Mar 26, 2021

Feb CMFD

Feb CMFD

DIPHENHYDRAMINE HYDROCHLORIDE

ELIXIR;ORAL

DIPHENHYDRAMINE HYDROCHLORIDE

+! PHARM ASSOC 12.5MG/5ML A087513 001 Feb 10, 1982 Apr CRLD

DIPYRIDAMOLE

INJECTABLE;INJECTION

DIPYRIDAMOLE

@ FRESENIUS KABI USA

TABLET;ORAL

DIPYRIDAMOLE

5MG/ML A074956 001 Sep 30, 1998 Jun DISC

AB

AB

AB

@ ANI PHARMS

@

@

RISING

25MG

50MG

75MG

25MG

50MG

75MG

A086944

A086944

A086944

A040733

A040733

A040733

002 Apr 16, 1991

001 Feb 25, 1992

003 Feb 25, 1992

001 Feb 13, 2007

002 Feb 13, 2007

003 Feb 13, 2007

Apr DISC

Apr DISC

Apr DISC

Sep CAHN

Sep CAHN

Sep CAHN

DISULFIRAM

TABLET;ORAL

DISULFIRAM

>D>

>A>

>D>

>A>

AB

AB

AB

AB

!

@

@

@

@

CHARTWELL MOLECULES

DASH PHARMS

HIKMA

500MG

250MG

500MG

250MG

250MG

500MG

500MG

500MG

A091563

A203916

A203916

A202652

A202652

A202652

A202652

A202652

002 Dec 31, 2012

001 Mar 04, 2015

002 Mar 04, 2015

001 Feb 05, 2014

001 Feb 05, 2014

002 Feb 05, 2014

002 Feb 05, 2014

002 Feb 05, 2014

Aug CHRS

Feb CAHN

Feb CAHN

Dec DISC

Dec DISC

Dec DISC

Dec DISC

Aug CHRS

DIVALPROEX SODIUM

TABLET, DELAYED RELEASE;ORAL

DIVALPROEX SODIUM

AB

AB

AB

@ ACTAVIS LABS FL INC EQ 500MG VALPROIC ACID

CHARTWELL RX EQ 125MG VALPROIC ACID

EQ 250MG VALPROIC ACID

EQ 500MG VALPROIC ACID

TABLET, EXTENDED RELEASE;ORAL

DEPAKOTE ER

A079080

A077296

A077296

A077296

001 Feb 25, 2011

001 Jul 31, 2008

002 Jul 31, 2008

003 Jul 31, 2008

Sep DISC

Jun CAHN

Jun CAHN

Jun CAHN

AB + ABBVIE

DIVALPROEX SODIUM

EQ 500MG VALPROIC ACID N021168 001 Aug 04, 2000 Aug CHRS

AB ! AMNEAL PHARMS EQ 500MG VALPROIC ACID A203730 002 May 29, 2015 Aug CHRS
RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - December 2023 1-46

TABLET, EXTENDED RELEASE;ORAL

AB

AB

DIVALPROEX SODIUM

ANNORA PHARMA EQ 250MG VALPROIC ACID

EQ 500MG VALPROIC ACID

A215527

A215527

001

002

Sep 26, 2023

Sep 26, 2023

Sep NEWA

Sep NEWA

DOCETAXEL

AP

AP

AP

AP

AP

AP

AP

INJECTABLE;INJECTION

DOCETAXEL

ALEMBIC

@ MYLAN LABS LTD

@

@ NOVAST LABS

SOLUTION;INTRAVENOUS

DOCETAXEL

+ @ INGENUS PHARMS LLC

+ @

+ @

+ @ MERIDIAN LABS

+ @

+ @

20MG/2ML (10MG/ML)

80MG/8ML (10MG/ML)

160MG/16ML (10MG/ML)

20MG/ML (20MG/ML)

20MG/ML (20MG/ML)

80MG/4ML (20MG/ML)

80MG/4ML (20MG/ML)

20MG/2ML (10MG/ML)

80MG/8ML (10MG/ML)

160MG/16ML (10MG/ML)

20MG/2ML (10MG/ML)

80MG/8ML (10MG/ML)

160MG/16ML (10MG/ML)

20MG/2ML (10MG/ML)

80MG/8ML (10MG/ML)

160MG/16ML (10MG/ML)

A215744

A215744

A215744

A203892

A203892

A203892

A203892

A207563

A207563

A207563

N215813

N215813

N215813

N215813

N215813

N215813

001

002

003

001

001

002

002

001

002

003

001

002

003

001

002

003

Feb 28, 2023

Feb 28, 2023

Feb 28, 2023

May 11, 2023

May 11, 2023

May 11, 2023

May 11, 2023

Aug 31, 2017

Aug 31, 2017

Aug 31, 2017

Nov 22, 2022

Nov 22, 2022

Nov 22, 2022

Nov 22, 2022

Nov 22, 2022

Nov 22, 2022

Feb NEWA

Feb NEWA

Feb NEWA

Sep DISC

Apr NEWA

Sep DISC

Apr NEWA

Sep CAHN

Sep CAHN

Sep CAHN

Jul CAHN

Jul CAHN

Jul CAHN

May DISC

May DISC

May DISC

DOFETILIDE

CAPSULE;ORAL

DOFETILIDE

@ RK PHARMA

@

@

0.125MG

0.25MG

0.5MG

A215323

A215323

A215323

001

002

003

Apr 14, 2022

Apr 14, 2022

Apr 14, 2022

Jun CAHN

Jun CAHN

Jun CAHN

DONEPEZIL HYDROCHLORIDE

SOLUTION;ORAL

ARICEPT

+ @ EISAI INC 5MG/5ML N021719 001 Oct 18, 2004 Jun CRLD

>A>

>A>

>D>

>A>

AB

AB

DONEPEZIL HYDROCHLORIDE; MEMANTINE HYDROCHLORIDE

CAPSULE, EXTENDED RELEASE;ORAL

MEMANTINE HYDROCHLORIDE AND DONEPEZIL HYDROCHLORIDE

ANI PHARMS 10MG;21MG

NAMZARIC

+ ABBVIE 10MG;21MG

+ 10MG;21MG

A208237

N206439

N206439

001

004

004

Dec 15, 2023

Jul 18, 2016

Jul 18, 2016

Dec NFTG

Dec CFTG

Dec CFTG

DORZOLAMIDE HYDROCHLORIDE

AT

SOLUTION/DROPS;OPHTHALMIC

DORZOLAMIDE HYDROCHLORIDE

RUBICON EQ 2% BASE A078395 001 Oct 28, 2008 Aug CMFD

DORZOLAMIDE HYDROCHLORIDE; TIMOLOL MALEATE

SOLUTION/DROPS;OPHTHALMIC

COSOPT

AT1 +! THEA PHARMA EQ 2% BASE;EQ 0.5% BASE

COSOPT PF

AT2 +! THEA PHARMA EQ 2% BASE;EQ 0.5% BASE

DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE

AT1 AKORN EQ 2% BASE;EQ 0.5% BASE

AT1 EQ 2% BASE;EQ 0.5% BASE

AT1 ALEMBIC EQ 2% BASE;EQ 0.5% BASE

AT1 BAUSCH AND LOMB EQ 2% BASE;EQ 0.5% BASE

AT1 EPIC PHARMA LLC EQ 2% BASE;EQ 0.5% BASE

AT1 EUGIA PHARMA EQ 2% BASE;EQ 0.5% BASE

AT2 EQ 2% BASE;EQ 0.5% BASE

AT1 FDC LTD EQ 2% BASE;EQ 0.5% BASE

AT1 GLAND PHARMA LTD EQ 2% BASE;EQ 0.5% BASE

AT1 HIKMA EQ 2% BASE;EQ 0.5% BASE

AT1 INDOCO EQ 2% BASE;EQ 0.5% BASE

AT2 INGENUS PHARMS LLC EQ 2% BASE;EQ 0.5% BASE

AT EQ 2% BASE;EQ 0.5% BASE

N020869

N202667

A077847

A203058

A213099

A090037

A203058

A207629

A207630

A205295

A215520

A077847

A202054

A217260

A217260

001

001

001

001

001

001

001

001

001

001

001

001

001

001

001

Apr 07, 1998

Feb 01, 2012

Oct 28, 2008

Sep 22, 2014

May 04, 2021

Jul 14, 2009

Sep 22, 2014

May 14, 2021

Jul 24, 2018

Jun 13, 2019

Sep 19, 2022

Oct 28, 2008

Sep 03, 2014

May 01, 2023

May 01, 2023

May CTEC

May CTEC

May CTEC

May CTEC

May CTEC

May CTEC

Oct CAHN

May CTEC

May CTEC

May CTEC

May CTEC

Sep CAHN

May CTEC

May CTEC

Apr NEWA
RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - December 2023 1-47

SOLUTION/DROPS;OPHTHALMIC

DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE

AT1

AT2

AT1

AT1

AT1

AT1

@

MICRO LABS

SANDOZ

SOMERSET

TEVA PHARMS

EQ 2% BASE;EQ 0.5% BASE

EQ 2% BASE;EQ 0.5% BASE

EQ 2% BASE;EQ 0.5% BASE

EQ 2% BASE;EQ 0.5% BASE

EQ 2% BASE;EQ 0.5% BASE

EQ 2% BASE;EQ 0.5% BASE

EQ 2% BASE;EQ 0.5% BASE

A204777

A215936

A078749

A090604

A207523

A078704

A078704

001

001

001

001

001

001

001

May 28, 2020

Jan 25, 2022

Nov 06, 2008

Nov 18, 2009

Jun 25, 2019

Sep 28, 2009

Sep 28, 2009

May CTEC

May CTEC

May CTEC

May CTEC

May CTEC

Sep DISC

May CTEC

DOXAZOSIN MESYLATE

TABLET;ORAL

DOXAZOSIN MESYLATE

AB

AB

AB

AB

AB

AB

AB

AB

AB

AB

AB

AB

>A> AB

>A> AB

>A> AB

>A> AB

@

@

@

@

HERITAGE PHARMA

MLV

PLIVA

RISING

UNICHEM

EQ 1MG BASE

EQ 2MG BASE

EQ 4MG BASE

EQ 8MG BASE

EQ 1MG BASE

EQ 2MG BASE

EQ 4MG BASE

EQ 8MG BASE

EQ 1MG BASE

EQ 2MG BASE

EQ 4MG BASE

EQ 8MG BASE

EQ 1MG BASE

EQ 2MG BASE

EQ 4MG BASE

EQ 8MG BASE

EQ 1MG BASE

EQ 2MG BASE

EQ 4MG BASE

EQ 8MG BASE

A205210

A205210

A205210

A205210

A212727

A212727

A212727

A212727

A075750

A075750

A075750

A075750

A212727

A212727

A212727

A212727

A212329

A212329

A212329

A212329

001

002

003

004

001

002

003

004

001

002

003

004

001

002

003

004

001

002

003

004

Feb 13, 2018

Feb 13, 2018

Feb 13, 2018

Feb 13, 2018

Mar 15, 2022

Mar 15, 2022

Mar 15, 2022

Mar 15, 2022

Jun 08, 2001

Jun 08, 2001

Jun 08, 2001

Jun 08, 2001

Mar 15, 2022

Mar 15, 2022

Mar 15, 2022

Mar 15, 2022

Jan 10, 2024

Jan 10, 2024

Jan 10, 2024

Jan 10, 2024

Sep CTEC

Sep CTEC

Sep CTEC

Sep CTEC

Aug CAHN

Aug CAHN

Aug CAHN

Aug CAHN

Sep DISC

Sep DISC

Sep DISC

Sep DISC

Sep CAHN

Sep CAHN

Sep CAHN

Sep CAHN

Dec NEWA

Dec NEWA

Dec NEWA

Dec NEWA

DOXEPIN HYDROCHLORIDE

CAPSULE;ORAL

DOXEPIN HYDROCHLORIDE

AB

AB

AB

AB

AB

AB

AB

AB

AB

AB

AB

AB

AB

AB

AB

AB

AB

AB

AB

AB

AB

AB

AB

AB

AB

AB

AB

CHEMISTRY HLTH

MICRO LABS

UNIQUE PHARM

ZYDUS LIFESCIENCES

ZYDUS PHARMS

CONCENTRATE;ORAL

DOXEPIN HYDROCHLORIDE

EQ 10MG BASE

EQ 25MG BASE

EQ 50MG BASE

EQ 75MG BASE

EQ 100MG BASE

EQ 10MG BASE

EQ 25MG BASE

EQ 50MG BASE

EQ 75MG BASE

EQ 100MG BASE

EQ 10MG BASE

EQ 25MG BASE

EQ 50MG BASE

EQ 75MG BASE

EQ 100MG BASE

EQ 10MG BASE

EQ 25MG BASE

EQ 50MG BASE

EQ 75MG BASE

EQ 100MG BASE

EQ 150MG BASE

EQ 10MG BASE

EQ 25MG BASE

EQ 50MG BASE

EQ 75MG BASE

EQ 100MG BASE

EQ 150MG BASE

A211619

A211619

A211619

A211619

A211619

A217688

A217688

A217688

A217688

A217688

A217975

A217975

A217975

A217975

A217975

A210700

A210700

A210700

A210700

A210700

A210140

A210700

A210700

A210700

A210700

A210700

A210140

001

002

003

004

005

001

002

003

004

005

001

002

003

004

005

001

002

003

004

005

001

001

002

003

004

005

001

Mar 09, 2021

Mar 09, 2021

Mar 09, 2021

Mar 09, 2021

Mar 09, 2021

Jun 27, 2023

Jun 27, 2023

Jun 27, 2023

Jun 27, 2023

Jun 27, 2023

Aug 21, 2023

Aug 21, 2023

Aug 21, 2023

Aug 21, 2023

Aug 21, 2023

Mar 23, 2023

Mar 23, 2023

Mar 23, 2023

Mar 23, 2023

Mar 23, 2023

Mar 21, 2023

Mar 23, 2023

Mar 23, 2023

Mar 23, 2023

Mar 23, 2023

Mar 23, 2023

Mar 21, 2023

Oct CAHN

Oct CAHN

Oct CAHN

Oct CAHN

Oct CAHN

Jun NEWA

Jun NEWA

Jun NEWA

Jun NEWA

Jun NEWA

Aug NEWA

Aug NEWA

Aug NEWA

Aug NEWA

Aug NEWA

Mar CAHN

Mar CAHN

Mar CAHN

Mar CAHN

Mar CAHN

Mar CAHN

Mar NEWA

Mar NEWA

Mar NEWA

Mar NEWA

Mar NEWA

Mar NEWA

! LANNETT CO INC

@ PHARMOBEDIENT CNSLTG

@ XTTRIUM LABS INC

CREAM;TOPICAL

DOXEPIN HYDROCHLORIDE

EQ 10MG BASE/ML

EQ 10MG BASE/ML

EQ 10MG BASE/ML

A074721

A071918

A071918

001

001

001

Dec 29, 1998

Jul 20, 1988

Jul 20, 1988

Jul CTEC

Sep CAHN

Jul DISC

AB

AB

AMNEAL

TEVA PHARMS

5%

5%

A212357

A215408

001

001

Aug 16, 2023

Feb 17, 2023

Aug NEWA

Feb NFTG
RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - December 2023 1-48

>D>

>A>

>D>

>A>

AB

AB

AB

AB

AB

AB

AB

CREAM;TOPICAL

ZONALON

+! MYLAN

TABLET;ORAL

DOXEPIN HYDROCHLORIDE

MSN

ZYDUS PHARMS

@

@

5%

EQ 3MG BASE

EQ 6MG BASE

EQ 3MG BASE

EQ 3MG BASE

EQ 3MG BASE

EQ 6MG BASE

EQ 6MG BASE

EQ 6MG BASE

N020126

A214823

A214823

A202761

A202761

A202761

A202761

A202761

A202761

001 Apr 01, 1994

001 Apr 03, 2023

002 Apr 03, 2023

001 Aug 16, 2023

001 Aug 16, 2023

001 Aug 16, 2023

002 Aug 16, 2023

002 Aug 16, 2023

002 Aug 16, 2023

Feb CFTG

Mar NEWA

Mar NEWA

Dec DISC

Dec DISC

Aug NEWA

Dec DISC

Dec DISC

Aug NEWA

DOXERCALCIFEROL

AP

INJECTABLE;INJECTION

DOXERCALCIFEROL

ALEMBIC

@ EPIC PHARMA LLC

@

4MCG/2ML (2MCG/ML)

2MCG/ML (2MCG/ML)

4MCG/2ML (2MCG/ML)

A215810

A203929

A203929

001 Jun 15, 2023

002 Mar 28, 2016

001 May 07, 2015

Jun NEWA

Oct CAHN

Oct CAHN

DOXORUBICIN HYDROCHLORIDE

AB

AB

INJECTABLE;INJECTION

DOXORUBICIN HYDROCHLORIDE

! HIKMA 10MG/VIAL

@ PHARMACHEMIE BV 2MG/ML

@ 10MG/VIAL

@ 20MG/VIAL

@ 50MG/VIAL

@ 200MG/100ML

INJECTABLE, LIPOSOMAL;INJECTION

DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL)

BAXTER HLTHCARE CORP 20MG/10ML (2MG/ML)

50MG/25ML (2MG/ML)

A062921

A063336

A063097

A063097

A063097

A063336

A212219

A212219

001 Mar 17, 1989

001 Feb 28, 1995

001 May 21, 1990

002 May 21, 1990

003 May 21, 1990

004 Feb 28, 1995

001 Oct 19, 2022

002 Oct 19, 2022

Sep CTEC

Sep DISC

Sep DISC

Sep DISC

Sep DISC

Sep DISC

Sep CAHN

Sep CAHN

DOXYCYCLINE

TABLET;ORAL

DOXYCYCLINE

@ APPCO

@

@

@

@ UPSHER SMITH LABS

@

@

@

EQ 50MG BASE

EQ 75MG BASE

EQ 100MG BASE

EQ 150MG BASE

EQ 50MG BASE

EQ 75MG BASE

EQ 100MG BASE

EQ 150MG BASE

A065377

A065377

A065377

A065427

A065377

A065377

A065377

A065427

001 Nov 07, 2006

002 Nov 07, 2006

003 Nov 07, 2006

001 Jun 07, 2007

001 Nov 07, 2006

002 Nov 07, 2006

003 Nov 07, 2006

001 Jun 07, 2007

Nov CAHN

Nov CAHN

Nov CAHN

Nov CAHN

Sep CAHN

Sep CAHN

Sep CAHN

Sep CAHN

DOXYCYCLINE HYCLATE

AP

AP

AB

AB

AB

AB

INJECTABLE;INJECTION

DOXYCYCLINE

@ HIKMA EQ 100MG BASE/VIAL

! ZYDUS PHARMS EQ 100MG BASE/VIAL

DOXYCYCLINE HYCLATE

GLAND PHARMA LTD EQ 100MG BASE/VIAL

@ PAR STERILE PRODUCTS EQ 100MG BASE/VIAL

TABLET;ORAL

DOXYCYCLINE HYCLATE

MYLAN EQ 100MG BASE

@ ORYZA PHARMS SHENZHN EQ 100MG BASE

@ PHARMOBEDIENT EQ 100MG BASE

TABLET, DELAYED RELEASE;ORAL

DORYX

+ @ MAYNE PHARMA EQ 50MG BASE

+ EQ 80MG BASE

+ EQ 80MG BASE

+ @ EQ 100MG BASE

+ EQ 200MG BASE

DORYX MPC

+ MAYNE PHARMA EQ 60MG BASE

+ EQ 60MG BASE

+ @ EQ 120MG BASE

A062569

A207757

A215583

A216690

A062432

A213475

A213475

N050795

N050795

N050795

N050795

N050795

N050795

N050795

N050795

001 Mar 09, 1988

001 Sep 28, 2017

001 Apr 12, 2023

001 Dec 07, 2022

001 Feb 15, 1983

001 Mar 10, 2021

001 Mar 10, 2021

006 Dec 19, 2014

004 Apr 11, 2013

004 Apr 11, 2013

002 May 06, 2005

005 Apr 11, 2013

007 May 20, 2016

007 May 20, 2016

008 May 20, 2016

Aug DISC

Aug CHRS

Mar NEWA

Jun DISC

Sep CMFD

Feb CAHN

Aug CAHN

Jun DISC

Aug CTEC

Aug CFTG

Jun DISC

Jul CHRS

Aug CTEC

Aug CFTG

Jun DISC
RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - December 2023 1-49

TABLET, DELAYED RELEASE;ORAL

DOXYCYCLINE HYCLATE

AB

AB

AB

AB

AB

AB

AB

AB

!

@

@

@

@

@

@

@

@

@

AUROBINDO PHARMA USA

HERITAGE PHARMS

LUPIN

EQ 150MG BASE

EQ 200MG BASE

EQ 50MG BASE

EQ 50MG BASE

EQ 60MG BASE

EQ 60MG BASE

EQ 75MG BASE

EQ 75MG BASE

EQ 80MG BASE

EQ 80MG BASE

EQ 100MG BASE

EQ 100MG BASE

EQ 120MG BASE

EQ 120MG BASE

EQ 150MG BASE

EQ 150MG BASE

EQ 200MG BASE

EQ 200MG BASE

A091052

A200856

A208741

A208741

A208741

A208741

A208741

A208741

A208741

A208741

A208741

A208741

A208741

A208741

A208741

A208741

A208741

A208741

001 Feb 08, 2012

004 Nov 13, 2018

001 Aug 11, 2023

001 Aug 11, 2023

002 Aug 11, 2023

002 Aug 11, 2023

003 Aug 11, 2023

003 Aug 11, 2023

004 Aug 11, 2023

004 Aug 11, 2023

005 Aug 11, 2023

005 Aug 11, 2023

006 Aug 11, 2023

006 Aug 11, 2023

007 Aug 11, 2023

007 Aug 11, 2023

008 Aug 11, 2023

008 Aug 11, 2023

May CAHN

Jul CHRS

Aug DISC

Aug NEWA

Aug DISC

Aug NFTG

Aug DISC

Aug NEWA

Aug DISC

Aug NEWA

Aug DISC

Aug NEWA

Aug DISC

Aug NEWA

Aug DISC

Aug NEWA

Aug DISC

Aug NEWA

DOXYLAMINE SUCCINATE; PYRIDOXINE HYDROCHLORIDE

TABLET, DELAYED RELEASE;ORAL

DOXYLAMINE SUCCINATE AND PYRIDOXINE HYDROCHLORIDE

AB BIONPHARMA 10MG;10MG A217000 001 Aug 04, 2023 Jul NEWA

DROPERIDOL

INJECTABLE;INJECTION

DROPERIDOL

AP

AP

!

!

AM REGENT

@ HIKMA

@ HOSPIRA

INAPSINE

2.5MG/ML

2.5MG/ML

2.5MG/ML

2.5MG/ML

2.5MG/ML

A072123

A072123

A208197

A208197

A071981

001 Oct 24, 1988

001 Oct 24, 1988

001 Dec 14, 2017

001 Dec 14, 2017

001 Feb 29, 1988

Jul CTEC

Jul CHRS

Jul DISC

May CAHN

Jul DISC

+

+

@

@

AKORN

RISING

2.5MG/ML

2.5MG/ML

N016796

N016796

001

001

Jul DISC

Sep CAHN

DROPERIDOL; FENTANYL CITRATE

INJECTABLE;INJECTION

INNOVAR

@ EPIC PHARMA LLC 2.5MG/ML;EQ 0.05MG BASE/ML N016049 001 Nov CAHN

DROSPIRENONE

TABLET, CHEWABLE;ORAL

DROSPIRENONE

+ @ EXELTIS USA INC 3.5MG N216285 001 Jun 29, 2022 Jun DISC

DROSPIRENONE; ETHINYL ESTRADIOL

TABLET;ORAL

DROSPIRENONE AND ETHINYL ESTRADIOL

@ BARR 3MG;0.02MG

TABLET;ORAL-28

DROSPIRENONE AND ETHINYL ESTRADIOL

A078515 001 Mar 30, 2009 Sep DISC

@ BARR 3MG;0.03MG A077527 001 May 09, 2008 Sep DISC

DROXIDOPA

CAPSULE;ORAL

DROXIDOPA

>A>

>A>

>A>

>D>

>A>

>D>

>A>

>D>

>A>

>D>

AB

AB

AB

AB

AB

AB

AB

@

@

@

@

@

@

BLUEPHARMA INDUSTRIA

CHARTWELL RX

HIKMA

TRIS PHARMA INC

100MG

200MG

300MG

100MG

200MG

300MG

100MG

100MG

200MG

200MG

300MG

300MG

100MG

A214543

A214543

A214543

A214217

A214217

A214217

A212835

A212835

A212835

A212835

A212835

A212835

A214543

001 May 05, 2021

002 May 05, 2021

003 May 05, 2021

001 May 05, 2022

002 May 05, 2022

003 May 05, 2022

001 Feb 18, 2021

001 Feb 18, 2021

002 Feb 18, 2021

002 Feb 18, 2021

003 Feb 18, 2021

003 Feb 18, 2021

001 May 05, 2021

Dec CAHN

Dec CAHN

Dec CAHN

May CAHN

May CAHN

May CAHN

Dec DISC

Dec DISC

Dec DISC

Dec DISC

Dec DISC

Dec DISC

Dec CAHN
RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - December 2023 1-50

>D>

>D>

AB

AB

CAPSULE;ORAL

DROXIDOPA

200MG

300MG

A214543

A214543

002 May 05, 2021

003 May 05, 2021

Dec CAHN

Dec CAHN

DULOXETINE HYDROCHLORIDE

AB

CAPSULE, DELAYED REL PELLETS;ORAL

DRIZALMA SPRINKLE

+ @ SUN PHARM EQ 30MG BASE

+ @ EQ 40MG BASE

+ @ EQ 60MG BASE

DULOXETINE HYDROCHLORIDE

@ APOTEX EQ 20MG BASE

@ EQ 30MG BASE

@ EQ 60MG BASE

ZYDUS HLTHCARE EQ 40MG BASE

N212516

N212516

N212516

A202045

A202045

A202045

A090739

002 Jul 19, 2019

003 Jul 19, 2019

004 Jul 19, 2019

001 Jun 11, 2014

002 Jun 11, 2014

003 Jun 11, 2014

004 Apr 18, 2023

Mar DISC

Jan DISC

Mar DISC

Nov DISC

Nov DISC

Nov DISC

Apr NEWA

DURLOBACTAM SODIUM; DURLOBACTAM SODIUM; SULBACTAM SODIUM

POWDER;INTRAVENOUS

XACDURO (COPACKAGED)

+! ENTASIS THERAP EQ 500MG BASE/VIAL; EQ 500MG

BASE/VIAL;EQ 1GM BASE/VIAL

+! EQ 500MG BASE/VIAL; EQ 500MG

BASE/VIAL;EQ 1GM BASE/VIAL

N216974

N216974

001 May 23, 2023

001 May 24, 2023

Jun CMS1

May NEWA

DUTASTERIDE

AB

CAPSULE;ORAL

DUTASTERIDE

ADAPTIS 0.5MG A204376 001 Apr 07, 2017 Sep CAHN

DYCLONINE HYDROCHLORIDE

SOLUTION;TOPICAL

DYCLOPRO

! SEPTODONT

!

0.5%

1%

A200480

A200480

001 Nov 20, 2018

002 Nov 20, 2018

May CAHN

May CAHN

ECONAZOLE NITRATE

>D>

>A>

CREAM;TOPICAL

ECONAZOLE NITRATE

@ AUROBINDO PHARMA USA

@ PAI HOLDINGS PHARM

@

@ VERTICE

1%

1%

1%

1%

A210364

A076574

A076574

A076574

001 Apr 18, 2018

001 Dec 17, 2004

001 Dec 17, 2004

001 Dec 17, 2004

Apr CAHN

Dec CAHN

May DISC

Dec CAHN

EDETATE CALCIUM DISODIUM

INJECTABLE;INJECTION

EDETATE CALCIUM DISODIUM

! CASPER PHARMA LLC 200MG/ML

200MG/ML

A216435

A216435

001 May 03, 2023

001 May 03, 2023

Apr NFTG

Apr NFTG

EFAVIRENZ

CAPSULE;ORAL

EFAVIRENZ

AUROBINDO PHARMA

!

SUSTIVA

+ @ BRISTOL MYERS SQUIBB

+ @

50MG

200MG

200MG

50MG

200MG

A078064

A078064

A078064

N020972

N020972

001 Dec 15, 2017

003 Dec 15, 2017

003 Dec 15, 2017

001 Sep 17, 1998

003 Sep 17, 1998

Mar CTEC

Mar CHRS

Mar CTEC

Mar DISC

Mar DISC

AB

EFAVIRENZ; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE

TABLET;ORAL

EFAVIRENZ; EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE

STRIDES PHARMA 600MG;200MG;300MG A201802 001 Oct 03, 2023 Sep NEWA

EFLORNITHINE HYDROCHLORIDE

>A>

>A>

TABLET;ORAL

IWILFIN

+! USWM EQ 192MG BASE N215500 001 Dec 13, 2023 Dec NEWA
RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - December 2023 1-51

ELACESTRANT DIHYDROCHLORIDE

TABLET;ORAL

ORSERDU

+

+!

STEMLINE THERAP EQ 86MG BASE

EQ 345MG BASE

N217639

N217639

001

002

Jan 27, 2023

Jan 27, 2023

Jan NEWA

Jan NEWA

ELETRIPTAN HYDROBROMIDE

TABLET;ORAL

ELETRIPTAN HYDROBROMIDE

>D>

>D>

>A>

>A>

@

@

@

@

AMNEAL PHARMS CO

STEVENS J

EQ 20MG BASE

EQ 40MG BASE

EQ 20MG BASE

EQ 40MG BASE

A206787

A206787

A206787

A206787

001

002

001

002

May 25, 2018

May 25, 2018

May 25, 2018

May 25, 2018

Dec CAHN

Dec CAHN

Dec CAHN

Dec CAHN

ELEXACAFTOR, IVACAFTOR, TEZACAFTOR; IVACAFTOR

GRANULES;ORAL

TRIKAFTA (COPACKAGED)

+ VERTEX PHARMS INC 80MG, 60MG, 40MG;59.5MG

+! 100MG, 75MG, 50MG;75MG

N217660

N217660

001

002

Apr 26, 2023

Apr 26, 2023

Apr NEWA

Apr NEWA

ELIGLUSTAT TARTRATE

CAPSULE;ORAL

ELIGLUSTAT TARTRATE

AB

AB

UPSHER SMITH LABS

ZENARA

EQ 84MG BASE

EQ 84MG BASE

A212420

A212420

001

001

May 02, 2023

May 02, 2023

Sep CAHN

Apr NEWA

ELTROMBOPAG CHOLINE

TABLET;ORAL

ALVAIZ

+

+

+

+!

TEVA PHARMS INC EQ 9MG BASE

EQ 18MG BASE

EQ 36MG BASE

EQ 54MG BASE

N216774

N216774

N216774

N216774

001

002

003

004

Nov 29, 2023

Nov 29, 2023

Nov 29, 2023

Nov 29, 2023

Nov NEWA

Nov NEWA

Nov NEWA

Nov NEWA

EMPAGLIFLOZIN

TABLET;ORAL

EMPAGLIFLOZIN

@ ZYDUS PHARMS

@

JARDIANCE

10MG

25MG

A212138

A212138

001

002

Aug 03, 2022

Aug 03, 2022

Jan DISC

Jan DISC

+

+!

BOEHRINGER INGELHEIM 10MG

25MG

N204629

N204629

001

002

Aug 01, 2014

Aug 01, 2014

Jan CTEC

Jan CTEC

EMTRICITABINE

CAPSULE;ORAL

EMTRICITABINE

AB AUROBINDO PHARMA LTD 200MG A079188 001 Mar 15, 2023 Mar NEWA

EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE

TABLET;ORAL

EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE

>D>

>A>

>D>

>A>

>D>

>A>

AB

AB

AB

AB

AB

AB

@

@

@

@

@

@

@

@

APOTEX

AUROBINDO PHARMA LTD

CIPLA

200MG;300MG

100MG;150MG

100MG;150MG

100MG;150MG

100MG;150MG

133MG;200MG

133MG;200MG

133MG;200MG

133MG;200MG

167MG;250MG

167MG;250MG

167MG;250MG

167MG;250MG

200MG;300MG

A208740

A211640

A211640

A211640

A211640

A211640

A211640

A211640

A211640

A211640

A211640

A211640

A211640

A090958

001

001

001

001

001

002

002

002

002

003

003

003

003

001

Jun 16, 2021

Mar 09, 2023

Mar 09, 2023

Mar 09, 2023

Mar 09, 2023

Mar 09, 2023

Mar 09, 2023

Mar 09, 2023

Mar 09, 2023

Mar 09, 2023

Mar 09, 2023

Mar 09, 2023

Mar 09, 2023

Apr 02, 2021

Apr DISC

Dec CMFD

Dec CMFD

Sep DISC

Mar NEWA

Dec CMFD

Dec CMFD

Sep DISC

Mar NEWA

Dec CMFD

Dec CMFD

Sep DISC

Mar NEWA

Sep DISC
RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - December 2023 1-52

ENALAPRIL MALEATE

SOLUTION;ORAL

ENALAPRIL MALEATE

>A> AB AUROBINDO PHARMA

TABLET;ORAL

ENALAPRIL MALEATE

1MG/ML A216458 001 Jan 08, 2024 Dec NEWA

@ CHARTWELL RX

@

@

@

2.5MG

5MG

10MG

20MG

A075048

A075048

A075048

A075048

001

002

003

004

Aug 22, 2000

Aug 22, 2000

Aug 22, 2000

Aug 22, 2000

May CAHN

May CAHN

May CAHN

May CAHN

ENALAPRILAT

INJECTABLE;INJECTION

ENALAPRILAT

AP DR REDDYS 1.25MG/ML A075578 001 Aug 22, 2000 Apr CMFD

ENOXAPARIN SODIUM

AP

AP

AP

AP

AP

AP

AP

AP

AP

AP

AP

AP

AP

AP

AP

AP

AP

AP

AP

AP

AP

INJECTABLE;SUBCUTANEOUS

ENOXAPARIN SODIUM (PRESERVATIVE FREE)

BE PHARMS 30MG/0.3ML (100MG/ML)

40MG/0.4ML (100MG/ML)

60MG/0.6ML (100MG/ML)

80MG/0.8ML (100MG/ML)

100MG/ML (100MG/ML)

120MG/0.8ML (150MG/ML)

150MG/ML (150MG/ML)

GLAND 30MG/0.3ML (100MG/ML)

40MG/0.4ML (100MG/ML)

60MG/0.6ML (100MG/ML)

80MG/0.8ML (100MG/ML)

100MG/ML (100MG/ML)

120MG/0.8ML (150MG/ML)

150MG/ML (150MG/ML)

SHENZHEN TECHDOW 30MG/0.3ML (100MG/ML)

40MG/0.4ML (100MG/ML)

60MG/0.6ML (100MG/ML)

80MG/0.8ML (100MG/ML)

100MG/ML (100MG/ML)

120MG/0.8ML (150MG/ML)

150MG/ML (150MG/ML)

A214646

A214646

A214646

A214646

A214646

A214646

A214646

A078990

A078990

A078990

A078990

A078990

A078990

A078990

A205660

A205660

A205660

A205660

A205660

A205660

A205660

001

002

003

004

005

006

007

001

002

003

004

005

006

007

001

002

003

004

005

006

007

Jun 06, 2023

Jun 06, 2023

Jun 06, 2023

Jun 06, 2023

Jun 06, 2023

Jun 06, 2023

Jun 06, 2023

Sep 28, 2018

Sep 28, 2018

Sep 28, 2018

Sep 28, 2018

Sep 28, 2018

Sep 28, 2018

Sep 28, 2018

Mar 15, 2023

Mar 15, 2023

Mar 15, 2023

Mar 15, 2023

Mar 15, 2023

Mar 15, 2023

Mar 15, 2023

May NEWA

May NEWA

May NEWA

May NEWA

May NEWA

May NEWA

May NEWA

Jun CAHN

Jun CAHN

Jun CAHN

Jun CAHN

Jun CAHN

Jun CAHN

Jun CAHN

Mar NEWA

Mar NEWA

Mar NEWA

Mar NEWA

Mar NEWA

Mar NEWA

Mar NEWA

ENTECAVIR

TABLET;ORAL

ENTECAVIR

AB

AB

@

@

CASI PHARMS INC

VITRUVIAS

0.5MG

1MG

0.5MG

1MG

A206672

A206672

A212106

A212106

001

002

001

002

May 11, 2017

May 11, 2017

Aug 10, 2020

Aug 10, 2020

Nov DISC

Nov DISC

Sep CAHN

Sep CAHN

ENTRECTINIB

PELLETS;ORAL

ROZLYTREK

+! GENENTECH INC 50MG/PACKET N218550 001 Oct 20, 2023 Oct NEWA

EPHEDRINE HYDROCHLORIDE

SOLUTION;INTRAVENOUS

REZIPRES

>A> +! DR REDDYS LABS SA 47MG/10ML (4.7MG/ML) N213536 004 Dec 07, 2023 Dec NEWA

EPHEDRINE SULFATE

SOLUTION;INTRAVENOUS

EPHEDRINE SULFATE

AP

AP

AP

AP

+!

+!

@

@

OAK TREE PHARMA

OPERAND PHARMS

RENEW PHARMS

SAGENT PHARMS INC

ZYDUS PHARMS

50MG/ML (50MG/ML)

25MG/5ML (5MG/ML)

50MG/10ML (5MG/ML)

50MG/ML (50MG/ML)

50MG/ML (50MG/ML)

50MG/ML (50MG/ML)

50MG/ML (50MG/ML)

50MG/ML (50MG/ML)

N208609

N213994

N213994

N208609

N208609

A214528

A217276

A217276

001

002

001

001

001

001

001

001

Mar 01, 2017

Apr 22, 2022

Oct 16, 2020

Mar 01, 2017

Mar 01, 2017

Mar 09, 2023

May 16, 2023

May 16, 2023

Aug CAHN

Jun CAHN

Jun CAHN

Nov DISC

Aug CAHN

Feb NEWA

Sep DISC

May NEWA
RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - December 2023 1-53

EPINASTINE HYDROCHLORIDE

SOLUTION/DROPS;OPHTHALMIC

EPINASTINE HYDROCHLORIDE

@ EPIC PHARMA LLC 0.05% A204055 001 May 05, 2017 Oct CAHN

EPINEPHRINE

SOLUTION;INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS

ADRENALIN

+! PAR STERILE PRODUCTS EQ 1MG BASE/ML (EQ 1MG BASE/ML)

EPINEPHRINE

@ AM REGENT EQ 1MG BASE/ML (EQ 1MG BASE/ML)

SOLUTION;INTRAMUSCULAR, SUBCUTANEOUS

SYMJEPI

+ @ ADAMIS PHARMS CORP 0.15MG/0.3ML (0.15MG/0.3ML)

SOLUTION;INTRAVENOUS

ADRENALIN

+! PAR STERILE PRODUCTS 2MG/250ML (8MCG/ML)

+! 2MG/250ML (8MCG/ML)

+! 4MG/250ML (16MCG/ML)

+! 4MG/250ML (16MCG/ML)

+! 5MG/250ML (20MCG/ML)

+! 5MG/250ML (20MCG/ML)

+! 8MG/250ML (32MCG/ML)

+! 8MG/250ML (32MCG/ML)

+! 10MG/250ML (40MCG/ML)

+! 10MG/250ML (40MCG/ML)

EPINEPHRINE

+! BPI LABS 1MG/ML (1MG/ML)

N204200

A207568

N207534

N215875

N215875

N215875

N215875

N215875

N215875

N215875

N215875

N215875

N215875

N205029

001

001

002

001

001

002

002

003

003

004

004

005

005

003

Dec 07, 2012

Jul 06, 2018

Sep 27, 2018

Apr 21, 2023

Apr 21, 2023

Apr 21, 2023

Apr 21, 2023

Apr 21, 2023

Apr 21, 2023

Apr 21, 2023

Apr 21, 2023

Apr 21, 2023

Apr 21, 2023

May 12, 2023

Sep CTEC

Sep DISC

Oct DISC

Oct CTNA

Apr NEWA

Oct CTNA

Apr NEWA

Oct CTNA

Apr NEWA

Oct CTNA

Apr NEWA

Oct CTNA

Apr NEWA

Jun NEWA

EPINEPHRINE; LIDOCAINE HYDROCHLORIDE

INJECTABLE;INJECTION

LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE

! HOSPIRA 0.01MG/ML;2%

XYLOCAINE W/ EPINEPHRINE

+! FRESENIUS KABI USA 0.02MG/ML;2%

A089646

N006488

001

005

Jun 21, 1988 Apr CTEC

May CTEC

EPLERENONE

AB

AB

AB

AB

TABLET;ORAL

EPLERENONE

ANNORA PHARMA

RISING

25MG

50MG

25MG

50MG

A213812

A213812

A214663

A214663

001

002

001

002

Jun 02, 2023

Jun 02, 2023

Mar 23, 2022

Mar 23, 2022

May NEWA

May NEWA

Oct CAHN

Oct CAHN

>A> EPLONTERSEN SODIUM

>A>

>A>

>A>

SOLUTION;SUBCUTANEOUS

WAINUA

+! IONIS PHARMS INC EQ 45MG BASE/0.8ML (EQ 45MG

BASE/0.8ML)

N217388 001 Dec 21, 2023 Dec NEWA

EPOPROSTENOL SODIUM

AP2

AP2

INJECTABLE;INJECTION

EPOPROSTENOL SODIUM

! SUN PHARM

VELETRI

+ ACTELION

EQ 0.5MG BASE/VIAL

EQ 0.5MG BASE/VIAL

A210473

N022260

001

002

Jan 15, 2021

Jun 28, 2012

Feb CHRS

Feb CHRS

EPTIFIBATIDE

AP

AP

INJECTABLE;INJECTION

EPTIFIBATIDE

SLATE RUN PHARMA 2MG/ML

75MG/100ML

A209864

A209864

001

002

Jan 25, 2019

Jan 25, 2019

Sep CAHN

Sep CAHN

ERGOCALCIFEROL

>A>

>D>

AA

AA

AA

CAPSULE;ORAL

DRISDOL

+ SS PHARMA

+ VALIDUS PHARMS

+

50,000 IU

50,000 IU

50,000 IU

N003444

N003444

N003444

001

001

001

Dec CAHN

Dec CAHN

Feb CHRS
RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - December 2023 1-54

CAPSULE;ORAL

ERGOCALCIFEROL

>D>

>A>

AA

AA

AA

!

@

CHARTWELL RX

STRIDES PHARMA

SUN PHARM INDS INC

50,000 IU

50,000 IU

50,000 IU

50,000 IU

A040833

A090455

A040865

A040865

001 May 20, 2009

001 Aug 03, 2010

001 Dec 29, 2009

001 Dec 29, 2009

Feb CAHN

Feb CHRS

Dec DISC

Dec DISC

ERLOTINIB HYDROCHLORIDE

TABLET;ORAL

ERLOTINIB HYDROCHLORIDE

AB ! ZYDUS PHARMS

TARCEVA

EQ 150MG BASE A213065 003 Apr 16, 2020 Apr CHRS

+

+

+

@

@

@

OSI PHARMS EQ 25MG BASE

EQ 100MG BASE

EQ 150MG BASE

N021743

N021743

N021743

001 Nov 18, 2004

002 Nov 18, 2004

003 Nov 18, 2004

Apr DISC

Apr DISC

Apr DISC

ERTUGLIFLOZIN

TABLET;ORAL

ERTUGLIFLOZIN

AB

AB

@ AUROBINDO PHARMA LTD

@

STEGLATRO

5MG

5MG

15MG

15MG

A216947

A216947

A216947

A216947

001 Jul 13, 2023

001 Jul 13, 2023

002 Jul 13, 2023

002 Jul 13, 2023

Jul DISC

Jul NFTG

Jul DISC

Jul NFTG

AB

AB

+

+

+!

+!

MSD SUB MERCK 5MG

5MG

15MG

15MG

N209803

N209803

N209803

N209803

001 Dec 19, 2017

001 Dec 19, 2017

002 Dec 19, 2017

002 Dec 19, 2017

Jul CTEC

Jul CFTG

Jul CTEC

Jul CFTG

ERYTHROMYCIN

GEL;TOPICAL

ERYTHROMYCIN

>D>

>A>

@

@

@

PAI HOLDINGS PHARM

VERTICE

2%

2%

2%

A208154

A208154

A208154

001 Jul 19, 2017

001 Jul 19, 2017

001 Jul 19, 2017

Dec CAHN

May DISC

Dec CAHN

OINTMENT;OPHTHALMIC

ERYTHROMYCIN

AT SENTISS

SOLUTION;TOPICAL

ERYTHROMYCIN

0.5% A064030 001 Jul 18, 1996 Aug CAHN

@ PAI HOLDINGS PHARM

@ PHARMOBEDIENT CNSLTG

@ XTTRIUM LABS INC

2%

2%

2%

A208100

A062825

A062825

001 Nov 20, 2017

001 Oct 23, 1987

001 Oct 23, 1987

Aug DISC

Sep CAHN

Jul DISC

TABLET;ORAL

ERYTHROMYCIN

AB

AB

AB

ALEMBIC

ARBOR PHARMS LLC

250MG

500MG

500MG

A215661

A215661

A061621

001 Aug 24, 2023

002 Aug 24, 2023

002

Aug NEWA

Aug NEWA

Jan CHRS

>D>

>A>

>D>

>A>

AB

AB

AB

AB

AB

AB

AB

! CADILA PHARMS LTD

ZYDUS

ZYDUS PHARMS

@

@

500MG

250MG

500MG

250MG

250MG

250MG

500MG

500MG

500MG

A213628

A212693

A212693

A215440

A215440

A215440

A215440

A215440

A215440

002 Jun 28, 2021

001 Mar 07, 2023

002 Mar 07, 2023

001 Aug 31, 2023

001 Aug 31, 2023

001 Aug 31, 2023

002 Aug 31, 2023

002 Aug 31, 2023

002 Aug 31, 2023

Jan CHRS

Feb NEWA

Feb NEWA

Dec DISC

Dec DISC

Aug NEWA

Dec DISC

Dec DISC

Aug NEWA

ERYTHROMYCIN ETHYLSUCCINATE

TABLET;ORAL

ERYTHROMYCIN ETHYLSUCCINATE

@ AUROBINDO PHARMA USA EQ 400MG BASE A062847 001 Sep 14, 1988 Apr CAHN

ERYTHROMYCIN LACTOBIONATE

INJECTABLE;INJECTION

ERYTHROMYCIN LACTOBIONATE

@ EXELA PHARMA EQ 500MG BASE/VIAL A211086 001 Sep 17, 2020 May DISC
RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - December 2023 1-55

ESCITALOPRAM OXALATE

AA

AB

AB

AB

AB

AB

AB

AB

AB

AB

SOLUTION;ORAL

ESCITALOPRAM OXALATE

CHARTWELL MOLECULAR

LEXAPRO

+ @ ABBVIE

TABLET;ORAL

ESCITALOPRAM OXALATE

@ DASH PHARMS

@

@

JUBILANT CADISTA

MACLEODS PHARMS LTD

LEXAPRO

+ ABBVIE

+

+!

EQ 5MG BASE/5ML

EQ 5MG BASE/5ML

EQ 5MG BASE

EQ 10MG BASE

EQ 20MG BASE

EQ 5MG BASE

EQ 10MG BASE

EQ 20MG BASE

EQ 5MG BASE

EQ 10MG BASE

EQ 20MG BASE

EQ 5MG BASE

EQ 10MG BASE

EQ 20MG BASE

A090477

N021365

A077550

A077550

A077550

A202280

A202280

A202280

A202210

A202210

A202210

N021323

N021323

N021323

001

001

001

002

003

001

002

003

001

002

003

001

002

003

Jun 12, 2013

Nov 27, 2002

May 14, 2015

May 14, 2015

May 14, 2015

Sep 12, 2012

Sep 12, 2012

Sep 12, 2012

Sep 11, 2012

Sep 11, 2012

Sep 11, 2012

Aug 14, 2002

Aug 14, 2002

Aug 14, 2002

Jul CAHN

Jan CAHN

Feb CAHN

Feb CAHN

Feb CAHN

May CAHN

May CAHN

May CAHN

Nov CMFD

Nov CMFD

Nov CMFD

Jan CAHN

Jan CAHN

Jan CAHN

ESLICARBAZEPINE ACETATE

>A>

>A>

>A>

>A>

AB

AB

AB

AB

AB

AB

AB

AB

AB

AB

AB

AB

AB

AB

AB

AB

TABLET;ORAL

APTIOM

+ SUMITOMO PHARMA AM

+

+

+!

ESLICARBAZEPINE ACETATE

ALKEM LABS LTD

APOTEX

HETERO LABS LTD V

200MG

400MG

600MG

800MG

200MG

400MG

600MG

800MG

200MG

400MG

600MG

800MG

200MG

400MG

600MG

800MG

N022416

N022416

N022416

N022416

A211199

A211199

A211199

A211199

A211236

A211236

A211236

A211236

A211186

A211186

A211186

A211186

001

002

003

004

001

002

003

004

001

002

003

004

001

002

003

004

Nov 08, 2013

Nov 08, 2013

Nov 08, 2013

Nov 08, 2013

Oct 06, 2023

Oct 06, 2023

Oct 06, 2023

Oct 06, 2023

Dec 07, 2023

Dec 07, 2023

Dec 07, 2023

Dec 07, 2023

Aug 03, 2023

Aug 03, 2023

Aug 03, 2023

Aug 03, 2023

Jul CAHN

Jul CAHN

Jul CAHN

Jul CAHN

Sep NEWA

Sep NEWA

Sep NEWA

Sep NEWA

Dec NEWA

Dec NEWA

Dec NEWA

Dec NEWA

Jul NEWA

Jul NEWA

Jul NEWA

Jul NEWA

ESMOLOL HYDROCHLORIDE

AP

AP

AP

AP

AP

AP

AP

AP

AP

AP

AP

AP

INJECTABLE;INJECTION

BREVIBLOC DOUBLE STRENGTH IN PLASTIC CONTAINER

+! BAXTER HLTHCARE 2GM/100ML

BREVIBLOC IN PLASTIC CONTAINER

+! BAXTER HLTHCARE 1GM/100ML

ESMOLOL HYDROCHLORIDE

AMNEAL 1GM/100ML

2GM/100ML

EUGIA PHARMA 1GM/100ML

2GM/100ML

@ FRESENIUS KABI USA 10MG/ML

@ 20MG/ML

20MG/ML

HQ SPCLT PHARMA 1GM/100ML

2GM/100ML

MYLAN LABS LTD 1GM/100ML

2GM/100ML

SAGENT PHARMS INC 1GM/100ML

2GM/100ML

N019386

N019386

A216603

A216603

A216244

A216244

A076573

A076573

A076573

A214172

A214172

A206608

A206608

A207107

A207107

005

004

001

002

001

002

001

002

002

001

002

001

002

001

002

Jan 27, 2003

Feb 16, 2001

Dec 13, 2022

Dec 13, 2022

Mar 21, 2022

Mar 21, 2022

May 02, 2005

Aug 23, 2023

Aug 23, 2023

Dec 02, 2022

Dec 02, 2022

Jun 08, 2018

Jun 08, 2018

Jun 08, 2018

Jun 08, 2018

Jan CTEC

Jan CTEC

Jan CPOT

Jan CPOT

Jan CPOT

Jan CPOT

Oct DISC

Oct DISC

Aug NEWA

Jan CPOT

Jan CPOT

Jan CPOT

Jan CPOT

Jan CPOT

Jan CPOT

ESOMEPRAZOLE MAGNESIUM

AB

AB

AB

AB

AB

CAPSULE, DELAYED REL PELLETS;ORAL

ESOMEPRAZOLE MAGNESIUM

GRANULES EQ 20MG BASE

EQ 40MG BASE

GUANGZHOU NOVAKEN EQ 20MG BASE

EQ 40MG BASE

PRINSTON INC EQ 20MG BASE

A217427

A217427

A213859

A213859

A214920

001

002

001

002

001

Oct 18, 2023

Oct 18, 2023

Nov 18, 2020

Nov 18, 2020

Mar 28, 2023

Oct NEWA

Oct NEWA

Aug CMFD

Aug CMFD

Mar NEWA
RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - December 2023 1-56

>A>

>A>

CAPSULE, DELAYED REL PELLETS;ORAL

ESOMEPRAZOLE MAGNESIUM

AB EQ 40MG BASE

@ TORRENT EQ 20MG BASE

@ EQ 40MG BASE

AB ZHEJIANG YONGTAI EQ 20MG BASE

AB EQ 40MG BASE

FOR SUSPENSION, DELAYED RELEASE;ORAL

ESOMEPRAZOLE MAGNESIUM

AB ZYDUS PHARMS EQ 20MG BASE/PACKET

AB EQ 40MG BASE/PACKET

ESOMEPRAZOLE MAGNESIUM; NAPROXEN

TABLET, DELAYED RELEASE;ORAL

NAPROXEN AND ESOMEPRAZOLE MAGNESIUM

@ ACTAVIS LABS FL INC EQ 20MG BASE;375MG

@ EQ 20MG BASE;500MG

AB ! DR REDDYS EQ 20MG BASE;500MG

@ MYLAN EQ 20MG BASE;375MG

@ EQ 20MG BASE;500MG

AB SCIEGEN PHARMS INC EQ 20MG BASE;375MG

AB EQ 20MG BASE;500MG

ESOMEPRAZOLE SODIUM

INJECTABLE;INTRAVENOUS

ESOMEPRAZOLE SODIUM

AP EUGIA PHARMA EQ 40MG BASE/VIAL

GLAND PHARMA LTD EQ 20MG BASE/VIAL

ESTRADIOL

CREAM;VAGINAL

ESTRADIOL

AB PRASCO 0.01%

FILM, EXTENDED RELEASE;TRANSDERMAL

ALORA

@ ABBVIE 0.025MG/24HR

@ 0.05MG/24HR

@ 0.075MG/24HR

@ 0.1MG/24HR

ESTRADIOL

AB2 ZYDUS NOVELTECH INC 0.025MG/24HR

AB2 0.0375MG/24HR

AB2 0.05MG/24HR

AB 0.06MG/24HR

AB2 0.075MG/24HR

AB2 0.1MG/24HR

@ ZYDUS PHARMS 0.025MG/24HR

AB2 0.025MG/24HR

@ 0.0375MG/24HR

AB2 0.0375MG/24HR

@ 0.05MG/24HR

AB2 0.05MG/24HR

@ 0.06MG/24HR

AB 0.06MG/24HR

@ 0.075MG/24HR

AB2 0.075MG/24HR

@ 0.1MG/24HR

AB2 0.1MG/24HR

GEL;TRANSDERMAL

ESTRADIOL

AB NOVITIUM PHARMA 0.1%

AB PADAGIS ISRAEL 0.1%

INSERT;VAGINAL

IMVEXXY

+ MAYNE PHARMA 0.004MG

+! 0.01MG

SYSTEM;TRANSDERMAL

ESTRADIOL

AB ZYDUS NOVELTECH INC 0.014MG/24HR

AB ZYDUS PHARMS 0.014MG/24HR

AB1 0.025MG/24HR

AB1 0.0375MG/24HR

A214920

A203636

A203636

A217022

A217022

A206055

A206055

A204470

A204470

A204206

A204920

A204920

A217738

A217738

A204657

A203349

A212313

N020655

N020655

N020655

N020655

A202985

A202985

A202985

A202985

A202985

A202985

A202985

A202985

A202985

A202985

A202985

A202985

A202985

A202985

A202985

A202985

A202985

A202985

A217610

A216524

N208564

N208564

A204379

A204379

A206241

A206241

002 Mar 28, 2023

001 Oct 19, 2015

002 Oct 19, 2015

001 Dec 27, 2023

002 Dec 27, 2023

001 Jun 07, 2023

002 Jun 07, 2023

001 Aug 24, 2022

002 Aug 24, 2022

002 Feb 18, 2020

001 Jul 20, 2021

002 Jul 20, 2021

001 Oct 11, 2023

002 Oct 11, 2023

002 Aug 10, 2016

001 Apr 01, 2020

001 Jul 15, 2021

004 Apr 05, 2002

001 Dec 20, 1996

002 Dec 20, 1996

003 Dec 20, 1996

001 Mar 29, 2023

002 Mar 29, 2023

003 Mar 29, 2023

004 Mar 29, 2023

005 Mar 29, 2023

006 Mar 29, 2023

001 Mar 29, 2023

001 Mar 29, 2023

002 Mar 29, 2023

002 Mar 29, 2023

003 Mar 29, 2023

003 Mar 29, 2023

004 Mar 29, 2023

004 Mar 29, 2023

005 Mar 29, 2023

005 Mar 29, 2023

006 Mar 29, 2023

006 Mar 29, 2023

001 Aug 24, 2023

001 Nov 14, 2023

001 May 29, 2018

002 May 29, 2018

001 Apr 17, 2023

001 Apr 17, 2023

001 Dec 01, 2022

002 Dec 01, 2022

Mar NEWA

Aug DISC

Aug DISC

Dec NEWA

Dec NEWA

May NEWA

May NEWA

Feb DISC

Feb DISC

Aug CHRS

Oct DISC

Oct DISC

Sep NEWA

Sep NEWA

Jan CHRS

Apr CTEC

Jun CAHN

Oct CAHN

Oct CAHN

Oct CAHN

Oct CAHN

Mar NEWA

Mar NEWA

Mar NEWA

Mar NEWA

Mar NEWA

Mar NEWA

Jul DISC

Apr CAHN

Jul DISC

Apr CAHN

Jul DISC

Apr CAHN

Jul DISC

Apr CAHN

Jul DISC

Apr CAHN

Jul DISC

Apr CAHN

Aug NEWA

Nov NEWA

Jan CAHN

Jan CAHN

Apr NFTG

May CAHN

May CAHN

May CAHN
RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - December 2023 1-57

SYSTEM;TRANSDERMAL

ESTRADIOL

AB1

AB1

AB1

MENOSTAR

0.05MG/24HR

0.075MG/24HR

0.1MG/24HR

A206241

A206241

A206241

003 Dec 01, 2022

004 Dec 01, 2022

005 Dec 01, 2022

May CAHN

May CAHN

May CAHN

AB +! BAYER HLTHCARE

VIVELLE

0.014MG/24HR N021674 001 Jun 08, 2004 Apr CFTG

@ SANDOZ

@

@

@

@

VIVELLE-DOT

0.025MG/24HR

0.0375MG/24HR

0.05MG/24HR

0.075MG/24HR

0.1MG/24HR

N020323

N020323

N020323

N020323

N020323

005 Aug 16, 2000

001 Oct 28, 1994

002 Oct 28, 1994

003 Oct 28, 1994

004 Oct 28, 1994

May CAHN

May CAHN

May CAHN

May CAHN

May CAHN

AB1

AB1

AB1

AB1

AB1

+ SANDOZ

+

+

+

+!

TABLET;ORAL

ESTRADIOL

0.025MG/24HR

0.0375MG/24HR

0.05MG/24HR

0.075MG/24HR

0.1MG/24HR

N020538

N020538

N020538

N020538

N020538

009 May 03, 2002

005 Jan 08, 1999

006 Jan 08, 1999

007 Jan 08, 1999

008 Jan 08, 1999

May CAHN

May CAHN

May CAHN

May CAHN

May CAHN

AB

AB

AB

NOVITIUM PHARMA 0.5MG

1MG

2MG

A217334

A217334

A217334

001 Sep 06, 2023

002 Sep 06, 2023

003 Sep 06, 2023

Aug NEWA

Aug NEWA

Aug NEWA

ESTRADIOL VALERATE

INJECTABLE;INJECTION

ESTRADIOL VALERATE

AO

AO

AO

XIROMED 10MG/ML

20MG/ML

40MG/ML

A216656

A216656

A216656

001 Apr 28, 2023

002 Apr 28, 2023

003 Apr 28, 2023

Apr NEWA

Apr NEWA

Apr NEWA

ESTRADIOL; NORETHINDRONE ACETATE

TABLET;ORAL

ESTRADIOL AND NORETHINDRONE ACETATE

>D>

>D>

>A>

>A>

AB

AB

AB

AB

AUROBINDO PHARMA LTD

ETYQA

@ AUROBINDO PHARMA LTD

@

0.5MG;0.1MG

0.5MG;0.1MG

1MG;0.5MG

1MG;0.5MG

0.5MG;0.1MG

1MG;0.5MG

A214729

A214729

A214729

A214729

A214729

A214729

001 Jun 30, 2023

001 Jun 30, 2023

002 Jun 30, 2023

002 Jun 30, 2023

001 Jun 30, 2023

002 Jun 30, 2023

Dec DISC

Jun NEWA

Dec DISC

Jun NEWA

Dec DISC

Dec DISC

ESTRADIOL; PROGESTERONE

CAPSULE;ORAL

BIJUVA

>D>

>A>

+

+

@ MAYNE PHARMA 0.5MG;100MG

0.5MG;100MG

N210132

N210132

002 Dec 28, 2021

002 Dec 28, 2021

Dec CMFD

Dec CMFD

ESZOPICLONE

TABLET;ORAL

ESZOPICLONE

>A>

>A>

>A>

>A>

>A>

>A>

AB

AB

AB

AB

AB

AB

HETERO LABS LTD V

IPCA LABS LTD

1MG

2MG

3MG

1MG

2MG

3MG

A205504

A205504

A205504

A206222

A206222

A206222

001 Jan 04, 2024

002 Jan 04, 2024

003 Jan 04, 2024

001 Dec 29, 2023

002 Dec 29, 2023

003 Dec 29, 2023

Dec NEWA

Dec NEWA

Dec NEWA

Dec NEWA

Dec NEWA

Dec NEWA

ETHACRYNIC ACID

TABLET;ORAL

ETHACRYNIC ACID

>D>

>A>

AB

@

HIKMA 25MG

25MG

A207262

A207262

001 Feb 23, 2017

001 Feb 23, 2017

Dec DISC

Dec DISC

ETHINYL ESTRADIOL; ETONOGESTREL

RING;VAGINAL

ENILLORING

AB XIROMED 0.015MG/24HR;0.12MG/24HR A211157 001 Jun 29, 2023 Jun NEWA
RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - December 2023 1-58

ETHINYL ESTRADIOL; LEVONORGESTREL

TABLET;ORAL

BALCOLTRA

AB3 +! AVION PHARMS 0.02MG;0.1MG

LEVONORGESTREL AND ETHINYL ESTRADIOL AND FERROUS FUMARATE

N208612 001 Jan 09, 2018 Aug CFTG

AB3 XIROMED 0.02MG;0.1MG

TABLET;ORAL-28

LEVONORGESTREL AND ETHINYL ESTRADIOL

A214640 001 Aug 16, 2023 Aug NFTG

AB1

AB

@

@

AMNEAL PHARMS

HETERO LABS

LUPIN LTD

0.02MG;0.1MG

0.03MG;0.15MG

0.02MG;0.1MG

0.03MG,0.04MG,0.03MG;0.05MG,0.075M

G,0.125MG

A201108

A201095

A212298

A200248

001

001

001

001

Feb 05, 2014

Dec 08, 2014

Feb 13, 2023

Nov 19, 2015

Jan DISC

Jan DISC

Feb NEWA

Jan CTEC

ETHINYL ESTRADIOL; NORELGESTROMIN

FILM, EXTENDED RELEASE;TRANSDERMAL

ETHINYL ESTRADIOL AND NORELGESTROMIN

AB ZYDUS NOVELTECH INC 0.035MG/24HR;0.15MG/24HR A214594 001 Sep 14, 2023 Sep NEWA

ETHINYL ESTRADIOL; NORETHINDRONE

TABLET;ORAL-28

RHUZDAH

@ AUROBINDO PHARMA 0.035MG;0.4MG A207585 001 Oct 11, 2022 Apr DISC

ETHINYL ESTRADIOL; NORETHINDRONE ACETATE

TABLET;ORAL

HAILEY 24 FE

AB ! GLENMARK PHARMS LTD

MINASTRIN 24 FE

0.02MG;1MG A204847 001 Nov 17, 2017 Feb CTNA

+ @ APIL 0.02MG;1MG N203667

NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE

001 May 08, 2013 Apr DISC

AB ! GLENMARK PHARMS LTD

OSHIH

0.02MG;1MG A210369 001 Dec 26, 2017 Apr CHRS

AB AUROBINDO PHARMA

TABLET;ORAL-21

TRI-LEGEST 21

0.02MG;1MG A216558 001 Dec 06, 2023 Nov NEWA

@ BARR 0.02MG,0.03MG,0.035MG;1MG,1MG,1MG A076405 001 Oct 26, 2007 Sep DISC

ETHINYL ESTRADIOL; NORGESTIMATE

TABLET;ORAL-28

NORGESTIMATE AND ETHINYL ESTRADIOL

@

@

AMNEAL PHARMS 0.035MG,0.035MG,0.035MG;0.18MG,0.2

15MG,0.25MG

0.035MG;0.25MG

A203870

A203865

001

001

Nov 12, 2015

Oct 27, 2015

Jan DISC

Jun DISC

AB

ETHINYL ESTRADIOL; NORGESTREL

TABLET;ORAL-28

TURQOZ

LUPIN LTD 0.03MG;0.3MG A202980 001 Jul 31, 2023 Jul NEWA

ETHINYL ESTRADIOL; SEGESTERONE ACETATE

RING;VAGINAL

ANNOVERA

+! MAYNE PHARMA 0.013MG/24HR;0.15MG/24HR N209627 001 Aug 10, 2018 Jan CAHN

ETODOLAC

TABLET;ORAL

ETODOLAC

@

@

@

@

EDENBRIDGE PHARMS

SHREE HARI INTL

400MG

500MG

400MG

400MG

A209888

A209888

A074839

A074846

001

002

001

001

Nov 30, 2018

Nov 30, 2018

Jul 11, 1997

Feb 28, 1997

Aug DISC

Aug DISC

Sep CAHN

Sep CAHN

ETOMIDATE

INJECTABLE;INJECTION

ETOMIDATE

@ AVET LIFESCIENCES 2MG/ML A204618 001 Aug 13, 2014 Sep DISC
RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - December 2023 1-59

ETONOGESTREL

IMPLANT;IMPLANTATION

NEXPLANON

+! ORGANON 68MG/IMPLANT N021529 002 May 13, 2011 Nov CMS1

ETOPOSIDE

INJECTABLE;INJECTION

ETOPOSIDE

>D> AP

AP

>A> AP

@

@

DASH PHARMS

DASH PHARMS NATCO

HONG KONG

MEITHEAL

20MG/ML

20MG/ML

20MG/ML

20MG/ML

20MG/ML

A204927

A203507

A074529

A074529

A074529

001

001

001

001

001

Oct 31, 2017

Nov 20, 2017

Jul 24, 1996

Jul 24, 1996

Jul 24, 1996

Mar CAHN

Feb CAHN

Dec CAHN

Oct CAHN

Dec CAHN

ETRASIMOD ARGININE

TABLET;ORAL

VELSIPITY

+! PFIZER EQ 2MG BASE N216956 001 Oct 12, 2023 Oct NEWA

EVEROLIMUS

TABLET;ORAL

EVEROLIMUS

AB TEVA PHARMS USA 10MG A210050 004 Dec 09, 2019 Apr CMFD

EXEMESTANE

TABLET;ORAL

EXEMESTANE

@ ALVOGEN 25MG A200898 001 Jul 28, 2014 Feb DISC

EZETIMIBE

TABLET;ORAL

EZETIMIBE

AB

@

ORIENT PHARMA 10MG

10MG

A215693

A215693

001

001

Sep 13, 2022

Sep 13, 2022

Nov CMFD

Mar DISC

FAMOTIDINE

FOR SUSPENSION;ORAL

FAMOTIDINE

AB

AB

AB

AB

AB

AB

AB

AB

AB

AJANTA PHARMA LTD

ALKEM LABS LTD

ANNORA PHARMA

APPCO

CARNEGIE

LUPIN LTD

MICRO LABS

! NOVITIUM PHARMA

UPSHER SMITH LABS

INJECTABLE;INJECTION

FAMOTIDINE

40MG/5ML

40MG/5ML

40MG/5ML

40MG/5ML

40MG/5ML

40MG/5ML

40MG/5ML

40MG/5ML

40MG/5ML

A217529

A216400

A217330

A217655

A217137

A090440

A217842

A215043

A217655

001

001

001

001

001

001

001

001

001

Sep 18, 2023

May 15, 2023

Aug 17, 2023

Jun 16, 2023

Jul 07, 2023

Jun 29, 2010

Sep 14, 2023

Apr 20, 2021

Jun 16, 2023

Sep NEWA

May NEWA

Aug NEWA

Jun NEWA

Jun NEWA

Jun CHRS

Sep NEWA

Jun CHRS

Sep CAHN

AP

AP

SAGENT 10MG/ML

10MG/ML

@ ZYDUS PHARMS 10MG/ML

FAMOTIDINE PRESERVATIVE FREE

A075651

A075684

A215828

001

001

001

Apr 16, 2001

Apr 16, 2001

Nov 22, 2022

Aug CAHN

Oct CAHN

Apr DISC

AP

AP

SAGENT

TABLET;ORAL

FAMOTIDINE

10MG/ML

10MG/ML

A075622

A075825

001

001

Apr 16, 2001

Apr 17, 2001

Aug CAHN

Aug CAHN

AB

AB

AB

AB

>D> AB

>D> AB

>A> AB

AB

>A> AB

AB

>A> AB

>A> AB

>A> AB

>A> AB

ALKEM LABS LTD

CELLTRION

CHARTWELL RX

CONTRACT PHARMACAL

GRAVITI PHARMS

20MG

20MG

40MG

40MG

20MG

40MG

20MG

20MG

40MG

40MG

20MG

40MG

20MG

40MG

A215630

A217375

A215630

A217375

A075786

A075786

A075786

A215630

A075786

A215630

A217669

A217669

A218181

A218181

001

001

002

002

001

002

001

001

002

002

001

002

001

002

Jan 07, 2022

Apr 24, 2023

Jan 07, 2022

Apr 24, 2023

Apr 16, 2001

Apr 16, 2001

Apr 16, 2001

Jan 07, 2022

Apr 16, 2001

Jan 07, 2022

Dec 20, 2023

Dec 20, 2023

Dec 22, 2023

Dec 22, 2023

Sep CAHN

Apr NEWA

Sep CAHN

Apr NEWA

Dec CAHN

Dec CAHN

Dec CAHN

Aug CAHN

Dec CAHN

Aug CAHN

Dec NEWA

Dec NEWA

Dec NEWA

Dec NEWA
RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - December 2023 1-60

TABLET;ORAL

FAMOTIDINE

AB

AB

AB

AB

MANKIND PHARMA

VKT PHARMA

20MG

40MG

20MG

40MG

A075302

A075302

A215630

A215630

001 Apr 16, 2001

002 Apr 16, 2001

001 Jan 07, 2022

002 Jan 07, 2022

Oct CMFD

Oct CMFD

Jan CAHN

Jan CAHN

FAMOTIDINE; IBUPROFEN

TABLET;ORAL

IBUPROFEN AND FAMOTIDINE

AB ASCENT PHARMS INC 26.6MG;800MG A216814 001 Mar 15, 2023 Mar NEWA

FEBUXOSTAT

TABLET;ORAL

FEBUXOSTAT

>A>

>A>

AB

AB

AB

AB

AB

AB

@

@

@

@

AUROBINDO PHARMA LTD

MACLEODS PHARMS LTD

MYLAN

TORRENT

ZYDUS LIFESCIENCES

40MG

80MG

40MG

80MG

40MG

80MG

40MG

80MG

40MG

80MG

A210741

A210741

A207293

A207293

A205385

A205385

A211837

A211837

A205443

A205443

001 Oct 25, 2023

002 Oct 25, 2023

001 Sep 28, 2023

002 Sep 28, 2023

001 Jul 01, 2019

002 Jul 01, 2019

001 Dec 19, 2023

002 Dec 19, 2023

001 Jan 09, 2023

002 Jan 09, 2023

Oct NEWA

Oct NEWA

Sep NEWA

Sep NEWA

Oct DISC

Jun DISC

Dec DISC

Dec DISC

Jan CAHN

Jan CAHN

FELODIPINE

TABLET, EXTENDED RELEASE;ORAL

FELODIPINE

>D>

>A>

>D>

>A>

>D>

>A>

AB

AB

AB

@

@

@

SUN PHARM INDUSTRIES 2.5MG

2.5MG

5MG

5MG

10MG

10MG

A075896

A075896

A075896

A075896

A075896

A075896

001 Nov 02, 2004

001 Nov 02, 2004

002 Nov 02, 2004

002 Nov 02, 2004

003 Nov 02, 2004

003 Nov 02, 2004

Dec DISC

Dec DISC

Dec DISC

Dec DISC

Dec DISC

Dec DISC

FENFLURAMINE HYDROCHLORIDE

SOLUTION;ORAL

FINTEPLA

+! UCB INC EQ 2.2MG BASE/ML N212102 001 Jun 25, 2020 Jun CAHN

FENOFIBRATE

CAPSULE;ORAL

ANTARA (MICRONIZED)

+ @ LUPIN

TABLET;ORAL

FENOFIBRATE

90MG N021695 005 Oct 18, 2013 Jun DISC

AB

AB

AB

AB

CHARTWELL RX

CREEKWOOD PHARMS

54MG

160MG

40MG

120MG

A209660

A209660

A217732

A217732

001 Feb 11, 2019

002 Feb 11, 2019

001 Sep 07, 2023

002 Sep 07, 2023

Feb CAHN

Feb CAHN

Sep NEWA

Sep NEWA

FENOPROFEN CALCIUM

CAPSULE;ORAL

FENOPROFEN CALCIUM

AB

AB

MISEMER

NALFON

EQ 200MG BASE

EQ 300MG BASE

EQ 400MG BASE

A215548

A215548

A215548

001 May 16, 2023

002 May 16, 2023

003 May 16, 2023

May NEWA

May NEWA

May NEWA

AB + XSPIRE PHARMA

TABLET;ORAL

NALFON

EQ 200MG BASE N017604 003 May CTEC

+ @ DISTA EQ 600MG BASE N017710 001 Oct CRLD

FENTANYL

FILM, EXTENDED RELEASE;TRANSDERMAL

FENTANYL-100

AB AVEVA 100MCG/HR A077449 004 Oct 20, 2008 Jul CMFD

AB ZYDUS NOVELTECH INC 100MCG/HR A209655 008 Jan 24, 2023 Jan NEWA

@ ZYDUS PHARMS 100MCG/HR A209655 008 Jan 24, 2023 Jun DISC

AB 100MCG/HR A209655 008 Jan 24, 2023 May CAHN
RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - December 2023 1-61

FILM, EXTENDED RELEASE;TRANSDERMAL

FENTANYL-12

AB

AB

AB

AVEVA

ZYDUS NOVELTECH INC

@ ZYDUS PHARMS

FENTANYL-25

12.5MCG/HR

12.5MCG/HR

12.5MCG/HR

12.5MCG/HR

A077449

A209655

A209655

A209655

005

001

001

001

Sep 11, 2015

Jan 24, 2023

Jan 24, 2023

Jan 24, 2023

Jul CMFD

Jan NEWA

Jun DISC

May CAHN

AB

AB

AB

AVEVA

ZYDUS NOVELTECH INC

@ ZYDUS PHARMS

FENTANYL-37

25MCG/HR

25MCG/HR

25MCG/HR

25MCG/HR

A077449

A209655

A209655

A209655

001

002

002

002

Oct 20, 2008

Jan 24, 2023

Jan 24, 2023

Jan 24, 2023

Jul CMFD

Jan NEWA

Jun DISC

May CAHN

AB

AB

AB

AVEVA

ZYDUS NOVELTECH INC

@ ZYDUS PHARMS

FENTANYL-50

37.5MCG/HR

37.5MCG/HR

37.5MCG/HR

37.5MCG/HR

A077449

A209655

A209655

A209655

006

003

003

003

Dec 06, 2017

Jan 24, 2023

Jan 24, 2023

Jan 24, 2023

Jul CMFD

Jan NEWA

Jun DISC

May CAHN

AB

AB

AB

AVEVA

ZYDUS NOVELTECH INC

@ ZYDUS PHARMS

FENTANYL-62

50MCG/HR

50MCG/HR

50MCG/HR

50MCG/HR

A077449

A209655

A209655

A209655

002

004

004

004

Oct 20, 2008

Jan 24, 2023

Jan 24, 2023

Jan 24, 2023

Jul CMFD

Jan NEWA

Jun DISC

May CAHN

AB

AB

AB

AVEVA

ZYDUS NOVELTECH INC

@ ZYDUS PHARMS

FENTANYL-75

62.5MCG/HR

62.5MCG/HR

62.5MCG/HR

62.5MCG/HR

A077449

A209655

A209655

A209655

007

005

005

005

Dec 06, 2017

Jan 24, 2023

Jan 24, 2023

Jan 24, 2023

Jul CMFD

Jan NEWA

Jun DISC

May CAHN

AB

AB

AB

AVEVA

ZYDUS NOVELTECH INC

@ ZYDUS PHARMS

FENTANYL-87

75MCG/HR

75MCG/HR

75MCG/HR

75MCG/HR

A077449

A209655

A209655

A209655

003

006

006

006

Oct 20, 2008

Jan 24, 2023

Jan 24, 2023

Jan 24, 2023

Jul CMFD

Jan NEWA

Jun DISC

May CAHN

AB

AB

AB

AB

AB

AVEVA

MYLAN TECHNOLOGIES

ZYDUS NOVELTECH INC

@ ZYDUS PHARMS

87.5MCG/HR

87.5MCG/HR

87.5MCG/HR

87.5MCG/HR

87.5MCG/HR

87.5MCG/HR

87.5MCG/HR

A077449

A076258

A076258

A076258

A209655

A209655

A209655

008

008

008

008

007

007

007

Dec 06, 2017

Dec 29, 2014

Dec 29, 2014

Dec 29, 2014

Jan 24, 2023

Jan 24, 2023

Jan 24, 2023

Jul CMFD

Jul CTEC

Jun CTEC

Jan CTEC

Jan NEWA

Jun DISC

May CAHN

FENTANYL CITRATE

INJECTABLE;INJECTION

FENTANYL CITRATE

AP

+! HIKMA EQ 0.025MG BASE/0.5ML

+! EQ 0.05MG BASE/ML

SUBLIMAZE PRESERVATIVE FREE

N019101

N019101

002

001

Jan 20, 2023

Jul 11, 1984

Jan NEWA

Jan CTNA

AP +! RISING

SOLUTION;INTRAVENOUS

FENTANYL CITRATE

EQ 0.05MG BASE/ML N016619 001 Sep CAHN

+ @ EXELA PHARMA

+!

+ @

+!

TABLET;BUCCAL, SUBLINGUAL

FENTORA

EQ 2.5MG BASE/50ML (EQ 0.05MG

BASE/ML)

EQ 2.5MG BASE/50ML (EQ 0.05MG

BASE/ML)

EQ 5MG BASE/100ML (EQ 0.05MG

BASE/ML)

EQ 5MG BASE/100ML (EQ 0.05MG

BASE/ML)

N215870

N215870

N215870

N215870

001

001

002

002

Feb 08, 2023

Feb 08, 2023

Feb 08, 2023

Feb 08, 2023

May DISC

Feb NEWA

May DISC

Feb NEWA

>D>

>A>

>D>

>A>

>D>

>A>

>D>

>A>

>D>

>A>

>D>

>A>

+ CEPHALON

+

+

+

+ @

+ @

+!

+!

+

+

+

+

EQ 0.1MG BASE

EQ 0.1MG BASE

EQ 0.2MG BASE

EQ 0.2MG BASE

EQ 0.3MG BASE

EQ 0.3MG BASE

EQ 0.4MG BASE

EQ 0.4MG BASE

EQ 0.6MG BASE

EQ 0.6MG BASE

EQ 0.8MG BASE

EQ 0.8MG BASE

N021947

N021947

N021947

N021947

N021947

N021947

N021947

N021947

N021947

N021947

N021947

N021947

001

001

002

002

006

006

003

003

004

004

005

005

Sep 25, 2006

Sep 25, 2006

Sep 25, 2006

Sep 25, 2006

Mar 02, 2007

Mar 02, 2007

Sep 25, 2006

Sep 25, 2006

Sep 25, 2006

Sep 25, 2006

Sep 25, 2006

Sep 25, 2006

Dec CAHN

Dec CAHN

Dec CAHN

Dec CAHN

Dec CAHN

Dec CAHN

Dec CAHN

Dec CAHN

Dec CAHN

Dec CAHN

Dec CAHN

Dec CAHN
RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - December 2023 1-62

TROCHE/LOZENGE;TRANSMUCOSAL

ACTIQ

+ CEPHALON EQ 0.2MG BASE

+ EQ 0.2MG BASE

+! EQ 0.4MG BASE

+! EQ 0.4MG BASE

+ EQ 0.6MG BASE

+ EQ 0.6MG BASE

+ EQ 0.8MG BASE

+ EQ 0.8MG BASE

+ EQ 1.2MG BASE

+ EQ 1.2MG BASE

+ EQ 1.6MG BASE

+ EQ 1.6MG BASE

FENTANYL CITRATE

@ SPECGX LLC EQ 0.2MG BASE

@ EQ 0.4MG BASE

@ EQ 0.6MG BASE

@ EQ 0.8MG BASE

@ EQ 1.2MG BASE

@ EQ 1.6MG BASE

N020747

N020747

N020747

N020747

N020747

N020747

N020747

N020747

N020747

N020747

N020747

N020747

A078907

A078907

A078907

A078907

A078907

A078907

001 Nov 04, 1998

001 Nov 04, 1998

002 Nov 04, 1998

002 Nov 04, 1998

003 Nov 04, 1998

003 Nov 04, 1998

004 Nov 04, 1998

004 Nov 04, 1998

005 Nov 04, 1998

005 Nov 04, 1998

006 Nov 04, 1998

006 Nov 04, 1998

001 Oct 30, 2009

002 Oct 30, 2009

003 Oct 30, 2009

004 Oct 30, 2009

005 Oct 30, 2009

006 Oct 30, 2009

Oct CAHN

Sep CTEC

Oct CAHN

Sep CTEC

Oct CAHN

Sep CTEC

Oct CAHN

Sep CTEC

Oct CAHN

Sep CTEC

Oct CAHN

Sep CTEC

Sep DISC

Sep DISC

Sep DISC

Sep DISC

Sep DISC

Sep DISC

FERRIC PYROPHOSPHATE CITRATE

POWDER;INTRAVENOUS

TRIFERIC

+ @ ROCKWELL MEDICAL INC 272MG IRON/PACKET N208551 001 Apr 25, 2016 Oct CDFR

FESOTERODINE FUMARATE

>A>

>A>

AB

AB

TABLET, EXTENDED RELEASE;ORAL

FESOTERODINE FUMARATE

@ ACCORD HLTHCARE 4MG

@ 8MG

@ ACTAVIS LABS FL INC 4MG

@ 8MG

HETERO LABS LTD V 4MG

8MG

@ LUPIN LTD 4MG

@ 8MG

A205012

A205012

A204868

A204868

A204792

A204792

A204983

A204983

001 Jan 04, 2023

002 Jan 04, 2023

001 Jan 04, 2023

002 Jan 04, 2023

001 Jan 09, 2024

002 Jan 09, 2024

001 Jan 05, 2023

002 Jan 05, 2023

Jul DISC

Jul DISC

Jul DISC

Jul DISC

Dec NEWA

Dec NEWA

Feb DISC

Feb DISC

FEZOLINETANT

TABLET;ORAL

VEOZAH

+! ASTELLAS 45MG N216578 001 May 12, 2023 May NEWA

FINAFLOXACIN

SUSPENSION/DROPS;OTIC

XTORO

+ @ FONSECA BIOSCIENCES 0.3% N206307 001 Dec 17, 2014 Jan CAHN

FINASTERIDE; TADALAFIL

CAPSULE;ORAL

ENTADFI

+! BLUE WATER BIOTECH 5MG;5MG N215423 001 Dec 09, 2021 Jul CAHN

FINGOLIMOD HYDROCHLORIDE

>D>

>A>

AB

AB

AB

AB

CAPSULE;ORAL

FINGOLIMOD HYDROCHLORIDE

@ BIOCON LTD EQ 0.5MG BASE

EQ 0.5MG BASE

BIONPHARMA EQ 0.5MG BASE

EZRA VENTURES EQ 0.5MG BASE

@ TEVA PHARMS USA EQ 0.5MG BASE

EQ 0.5MG BASE

A207979

A207979

A210252

A207945

A208008

A208008

001 Dec 04, 2019

001 Dec 04, 2019

001 May 24, 2023

001 Dec 06, 2023

001 Jul 02, 2020

001 Jul 02, 2020

Sep DISC

Jan CMFD

May NEWA

Nov NEWA

Dec CMFD

Dec CMFD

FINGOLIMOD LAURYL SULFATE

TABLET, ORALLY DISINTEGRATING;ORAL

TASCENSO ODT

+ CYCLE EQ 0.25MG BASE

+! EQ 0.5MG BASE

N214962

N214962

001 Dec 23, 2021

002 Dec 09, 2022

Jan CAHN

Jan CAHN
RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - December 2023 1-63

FLORBETAPIR F-18

SOLUTION;INTRAVENOUS

AMYVID

+ @

+!

+ @

AVID RADIOPHARMS INC 10ML (13.5-51mCi/ML)

10-100ML (13.5-51mCi/ML)

10-30ML (13.5-51mCi/ML)

N202008

N202008

N202008

001

004

002

Apr 06, 2012

Oct 13, 2023

Apr 06, 2012

Nov CRLD

Nov NEWA

Nov DISC

FLOTUFOLASTAT F-18 GALLIUM

SOLUTION;INTRAVENOUS

POSLUMA

+!

+!

BLUE EARTH 25ML (8-158mCi/ML)

50ML (8-158mCi/ML)

N216023

N216023

001

001

May 25, 2023

May 25, 2023

Aug CPOT

May NEWA

FLUCONAZOLE

FOR SUSPENSION;ORAL

FLUCONAZOLE

AB HAINAN POLY 200MG/5ML

INJECTABLE;INJECTION

FLUCONAZOLE IN SODIUM CHLORIDE 0.9%

A215738 001 Sep 21, 2023 Sep NEWA

@ BAXTER HLTHCARE CORP

@

TABLET;ORAL

FLUCONAZOLE

200MG/100ML (2MG/ML)

400MG/200ML (2MG/ML)

A077947

A077947

001

002

May 26, 2010

May 26, 2010

Aug DISC

Aug DISC

>D>

>A>

>D>

>A>

>D>

>A>

>D>

>A>

AB

AB

AB

AB

AB

AB

AB

AB

LUPIN LTD

@

@

@

@

50MG

50MG

50MG

100MG

100MG

100MG

150MG

150MG

150MG

200MG

200MG

200MG

A209146

A209146

A209146

A209146

A209146

A209146

A209146

A209146

A209146

A209146

A209146

A209146

001

001

001

002

002

002

003

003

003

004

004

004

Oct 20, 2023

Oct 20, 2023

Oct 20, 2023

Oct 20, 2023

Oct 20, 2023

Oct 20, 2023

Oct 20, 2023

Oct 20, 2023

Oct 20, 2023

Oct 20, 2023

Oct 20, 2023

Oct 20, 2023

Dec DISC

Dec DISC

Oct NEWA

Dec DISC

Dec DISC

Oct NEWA

Dec DISC

Dec DISC

Oct NEWA

Dec DISC

Dec DISC

Oct NEWA

FLUCYTOSINE

CAPSULE;ORAL

FLUCYTOSINE

>D>

>A>

>D>

>A>

AB

AB

@

@

HIKMA 250MG

250MG

500MG

500MG

A206550

A206550

A206550

A206550

001

001

002

002

Oct 17, 2017

Oct 17, 2017

Oct 17, 2017

Oct 17, 2017

Dec DISC

Dec DISC

Dec DISC

Dec DISC

FLUDARABINE PHOSPHATE

INJECTABLE;INJECTION

FLUDARABINE PHOSPHATE

AP2

AP1

AP1

AP

AP1

AP2

@

+ @

+!

ACTAVIS LLC

AREVA PHARMS

FRESENIUS KABI USA

SAGENT PHARMS INC

SANDOZ

50MG/2ML (25MG/ML)

50MG/2ML (25MG/ML)

50MG/2ML (25MG/ML)

50MG/2ML (25MG/ML)

50MG/2ML (25MG/ML)

50MG/2ML (25MG/ML)

50MG/2ML (25MG/ML)

50MG/2ML (25MG/ML)

A203738

A203738

A090724

A078393

A078393

A076661

N022137

N022137

001

001

001

001

001

001

001

001

Feb 28, 2017

Feb 28, 2017

Sep 27, 2010

Oct 15, 2007

Oct 15, 2007

Apr 28, 2004

Sep 21, 2007

Sep 21, 2007

Jun DISC

Jan CTEC

Jan CTEC

Jan CTEC

Jan CHRS

Jan CTEC

Jun DISC

Jan CTEC

FLUDEOXYGLUCOSE F-18

INJECTABLE;INTRAVENOUS

FLUDEOXYGLUCOSE F18

>A>

>D>

AP

AP

PHARMALOGIC

SHERTECH LABS LLC

20-300mCi/ML

20-300mCi/ML

A204264

A204264

001

001

Dec 18, 2014

Dec 18, 2014

Dec CAHN

Dec CAHN

FLUDROCORTISONE ACETATE

TABLET;ORAL

FLUDROCORTISONE ACETATE

@ HIKMA 0.1MG A216013 001 Oct 27, 2022 Apr DISC
RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - December 2023 1-64

FLUOCINOLONE ACETONIDE

AT

AT

AT

AT

CREAM;TOPICAL

FLUOCINOLONE ACETONIDE

@ INVATECH

IMPLANT;INTRAVITREAL

YUTIQ

+! ALIMERA SCIENCES INC

OIL;TOPICAL

FLUOCINOLONE ACETONIDE

NOVEL LABS INC

OIL/DROPS;OTIC

FLAC

PATRIN

SOLUTION;TOPICAL

FLUOCINOLONE ACETONIDE

CHARTWELL RX

0.025%

0.18MG

0.01%

0.01%

0.01%

0.01%

A088045

N210331

A207345

A207347

A210736

A209596

001

001

001

001

001

001

Dec 16, 1982

Oct 12, 2018

Jul 31, 2023

Aug 07, 2023

Apr 11, 2018

Dec 26, 2017

Mar CAHN

Jun CAHN

Jul NEWA

Jul NEWA

Sep CAHN

May CAHN

FLUOCINONIDE

AB1

AB

AT

CREAM;TOPICAL

FLUOCINONIDE

! AMNEAL

@ ENCUBE

@ PAI HOLDINGS PHARM

OINTMENT;TOPICAL

FLUOCINONIDE

CHARTWELL RX

@ PAI HOLDINGS PHARM

SOLUTION;TOPICAL

FLUOCINONIDE

CHARTWELL RX

@ PAI HOLDINGS PHARM

LIDEX

+ @ ALVOGEN

0.05%

0.05%

0.1%

0.05%

0.05%

0.05%

0.05%

0.05%

A210554

A211410

A211758

A207538

A207680

A209118

A207554

N018849

001

001

001

001

001

001

001

001

Aug 21, 2018

Oct 16, 2018

Apr 03, 2019

Jul 31, 2017

Sep 28, 2018

Apr 23, 2018

Mar 18, 2019

Apr 06, 1984

Feb CHRS

Oct CAHN

Aug DISC

Apr CAHN

Aug DISC

May CAHN

May DISC

Nov DISC

FLUORESCEIN SODIUM

AP

AP

AP

AP

AP

INJECTABLE;INTRAVENOUS

AK-FLUOR 10%

+! LONG GROVE PHARMS

+

AK-FLUOR 25%

+! LONG GROVE PHARMS

+!

FLUORESCEIN SODIUM

NEXUS PHARMS

EQ 500MG BASE/5ML (EQ 100MG

BASE/ML)

EQ 500MG BASE/5ML (EQ 100MG

BASE/ML)

EQ 500MG BASE/2ML (EQ 250MG

BASE/ML)

EQ 500MG BASE/2ML (EQ 250MG

BASE/ML)

EQ 500MG BASE/5ML (EQ 100MG

BASE/ML)

EQ 500MG BASE/2ML (EQ 250MG

BASE/ML)

N022186

N022186

N022186

N022186

A215709

A215709

001

001

002

002

001

002

Aug 08, 2008

Aug 08, 2008

Aug 08, 2008

Aug 08, 2008

Sep 25, 2023

Sep 25, 2023

Nov CHRS

Aug CAHN

Sep CFTG

Aug CAHN

Sep NEWA

Sep NFTG

FLUOROESTRADIOL F-18

SOLUTION;INTRAVENOUS

CERIANNA

+! GE HEALTHCARE 50ML (4-100mCi/ML) N212155 001 May 20, 2020 Aug CAHN

FLUOROMETHOLONE

>A>

>A>

>D>

>A>

AB

AB

SUSPENSION/DROPS;OPHTHALMIC

FLUOROMETHOLONE

AMNEAL 0.1%

FML

+! ABBVIE 0.1%

+! 0.1%

+! 0.1%

FML FORTE

+! ABBVIE 0.25%

A216348

N016851

N016851

N016851

N019216

001

002

002

002

001

Jan 09, 2024

Jul 28, 1982

Jul 28, 1982

Jul 28, 1982

Apr 23, 1986

Dec NEWA

Dec CTEC

Dec CTEC

Jan CAHN

Jan CAHN
RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - December 2023 1-65

FLUOROMETHOLONE ACETATE

SUSPENSION/DROPS;OPHTHALMIC

FLAREX

+! HARROW EYE 0.1% N019079 001 Feb 11, 1986 Oct CAHN

FLUOROMETHOLONE ACETATE; TOBRAMYCIN

SUSPENSION/DROPS;OPHTHALMIC

TOBRASONE

@ HARROW EYE 0.1%;0.3% N050628 001 Jul 21, 1989 Oct CAHN

FLUOROURACIL

INJECTABLE;INJECTION

FLUOROURACIL

AP

AP

ALEMBIC

SOLUTION;TOPICAL

FLUOROURACIL

2.5GM/50ML (50MG/ML)

5GM/100ML (50MG/ML)

A217295

A217676

001

001

Mar 03, 2023

Oct 18, 2023

Feb NEWA

Oct NEWA

AT

AT !

ENCUBE

TARO

5%

5%

A215612

A076526

001

002

Nov 02, 2023

Nov 05, 2003

Oct NEWA

Oct CTEC

FLUOXETINE HYDROCHLORIDE

CAPSULE;ORAL

FLUOXETINE HYDROCHLORIDE

>D>

>D>

>A>

>A>

@

@

@

@

MYLAN

NATCO PHARMA USA

EQ 10MG BASE

EQ 20MG BASE

EQ 10MG BASE

EQ 20MG BASE

A078045

A078045

A078045

A078045

001

002

001

002

Nov 17, 2008

Nov 17, 2008

Nov 17, 2008

Nov 17, 2008

Dec CAHN

Dec CAHN

Dec CAHN

Dec CAHN

SOLUTION;ORAL

FLUOXETINE HYDROCHLORIDE

AA

AA

@ CHARTWELL MOLECULAR EQ 20MG BASE/5ML

NOSTRUM LABS INC EQ 20MG BASE/5ML

@ PHARMOBEDIENT CNSLTG EQ 20MG BASE/5ML

@ XTTRIUM LABS INC EQ 20MG BASE/5ML

EQ 20MG BASE/5ML

TABLET;ORAL

FLUOXETINE HYDROCHLORIDE

A076458

A075292

A075514

A075514

A075514

001

001

001

001

001

May 14, 2004

Feb 07, 2002

Aug 29, 2002

Aug 29, 2002

Aug 29, 2002

Jul CAHN

Mar CMFD

Sep CAHN

Jul DISC

Jan CAHN

AB

@

@

@

@

+!

PIRAMAL HLTHCARE UK

SLATE RUN PHARMA

TWI PHARMS

EQ 10MG BASE

EQ 20MG BASE

EQ 10MG BASE

EQ 20MG BASE

EQ 60MG BASE

A211444

A211444

A211444

A211444

N202133

001

002

001

002

001

Sep 13, 2022

Sep 13, 2022

Sep 13, 2022

Sep 13, 2022

Oct 06, 2011

Mar DISC

Mar DISC

Sep CAHN

Sep CAHN

Nov CAHN

FLUPHENAZINE DECANOATE

INJECTABLE;INJECTION

FLUPHENAZINE DECANOATE

AO

AO

GLAND PHARMA LTD

MSN

25MG/ML

25MG/ML

A215509

A215365

001

001

Mar 30, 2023

Nov 02, 2023

Mar NEWA

Oct NEWA

FLUPHENAZINE HYDROCHLORIDE

TABLET;ORAL

FLUPHENAZINE HYDROCHLORIDE

AB

AB

AB

AB

AB

AB

AB

AB

AB

AB

AB

AB

AB

AB

AB

AB

@

@

@

@

AJANTA PHARMA LTD

AUROBINDO PHARMA LTD

CHARTWELL RX

DR REDDYS

1MG

1MG

2.5MG

2.5MG

5MG

5MG

10MG

10MG

1MG

2.5MG

5MG

10MG

1MG

2.5MG

5MG

10MG

1MG

2.5MG

5MG

10MG

A217410

A217410

A217410

A217410

A217410

A217410

A217410

A217410

A218055

A218055

A218055

A218055

A215141

A215141

A215141

A215141

A214534

A214534

A214534

A214534

001

001

002

002

003

003

004

004

001

002

003

004

001

002

003

004

001

002

003

004

Jan 05, 2023

Jan 05, 2023

Jan 05, 2023

Jan 05, 2023

Jan 05, 2023

Jan 05, 2023

Jan 05, 2023

Jan 05, 2023

Aug 18, 2023

Aug 18, 2023

Aug 18, 2023

Aug 18, 2023

Oct 20, 2021

Oct 20, 2021

Oct 20, 2021

Oct 20, 2021

Jan 07, 2021

Jan 07, 2021

Jan 07, 2021

Jan 07, 2021

Sep CMFD

Jun DISC

Sep CMFD

Jun DISC

Sep CMFD

Jun DISC

Sep CMFD

Jun DISC

Aug NEWA

Aug NEWA

Aug NEWA

Aug NEWA

Sep CAHN

Sep CAHN

Sep CAHN

Sep CAHN

Sep CAHN

Sep CAHN

Sep CAHN

Sep CAHN
RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - December 2023 1-66

TABLET;ORAL

FLUPHENAZINE HYDROCHLORIDE

AB

AB

AB

AB

AB

AB

AB

AB

@

@

@

@

GLENMARK PHARMS LTD

MSN

PRASCO

1MG

2.5MG

5MG

10MG

1MG

2.5MG

5MG

10MG

1MG

2.5MG

5MG

10MG

A216350

A216350

A216350

A216350

A217189

A217189

A217189

A217189

A089804

A089804

A089804

A089804

001

002

003

004

001

002

003

004

002

003

004

001

Nov 06, 2023

Nov 06, 2023

Nov 06, 2023

Nov 06, 2023

Sep 11, 2023

Sep 11, 2023

Sep 11, 2023

Sep 11, 2023

Aug 12, 1988

Aug 12, 1988

Aug 12, 1988

Aug 12, 1988

Oct NEWA

Oct NEWA

Oct NEWA

Oct NEWA

Sep NEWA

Sep NEWA

Sep NEWA

Sep NEWA

Apr DISC

Apr DISC

Apr DISC

Apr DISC

FLURANDRENOLIDE

CREAM;TOPICAL

FLURANDRENOLIDE

@ CHARTWELL RX

LOTION;TOPICAL

CORDRAN

0.05% A205342 001 Apr 13, 2016 Aug CAHN

+ @ ALMIRALL

FLURANDRENOLIDE

0.05% N013790 001 May DISC

AT

@ CHARTWELL RX

! PADAGIS ISRAEL

!

OINTMENT;TOPICAL

CORDRAN

0.05%

0.05%

0.05%

A205343

A207133

A207133

001

001

001

Dec 22, 2016

Aug 30, 2016

Aug 30, 2016

Aug CAHN

May CTEC

May CHRS

+ @ ALMIRALL

FLURANDRENOLIDE

0.05% N012806 001 May DISC

AT

!

!

TELIGENT 0.05%

0.05%

A207851

A207851

001

001

Dec 30, 2016

Dec 30, 2016

May CTEC

May CHRS

FLURAZEPAM HYDROCHLORIDE

CAPSULE;ORAL

FLURAZEPAM HYDROCHLORIDE

>D>

>A>

>D>

>A>

>D>

>A>

>D>

>A>

AB

AB

AB

AB

!

!

@

@

CHARTWELL RX

RISING

15MG

15MG

30MG

30MG

15MG

15MG

30MG

30MG

A072368

A072368

A072369

A072369

A070345

A070345

A070345

A070345

001

001

001

001

002

002

001

001

Mar 30, 1989

Mar 30, 1989

Mar 30, 1989

Mar 30, 1989

Nov 27, 1985

Nov 27, 1985

Nov 27, 1985

Nov 27, 1985

Dec CMFD

Dec CMFD

Dec CMFD

Dec CMFD

Dec CTEC

Dec CTEC

Dec CTEC

Dec CTEC

FLURBIPROFEN

TABLET;ORAL

ANSAID

+

+

@

@

PHARMACIA AND UPJOHN 50MG

100MG

N018766

N018766

002

003

Oct 31, 1988

Oct 31, 1988

Oct CRLD

Oct CRLD

FLUTICASONE FUROATE; VILANTEROL TRIFENATATE

POWDER;INHALATION

BREO ELLIPTA

+ GLAXO GRP LTD 0.05MG/INH;EQ 0.025MG BASE/INH N204275 003 May 12, 2023 May NEWA

FLUTICASONE PROPIONATE

OINTMENT;TOPICAL

FLUTICASONE PROPIONATE

AB

@ BRIGHT

SPRAY, METERED;NASAL

FLUTICASONE PROPIONATE

0.005%

0.005%

A215343

A215343

001

001

Sep 01, 2023

Sep 01, 2023

Nov DISC

Aug NEWA

AB CHARTWELL RX 0.05MG/SPRAY A078492 001 Jan 09, 2012 Sep CAHN

FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE

POWDER;INHALATION

FLUTICASONE PROPIONATE AND SALMETEROL XINAFOATE

>A> AB HIKMA 0.5MG/INH;EQ 0.05MG BASE/INH A203433 003 Dec 19, 2023 Dec NEWA
RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - December 2023 1-67

FLUVASTATIN SODIUM

TABLET, EXTENDED RELEASE;ORAL

LESCOL XL

AB +! SANDOZ EQ 80MG BASE N021192 001 Oct 06, 2000 Sep CAHN

FLUVOXAMINE MALEATE

TABLET;ORAL

LUVOX

AB

AB

AB

+

+

+

ANI PHARMS 25MG

50MG

100MG

N021519

N021519

N021519

001

002

003

Dec 20, 2007

Dec 20, 2007

Dec 20, 2007

Jan CRLD

Jan CRLD

Jan CRLD

FOMEPIZOLE

INJECTABLE;INJECTION

FOMEPIZOLE

AP GLAND PHARMA LTD 1.5GM/1.5ML (1GM/ML) A216791 001 Jul 06, 2023 Jun NEWA

FORMOTEROL FUMARATE

SOLUTION;INHALATION

FORMOTEROL FUMARATE

AN MANKIND PHARMA 0.02MG/2ML A215883 001 Mar 22, 2023 Mar NEWA

FOSAMPRENAVIR CALCIUM

>D>

>D>

SUSPENSION;ORAL

LEXIVA

>D>

>A>

+!

+ @

VIIV HLTHCARE EQ 50MG BASE/ML

EQ 50MG BASE/ML

N022116

N022116

001

001

Jun 14, 2007

Jun 14, 2007

Dec DISC

Dec DISC

FOSAPREPITANT DIMEGLUMINE

POWDER;INTRAVENOUS

FOSAPREPITANT DIMEGLUMINE

AP PIRAMAL CRITICAL

SOLUTION;INTRAVENOUS

FOCINVEZ

EQ 150MG BASE/VIAL A214683 001 May 16, 2023 May NEWA

+!

+!

SPES PHARMS

STERISCIENCE

EQ 150MG BASE/50ML (EQ 3MG

BASE/ML)

EQ 150MG BASE/50ML (EQ 3MG

BASE/ML)

N216686

N216686

001

001

Aug 22, 2023

Aug 22, 2023

Aug NEWA

Oct CAHN

FOSCARNET SODIUM

INJECTABLE;INJECTION

FOSCARNET SODIUM

AP

AP

AVET LIFESCIENCES

BEIJING

2.4GM/100ML

2.4GM/100ML

A213807

A213987

001

001

Jun 05, 2023

Nov 29, 2023

May NEWA

Nov NEWA

FOSNETUPITANT CHLORIDE HYDROCHLORIDE; PALONOSETRON HYDROCHLORIDE

POWDER;INTRAVENOUS

AKYNZEO

+ @ HELSINN HLTHCARE EQ 235MG BASE/VIAL;EQ 0.25MG

BASE/VIAL

N210493 001 Apr 19, 2018 Sep DISC

FOSPHENYTOIN SODIUM

INJECTABLE;INJECTION

FOSPHENYTOIN SODIUM

AP

@

GLAND PHARMA LTD

MYLAN LABS LTD

EQ 50MG PHENYTOIN NA/ML

EQ 50MG PHENYTOIN NA/ML

A214926

A078736

001

001

Oct 13, 2023

Jun 08, 2010

Oct NEWA

Apr DISC

FROVATRIPTAN SUCCINATE

TABLET;ORAL

FROVATRIPTAN SUCCINATE

@ MYLAN EQ 2.5MG BASE A202931 001 Aug 28, 2014 Apr DISC

FRUQUINTINIB

CAPSULE;ORAL

FRUZAQLA

+ TAKEDA PHARMS USA

+!

1MG

5MG

N217564

N217564

001

002

Nov 08, 2023

Nov 08, 2023

Nov NEWA

Nov NEWA
RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - December 2023 1-68

FULVESTRANT

SOLUTION;INTRAMUSCULAR

FULVESTRANT

AO EUGIA PHARMA 250MG/5ML (50MG/ML) A215169 001 Jun 30, 2023 Jun NEWA

FUROSEMIDE

INJECTABLE;INJECTION

FUROSEMIDE

AP

AP

AMNEAL PHARMS CO

SAGENT

SOLUTION;ORAL

FUROSEMIDE

10MG/ML

10MG/ML

A207552

A214766

001

001

Jul 20, 2016

Jan 27, 2021

Aug CMFD

Aug CAHN

@ PHARMOBEDIENT CNSLTG

@ XTTRIUM LABS INC

TABLET;ORAL

FUROSEMIDE

10MG/ML

10MG/ML

A070655

A070655

001

001

Oct 02, 1987

Oct 02, 1987

Sep CAHN

Jan CAHN

@

@

CHARTWELL RX 20MG

40MG

N018413

N018413

001

002

Nov 30, 1983

Nov 30, 1983

Mar CAHN

Mar CAHN

GABAPENTIN

CAPSULE;ORAL

GABAPENTIN

AB

AB

AB

AB

AB

AB

IPCA LABS LTD

LAURUS

SOLUTION;ORAL

GABAPENTIN

100MG

300MG

400MG

100MG

300MG

400MG

A208928

A208928

A208928

A217546

A217546

A217546

001

002

003

001

002

003

Nov 20, 2023

Nov 20, 2023

Nov 20, 2023

May 12, 2023

May 12, 2023

May 12, 2023

Nov NEWA

Nov NEWA

Nov NEWA

May NEWA

May NEWA

May NEWA

AA

AA

MISSION PHARMACAL

RUBICON

TABLET;ORAL

GABAPENTIN

250MG/5ML

250MG/5ML

A078974

A216492

001

001

Feb 18, 2011

Jan 18, 2023

Aug CAHN

Jan NEWA

AB

AB

AB

AB

AB

AB

@ CHARTWELL RX

@

GRANULES

GRAVITI PHARMS

RISING

GRALISE

600MG

800MG

600MG

800MG

600MG

800MG

600MG

800MG

A076120

A076120

A217116

A217116

A217995

A217995

A217995

A217995

001

002

001

002

001

002

001

002

Jan 27, 2006

Jan 27, 2006

Mar 28, 2023

Mar 28, 2023

Jul 19, 2023

Jul 19, 2023

Jul 19, 2023

Jul 19, 2023

May CAHN

May CAHN

Mar NEWA

Mar NEWA

Jul NEWA

Jul NEWA

Aug CAHN

Aug CAHN

+

+

ALMATICA 450MG

750MG

N022544

N022544

003

004

Apr 18, 2023

Apr 18, 2023

Aug NEWA

Aug NEWA

GADOBUTROL

SOLUTION;INTRAVENOUS

GADAVIST

AP

AP

+! BAYER HLTHCARE

+!

GADOBUTROL

18.1416GM/30ML (604.72MG/ML)

39.3068GM/65ML (604.72MG/ML)

N201277

N201277

004

005

Mar 14, 2011

Mar 14, 2011

Sep CFTG

Sep CFTG

AP

AP

AP

AP

AP

AP

@

@

HAINAN POLY PHARM

HENGRUI PHARMA

4.5354GM/7.5ML (604.72MG/ML)

4.5354GM/7.5ML (604.72MG/ML)

4.5354GM/7.5ML (604.72MG/ML)

9.0708GM/15ML (604.72MG/ML)

9.0708GM/15ML (604.72MG/ML)

9.0708GM/15ML (604.72MG/ML)

18.1416GM/30ML (604.72MG/ML)

39.3068GM/65ML (604.72MG/ML)

A217480

A217480

A217480

A217480

A217480

A217480

A216081

A216081

001

001

001

002

002

002

001

002

Mar 15, 2023

Mar 15, 2023

Mar 15, 2023

Mar 15, 2023

Mar 15, 2023

Mar 15, 2023

Sep 08, 2023

Sep 08, 2023

Nov CMFD

Sep DISC

Mar NEWA

Nov CMFD

Sep DISC

Mar NEWA

Sep NFTG

Sep NFTG

GADOTERATE MEGLUMINE

SOLUTION;INTRAVENOUS

GADOTERATE MEGLUMINE

AP HENGRUI PHARMA 37.69GM/100ML (376.9MG/ML) A215304 005 Apr 15, 2022 Feb CMS1
RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - December 2023 1-69

GALANTAMINE HYDROBROMIDE

CAPSULE, EXTENDED RELEASE;ORAL

GALANTAMINE HYDROBROMIDE

AB ! AUROBINDO PHARMA EQ 8MG BASE A204895 001 Aug 05, 2016 Jul CHRS

GALLIUM CITRATE GA-67

INJECTABLE;INJECTION

GALLIUM CITRATE GA 67

@ LANTHEUS MEDCL 2mCi/ML N017478 001 Sep DISC

GALLIUM GA-68 DOTATOC

SOLUTION;INTRAVENOUS

GALLIUM GA 68 EDOTREOTIDE

+! UIHC PET IMAGING 0.5-4mCi/ML N210828 001 Aug 21, 2019 Aug CTNA

GALLIUM GA-68 EDOTREOTIDE

SOLUTION;INTRAVENOUS

GALLIUM GA 68 EDOTREOTIDE

+! UIHC PET IMAGING 0.5-4mCi/ML N210828 001 Aug 21, 2019 Aug CAIN

GALLIUM GA-68 GOZETOTIDE

POWDER;INTRAVENOUS

LOCAMETZ

+! NOVARTIS N/A N215841 001 Mar 23, 2022 Nov CAHN

GANCICLOVIR SODIUM

INJECTABLE;INJECTION

GANCICLOVIR SODIUM

AP SLATE RUN PHARMA EQ 500MG BASE/VIAL A204204 001 Nov 08, 2018 Sep CAHN

GANIRELIX ACETATE

INJECTABLE;INJECTION

GANIRELIX ACETATE

AP

AP

AP +!

GLAND PHARMA LTD

LUPIN LTD

ORGANON USA ORGANON

250MCG/0.5ML

250MCG/0.5ML

250MCG/0.5ML

A215658

A216075

N021057

001

001

001

Feb 28, 2023

Nov 16, 2023

Jul 29, 1999

Feb NEWA

Nov NEWA

May CAHN

GATIFLOXACIN

SOLUTION/DROPS;OPHTHALMIC

ZYMAR

+ @ ALLERGAN

ZYMAXID

0.3% N021493 001 Mar 28, 2003 Mar DISC

AT +! ABBVIE 0.5% N022548 001 May 18, 2010 Jan CAHN

GEFITINIB

TABLET;ORAL

GEFITINIB

AB

AB

AB

ACTAVIS LABS FL INC

NATCO

QILU PHARM HAINAN

250MG

250MG

250MG

A208913

A212827

A211591

001

001

001

Apr 26, 2023

May 31, 2023

Feb 13, 2023

Apr NEWA

May NEWA

Feb NEWA

GEMCITABINE HYDROCHLORIDE

INJECTABLE;INJECTION

GEMCITABINE HYDROCHLORIDE

AP

AP

AP

AP

AP

AP

HIKMA

NOVAST LABS

SOLUTION;INTRAVENOUS

INFUGEM

200MG/5.26ML (38MG/ML)

1GM/26.3ML (38MG/ML)

2GM/52.6ML (38MG/ML)

200MG/5.26ML (38MG/ML)

1GM/26.3ML (38MG/ML)

2GM/52.6ML (38MG/ML)

A213175

A213175

A213175

A210383

A210383

A210383

001

002

003

001

002

003

Mar 07, 2023

Mar 07, 2023

Mar 07, 2023

Feb 14, 2019

Feb 14, 2019

Feb 14, 2019

Feb NEWA

Feb NEWA

Feb NEWA

Jun CMFD

Jun CMFD

Jun CMFD

+ @ SUN PHARM

+ @

+ @

+ @

+ @

EQ 1200MG BASE/120ML (EQ 10MG

BASE/ML)

EQ 1300MG BASE/130ML (EQ 10MG

BASE/ML)

EQ 1400MG BASE/140ML (EQ 10MG

BASE/ML)

EQ 1500MG BASE/150ML (EQ 10MG

BASE/ML)

EQ 1600MG BASE/160ML (EQ 10MG

BASE/ML)

N208313

N208313

N208313

N208313

N208313

001

002

003

004

005

Jul 16, 2018

Jul 16, 2018

Jul 16, 2018

Jul 16, 2018

Jul 16, 2018

Jul DISC

Jul DISC

Jul DISC

Jul DISC

Jul DISC
RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - December 2023 1-70

SOLUTION;INTRAVENOUS

INFUGEM

+ @

+ @

+ @

+ @

+ @

EQ 1700MG BASE/170ML (EQ 10MG

BASE/ML)

EQ 1800MG BASE/180ML (EQ 10MG

BASE/ML)

EQ 1900MG BASE/190ML (EQ 10MG

BASE/ML)

EQ 2000MG BASE/200ML (EQ 10MG

BASE/ML)

EQ 2200MG BASE/220ML (EQ 10MG

BASE/ML)

N208313

N208313

N208313

N208313

N208313

006 Jul 16, 2018

007 Jul 16, 2018

008 Jul 16, 2018

009 Jul 16, 2018

010 Jul 16, 2018

Jul DISC

Jul DISC

Jul DISC

Jul DISC

Jul DISC

GENTAMICIN SULFATE

>A>

>A>

>D>

>A>

AP

AP

AP

AP

AT

AT

INJECTABLE;INJECTION

GENTAMICIN SULFATE

EUGIA PHARMA

HIKMA

OINTMENT;OPHTHALMIC

GENTAMICIN SULFATE

@ AKORN

! FERA PHARMS LLC

!

OINTMENT;TOPICAL

GENTAMICIN SULFATE

@ PAI HOLDINGS PHARM

@

@ VERTICE

SOLUTION/DROPS;OPHTHALMIC

GENOPTIC

@ ALLERGAN

GENTAK

@ AKORN

GENTAMICIN SULFATE

! SANDOZ

EQ 10MG BASE/ML

EQ 40MG BASE/ML

EQ 10MG BASE/ML

EQ 40MG BASE/ML

EQ 0.3% BASE

EQ 0.3% BASE

EQ 0.3% BASE

EQ 0.1% BASE

EQ 0.1% BASE

EQ 0.1% BASE

EQ 0.3% BASE

EQ 0.3% BASE

EQ 0.3% BASE

A215236

A215237

A062251

A062251

A064093

A065024

A065024

A209233

A209233

A209233

A062452

A064163

A062196

001 Jan 08, 2024

001 Jan 08, 2024

002

001

001 Aug 31, 1995

001 Jul 30, 2004

001 Jul 30, 2004

001 Dec 31, 2018

001 Dec 31, 2018

001 Dec 31, 2018

001 Oct 10, 1984

001 Oct 12, 2001

001

Dec NEWA

Dec NEWA

Sep CMFD

Sep CMFD

Feb DISC

Feb CTEC

Feb CHRS

Dec CAHN

May DISC

Dec CAHN

Feb DISC

Feb DISC

Feb CHRS

GENTAMICIN SULFATE; PREDNISOLONE ACETATE

OINTMENT;OPHTHALMIC

PRED-G

+ @ ALLERGAN EQ 0.3% BASE;0.6% N050612 001 Dec 01, 1989 Jan DISC

GEPIRONE HYDROCHLORIDE

TABLET, EXTENDED RELEASE;ORAL

EXXUA

+ FABRE KRAMER EQ 18.2MG BASE

+ EQ 36.3MG BASE

+ EQ 54.5MG BASE

+! EQ 72.6MG BASE

N021164

N021164

N021164

N021164

001 Sep 22, 2023

002 Sep 22, 2023

003 Sep 22, 2023

004 Sep 22, 2023

Sep NEWA

Sep NEWA

Sep NEWA

Sep NEWA

GLATIRAMER ACETATE

FOR SOLUTION;SUBCUTANEOUS

COPAXONE

+ @ TEVA PHARMS USA 20MG/VIAL N020622 001 Dec 20, 1996 Jun CRLD

GLIPIZIDE

AB

AB

TABLET;ORAL

GLIPIZIDE

RUBICON

@ SUN PHARM INDS INC

@

GLUCOTROL

+ @ PFIZER

+ @

+ @

2.5MG

5MG

10MG

5MG

10MG

2.5MG

5MG

10MG

A214874

A214874

A214874

A077820

A077820

N017783

N017783

N017783

001 Oct 03, 2023

002 Oct 03, 2023

003 Oct 03, 2023

001 Jul 11, 2006

002 Jul 11, 2006

003 May 11, 1993

001 May 08, 1984

002 May 08, 1984

Sep NFTG

Sep NEWA

Sep NEWA

Nov DISC

Nov DISC

Sep CFTG

Sep CFTG

Sep CFTG
RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - December 2023 1-71

GLIPIZIDE; METFORMIN HYDROCHLORIDE

TABLET;ORAL

GLIPIZIDE AND METFORMIN HYDROCHLORIDE

@

@

@

DASH PHARMS 2.5MG;250MG

2.5MG;500MG

5MG;500MG

A078083

A078083

A078083

001

002

003

Apr 12, 2007

Apr 12, 2007

Apr 12, 2007

Feb CAHN

Feb CAHN

Feb CAHN

GLUCAGON

INJECTABLE;INJECTION

GLUCAGON

AP

! AMPHASTAR PHARMS INC

!

+ @ LILLY

POWDER;NASAL

BAQSIMI

+! AMPHASTAR PHARMS INC

SOLUTION;SUBCUTANEOUS

GVOKE KIT

1MG/VIAL

1MG/VIAL

1MG/VIAL

3MG

A208086

A208086

N020928

N210134

001

001

001

001

Dec 28, 2020

Dec 28, 2020

Sep 11, 1998

Jul 24, 2019

Oct CTEC

Oct CHRS

Oct DISC

Sep CAHN

+! XERIS

GVOKE PFS

1MG/0.2ML (1MG/0.2ML) N212097 005 Aug 20, 2021 May NEWA

+ @ XERIS 0.5MG/0.1ML (0.5MG/0.1ML) N212097 001 Sep 10, 2019 Jan DISC

GLYBURIDE

TABLET;ORAL

GLYBURIDE (MICRONIZED)

@ HIKMA

@

@

1.5MG

3MG

6MG

A075890

A075890

A075890

001

002

003

Jul 31, 2003

Jul 31, 2003

Jul 31, 2003

Nov DISC

Nov DISC

Nov DISC

GLYCEROL PHENYLBUTYRATE

LIQUID;ORAL

RAVICTI

+! HORIZON THERAP US 1.1GM/ML N203284 001 Feb 01, 2013 Jan CAHN

GLYCOPYRROLATE

INJECTABLE;INJECTION

GLYCOPYRROLATE

AP

AP

AP

AP

@ LUPIN LTD

@ MANKIND PHARMA

SAGENT

UMEDICA

SOLUTION;INHALATION

LONHALA MAGNAIR KIT

0.2MG/ML

0.2MG/ML

0.2MG/ML

0.2MG/ML

0.2MG/ML

0.2MG/ML

A213655

A213655

A217354

A217354

A210083

A212591

001

001

001

001

001

001

Feb 07, 2023

Feb 07, 2023

Feb 27, 2023

Feb 27, 2023

Feb 21, 2020

Oct 13, 2021

Apr DISC

Jan NEWA

Aug DISC

Feb NEWA

Aug CAHN

Sep CAHN

+ @ SUMITOMO PHARMA AM

+ @ SUNOVION RESP

TABLET;ORAL

GLYCOPYRROLATE

25MCG/ML

25MCG/ML

N208437

N208437

001

001

Dec 05, 2017

Dec 05, 2017

Jul CAHN

Jul DISC

AA

AA

AA

AA

AA

AA

ALEMBIC 1MG

2MG

AUROBINDO PHARMA 1MG

2MG

INDOCO 1MG

2MG

TABLET, ORALLY DISINTEGRATING;ORAL

DARTISLA ODT

A203657

A203657

A202675

A202675

A091182

A091182

001

002

001

002

001

002

Nov 30, 2018

Nov 30, 2018

Apr 15, 2013

Oct 30, 2018

Feb 03, 2014

Feb 03, 2014

Feb CAHN

Feb CAHN

Jan CAHN

Jan CAHN

Sep CAHN

Sep CAHN

+

@

@

EDENBRIDGE PHARMS 0.85MG

0.85MG

1.7MG

N215019

N215019

N215019

002

002

001

Oct 11, 2023

Oct 11, 2023

Dec 16, 2021

Nov DISC

Nov NEWA

Jun DISC

GLYCOPYRROLATE; NEOSTIGMINE METHYLSULFATE

SOLUTION;INTRAVENOUS

PREVDUO

+! SLAYBACK PHARMA LLC 0.6MG/3ML (0.2MG/ML);3MG/3ML

(1MG/ML)

N216903 001 Feb 23, 2023 Feb NEWA
RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - December 2023 1-72

GRANISETRON

FILM, EXTENDED RELEASE;TRANSDERMAL

SANCUSO

+! CUMBERLAND 3.1MG/24HR N022198 001 Sep 12, 2008 Sep CAHN

GRANISETRON HYDROCHLORIDE

TABLET;ORAL

GRANISETRON HYDROCHLORIDE

>D> AB

>A>

>D> AB

>A> AB

@

!

@

!

AUROBINDO PHARMA USA

HIKMA

ORBION PHARMS

EQ 1MG BASE

EQ 1MG BASE

EQ 1MG BASE

EQ 1MG BASE

EQ 1MG BASE

A078725

A077842

A077842

A078678

A078678

001

001

001

001

001

Jan 30, 2008

Dec 31, 2007

Dec 31, 2007

Feb 13, 2008

Feb 13, 2008

May CAHN

Dec DISC

Dec DISC

Dec CHRS

Dec CHRS

GUANFACINE HYDROCHLORIDE

TABLET;ORAL

GUANFACINE HYDROCHLORIDE

AB

AB

AB

AB

AB

AB

AB

AB

AJANTA PHARMA LTD EQ 1MG BASE

EQ 2MG BASE

AUROBINDO PHARMA USA EQ 1MG BASE

EQ 2MG BASE

I 3 PHARMS EQ 1MG BASE

EQ 2MG BASE

RUBICON EQ 1MG BASE

EQ 2MG BASE

TABLET, EXTENDED RELEASE;ORAL

GUANFACINE HYDROCHLORIDE

A217293

A217293

A074796

A074796

A216828

A216828

A216762

A216762

001

002

001

002

001

002

001

002

Apr 27, 2023

Apr 27, 2023

Jan 27, 1997

Jan 27, 1997

Oct 05, 2023

Oct 05, 2023

Oct 17, 2023

Oct 17, 2023

Apr NEWA

Apr NEWA

Jul CMFD

Jul CMFD

Sep NEWA

Sep NEWA

Oct NEWA

Oct NEWA

AB

AB

AB

AB

ALEMBIC EQ 1MG BASE

EQ 2MG BASE

EQ 3MG BASE

EQ 4MG BASE

A217269

A217269

A217269

A217269

001

002

003

004

Aug 07, 2023

Aug 07, 2023

Aug 07, 2023

Aug 07, 2023

Jul NEWA

Jul NEWA

Jul NEWA

Jul NEWA

HALCINONIDE

CREAM;TOPICAL

HALCINONIDE

AB CHARTWELL RX 0.1% A214723 001 Sep 08, 2021 May CAHN

HALOBETASOL PROPIONATE

AEROSOL, FOAM;TOPICAL

HALOBETASOL PROPIONATE

AB PADAGIS ISRAEL

LEXETTE

0.05% A215266 001 Aug 11, 2023 Aug NFTG

AB +! MAYNE PHARMA

OINTMENT;TOPICAL

HALOBETASOL PROPIONATE

0.05% N210566 001 May 24, 2018 Aug CFTG

>D>

>A>

@ PAI HOLDINGS PHARM

@

@ VERTICE

0.05%

0.05%

0.05%

A209978

A209978

A209978

001

001

001

Mar 20, 2018

Mar 20, 2018

Mar 20, 2018

Dec CAHN

May DISC

Dec CAHN

HALOPERIDOL

TABLET;ORAL

HALOPERIDOL

AB

AB

AB

AB

AB

AB

AB

AB

AB

@

@

@

@

@

@

@

@

@

ACTAVIS GROUP

AIPING PHARM INC

SCIEGEN PHARMS INC

ZYDUS PHARMS USA

0.5MG

1MG

2MG

5MG

10MG

20MG

0.5MG

1MG

2MG

5MG

10MG

20MG

2MG

5MG

10MG

0.5MG

1MG

2MG

A200854

A200854

A200854

A200854

A200854

A200854

A071128

A071129

A071130

A071131

A071132

A071133

A071130

A071131

A071132

A077580

A077580

A077580

001

002

003

004

005

006

001

001

001

001

001

001

001

001

001

001

002

006

Jul 01, 2022

Jul 01, 2022

Jul 01, 2022

Jul 01, 2022

Jul 01, 2022

Jul 01, 2022

Feb 17, 1987

Feb 17, 1987

Feb 17, 1987

Feb 17, 1987

May 12, 1987

May 12, 1987

Feb 17, 1987

Feb 17, 1987

May 12, 1987

Jan 17, 2023

Jan 17, 2023

Jan 17, 2023

Jan DISC

Jan DISC

Jan DISC

Jan DISC

Jan DISC

Jan DISC

Aug CAHN

Aug CAHN

Aug CAHN

Aug CAHN

Aug CAHN

Aug CAHN

Sep CAHN

Sep CAHN

Sep CAHN

Jan NEWA

Jan NEWA

Jan NEWA
RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - December 2023 1-73

HALOPERIDOL DECANOATE

INJECTABLE;INJECTION

HALOPERIDOL DECANOATE

AO

AO

MANKIND PHARMA EQ 50MG BASE/ML

EQ 100MG BASE/ML

A216730

A216730

001

002

May 23, 2023

May 23, 2023

May NEWA

May NEWA

HALOPERIDOL LACTATE

INJECTABLE;INJECTION

HALOPERIDOL

@ EPIC PHARMA LLC EQ 5MG BASE/ML A204849 001 Sep 06, 2017 Oct CAHN

HEPARIN SODIUM

INJECTABLE;INJECTION

HEPARIN SODIUM

AP

AP

AP

>A>

B BRAUN MEDICAL INC 5,000 UNITS/0.5ML A208827 001

@ EPIC PHARMA LLC 1,000 UNITS/ML N017486 001

@ 5,000 UNITS/ML N017486 002

@ 10,000 UNITS/ML N017486 003

@ 20,000 UNITS/ML N017486 004

@ 40,000 UNITS/ML N017486 005

HIKMA 5,000 UNITS/0.5ML N017037 013

NANJING KING-FRIEND 5,000 UNITS/ML A212061 001

HEPARIN SODIUM 2,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER

+! B BRAUN 200 UNITS/100ML N019953 002

HEPARIN SODIUM PRESERVATIVE FREE

Nov 19, 2018

Apr 07, 1986

Jul 15, 2020

Dec 15, 2023

Nov CTEC

Oct CAHN

Oct CAHN

Oct CAHN

Oct CAHN

Oct CAHN

Nov CMFD

Feb CMFD

Dec NEWA

AP NANJING KING-FRIEND 10,000 UNITS/ML A212060 001 Apr 02, 2020 Feb CMFD

>D>

>D>

HEPARIN SODIUM; TAUROLIDINE

SOLUTION;INJECTION

DEFENCATH

>D>

>D>

>A>

>A>

+! CORMEDIX

+!

+!

+!

SOLUTION;N/A

DEFENCATH

3,000 UNITS/3ML (1,000

UNITS/ML);40.5MG/3ML (13.5MG/ML)

3,000 UNITS/3ML (1,000

UNITS/ML);40.5MG/3ML (13.5MG/ML)

5,000 UNITS/5ML (1,000

UNITS/ML);67.5MG/5ML (13.5MG/ML)

5,000 UNITS/5ML (1,000

UNITS/ML);67.5MG/5ML (13.5MG/ML)

N214520

N214520

N214520

N214520

001

001

002

002

Nov 15, 2023

Nov 15, 2023

Nov 15, 2023

Nov 15, 2023

Dec CDFR

Nov NEWA

Dec CDFR

Nov NEWA

>A>

>A>

+!

+!

CORMEDIX 3,000 UNITS/3ML (1,000

UNITS/ML);40.5MG/3ML (13.5MG/ML)

5,000 UNITS/5ML (1,000

UNITS/ML);67.5MG/5ML (13.5MG/ML)

N214520

N214520

001

002

Nov 15, 2023

Nov 15, 2023

Dec CDFR

Dec CDFR

HOMATROPINE METHYLBROMIDE; HYDROCODONE BITARTRATE

SYRUP;ORAL

HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE

AA ! PAI HOLDINGS PHARM 1.5MG/5ML;5MG/5ML A040613 001 Feb 08, 2008 Oct CAHN

HYDRALAZINE HYDROCHLORIDE

INJECTABLE;INJECTION

HYDRALAZINE HYDROCHLORIDE

AP EUGIA PHARMA 20MG/ML

@ MYLAN INSTITUTIONAL 20MG/ML

TABLET;ORAL

HYDRALAZINE HYDROCHLORIDE

A215147

A204680

001

001

Feb 13, 2023

Apr 28, 2016

Feb NEWA

May DISC

>D>

>D>

>D>

>D>

AA

AA

AA

AA

>A>

>A>

>A>

@

@

@

@

@

@

@

@

@

@

@

APPCO

HERITAGE PHARMS INC

RISING

10MG

10MG

25MG

25MG

50MG

50MG

100MG

100MG

10MG

25MG

50MG

100MG

10MG

25MG

50MG

A209251

A209251

A209251

A209251

A209251

A209251

A209251

A209251

A040858

A040858

A040858

A040858

A209251

A209251

A209251

001

001

002

002

003

003

004

004

001

002

003

004

001

002

003

Jul 09, 2018

Jul 09, 2018

Jul 09, 2018

Jul 09, 2018

Jul 09, 2018

Jul 09, 2018

Jul 09, 2018

Jul 09, 2018

Feb 26, 2010

Feb 26, 2010

Feb 26, 2010

Feb 26, 2010

Jul 09, 2018

Jul 09, 2018

Jul 09, 2018

Dec CAHN

Nov CAHN

Dec CAHN

Nov CAHN

Dec CAHN

Nov CAHN

Dec CAHN

Nov CAHN

May CMFD

May CMFD

May CMFD

May CMFD

Dec CAHN

Dec CAHN

Dec CAHN
RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - December 2023 1-74

TABLET;ORAL

HYDRALAZINE HYDROCHLORIDE

>A> @ 100MG A209251 004 Jul 09, 2018 Dec CAHN

HYDROCHLOROTHIAZIDE

CAPSULE;ORAL

HYDROCHLOROTHIAZIDE

@ SUN PHARM INDS INC

TABLET;ORAL

HYDROCHLOROTHIAZIDE

12.5MG A090651 001 Apr 07, 2014 Sep DISC

AB HERITAGE PHARMS 12.5MG A085182 003 May 02, 2023 Apr NEWA

HYDROCHLOROTHIAZIDE; LISINOPRIL

TABLET;ORAL

LISINOPRIL AND HYDROCHLOROTHIAZIDE

AB

AB

!

!

INVAGEN PHARMS

ZESTORETIC

12.5MG;20MG

25MG;20MG

A204058

A204058

002 May 23, 2017

003 May 23, 2017

Jun CHRS

Jun CHRS

AB

AB

+

+

ALMATICA 12.5MG;20MG

25MG;20MG

N019888

N019888

001 Sep 20, 1990

002 Jul 20, 1989

Jun CHRS

Jun CHRS

HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM

TABLET;ORAL

LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE

AB

AB

AB

GRANULES 12.5MG;50MG

12.5MG;100MG

25MG;100MG

A218015

A218015

A218015

001 Sep 29, 2023

002 Sep 29, 2023

003 Sep 29, 2023

Sep NEWA

Sep NEWA

Sep NEWA

HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL

TABLET;ORAL

OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE

>D>

>D>

>D>

>A>

>A>

>A>

AB

AB

AB

AB

AB

AB

@

@

@

@

@

@

@

@

@

@

@

@

MACLEODS PHARMS LTD

MYLAN

NATCO PHARMA USA

TORRENT

ZYDUS PHARMS

12.5MG;20MG

12.5MG;40MG

25MG;40MG

12.5MG;20MG

12.5MG;40MG

25MG;40MG

12.5MG;20MG

12.5MG;40MG

25MG;40MG

12.5MG;20MG

12.5MG;40MG

25MG;40MG

12.5MG;20MG

12.5MG;20MG

12.5MG;40MG

12.5MG;40MG

25MG;40MG

25MG;40MG

A204801

A204801

A204801

A078827

A078827

A078827

A078827

A078827

A078827

A206515

A206515

A206515

A206377

A206377

A206377

A206377

A206377

A206377

001 Jun 01, 2023

002 Jun 01, 2023

003 Jun 01, 2023

001 Oct 26, 2016

002 Oct 26, 2016

003 Oct 26, 2016

001 Oct 26, 2016

002 Oct 26, 2016

003 Oct 26, 2016

001 May 03, 2017

002 May 03, 2017

003 May 03, 2017

001 Feb 24, 2023

001 Feb 24, 2023

002 Feb 24, 2023

002 Feb 24, 2023

003 Feb 24, 2023

003 Feb 24, 2023

May NEWA

May NEWA

May NEWA

Dec CAHN

Dec CAHN

Dec CAHN

Dec CAHN

Dec CAHN

Dec CAHN

Aug DISC

Aug DISC

Aug DISC

Jul DISC

Feb NEWA

Jul DISC

Feb NEWA

Jul DISC

Feb NEWA

AB

AB

AB

HYDROCHLOROTHIAZIDE; QUINAPRIL HYDROCHLORIDE

TABLET;ORAL

QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE

APOTEX 12.5MG;EQ 10MG BASE

12.5MG;EQ 20MG BASE

25MG;EQ 20MG BASE

@ CHARTWELL RX 12.5MG;EQ 10MG BASE

@ 12.5MG;EQ 20MG BASE

@ 25MG;EQ 20MG BASE

A091524

A091524

A091524

A076374

A076374

A076374

001 Mar 12, 2013

002 Mar 12, 2013

003 Mar 12, 2013

001 Mar 31, 2004

002 Mar 31, 2004

003 Mar 31, 2004

Jan CAHN

Jan CAHN

Jan CAHN

Apr CAHN

Apr CAHN

Apr CAHN

HYDROCHLOROTHIAZIDE; SPIRONOLACTONE

TABLET;ORAL

ALDACTAZIDE

+ @ PFIZER 50MG;50MG N012616 005 Dec 30, 1982 Sep DISC

HYDROCHLOROTHIAZIDE; VALSARTAN

TABLET;ORAL

VALSARTAN AND HYDROCHLOROTHIAZIDE

AB

AB

AB

AB

AMNEAL PHARMS 12.5MG;80MG

12.5MG;160MG

12.5MG;320MG

25MG;160MG

A204382

A204382

A204382

A204382

001 Aug 11, 2023

002 Aug 11, 2023

004 Aug 11, 2023

003 Aug 11, 2023

Aug NEWA

Aug NEWA

Aug NEWA

Aug NEWA
RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - December 2023 1-75

TABLET;ORAL

VALSARTAN AND HYDROCHLOROTHIAZIDE

AB 25MG;320MG A204382 005 Aug 11, 2023 Aug NEWA

HYDROCORTISONE

>D>

>A>

>D>

>A>

AB

AB

AB

CREAM;TOPICAL

HYDROCORTISONE

@ ENCUBE

LOTION;TOPICAL

ALA-SCALP

DERM RX

LEGACY PHARMA

HYDROCORTISONE

@ PAI HOLDINGS PHARM

@ VERTICE

TABLET;ORAL

HYDROCORTISONE

AUROBINDO PHARMA LTD

2.5%

2%

2%

2.5%

2.5%

5MG

10MG

20MG

A203810

A083231

A083231

A203804

A203804

A214649

A214649

A214649

001

001

001

001

001

001

002

003

Jul 23, 2018

Jul 27, 2018

Jul 27, 2018

Jul 17, 2023

Jul 17, 2023

Jul 17, 2023

Oct CAHN

Dec CAHN

Dec CAHN

Dec CAHN

Dec CAHN

Jul NEWA

Jul NEWA

Jul NEWA

HYDROCORTISONE ACETATE

INJECTABLE;INJECTION

HYDROCORTISONE ACETATE

@ EPIC PHARMA LLC

@

25MG/ML

50MG/ML

N009637

N009637

001

002

Nov CAHN

Nov CAHN

HYDROCORTISONE ACETATE; NEOMYCIN SULFATE

SUSPENSION/DROPS;OPHTHALMIC

COR-OTICIN

@ EPIC PHARMA LLC 1.5%;EQ 3.5MG BASE/ML A060188 001 Oct CAHN

HYDROMORPHONE HYDROCHLORIDE

>A>

AP

INJECTABLE;INJECTION

HYDROMORPHONE HYDROCHLORIDE

HIKMA 2MG/ML

HOSPIRA INC 0.25MG/0.5ML

4MG/ML

SOLUTION;INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS

HYDROMORPHONE HYDROCHLORIDE

+! HIKMA 40MG/20ML (2MG/ML)

A202159

N200403

N200403

N217812

001

005

003

001

Apr 27, 2018

Mar 03, 2023

Dec 01, 2011

Dec 14, 2023

May CAHN

Mar NEWA

Apr CTEC

Dec NEWA

HYDROXYAMPHETAMINE HYDROBROMIDE; TROPICAMIDE

SOLUTION/DROPS;OPHTHALMIC

PAREMYD

+ @ AKORN 1%;0.25%

+ @ EPIC PHARMA LLC 1%;0.25%

N019261

N019261

001

001

Jan 30, 1992

Jan 30, 1992

Feb DISC

Nov CAHN

AB

HYDROXYCHLOROQUINE SULFATE

TABLET;ORAL

HYDROXYCHLOROQUINE SULFATE

CHARTWELL RX 200MG

@ TEVA PHARMS 200MG

SOVUNA

+ NOVITIUM PHARMA 200MG

+! 300MG

A210543

A040081

N214581

N214581

001

001

001

002

Jul 06, 2018

Sep 30, 1994

Jan 14, 2022

Jan 14, 2022

May CAHN

Sep DISC

Sep CTNA

Sep CTNA

HYDROXYPROGESTERONE CAPROATE

INJECTABLE;INJECTION

HYDROXYPROGESTERONE CAPROATE

@ EPIC PHARMA LLC 125MG/ML N018004 001 Nov CAHN

HYDROXYPROPYL CELLULOSE

INSERT;OPHTHALMIC

LACRISERT

+! BAUSCH

+! BAUSCH AND LOMB INC

5MG

5MG

N018771

N018771

001

001

Jan CAHN

Jan CAHN
RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - December 2023 1-76

HYDROXYUREA

TABLET;ORAL

SIKLOS

+ THERAVIA 100MG

+! 1GM

HYDROXYZINE HYDROCHLORIDE

INJECTABLE;INJECTION

HYDROXYZINE HYDROCHLORIDE

+! AM REGENT 25MG/ML

+! 50MG/ML

SYRUP;ORAL

HYDROXYZINE HYDROCHLORIDE

AA +! CHARTWELL RX 10MG/5ML

TABLET;ORAL

HYDROXYZINE HYDROCHLORIDE

AB CHARTWELL RX 10MG

AB 25MG

AB 50MG

AB GRAVITI PHARMS 10MG

AB 25MG

AB 50MG

HYDROXYZINE PAMOATE

CAPSULE;ORAL

HYDROXYZINE PAMOATE

AB HERITAGE PHARMA EQ 25MG HYDROCHLORIDE

AB EQ 50MG HYDROCHLORIDE

IBRUTINIB

CAPSULE;ORAL

IMBRUVICA

+ PHARMACYCLICS LLC 70MG

+! 140MG

SUSPENSION;ORAL

IMBRUVICA

+! PHARMACYCLICS LLC 70MG/ML

TABLET;ORAL

IMBRUVICA

+ PHARMACYCLICS LLC 140MG

+ 280MG

+ 420MG

+ @ 560MG

+! 560MG

IBUPROFEN

SUSPENSION;ORAL

IBUPROFEN

@ PAI HOLDINGS PHARM 100MG/5ML

AB STRIDES PHARMA 100MG/5ML

ICATIBANT ACETATE

INJECTABLE;SUBCUTANEOUS

ICATIBANT ACETATE

AP EUGIA PHARMA EQ 30MG BASE/3ML (EQ 10MG BASE/ML)

ICOSAPENT ETHYL

CAPSULE;ORAL

ICOSAPENT ETHYL

>A> AB ASCENT PHARMS INC 500MG

AB DR REDDYS 500MG

AB HIKMA 500MG

>A> AB HUMANWELL PURACAP 500MG

>A> AB 1GM

AB STRIDES PHARMA 500MG

AB 1GM

AB ZYDUS 500MG

AB 1GM

N208843

N208843

A087408

A087408

A087294

A040804

A040804

A040804

A217652

A217652

A217652

A201507

A201507

N205552

N205552

N217003

N210563

N210563

N210563

N210563

N210563

A205647

A215311

A213521

A216811

A209499

A209457

A217919

A217919

A217844

A217844

A217656

A217656

001

002

001

002

001

001

002

003

001

002

003

001

002

002

001

001

001

002

003

004

004

001

001

001

001

002

002

001

002

001

002

001

002

Dec 21, 2017 Sep CAHN

Dec 21, 2017 Sep CAHN

Feb CRLD

Feb CRLD

Apr 12, 1982 Aug CAHN

Jun 30, 2008 Jan CAHN

Jun 30, 2008 Jan CAHN

Jun 30, 2008 Jan CAHN

Aug 17, 2023 Aug NEWA

Aug 17, 2023 Aug NEWA

Aug 17, 2023 Aug NEWA

Jun 03, 2013 Mar CTEC

Jun 03, 2013 Mar CTEC

Dec 20, 2017 Jun CAHN

Nov 13, 2013 Jun CAHN

Aug 24, 2022 Jun CAHN

Feb 16, 2018 Jun CAHN

Feb 16, 2018 Jun CAHN

Feb 16, 2018 Jun CAHN

Feb 16, 2018 Jul DISC

Feb 16, 2018 Jun CAHN

Nov 03, 2016 Oct CAHN

May 27, 2022 Aug CMFD

Aug 14, 2023 Aug NEWA

Dec 07, 2023 Dec NEWA

Mar 08, 2023 Feb NEWA

Mar 08, 2023 Feb NEWA

Dec 22, 2023 Dec NEWA

Dec 22, 2023 Dec NEWA

Sep 22, 2023 Sep NEWA

Sep 22, 2023 Sep NEWA

Apr 20, 2023 Apr NEWA

Apr 20, 2023 Apr NEWA
RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - December 2023 1-77

IDARUBICIN HYDROCHLORIDE

INJECTABLE;INJECTION

IDARUBICIN HYDROCHLORIDE

>D>

>A>

AP

AP

AP

AP

HONG KONG

MEITHEAL

1MG/ML

1MG/ML

1MG/ML

1MG/ML

A065036

A065036

A065036

A065036

001

001

001

001

May 01, 2002

May 01, 2002

May 01, 2002

May 01, 2002

Dec CAHN

Nov CTNA

Sep CAHN

Dec CAHN

IFOSFAMIDE

INJECTABLE;INJECTION

IFOSFAMIDE

>D>

>D>

>A>

>A>

AP

AP

AP

AP

AP

AP

!

!

!

!

!

!

HONG KONG

MEITHEAL

1GM/20ML (50MG/ML)

1GM/20ML (50MG/ML)

3GM/60ML (50MG/ML)

3GM/60ML (50MG/ML)

1GM/20ML (50MG/ML)

3GM/60ML (50MG/ML)

A076657

A076657

A076657

A076657

A076657

A076657

001

001

002

002

001

002

Apr 04, 2007

Apr 04, 2007

Apr 04, 2007

Apr 04, 2007

Apr 04, 2007

Apr 04, 2007

Dec CAHN

Sep CAHN

Dec CAHN

Sep CAHN

Dec CAHN

Dec CAHN

IMATINIB MESYLATE

TABLET;ORAL

IMATINIB MESYLATE

>D>

>A>

>D>

>A>

AB

AB

AB

AB

@

@

@

@

BRECKENRIDGE

CHARTWELL RX

HIKMA

EQ 100MG BASE

EQ 400MG BASE

EQ 100MG BASE

EQ 400MG BASE

EQ 100MG BASE

EQ 100MG BASE

EQ 400MG BASE

EQ 400MG BASE

A205990

A205990

A208429

A208429

A207586

A207586

A207586

A207586

001

002

001

002

001

001

002

002

Feb 08, 2019

Feb 08, 2019

Jan 17, 2019

Jan 17, 2019

Jul 13, 2018

Jul 13, 2018

Jul 13, 2018

Jul 13, 2018

Mar DISC

Jun DISC

Jan CAHN

Jan CAHN

Dec DISC

Dec DISC

Dec DISC

Dec DISC

IMIPRAMINE HYDROCHLORIDE

TABLET;ORAL

IMIPRAMINE HYDROCHLORIDE

@ SUN PHARM INDUSTRIES 10MG A081048 001 Jun 05, 1990 Nov DISC

IMIQUIMOD

CREAM;TOPICAL

ALDARA

AB

+

!

@ BAUSCH

IMIQUIMOD

GLENMARK GENERICS

5%

5%

N020723

A201994

001

001

Feb 27, 1997

Mar 06, 2012

Feb DISC

Feb CHRS

INDAPAMIDE

TABLET;ORAL

INDAPAMIDE

AB

AB

@

@

AUROBINDO PHARMA USA

RISING

1.25MG

2.5MG

1.25MG

2.5MG

A075105

A075105

A074461

A074461

001

002

002

001

Jul 23, 1998

Jul 23, 1998

Mar 26, 1997

Mar 27, 1996

Apr CAHN

Apr CAHN

Jul CMFD

Jul CMFD

INDOCYANINE GREEN

INJECTABLE;INJECTION

IC-GREEN

AP

AP

@ OAK TREE PHARMA

+!

@

@

@ RENEW PHARMS

+ @

+!

@

@

INDOCYANINE GREEN

10MG/VIAL

25MG/VIAL

40MG/VIAL

50MG/VIAL

10MG/VIAL

25MG/VIAL

25MG/VIAL

40MG/VIAL

50MG/VIAL

N011525

N011525

N011525

N011525

N011525

N011525

N011525

N011525

N011525

003

001

004

002

003

001

001

004

002

Aug CAHN

Aug CAHN

Aug CAHN

Aug CAHN

Aug CAHN

Sep DISC

Aug CAHN

Aug CAHN

Aug CAHN

AP

!

!

RENEW PHARMS 25MG/VIAL

25MG/VIAL

A040811

A040811

001

001

Nov 21, 2007

Nov 21, 2007

Sep CTEC

Sep CHRS
RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - December 2023 1-78

INDOMETHACIN

CAPSULE;ORAL

INDOCIN

+

+

@ ZYLA LIFE SCIENCES

@

INDOMETHACIN

25MG

50MG

N016059

N016059

001

002

Sep CAHN

Sep CAHN

AB

AB

CHARTWELL MOLECULES 25MG

50MG

CAPSULE, EXTENDED RELEASE;ORAL

INDOCIN SR

N018829

N018829

002

001

Aug 06, 1984

Aug 06, 1984

Feb CMFD

Feb CMFD

+ @ ZYLA

INDOMETHACIN

75MG N018185 001 Feb 23, 1982 Sep CAHN

>D>

>A>

>D>

>A>

AB

AB

AB

HETERO LABS LTD III

!

! SANDOZ

@

SUPPOSITORY;RECTAL

INDOCIN

75MG

75MG

75MG

75MG

A201807

A201807

A074464

A074464

001

001

001

001

Sep 28, 2012

Sep 28, 2012

May 28, 1998

May 28, 1998

Dec CHRS

Dec CHRS

Dec DISC

Dec DISC

+ @ ZYLA LIFE SCIENCES

INDOMETHACIN

50MG N017814 001 Aug 13, 1984 Jul CAHN

AB

AB

! COSETTE

ZYDUS

SUSPENSION;ORAL

INDOCIN

50MG

50MG

A073314

A216184

001

001

Aug 31, 1992

Aug 02, 2023

Jul CTEC

Jul NEWA

+! ZYLA 25MG/5ML N018332 001 Oct 10, 1985 Jun CAHN

INFIGRATINIB PHOSPHATE

CAPSULE;ORAL

TRUSELTIQ

+

+

@

@

HELSINN HLTHCARE 25MG

100MG

N214622

N214622

001

002

May 28, 2021

May 28, 2021

Apr DISC

Apr DISC

IOPAMIDOL

INJECTABLE;INJECTION

IOPAMIDOL

AP1

AP

AP2

AP

HAINAN POLY

ISOVUE-200

41%

41%

41%

61%

A215382

A215382

A217134

A215382

001

001

001

002

Feb 27, 2023

Feb 27, 2023

Sep 27, 2023

Feb 27, 2023

Sep CTEC

Feb NEWA

Sep NFTG

Feb NEWA

AP2 +! BRACCO

ISOVUE-250

41% N018735 006 Jul 07, 1987 Sep CFTG

+ @ BRACCO

ISOVUE-M 200

51% N020327 002 Oct 12, 1994 Jun DISC

AP1

AP

+! BRACCO

+!

ISOVUE-M 300

41%

41%

N018735

N018735

001

001

Dec 31, 1985

Dec 31, 1985

Sep CTEC

Feb CTEC

AP +! BRACCO 61% N018735 004 Dec 31, 1985 Feb CTEC

IPRATROPIUM BROMIDE

SPRAY, METERED;NASAL

IPRATROPIUM BROMIDE

@

@

AUROBINDO PHARMA USA 0.021MG/SPRAY

0.042MG/SPRAY

A075552

A075553

001

001

Mar 31, 2003

Mar 31, 2003

Apr CAHN

Apr CAHN

>A> IPTACOPAN HYDROCHLORIDE

>A>

>A>

CAPSULE;ORAL

FABHALTA

>A> +! NOVARTIS EQ 200MG BASE N218276 001 Dec 05, 2023 Dec NEWA

IRBESARTAN

TABLET;ORAL

IRBESARTAN

AB

AB

@

@

@

@

@

@

ANDA REPOSITORY

CHARTWELL RX

UNICHEM

75MG

150MG

300MG

75MG

150MG

300MG

75MG

150MG

A203161

A203161

A203161

A203161

A203161

A203161

A203020

A203020

001

002

003

001

002

003

001

002

Sep 27, 2012

Sep 27, 2012

Sep 27, 2012

Sep 27, 2012

Sep 27, 2012

Sep 27, 2012

Dec 07, 2015

Dec 07, 2015

Sep CAHN

Sep CAHN

Sep CAHN

Nov CAHN

Nov CAHN

Nov CAHN

Jun CMFD

Jun CMFD
RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - December 2023 1-79

AB

TABLET;ORAL

IRBESARTAN

@ UPSHER SMITH LABS

@

@

300MG

75MG

150MG

300MG

A203020

A200461

A200461

A200461

003 Dec 07, 2015

001 Sep 27, 2012

002 Sep 27, 2012

003 Sep 27, 2012

Jun CMFD

Sep CAHN

Sep CAHN

Sep CAHN

IRINOTECAN HYDROCHLORIDE

INJECTABLE;INJECTION

IRINOTECAN HYDROCHLORIDE

@ ANDA REPOSITORY 40MG/2ML (20MG/ML)

@ 100MG/5ML (20MG/ML)

@ CHARTWELL RX 40MG/2ML (20MG/ML)

@ 100MG/5ML (20MG/ML)

A078953

A078953

A078953

A078953

001 Apr 15, 2010

002 Apr 15, 2010

001 Apr 15, 2010

002 Apr 15, 2010

Sep CAHN

Sep CAHN

Nov CAHN

Nov CAHN

ISONIAZID

>D>

>D>

>A>

>A>

AA

AA

AA

AA

AA

AA

TABLET;ORAL

ISONIAZID

GENUS LIFESCIENCES

OMNIVIUM PHARMS

LANIAZID

@ CHARTWELL MOLECULAR

@

100MG

100MG

300MG

300MG

100MG

300MG

50MG

100MG

A040090

A040090

A040090

A040090

A040090

A040090

A080140

A080140

001 Jun 26, 1997

001 Jun 26, 1997

002 Jun 26, 1997

002 Jun 26, 1997

001 Jun 26, 1997

002 Jun 26, 1997

001

002

Dec CAHN

Sep CAHN

Dec CAHN

Sep CAHN

Dec CAHN

Dec CAHN

Feb CAHN

Feb CAHN

ISOPROTERENOL HYDROCHLORIDE

AP

AP

AP

INJECTABLE;INJECTION

ISOPROTERENOL HYDROCHLORIDE

@ AM REGENT 0.2MG/ML

HIKMA 0.2MG/ML

@ MYLAN LABS LTD 0.2MG/ML

PENN LIFE 0.2MG/ML

@ ZYDUS PHARMS 0.2MG/ML

0.2MG/ML

ISUPREL

+ @ BAUSCH 0.2MG/ML

A214775

A211703

A212573

A215542

A215557

A215557

N010515

001 Oct 19, 2022

001 Apr 26, 2023

001 Sep 06, 2022

001 Sep 20, 2022

001 Apr 14, 2023

001 Apr 14, 2023

001

Apr DISC

Apr NEWA

Jul DISC

May CAHN

Aug DISC

Apr NEWA

Jun DISC

ISOSORBIDE DINITRATE

>D>

>D>

>D>

>A>

TABLET, EXTENDED RELEASE;ORAL

ISOSORBIDE DINITRATE

! SUN PHARM INDS INC 40MG

@ 40MG

A040009

A040009

001 Dec 30, 1998

001 Dec 30, 1998

Dec DISC

Dec DISC

ISOSORBIDE MONONITRATE

TABLET, EXTENDED RELEASE;ORAL

ISOSORBIDE MONONITRATE

@ SHANDONG 120MG A214115 001 Apr 29, 2022 May DISC

ISOSULFAN BLUE

AP

INJECTABLE;INJECTION

ISOSULFAN BLUE

AM REGENT 1% A210294 001 May 17, 2023 May NEWA

ISOTRETINOIN

AB1

AB1

AB1

AB1

CAPSULE;ORAL

ISOTRETINOIN

ZYDUS PHARMS 10MG

20MG

30MG

40MG

A211568

A211568

A211568

A211568

001 Aug 29, 2023

002 Aug 29, 2023

003 Aug 29, 2023

004 Aug 29, 2023

Aug NEWA

Aug NEWA

Aug NEWA

Aug NEWA

ITRACONAZOLE

CAPSULE;ORAL

ITRACONAZOLE

@ PAR PHARM INC 100MG A205724 001 Dec 13, 2016 Nov DISC
RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - December 2023 1-80

IVABRADINE HYDROCHLORIDE

TABLET;ORAL

IVABRADINE HYDROCHLORIDE

AB

AB

ZYDUS PHARMS EQ 5MG BASE

EQ 7.5MG BASE

A213442

A213442

001

002

Nov 29, 2023

Nov 29, 2023

Nov NEWA

Nov NEWA

IVACAFTOR

GRANULE;ORAL

KALYDECO

+

+

VERTEX PHARMS INC 5.8MG/PACKET

13.4MG/PACKET

N207925

N207925

004

005

May 03, 2023

May 03, 2023

May NEWA

May NEWA

IVERMECTIN

CREAM;TOPICAL

IVERMECTIN

AB

AB

@

PADAGIS ISRAEL

ZYDUS

1%

1%

1%

A210225

A215210

A215210

001

001

001

Apr 13, 2020

Aug 02, 2022

Aug 02, 2022

Nov CMFD

Jul CMFD

Jan DISC

KETAMINE HYDROCHLORIDE

INJECTABLE;INJECTION

KETAMINE HYDROCHLORIDE

AP

AP

AP

AP

@

@

FRESENIUS KABI USA

GLAND PHARMA LTD

EQ 10MG BASE/ML

EQ 10MG BASE/ML

EQ 50MG BASE/ML

EQ 50MG BASE/ML

EQ 50MG BASE/ML

EQ 100MG BASE/ML

A215808

A215808

A215808

A215808

A216809

A216809

001

001

002

002

002

003

Jan 13, 2023

Jan 13, 2023

Jan 13, 2023

Jan 13, 2023

Jan 24, 2023

Jan 24, 2023

Jul DISC

Jan NEWA

Jul DISC

Jan NEWA

Jan NEWA

Jan NEWA

KETOCONAZOLE

TABLET;ORAL

KETOCONAZOLE

AB

@ AUROBINDO PHARMA USA

RISE PHARMA

200MG

200MG

A075597

A075912

001

001

Dec 23, 1999

Jan 10, 2002

May CAHN

Sep CAHN

KETOROLAC TROMETHAMINE

INJECTABLE;INJECTION

KETOROLAC TROMETHAMINE

AP

AP

AP

AP

ASPIRO

CAPLIN

SOLUTION/DROPS;OPHTHALMIC

ACULAR

15MG/ML

30MG/ML

15MG/ML

30MG/ML

A217166

A217166

A217789

A217789

001

002

001

002

Jun 20, 2023

Jun 20, 2023

May 10, 2023

May 10, 2023

Jun NEWA

Jun NEWA

Apr NEWA

Apr NEWA

AT +! ABBVIE

KETOROLAC TROMETHAMINE

0.5% N019700 001 Nov 09, 1992 Jan CAHN

@ AKORN

@ CHARTWELL RX

TABLET;ORAL

KETOROLAC TROMETHAMINE

0.5%

0.5%

A078434

A078434

001

001

Nov 05, 2009

Nov 05, 2009

Jan DISC

Sep CAHN

AB

AB

AB

AB

@ AIPING PHARM INC

BIONPHARMA

@ CHARTWELL RX

LEADING

10MG

10MG

10MG

10MG

10MG

10MG

A074790

A210616

A216759

A074790

A210616

A215745

001

001

001

001

001

001

Jun 26, 1997

Aug 16, 2018

Feb 23, 2023

Jun 26, 1997

Aug 16, 2018

Feb 23, 2023

Aug CAHN

Aug CAHN

Feb NEWA

Sep CAHN

Sep CAHN

Feb NEWA

KETOTIFEN FUMARATE

DRUG-ELUTING CONTACT LENS;OPHTHALMIC

ACUVUE THERAVISION WITH KETOTIFEN

+ @ JOHNSON JOHNSON VISN EQ 19MCG BASE N022388 001 Feb 25, 2022 May DISC

LABETALOL HYDROCHLORIDE

TABLET;ORAL

TRANDATE

+

+

@

@

ALVOGEN 200MG

300MG

N018716

N018716

002

003

Aug 01, 1984

Aug 01, 1984

Nov DISC

Nov DISC
RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - December 2023 1-81

LACOSAMIDE

CAPSULE, EXTENDED RELEASE;ORAL

MOTPOLY XR

+ AUCTA

+

+!

SOLUTION;INTRAVENOUS

LACOSAMIDE

100MG

150MG

200MG

N216185

N216185

N216185

001

002

003

May 04, 2023

May 04, 2023

May 04, 2023

May NEWA

May NEWA

May NEWA

AP

AP

APOTEX

MSN

SOLUTION;ORAL

LACOSAMIDE

200MG/20ML (10MG/ML)

200MG/20ML (10MG/ML)

A216670

A215979

001

001

Nov 13, 2023

Feb 09, 2023

Nov NEWA

Feb NEWA

>A>

AA

AA

AA

LEADING PHARMA

MEDLEY PHARMS

MSN

TABLET;ORAL

LACOSAMIDE

10MG/ML

10MG/ML

10MG/ML

A216461

A216461

A215379

001

001

001

Feb 06, 2023

Feb 06, 2023

Dec 22, 2023

Aug CAHN

Jan NEWA

Dec NEWA

>A>

>A>

>A>

>A>

AB

AB

AB

AB

@ ACCORD HLTHCARE

@

@

@

@ ACTAVIS LABS FL INC

@

@

@

@ APOTEX

@

@

@

ZYDUS PHARMS

50MG

100MG

150MG

200MG

50MG

100MG

150MG

200MG

50MG

100MG

150MG

200MG

50MG

100MG

150MG

200MG

A205011

A205011

A205011

A205011

A204855

A204855

A204855

A204855

A214567

A214567

A214567

A214567

A204947

A204947

A204947

A204947

001

002

003

004

001

002

003

004

001

002

003

004

001

002

003

004

Jul 12, 2022

Jul 12, 2022

Jul 12, 2022

Jul 12, 2022

Jan 05, 2023

Jan 05, 2023

Jan 05, 2023

Jan 05, 2023

Sep 23, 2022

Sep 23, 2022

Sep 23, 2022

Sep 23, 2022

Dec 15, 2023

Dec 15, 2023

Dec 15, 2023

Dec 15, 2023

Jan DISC

Jan DISC

Jan DISC

Jan DISC

Jul DISC

Jul DISC

Jul DISC

Jul DISC

Mar DISC

Mar DISC

Mar DISC

Mar DISC

Dec NEWA

Dec NEWA

Dec NEWA

Dec NEWA

LACTULOSE

SOLUTION;ORAL

LACTULOSE

AA

AA

AUROBINDO PHARMA LTD

@ VISTAPHARM

XTTRIUM LABS INC

SOLUTION;ORAL, RECTAL

LACTULOSE

10GM/15ML

10GM/15ML

10GM/15ML

A074602

A074138

A075911

001

001

001

Nov 14, 1996

Sep 30, 1992

Feb 21, 2002

Sep CAHN

Sep DISC

Mar CMFD

AA

AA

BAJAJ

PAI HOLDINGS PHARM

10GM/15ML

10GM/15ML

A076645

A074077

001

001

Jul 28, 2003

Jul 03, 1995

Feb CMFD

Oct CAHN

LAMIVUDINE

SOLUTION;ORAL

LAMIVUDINE

AA

AA

CHARTWELL MOLECULAR

HETERO LABS LTD III

TABLET;ORAL

LAMIVUDINE

10MG/ML

10MG/ML

A203564

A091475

001

001

Oct 31, 2014

Oct 06, 2023

Jul CAHN

Sep NEWA

@ AUROBINDO PHARMA USA 100MG A204002 001 Dec 31, 2014 May CAHN

LAMIVUDINE; TENOFOVIR DISOPROXIL FUMARATE

TABLET;ORAL

TEMIXYS

+ @ CHARTWELL RX 300MG;300MG N211284 001 Nov 16, 2018 Mar CAHN

LAMOTRIGINE

TABLET;ORAL

LAMOTRIGINE

@

@

@

@

CHARTWELL MOLECULAR 25MG

100MG

150MG

200MG

A077783

A077783

A077783

A077783

001

002

003

004

Nov 01, 2010

Nov 01, 2010

Nov 01, 2010

Nov 01, 2010

Jan CAHN

Jan CAHN

Jan CAHN

Jan CAHN
RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - December 2023 1-82

LANSOPRAZOLE

TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE;ORAL

LANSOPRAZOLE

AB

AB

AUROBINDO PHARMA LTD 15MG

30MG

A207167

A207167

001

002

Mar 28, 2023

Mar 28, 2023

Mar NEWA

Mar NEWA

LATANOPROST

SOLUTION/DROPS;OPHTHALMIC

LATANOPROST

>A>

>D>

AT

AT

@

@

AKORN

CARNEGIE

DR REDDYS LABS LTD

EPIC PHARMA LLC

0.005%

0.005%

0.005%

0.005%

A090887

A202077

A202077

A090887

001

001

001

001

Jul 19, 2011

Feb 11, 2013

Feb 11, 2013

Jul 19, 2011

Jan DISC

Dec CAHN

Dec CAHN

Oct CAHN

LATANOPROST; NETARSUDIL DIMESYLATE

SOLUTION/DROPS;OPHTHALMIC

ROCKLATAN

+! ALCON LABS INC 0.005%;EQ 0.02% BASE N208259 001 Mar 12, 2019 May CAHN

LEFAMULIN ACETATE

>D>

>D>

SOLUTION;INTRAVENOUS

XENLETA

>D>

>A>

+!

+ @

NABRIVA EQ 150MG BASE/15ML (EQ 10MG

BASE/ML)

EQ 150MG BASE/15ML (EQ 10MG

BASE/ML)

N211673

N211673

001

001

Aug 19, 2019

Aug 19, 2019

Dec DISC

Dec DISC

LENALIDOMIDE

CAPSULE;ORAL

LENALIDOMIDE

AB

AB

AB

AB

AB

AB

AB

AB

AB

AB

AB

AB

AB

AB

AB

AB

AB

AB

AB

AB

AB

AB

AB

AB

AB

AB

AB

AB

AB

AB

AB

AB

AB

APOTEX

ARROW INTL

CIPLA

EUGIA PHARMA

HETERO LABS LTD V

LOTUS PHARM CO LTD

MYLAN

SUN PHARM

@ TORRENT

@

@

ZYDUS PHARMS

REVLIMID

2.5MG

20MG

2.5MG

20MG

2.5MG

20MG

2.5MG

5MG

10MG

15MG

20MG

25MG

2.5MG

5MG

10MG

15MG

20MG

25MG

2.5MG

20MG

2.5MG

20MG

2.5MG

5MG

10MG

15MG

20MG

25MG

10MG

10MG

20MG

20MG

25MG

25MG

2.5MG

20MG

A211022

A211022

A201452

A201452

A214618

A210435

A213885

A213885

A213885

A213885

A213885

A213885

A212414

A212414

A212414

A212414

A212414

A212414

A210480

A210480

A213912

A213912

A211846

A211846

A211846

A211846

A211846

A211846

A213405

A213405

A213405

A213405

A213405

A213405

A210154

A210154

005

006

005

006

001

005

001

002

003

004

005

006

001

002

003

004

005

006

005

006

005

006

005

001

002

003

006

004

001

001

003

003

002

002

005

006

Mar 07, 2023

Mar 07, 2023

Mar 06, 2023

Mar 06, 2023

Mar 06, 2023

Mar 06, 2023

Mar 06, 2023

Mar 06, 2023

Mar 06, 2023

Mar 06, 2023

Mar 06, 2023

Mar 06, 2023

May 11, 2023

May 11, 2023

May 11, 2023

May 11, 2023

May 11, 2023

May 11, 2023

Mar 06, 2023

Mar 06, 2023

Mar 06, 2023

Mar 06, 2023

Mar 06, 2023

Feb 08, 2023

Feb 08, 2023

Feb 08, 2023

Mar 06, 2023

Feb 08, 2023

Feb 17, 2023

Feb 17, 2023

Aug 03, 2023

Aug 03, 2023

Feb 17, 2023

Feb 17, 2023

Mar 06, 2023

Mar 06, 2023

Feb NEWA

Feb NEWA

Feb NEWA

Feb NEWA

Feb NEWA

Feb NEWA

Feb NEWA

Feb NEWA

Feb NEWA

Feb NEWA

Feb NEWA

Feb NEWA

May NEWA

May NEWA

May NEWA

May NEWA

May NEWA

May NEWA

Feb NEWA

Feb NEWA

Feb NEWA

Feb NEWA

Feb NEWA

Jan NEWA

Jan NEWA

Jan NEWA

Feb NEWA

Jan NEWA

Aug DISC

Feb NEWA

Aug DISC

Jul NEWA

Aug DISC

Feb NEWA

Feb NEWA

Feb NEWA

AB

AB

AB

AB

AB

+

+

+

+

+

BRISTOL MYERS SQUIBB 2.5MG

5MG

10MG

15MG

20MG

N021880

N021880

N021880

N021880

N021880

005

001

002

003

006

Dec 21, 2011

Dec 27, 2005

Dec 27, 2005

Jun 29, 2006

Jun 05, 2013

Sep CAHN

Sep CAHN

Sep CAHN

Sep CAHN

Sep CAHN
RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - December 2023 1-83

CAPSULE;ORAL

REVLIMID

AB +! 25MG N021880 004 Jun 29, 2006 Sep CAHN

LENIOLISIB PHOSPHATE

TABLET;ORAL

JOENJA

+! PHARMING EQ 70MG BASE N217759 001 Mar 24, 2023 Mar NEWA

LETROZOLE

TABLET;ORAL

LETROZOLE

>A>

>D>

AB

AB

@

CARNEGIE

CHARTWELL RX

DR REDDYS LABS LTD

2.5MG

2.5MG

2.5MG

A091191

A202716

A091191

001 Jun 03, 2011

001 May 16, 2013

001 Jun 03, 2011

Dec CAHN

Feb CAHN

Dec CAHN

LEUCOVORIN CALCIUM

INJECTABLE;INJECTION

LEUCOVORIN CALCIUM

AP

AP

AP

AP

AP

AP

AP

AP

AP

!

!

FRESENIUS KABI USA EQ 10MG BASE/ML

EQ 10MG BASE/ML

EQ 10MG BASE/ML

HAINAN POLY EQ 50MG BASE/VIAL

EQ 100MG BASE/VIAL

EQ 200MG BASE/VIAL

EQ 500MG BASE/VIAL

KINDOS EQ 50MG BASE/VIAL

EQ 100MG BASE/VIAL

EQ 200MG BASE/VIAL

EQ 350MG BASE/VIAL

EQ 500MG BASE/VIAL

@ TEVA PHARMS USA EQ 100MG BASE/VIAL

@ EQ 350MG BASE/VIAL

LEUCOVORIN CALCIUM PRESERVATIVE FREE

A207226

A207226

A207241

A217021

A217021

A217021

A217021

A216590

A216590

A216590

A216590

A216590

A081277

A040174

001 Jul 27, 2018

001 Jul 27, 2018

001 Mar 14, 2018

001 Jul 10, 2023

002 Jul 10, 2023

003 Jul 10, 2023

004 Jul 10, 2023

001 Jul 19, 2023

002 Jul 19, 2023

003 Jul 19, 2023

004 Jul 19, 2023

005 Jul 19, 2023

001 Sep 28, 1993

001 Jun 12, 1997

Apr CHRS

Apr CTEC

Apr CHRS

Jun NEWA

Jun NEWA

Jun NEWA

Jun NEWA

Jul NEWA

Jul NEWA

Jul NEWA

Jul NEWA

Jul NEWA

Nov DISC

Nov DISC

@ HIKMA EQ 10MG BASE/ML A040347 001 Apr 25, 2000 Apr DISC

LEUPROLIDE ACETATE

>A>

FOR SUSPENSION;INTRAMUSCULAR

LEUPROLIDE ACETATE FOR DEPOT SUSPENSION

>A>

>D>

+! INVAGEN PHARMS

LUTRATE DEPOT KIT

22.5MG/VIAL N205054 001 Aug 28, 2018 Dec CTNA

>D> +! INVAGEN PHARMS

INJECTABLE;INJECTION

LEUPROLIDE ACETATE

22.5MG/VIAL N205054 001 Aug 28, 2018 Dec CTNA

>D>

>A>

AP

AP

AP

AP

HONG KONG

MEITHEAL

RK PHARMA

LUPRON DEPOT

1MG/0.2ML

1MG/0.2ML

1MG/0.2ML

1MG/0.2ML

A075471

A075471

A075471

A213829

001 Oct 25, 2000

001 Oct 25, 2000

001 Oct 25, 2000

001 Aug 13, 2021

Dec CAHN

Sep CAHN

Dec CAHN

Jun CAHN

+! ABBVIE ENDOCRINE INC

+!

+

+!

+!

POWDER;INTRAMUSCULAR

LUPRON DEPOT-PED KIT

7.5MG

11.25MG

22.5MG

30MG

45MG

N019732

N020708

N020517

N020517

N020517

001 Jan 26, 1989

001 Mar 07, 1997

001 Dec 22, 1995

002 May 30, 1997

003 Jun 17, 2011

Jul CPOT

Jul CPOT

Jul CPOT

Jul CPOT

Jul CPOT

+! ABBVIE ENDOCRINE INC

POWDER;SUBCUTANEOUS

ELIGARD KIT

45MG N020263 009 Apr 14, 2023 Apr NEWA

+!

+!

+!

+!

TOLMAR 7.5MG

22.5MG

30MG

45MG

N021343

N021379

N021488

N021731

001 Jan 23, 2002

001 Jul 24, 2002

001 Feb 13, 2003

001 Dec 14, 2004

Feb CAHN

Feb CAHN

Feb CAHN

Feb CAHN

LEVALBUTEROL HYDROCHLORIDE

SOLUTION;INHALATION

XOPENEX

AN

AN

AN

AN

+!

+!

+!

+!

HIKMA EQ 0.0103% BASE

EQ 0.021% BASE

EQ 0.042% BASE

EQ 0.25% BASE

N020837

N020837

N020837

N020837

003 Jan 30, 2002

001 Mar 25, 1999

002 Mar 25, 1999

004 Jul 18, 2003

Sep CAHN

Sep CAHN

Sep CAHN

Sep CAHN
RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - December 2023 1-84

LEVAMLODIPINE MALEATE

TABLET;ORAL

CONJUPRI

+

+

@

@

CSPC OUYI EQ 2.5MG BASE

EQ 5MG BASE

N212895

N212895

002

003

Dec 19, 2019

Dec 19, 2019

Sep DISC

Sep DISC

LEVETIRACETAM

INJECTABLE;INTRAVENOUS

LEVETIRACETAM

AP

AP

AP

BAXTER HLTHCARE CORP 500MG/100ML (5MG/ML)

1GM/100ML (10MG/ML)

1.5GM/100ML (15MG/ML)

LEVETIRACETAM IN SODIUM CHLORIDE

A217059

A217059

A217059

001

002

003

Oct 02, 2023

Oct 02, 2023

Oct 02, 2023

Sep NEWA

Sep NEWA

Sep NEWA

AP

AP

FRESENIUS KABI USA

SOLUTION;ORAL

LEVETIRACETAM

500MG/100ML (5MG/ML)

1.5GM/100ML (15MG/ML)

A208619

A208619

001

003

Jan 31, 2023

Jan 31, 2023

Jan NEWA

Jan NEWA

AA

AA

AA

AA

AA

AA

ALEMBIC

BIONPHARMA

@ PHARMOBEDIENT CNSLTG

QUAGEN

SCIEGEN PHARMS INC

STRIDES PHARMA

@ XTTRIUM LABS INC

TABLET;ORAL

LEVETIRACETAM

100MG/ML

100MG/ML

100MG/ML

100MG/ML

100MG/ML

100MG/ML

100MG/ML

100MG/ML

A203067

A079120

A090028

A090079

A090079

A090079

A214673

A090028

001

001

001

001

001

001

001

001

May 09, 2013

Jan 16, 2009

Mar 03, 2010

Apr 11, 2012

Apr 11, 2012

Apr 11, 2012

Nov 20, 2023

Mar 03, 2010

Feb CAHN

Jun CAHN

Sep CAHN

Oct CAHN

Feb CAHN

Sep CAHN

Nov NEWA

Mar CAHN

>A>

>A>

>A>

>A>

>D>

>D>

>D>

>D>

AB

AB

AB

AB

AB

AB

AB

AB

AB

AB

AB

AB

GRANULES 250MG

500MG

750MG

1GM

@ MYLAN 250MG

RISING 250MG

500MG

750MG

1GM

VKT PHARMA 250MG

500MG

750MG

1GM

TABLET, EXTENDED RELEASE;ORAL

ELEPSIA XR

A217878

A217878

A217878

A217878

A076919

A090767

A090767

A090767

A090767

A090767

A090767

A090767

A090767

001

002

003

004

001

001

002

003

004

001

002

003

004

Jun 13, 2023

Jun 13, 2023

Jun 13, 2023

Jun 13, 2023

Nov 04, 2008

Jul 28, 2010

Jul 28, 2010

Jul 28, 2010

Jul 28, 2010

Jul 28, 2010

Jul 28, 2010

Jul 28, 2010

Jul 28, 2010

Jun NEWA

Jun NEWA

Jun NEWA

Jun NEWA

Apr DISC

Dec CAHN

Dec CAHN

Dec CAHN

Dec CAHN

Dec CAHN

Dec CAHN

Dec CAHN

Dec CAHN

+

+

@ TRIPOINT

@

LEVETIRACETAM

1GM

1.5GM

N204417

N204417

001

002

Dec 20, 2018

Dec 20, 2018

Sep DISC

Sep DISC

AB

@ AUROBINDO PHARMA USA

@

@

@ CHARTWELL RX

@

OVERSEAS

@ SUN PHARM

@

500MG

750MG

1GM

500MG

750MG

500MG

500MG

750MG

A200475

A200475

A200475

A091291

A091291

A212688

A203059

A203059

001

002

003

001

002

002

001

002

Dec 19, 2011

Dec 19, 2011

Dec 07, 2015

Sep 12, 2011

Sep 12, 2011

May 05, 2023

Sep 09, 2013

Sep 09, 2013

Apr CAHN

Apr CAHN

Apr CAHN

Sep CAHN

Sep CAHN

Apr NEWA

Aug DISC

Aug DISC

LEVOBUNOLOL HYDROCHLORIDE

SOLUTION/DROPS;OPHTHALMIC

AKBETA

@ EPIC PHARMA LLC 0.25% A074779 001 Oct 29, 1996 Oct CAHN

LEVOFLOXACIN

SOLUTION;ORAL

LEVOFLOXACIN

AA ! NOVITIUM PHARMA

SOLUTION/DROPS;OPHTHALMIC

LEVOFLOXACIN

250MG/10ML A091678 001 Jun 20, 2011 Aug CAHN

@ AKORN

! RISING

0.5%

0.5%

A090268

A077700

001

001

Dec 20, 2010

Dec 20, 2010

Jan DISC

Jan CTEC
RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 

LEVOLEUCOVORIN

POWDER;INTRAVENOUS

KHAPZORY

+ @ ACROTECH BIOPHARMA 300MG/VIAL

LEVOLEUCOVORIN CALCIUM

SOLUTION;INTRAVENOUS

LEVOLEUCOVORIN CALCIUM

@ AILEX PHARMS LLC EQ 175MG BASE/17.5ML (EQ 10MG

BASE/ML)

AP ! GLAND PHARMA LTD EQ 250MG BASE/25ML (EQ 10MG

BASE/ML)

AP HAINAN POLY PHARM EQ 175MG BASE/17.5ML (EQ 10MG

BASE/ML)

AP EQ 250MG BASE/25ML (EQ 10MG

BASE/ML)

LEVOMILNACIPRAN HYDROCHLORIDE

CAPSULE, EXTENDED RELEASE;ORAL

FETZIMA

+ ABBVIE EQ 20MG BASE

AB + EQ 20MG BASE

+ EQ 40MG BASE

AB + EQ 40MG BASE

+ EQ 80MG BASE

AB + EQ 80MG BASE

+! EQ 120MG BASE

AB +! EQ 120MG BASE

LEVOMILNACIPRAN HYDROCHLORIDE

@ AUROBINDO PHARMA LTD EQ 20MG BASE

@ EQ 40MG BASE

@ EQ 80MG BASE

@ EQ 120MG BASE

AB PRINSTON INC EQ 20MG BASE

AB EQ 40MG BASE

AB EQ 80MG BASE

AB EQ 120MG BASE

LEVONORDEFRIN; MEPIVACAINE HYDROCHLORIDE

INJECTABLE;INJECTION

SCANDONEST L

@ DEPROCO 0.05MG/ML;2%

LEVORPHANOL TARTRATE

TABLET;ORAL

LEVORPHANOL TARTRATE

AB HIKMA 2MG

AB ! NOVITIUM PHARMA 3MG

AB SUN PHARM INDS INC 3MG

LEVOTHYROXINE SODIUM

CAPSULE;ORAL

LEVOTHYROXINE SODIUM

@ TEVA PHARMS USA INC 0.137MG

AB 0.137MG

@ 0.175MG

AB 0.175MG

@ 0.2MG

TIROSINT

+ IBSA 0.013MG

+ 0.025MG

+ 0.0375MG

+ 0.044MG

+ 0.05MG

+ 0.0625MG

+ 0.075MG

+ 0.088MG

+ 0.1MG

+ 0.112MG

+ 0.125MG

+ 0.137MG

+ 0.15MG

- December 

N211226

A213797

A210892

A217314

A217314

N204168

N204168

N204168

N204168

N204168

N204168

N204168

N204168

A210826

A210826

A210826

A210826

A210771

A210771

A210771

A210771

A088388

A074278

A213479

A213906

A211369

A211369

A211369

A211369

A211369

N021924

N021924

N021924

N021924

N021924

N021924

N021924

N021924

N021924

N021924

N021924

N021924

N021924

2023

002

001

002

001

002

001

001

002

002

003

003

004

004

001

002

003

004

001

002

003

004

001

001

002

002

005

005

006

006

004

013

002

014

015

003

016

004

010

005

008

006

009

007

Oct 19, 2018

Nov 02, 2021

Sep 14, 2018

May 22, 2023

May 22, 2023

Jul 25, 2013

Jul 25, 2013

Jul 25, 2013

Jul 25, 2013

Jul 25, 2013

Jul 25, 2013

Jul 25, 2013

Jul 25, 2013

Jan 06, 2023

Jan 06, 2023

Jan 06, 2023

Jan 06, 2023

Mar 20, 2023

Mar 20, 2023

Mar 20, 2023

Mar 20, 2023

Oct 10, 1984

Mar 31, 2000

Jan 12, 2021

Apr 25, 2023

May 02, 2023

May 02, 2023

May 02, 2023

May 02, 2023

Nov 09, 2022

Aug 01, 2007

Oct 13, 2006

Jun 22, 2022

Jun 22, 2022

Oct 13, 2006

Jun 22, 2022

Oct 13, 2006

Oct 02, 2009

Oct 13, 2006

Oct 02, 2009

Oct 13, 2006

Oct 02, 2009

Oct 13, 2006

1-85

Aug DISC

Sep CAHN

May CTEC

May NEWA

May NEWA

Mar CTEC

Jan CAHN

Mar CTEC

Jan CAHN

Mar CTEC

Jan CAHN

Mar CTEC

Jan CAHN

Mar DISC

Mar DISC

Mar DISC

Mar DISC

Mar NEWA

Mar NEWA

Mar NEWA

Mar NEWA

Sep DISC

Jan CMFD

Apr CTEC

Apr NEWA

May DISC

Apr NFTG

May DISC

Apr NFTG

May DISC

Aug CAHN

Aug CAHN

Aug CAHN

Aug CAHN

Aug CAHN

Aug CAHN

Aug CAHN

Aug CAHN

Aug CAHN

Aug CAHN

Aug CAHN

Aug CAHN

Aug CAHN
RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - December 2023 1-86

CAPSULE;ORAL

TIROSINT

+ 0.175MG N021924 011 Apr 25, 2017 Aug CAHN

+! 0.2MG N021924 012 Apr 25, 2017 Aug CAHN

+ INSTITUT BIOCHIMIQUE 0.137MG N021924 009 Oct 02, 2009 May CTEC

AB + 0.137MG N021924 009 Oct 02, 2009 Apr CFTG

+ 0.175MG N021924 011 Apr 25, 2017 May CTEC

AB + 0.175MG N021924 011 Apr 25, 2017 Apr CFTG

+! 0.2MG N021924 012 Apr 25, 2017 May CTEC

POWDER;INTRAVENOUS

LEVOTHYROXINE SODIUM

AP ZYDUS PHARMS 100MCG/VIAL A217066 001 Mar 24, 2023 Mar NEWA

AP 200MCG/VIAL A217066 002 Mar 24, 2023 Mar NEWA

AP 500MCG/VIAL A217066 003 Mar 24, 2023 Mar NEWA

SOLUTION;ORAL

TIROSINT-SOL

+ IBSA 13MCG/ML N206977 001 Dec 15, 2016 Aug CAHN

+ 25MCG/ML N206977 002 Dec 15, 2016 Aug CAHN

+ 37.5MCG/ML N206977 013 Jan 13, 2021 Aug CAHN

+ 44MCG/ML N206977 014 Jan 13, 2021 Aug CAHN

+ 50MCG/ML N206977 003 Dec 15, 2016 Aug CAHN

+ 62.5MCG/ML N206977 015 Jan 13, 2021 Aug CAHN

+ 75MCG/ML N206977 004 Dec 15, 2016 Aug CAHN

+ 88MCG/ML N206977 005 Dec 15, 2016 Aug CAHN

+ 100MCG/ML N206977 006 Dec 15, 2016 Aug CAHN

+ 112MCG/ML N206977 007 Dec 15, 2016 Aug CAHN

+ 125MCG/ML N206977 008 Dec 15, 2016 Aug CAHN

+ 137MCG/ML N206977 009 Dec 15, 2016 Aug CAHN

+ 150MCG/ML N206977 010 Dec 15, 2016 Aug CAHN

+ 175MCG/ML N206977 011 Dec 15, 2016 Aug CAHN

+! 200MCG/ML N206977 012 Dec 15, 2016 Aug CAHN

LEVOTHYROXINE SODIUM **

**See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium

TABLET;ORAL

LEVOTHYROXINE SODIUM

AB4 ASCENT PHARMS INC 0.025MG A215259 001 Jan 18, 2023 Jan NEWA

AB4 0.05MG A215259 002 Jan 18, 2023 Jan NEWA

AB4 0.075MG A215259 003 Jan 18, 2023 Jan NEWA

AB4 0.088MG A215259 004 Jan 18, 2023 Jan NEWA

AB4 0.1MG A215259 005 Jan 18, 2023 Jan NEWA

AB4 0.112MG A215259 006 Jan 18, 2023 Jan NEWA

AB4 0.125MG A215259 007 Jan 18, 2023 Jan NEWA

AB4 0.137MG A215259 008 Jan 18, 2023 Jan NEWA

AB4 0.15MG A215259 009 Jan 18, 2023 Jan NEWA

AB4 0.175MG A215259 010 Jan 18, 2023 Jan NEWA

AB4 0.2MG A215259 011 Jan 18, 2023 Jan NEWA

AB4 0.3MG A215259 012 Jan 18, 2023 Jan NEWA

AB2 MACLEODS PHARMS LTD 0.025MG A211417 001 Dec 21, 2022 Jan CTEC

AB2 0.05MG A211417 002 Dec 21, 2022 Jan CTEC

AB2 0.075MG A211417 003 Dec 21, 2022 Jan CTEC

AB2 0.088MG A211417 004 Dec 21, 2022 Jan CTEC

AB2 0.1MG A211417 005 Dec 21, 2022 Jan CTEC

AB2 0.112MG A211417 006 Dec 21, 2022 Jan CTEC

AB2 0.125MG A211417 007 Dec 21, 2022 Jan CTEC

AB2 0.137MG A211417 008 Dec 21, 2022 Jan CTEC

AB2 0.15MG A211417 009 Dec 21, 2022 Jan CTEC

AB2 0.175MG A211417 010 Dec 21, 2022 Jan CTEC

AB2 0.2MG A211417 011 Dec 21, 2022 Jan CTEC

AB2 0.3MG A211417 012 Dec 21, 2022 Jan CTEC

LIDOCAINE

OINTMENT;TOPICAL

LIDOCAINE

@ AILEX PHARMS LLC 5% A212486 001 Oct 17, 2019 Sep CAHN

>D> @ PAI HOLDINGS PHARM 5% A205318 001 Feb 01, 2016 Dec CAHN

@ 5% A205318 001 Feb 01, 2016 May DISC

>A> @ VERTICE 5% A205318 001 Feb 01, 2016 Dec CAHN

@ VITRUVIAS THERAP 5% A208822 001 Sep 25, 2017 Oct DISC

PATCH;TOPICAL

LIDOCAINE

AB IBSA 5% A209190 001 Apr 30, 2020 Aug CAHN

AB INST BIOCHIMIQUE SA 5% A209190 001 Apr 30, 2020 Apr CAHN
RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - December 2023 1-87

LIDOCAINE HYDROCHLORIDE

INJECTABLE;INJECTION

LIDOCAINE HYDROCHLORIDE

>A> AP

AP

AP

AP

AP

AP

AP

AP

AP

ASPIRO

+! HOSPIRA

+!

HUONS

MANKIND PHARMA

JELLY;TOPICAL

GLYDO

2%

1%

2%

2%

1%

1%

1%

2%

2%

A214336

A083158

A083158

A212821

A217692

A217692

A217693

A217692

A217693

002

001

002

002

001

003

001

002

002

Dec 13, 2023

Jun 15, 2023

Jun 16, 2023

Nov 29, 2023

Jul 11, 2023

Jun 16, 2023

Jul 11, 2023

Dec NEWA

Aug CRLD

Aug CRLD

Jun NEWA

Jun NEWA

Nov NEWA

Jun NEWA

Jun NEWA

Jun NEWA

AT ! SAGENT PHARMS INC

LIDOCAINE HYDROCHLORIDE

2% A201094 001 Apr 28, 2014 Apr CHRS

AT

AT

AKORN

SENTISS

XYLOCAINE

2%

2%

A040433

A040433

001

001

Feb 12, 2003

Feb 12, 2003

Apr CHRS

Aug CAHN

+ @ EPIC PHARMA LLC

SOLUTION;ORAL

LIDOCAINE HYDROCHLORIDE

2% N008816 001 Sep CAHN

AT

AT

!

@ HIKMA 2%

RUBICON 2%

2%

LIDOCAINE HYDROCHLORIDE VISCOUS

A040014

A216780

A216780

001

001

001

Jul 10, 1995

Mar 28, 2023

Mar 28, 2023

Nov DISC

Nov CHRS

Mar NEWA

AT CHARTWELL MOLECULAR

SOLUTION;TOPICAL

LIDOCAINE HYDROCHLORIDE

2% A040708 001 Feb 27, 2007 Jul CAHN

>A> AT TARO 4% A218182 001 Dec 07, 2023 Dec NEWA

LIDOCAINE; PRILOCAINE

CREAM;TOPICAL

LIDOCAINE AND PRILOCAINE

AB

AB

!

@

FOUGERA PHARMS

HIKMA

PAI HOLDINGS PHARM

2.5%;2.5%

2.5%;2.5%

2.5%;2.5%

A076453

A076290

A205887

001

001

001

Aug 18, 2003

Sep 25, 2003

Jun 29, 2018

Oct CHRS

Oct CHRS

May DISC

LIDOCAINE; TETRACAINE

CREAM;TOPICAL

PLIAGLIS

+ @ TARO 7%;7% N021717 001 Jun 29, 2006 Aug DISC

LIFITEGRAST

SOLUTION/DROPS;OPHTHALMIC

LIFITEGRAST

AB EUGIA PHARMA 5% A215063 001 Nov 07, 2023 Oct NEWA

LINACLOTIDE

CAPSULE;ORAL

LINACLOTIDE

AB

AB

@ AUROBINDO PHARMA

@

LINZESS

145MCG

145MCG

290MCG

290MCG

A209611

A209611

A209611

A209611

001

001

002

002

Feb 07, 2023

Feb 07, 2023

Feb 07, 2023

Feb 07, 2023

Mar DISC

Jan NEWA

Mar DISC

Jan NEWA

AB

AB

+!

+

+!

+

ABBVIE

ALLERGAN

145MCG

290MCG

145MCG

290MCG

N202811

N202811

N202811

N202811

001

002

001

002

Aug 30, 2012

Aug 30, 2012

Aug 30, 2012

Aug 30, 2012

Mar CTEC

Mar CTEC

Jan CTEC

Jan CTEC

LINAGLIPTIN

TABLET;ORAL

LINAGLIPTIN

AB

@ ZYDUS PHARMS 5MG

5MG

A208448

A208448

001

001

Mar 30, 2023

Mar 30, 2023

Jul DISC

Mar NEWA
RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - December 2023 1-88

LINAGLIPTIN; METFORMIN HYDROCHLORIDE

TABLET;ORAL

LINAGLIPTIN AND METFORMIN HYDROCHLORIDE

AB

AB

AB

@

@

@

ZYDUS PHARMS 2.5MG;500MG

2.5MG;500MG

2.5MG;850MG

2.5MG;850MG

2.5MG;1GM

2.5MG;1GM

A208449

A208449

A208449

A208449

A208449

A208449

001

001

002

002

003

003

Mar 30, 2023

Mar 30, 2023

Mar 30, 2023

Mar 30, 2023

Mar 30, 2023

Mar 30, 2023

Jul DISC

Mar NEWA

Jul DISC

Mar NEWA

Jul DISC

Mar NEWA

LINCOMYCIN HYDROCHLORIDE

INJECTABLE;INJECTION

LINCOMYCIN HYDROCHLORIDE

@

@

@

@

GENEYORK PHARMS

HAINAN POLY

PRAXGEN PHARMS

SLATE RUN PHARMA

EQ 300MG BASE/ML

EQ 300MG BASE/ML

EQ 300MG BASE/ML

EQ 300MG BASE/ML

A212770

A216662

A212770

A216662

001

001

001

001

Mar 12, 2021

Dec 21, 2022

Mar 12, 2021

Dec 21, 2022

Sep CAHN

Jun DISC

Jul CAHN

Sep CAHN

LINEZOLID

SOLUTION;INTRAVENOUS

LINEZOLID

AP HIKMA

TABLET;ORAL

LINEZOLID

600MG/300ML (2MG/ML) A206454 001 Aug 22, 2022 Sep CAHN

>D>

>A>

AB

AB

CHARTWELL RX

@ RISING

600MG

600MG

600MG

A210702

A078845

A078845

001

001

001

Apr 25, 2019

Dec 21, 2015

Dec 21, 2015

Mar CAHN

Dec CMFD

Dec CMFD

LIOTHYRONINE SODIUM

INJECTABLE;INJECTION

LIOTHYRONINE SODIUM

! XGEN PHARMS

TRIOSTAT

EQ 0.01MG BASE/ML

EQ 0.01MG BASE/ML

A076923

A076923

001

001

Aug 17, 2005

Aug 17, 2005

Jun CHRS

Jun CTEC

+ @ PAR STERILE PRODUCTS EQ 0.01MG BASE/ML N020105 001 Dec 31, 1991 Jun DISC

LISDEXAMFETAMINE DIMESYLATE

CAPSULE;ORAL

LISDEXAMFETAMINE DIMESYLATE

AB

AB

AB

AB

AB

AB

AB

AB

AB

AB

AB

AB

AB

AB

AB

AB

AB

AB

AB

AB

AB

AB

AB

AB

AB

AB

AB

AB

AB

AB

AB

AB

AB

ACTAVIS ELIZABETH

ALKEM LABS LTD

AMNEAL

APOTEX

ASCENT PHARMS INC

10MG

20MG

30MG

40MG

50MG

60MG

70MG

10MG

20MG

30MG

40MG

50MG

60MG

70MG

20MG

30MG

40MG

50MG

60MG

70MG

10MG

20MG

30MG

40MG

50MG

60MG

70MG

10MG

20MG

30MG

40MG

50MG

60MG

A202802

A202802

A202802

A202802

A202802

A202802

A202802

A217194

A217194

A217194

A217194

A217194

A217194

A217194

A202830

A202830

A202830

A202830

A202830

A202830

A216944

A216944

A216944

A216944

A216944

A216944

A216944

A217442

A217442

A217442

A217442

A217442

A217442

001

002

003

004

005

006

007

001

002

003

004

005

006

007

001

002

003

004

005

006

001

002

003

004

005

006

007

001

002

003

004

005

006

Aug 25, 2023

Aug 25, 2023

Aug 25, 2023

Aug 25, 2023

Aug 25, 2023

Aug 25, 2023

Aug 25, 2023

Aug 25, 2023

Aug 25, 2023

Aug 25, 2023

Aug 25, 2023

Aug 25, 2023

Aug 25, 2023

Aug 25, 2023

Aug 25, 2023

Aug 25, 2023

Aug 25, 2023

Aug 25, 2023

Aug 25, 2023

Aug 25, 2023

Aug 25, 2023

Aug 25, 2023

Aug 25, 2023

Aug 25, 2023

Aug 25, 2023

Aug 25, 2023

Aug 25, 2023

Aug 25, 2023

Aug 25, 2023

Aug 25, 2023

Aug 25, 2023

Aug 25, 2023

Aug 25, 2023

Aug NFTG

Aug NFTG

Aug NFTG

Aug NFTG

Aug NFTG

Aug NFTG

Aug NFTG

Aug NFTG

Aug NFTG

Aug NFTG

Aug NFTG

Aug NFTG

Aug NFTG

Aug NFTG

Aug NFTG

Aug NFTG

Aug NFTG

Aug NFTG

Aug NFTG

Aug NFTG

Aug NFTG

Aug NFTG

Aug NFTG

Aug NFTG

Aug NFTG

Aug NFTG

Aug NFTG

Aug NFTG

Aug NFTG

Aug NFTG

Aug NFTG

Aug NFTG

Aug NFTG
RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - December 2023 1-89

CAPSULE;ORAL

LISDEXAMFETAMINE DIMESYLATE

AB 70MG A217442 007 Aug 25, 2023 Aug NFTG

AB HIKMA 20MG A202827 001 Aug 25, 2023 Aug NFTG

AB 30MG A202827 002 Aug 25, 2023 Aug NFTG

AB 40MG A202827 003 Aug 25, 2023 Aug NFTG

AB 50MG A202827 004 Aug 25, 2023 Aug NFTG

AB 60MG A202827 005 Aug 25, 2023 Aug NFTG

AB 70MG A202827 006 Aug 25, 2023 Aug NFTG

AB LANNETT CO INC 10MG A215802 001 Aug 25, 2023 Aug NFTG

AB 20MG A215802 002 Aug 25, 2023 Aug NFTG

AB 30MG A215802 003 Aug 25, 2023 Aug NFTG

AB 40MG A215802 004 Aug 25, 2023 Aug NFTG

AB 50MG A215802 005 Aug 25, 2023 Aug NFTG

AB 60MG A215802 006 Aug 25, 2023 Aug NFTG

AB 70MG A215802 007 Aug 25, 2023 Aug NFTG

AB MYLAN 10MG A202835 001 Aug 25, 2023 Aug NFTG

AB 20MG A202835 002 Aug 25, 2023 Aug NFTG

AB 30MG A202835 003 Aug 25, 2023 Aug NFTG

AB 40MG A202835 004 Aug 25, 2023 Aug NFTG

AB 50MG A202835 005 Aug 25, 2023 Aug NFTG

AB 60MG A202835 006 Aug 25, 2023 Aug NFTG

AB 70MG A202835 007 Aug 25, 2023 Aug NFTG

AB NORWICH 10MG A214547 001 Aug 25, 2023 Aug NFTG

AB 20MG A214547 002 Aug 25, 2023 Aug NFTG

AB 30MG A214547 003 Aug 25, 2023 Aug NFTG

AB 40MG A214547 004 Aug 25, 2023 Aug NFTG

AB 50MG A214547 005 Aug 25, 2023 Aug NFTG

AB 60MG A214547 006 Aug 25, 2023 Aug NFTG

AB 70MG A214547 007 Aug 25, 2023 Aug NFTG

AB PRINSTON INC 10MG A216266 001 Aug 25, 2023 Aug NFTG

AB 20MG A216266 002 Aug 25, 2023 Aug NFTG

AB 30MG A216266 003 Aug 25, 2023 Aug NFTG

AB 40MG A216266 004 Aug 25, 2023 Aug NFTG

AB 50MG A216266 005 Aug 25, 2023 Aug NFTG

AB 60MG A216266 006 Aug 25, 2023 Aug NFTG

AB 70MG A216266 007 Aug 25, 2023 Aug NFTG

AB RHODES PHARMS 10MG A215330 001 Aug 25, 2023 Aug NFTG

AB 20MG A215330 002 Aug 25, 2023 Aug NFTG

AB 30MG A215330 003 Aug 25, 2023 Aug NFTG

AB 40MG A215330 004 Aug 25, 2023 Aug NFTG

AB 50MG A215330 005 Aug 25, 2023 Aug NFTG

AB 60MG A215330 006 Aug 25, 2023 Aug NFTG

AB 70MG A215330 007 Aug 25, 2023 Aug NFTG

AB SPECGX LLC 10MG A211840 001 Aug 25, 2023 Aug NFTG

AB 20MG A211840 002 Aug 25, 2023 Aug NFTG

AB 30MG A211840 003 Aug 25, 2023 Aug NFTG

AB 40MG A211840 004 Aug 25, 2023 Aug NFTG

AB 50MG A211840 005 Aug 25, 2023 Aug NFTG

AB 60MG A211840 006 Aug 25, 2023 Aug NFTG

AB 70MG A211840 007 Aug 25, 2023 Aug NFTG

AB SUN PHARM INDS INC 10MG A214484 001 Aug 25, 2023 Aug NFTG

AB 20MG A214484 002 Aug 25, 2023 Aug NFTG

AB 30MG A214484 003 Aug 25, 2023 Aug NFTG

AB 40MG A214484 004 Aug 25, 2023 Aug NFTG

AB 50MG A214484 005 Aug 25, 2023 Aug NFTG

AB 60MG A214484 006 Aug 25, 2023 Aug NFTG

AB 70MG A214484 007 Aug 25, 2023 Aug NFTG

VYVANSE

AB + TAKEDA PHARMS USA 10MG N021977 007 Oct 30, 2014 Aug CFTG

AB + 20MG N021977 004 Dec 10, 2007 Aug CFTG

AB + 30MG N021977 001 Feb 23, 2007 Aug CFTG

AB + 40MG N021977 005 Dec 10, 2007 Aug CFTG

AB + 50MG N021977 002 Feb 23, 2007 Aug CFTG

AB + 60MG N021977 006 Dec 10, 2007 Aug CFTG

AB +! 70MG N021977 003 Feb 23, 2007 Aug CFTG

TABLET, CHEWABLE;ORAL

LISDEXAMFETAMINE DIMESYLATE

AB ASCENT PHARMS INC 10MG A217068 001 Aug 25, 2023 Aug NFTG

AB 20MG A217068 002 Aug 25, 2023 Aug NFTG

AB 30MG A217068 003 Aug 25, 2023 Aug NFTG

AB 40MG A217068 004 Aug 25, 2023 Aug NFTG

AB 50MG A217068 005 Aug 25, 2023 Aug NFTG

AB 60MG A217068 006 Aug 25, 2023 Aug NFTG
RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - December 2023 1-90

TABLET, CHEWABLE;ORAL

LISDEXAMFETAMINE DIMESYLATE

AB

AB

AB

AB

AB

AB

AB

AB

AB

AB

AB

AB

SUN PHARM INDS INC

TEVA PHARMS

VYVANSE

10MG

20MG

30MG

40MG

50MG

60MG

10MG

20MG

30MG

40MG

50MG

60MG

A214134

A214134

A214134

A214134

A214134

A214134

A215415

A215415

A215415

A215415

A215415

A215415

001

002

003

004

005

006

001

002

003

004

005

006

Aug 25, 2023

Aug 25, 2023

Aug 25, 2023

Aug 25, 2023

Aug 25, 2023

Aug 25, 2023

Aug 25, 2023

Aug 25, 2023

Aug 25, 2023

Aug 25, 2023

Aug 25, 2023

Aug 25, 2023

Aug NFTG

Aug NFTG

Aug NFTG

Aug NFTG

Aug NFTG

Aug NFTG

Aug NFTG

Aug NFTG

Aug NFTG

Aug NFTG

Aug NFTG

Aug NFTG

AB

AB

AB

AB

AB

AB

+

+

+

+

+

+!

TAKEDA PHARMS USA 10MG

20MG

30MG

40MG

50MG

60MG

N208510

N208510

N208510

N208510

N208510

N208510

001

002

003

004

005

006

Jan 28, 2017

Jan 28, 2017

Jan 28, 2017

Jan 28, 2017

Jan 28, 2017

Jan 28, 2017

Aug CFTG

Aug CFTG

Aug CFTG

Aug CFTG

Aug CFTG

Aug CFTG

LISINOPRIL

TABLET;ORAL

LISINOPRIL

AB

AB

AB

AB

AB

AB

AB

AB

AB

AB

AB

AB

@ HERITAGE PHARMA

@

@

@

@

@

@ RISING

@

@

@

@

@

SCIEGEN PHARMS INC

ZESTRIL

2.5MG

2.5MG

5MG

5MG

10MG

10MG

20MG

20MG

30MG

30MG

40MG

40MG

2.5MG

5MG

10MG

20MG

30MG

40MG

2.5MG

5MG

10MG

20MG

30MG

40MG

A075752

A075752

A075752

A075752

A075752

A075752

A075752

A075752

A075752

A075752

A075752

A075752

A075999

A075999

A075999

A075999

A075999

A075999

A212041

A212041

A212041

A208920

A208920

A208920

001

001

002

002

003

003

004

004

005

005

006

006

001

002

003

004

005

006

001

002

003

001

002

003

Jul 01, 2002

Jul 01, 2002

Jul 01, 2002

Jul 01, 2002

Jul 01, 2002

Jul 01, 2002

Jul 01, 2002

Jul 01, 2002

Jul 01, 2002

Jul 01, 2002

Jul 01, 2002

Jul 01, 2002

Jul 01, 2002

Jul 01, 2002

Jul 01, 2002

Jul 01, 2002

Jul 01, 2002

Jul 01, 2002

Sep 15, 2020

Sep 15, 2020

Sep 15, 2020

Mar 04, 2021

Mar 04, 2021

Mar 04, 2021

Aug DISC

Mar CMFD

Aug DISC

Mar CMFD

Aug DISC

Mar CMFD

Aug DISC

Mar CMFD

Aug DISC

Mar CMFD

Aug DISC

Mar CMFD

Aug CAHN

Aug CAHN

Aug CAHN

Aug CAHN

Aug CAHN

Aug CAHN

Nov CAHN

Nov CAHN

Nov CAHN

Nov CAHN

Nov CAHN

Nov CAHN

AB

AB

AB

AB

AB

AB

+

+

+

+

+

+!

TWI PHARMS 2.5MG

5MG

10MG

20MG

30MG

40MG

N019777

N019777

N019777

N019777

N019777

N019777

005

001

002

003

006

004

Apr 29, 1993

May 19, 1988

May 19, 1988

May 19, 1988

Jan 20, 1999

May 19, 1988

Nov CAHN

Nov CAHN

Nov CAHN

Nov CAHN

Nov CAHN

Nov CAHN

LITHIUM CITRATE

SYRUP;ORAL

LITHIUM CITRATE

AA

AA

! PAI HOLDINGS PHARM

RUBICON

EQ 300MG CARBONATE/5ML

EQ 300MG CARBONATE/5ML

A070755

A218036

001

001

May 21, 1986

Aug 14, 2023

Aug CTEC

Aug NEWA

LOPERAMIDE HYDROCHLORIDE

CAPSULE;ORAL

LOPERAMIDE HYDROCHLORIDE

AB

AB

AB

AB

AB

AUROBINDO PHARMA LTD

JUBILANT CADISTA

RUBICON

ZYDUS LIFESCIENCES

ZYDUS PHARMS

2MG

2MG

2MG

2MG

2MG

A218122

A217840

A216876

A217471

A217471

001

001

001

001

001

Sep 05, 2023

Jul 05, 2023

Jan 26, 2023

Mar 23, 2023

Mar 23, 2023

Aug NEWA

Jun NEWA

Jan NEWA

Apr CAHN

Mar NEWA
RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 -

LORAZEPAM

TABLET;ORAL

LORAZEPAM

@ AMNEAL PHARMS 0.5MG

@ 1MG

@ 2MG

AB SUN PHARM INDS LTD 0.5MG

AB 1MG

AB 2MG

LOSARTAN POTASSIUM

TABLET;ORAL

LOSARTAN POTASSIUM

AB GRANULES 25MG

AB 50MG

AB 100MG

AB MSN 25MG

AB 50MG

AB 100MG

LOTEPREDNOL ETABONATE

GEL;OPHTHALMIC

LOTEPREDNOL ETABONATE

AB SENTISS 0.5%

AB SLAYBACK PHARMA LLC 0.5%

AB SUN PHARM 0.5%

SUSPENSION/DROPS;OPHTHALMIC

ALREX

AB +! BAUSCH AND LOMB 0.2%

LOTEPREDNOL ETABONATE

AB AKORN 0.2%

>A> AB LUPIN LTD 0.2%

AB SENTISS 0.2%

AB 0.5%

LOTILANER

SOLUTION/DROPS;OPHTHALMIC

XDEMVY

+! TARSUS 0.25%

LOVASTATIN

TABLET;ORAL

LOVASTATIN

@ AUROBINDO PHARMA USA 10MG

@ 10MG

@ 20MG

@ 20MG

@ 40MG

@ 40MG

LUBIPROSTONE

CAPSULE;ORAL

LUBIPROSTONE

AB AMNEAL 8MCG

AB 24MCG

AB ZYDUS PHARMS 8MCG

AB 24MCG

LUCINACTANT

SUSPENSION;INTRATRACHEAL

SURFAXIN

>A> @ LEES PHARM HK 8.5ML

>D> @ WINDTREE THERAP 8.5ML

LUMASIRAN SODIUM

SOLUTION;SUBCUTANEOUS

OXLUMO

+! ALNYLAM PHARMS INC EQ 94.5MG BASE/0.5ML (EQ 94.5MG

BASE/0.5ML)

December 

A078826

A078826

A078826

A076045

A076045

A076045

A215959

A215959

A215959

A217396

A217396

A217396

A212080

A213956

A215384

N020803

A215933

A215550

A215933

A207609

N217603

A075451

A075935

A075451

A075935

A075451

A075935

A209450

A209450

A214131

A214131

N021746

N021746

N214103

2023

001

002

003

001

002

003

001

002

003

001

002

003

001

001

001

001

001

001

001

001

001

001

001

002

002

003

003

001

002

001

002

001

001

001

Jun 23, 2010

Jun 23, 2010

Jun 23, 2010

Aug 29, 2001

Aug 29, 2001

Aug 29, 2001

Feb 23, 2023

Feb 23, 2023

Feb 23, 2023

Aug 14, 2023

Aug 14, 2023

Aug 14, 2023

Feb 10, 2021

Nov 29, 2023

Aug 09, 2023

Mar 09, 1998

Apr 12, 2023

Dec 26, 2023

Apr 12, 2023

Apr 17, 2019

Jul 24, 2023

Dec 17, 2001

Dec 17, 2001

Dec 17, 2001

Dec 17, 2001

Dec 17, 2001

Dec 17, 2001

Nov 30, 2021

Nov 30, 2021

Mar 23, 2023

Mar 23, 2023

Mar 06, 2012

Mar 06, 2012

Nov 23, 2020

1-91

May DISC

May DISC

May DISC

Sep CMFD

Sep CMFD

Sep CMFD

Feb NEWA

Feb NEWA

Feb NEWA

Aug NEWA

Aug NEWA

Aug NEWA

Aug CAHN

Nov NEWA

Jul NEWA

Mar CFTG

Mar NFTG

Dec NEWA

Aug CAHN

Jul CAHN

Jul NEWA

May CAHN

Apr CAHN

May CAHN

Apr CAHN

May CAHN

Apr CAHN

Jan CMFD

Jan CMFD

Mar NEWA

Mar NEWA

Dec CAHN

Dec CAHN

Aug CPOT
RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - December 2023 1-92

LURASIDONE HYDROCHLORIDE

AB

AB

AB

AB

AB

AB

AB

AB

AB

AB

AB

AB

AB

AB

AB

AB

AB

AB

AB

AB

AB

AB

AB

AB

AB

AB

AB

AB

AB

AB

AB

AB

AB

AB

AB

TABLET;ORAL

LURASIDONE HYDROCHLORIDE

AMNEAL PHARMS CO 20MG

40MG

60MG

80MG

120MG

AUROBINDO PHARMA LTD 20MG

40MG

60MG

80MG

120MG

AVET LIFESCIENCES 20MG

40MG

60MG

80MG

120MG

@ 120MG

120MG

LUPIN LTD 20MG

40MG

60MG

80MG

120MG

MACLEODS PHARMS LTD 20MG

40MG

60MG

80MG

120MG

PIRAMAL HLTHCARE UK 20MG

40MG

60MG

80MG

120MG

TORRENT 20MG

40MG

80MG

120MG

A208002

A208002

A208002

A208002

A208002

A208045

A208045

A208045

A208045

A208045

A208058

A208058

A208058

A208058

A208058

A208058

A208058

A208031

A208031

A208031

A208031

A208031

A212124

A212124

A212124

A212124

A212124

A212091

A212091

A212091

A212091

A212091

A208055

A208055

A208055

A208055

001

002

003

004

005

001

002

003

004

005

001

002

003

004

005

005

005

001

002

003

004

005

001

002

003

004

005

001

002

003

004

005

001

002

003

004

Jan 03, 2019

Jan 03, 2019

Jan 03, 2019

Jan 03, 2019

Jan 03, 2019

Mar 10, 2023

Mar 10, 2023

Mar 10, 2023

Mar 10, 2023

Mar 10, 2023

Sep 04, 2019

Sep 04, 2019

Sep 04, 2019

Sep 04, 2019

Feb 28, 2023

Feb 28, 2023

Feb 28, 2023

Jan 03, 2019

Jan 03, 2019

Jan 03, 2019

Jan 03, 2019

Jan 03, 2019

Jun 09, 2023

Jun 09, 2023

Jun 09, 2023

Jun 09, 2023

Jun 09, 2023

Dec 28, 2020

Dec 28, 2020

Dec 28, 2020

Dec 28, 2020

Dec 28, 2020

Jan 03, 2019

Jan 03, 2019

Jan 03, 2019

Jan 03, 2019

Feb CMFD

Feb CMFD

Feb CMFD

Feb CMFD

Feb CMFD

Mar NEWA

Mar NEWA

Mar NEWA

Mar NEWA

Mar NEWA

Sep CMFD

Sep CMFD

Sep CMFD

Sep CMFD

Sep CMFD

Mar DISC

Feb NEWA

Feb CMFD

Feb CMFD

Feb CMFD

Feb CMFD

Feb CMFD

Jun NEWA

Jun NEWA

Jun NEWA

Jun NEWA

Jun NEWA

Feb CMFD

Feb CMFD

Feb CMFD

Feb CMFD

Feb CMFD

Feb CMFD

Feb CMFD

Feb CMFD

Feb CMFD

LUSUTROMBOPAG

>D>

>A>

TABLET;ORAL

MULPLETA

+! SHIONOGI INC

+! VANCOCIN ITALIA

3MG

3MG

N210923

N210923

001

001

Jul 31, 2018

Jul 31, 2018

Dec CAHN

Dec CAHN

LUTETIUM LU-177 VIPIVOTIDE TETRAXETAN

SOLUTION;INTRAVENOUS

PLUVICTO

+! NOVARTIS 27mCi/ML N215833 001 Mar 23, 2022 Nov CAHN

MACIMORELIN ACETATE

FOR SOLUTION;ORAL

MACRILEN

+ @ NOVO EQ 60MG BASE/POUCH N205598 001 Dec 20, 2017 May DISC

MACITENTAN

>A>

>D>

>A>

AB

AB

AB

AB

TABLET;ORAL

MACITENTAN

APOTEX

@ AUROBINDO PHARMA LTD

OPSUMIT

+! ACTELION

+!

+!

+!

10MG

10MG

10MG

10MG

10MG

10MG

10MG

A211195

A211198

A211198

N204410

N204410

N204410

N204410

001

001

001

001

001

001

001

Jan 09, 2024

Apr 18, 2023

Apr 18, 2023

Oct 18, 2013

Oct 18, 2013

Oct 18, 2013

Oct 18, 2013

Dec NEWA

Apr DISC

Apr NEWA

Dec CTEC

Dec CTEC

Apr CTEC

Apr CFTG
RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - December 2023 1-93

MAFENIDE ACETATE

FOR SOLUTION;TOPICAL

MAFENIDE ACETATE

@ NOVAST LABS 5% A206716 001 Jul 31, 2017 May DISC

MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM ACETATE; SODIUM CHLORIDE; SODIUM GLUCONATE

INJECTABLE;INJECTION

MULTIPLE ELECTROLYTES INJECTION TYPE 1 USP PH 5.5

AP FRESENIUS KABI USA 30MG/100ML;37MG/100ML;368MG/100ML; A215370 001 Jun 29, 2022 Mar CMFD

526MG/100ML;502MG/100ML

MULTIPLE ELECTROLYTES INJECTION TYPE 1 USP PH 7.4

AP FRESENIUS KABI USA 30MG/100ML;37MG/100ML;368MG/100ML; A215371 001 Jun 08, 2022 Mar CMFD

526MG/100ML;502MG/100ML

PLASMA-LYTE 148 IN WATER IN PLASTIC CONTAINER

AP +! BAXTER HLTHCARE 30MG/100ML;37MG/100ML;368MG/100ML; N017378 001 Mar CTEC

526MG/100ML;502MG/100ML

PLASMA-LYTE A IN PLASTIC CONTAINER

AP +! BAXTER HLTHCARE 30MG/100ML;37MG/100ML;368MG/100ML; N017378 002 Nov 22, 1982 Mar CTEC

526MG/100ML;502MG/100ML

MAGNESIUM SULFATE

INJECTABLE;INJECTION

MAGNESIUM SULFATE IN PLASTIC CONTAINER

AP AMNEAL 2GM/50ML (40MG/ML) A216597 001 Feb 15, 2023 Feb NEWA

AP 4GM/100ML (40MG/ML) A216597 002 Feb 15, 2023 Feb NEWA

MAGNESIUM SULFATE; POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM SULFATE

FOR SOLUTION;ORAL

SUFLAVE

+! BRAINTREE LABS 0.9GM/BOT;178.7GM/BOT;1.12GM/BOT;0 N215344 001 Jun 15, 2023 Jun NEWA

.5GM/BOT;7.3GM/BOT

MAGNESIUM SULFATE; POTASSIUM SULFATE; SODIUM SULFATE

SOLUTION;ORAL

SODIUM SULFATE, POTASSIUM SULFATE AND MAGNESIUM SULFATE

>A> AA ALKEM LABS LTD 1.6GM/BOT;3.13GM/BOT;17.5GM/BOT A213924 001 Dec 29, 2023 Dec NEWA

AA STRIDES PHARMA 1.6GM/BOT;3.13GM/BOT;17.5GM/BOT A215469 001 Nov 22, 2023 Nov NEWA

MANNITOL

POWDER;INHALATION

ARIDOL KIT

+! ARNA PHARMA N/A,5MG,10MG,20MG,40MG N022368 001 Oct 05, 2010 Nov CAHN

MARAVIROC

TABLET;ORAL

MARAVIROC

AB I 3 PHARMS 150MG A217114 001 Aug 17, 2023 Aug NEWA

AB 300MG A217114 002 Aug 17, 2023 Aug NEWA

MAVACAMTEN

CAPSULE;ORAL

CAMZYOS

+! BRISTOL 5MG N214998 002 Apr 28, 2022 Sep CHRS

+ 15MG N214998 004 Apr 28, 2022 Sep CHRS

MECLIZINE HYDROCHLORIDE

TABLET;ORAL

MECLIZINE HYDROCHLORIDE

@ ANI PHARMS 12.5MG A084657 002 Aug DISC

@ 25MG A084657 001 Aug DISC

AA AUROBINDO PHARMA USA 12.5MG A202640 001 Sep 17, 2012 Sep CMFD

AA 25MG A202640 002 Sep 17, 2012 Sep CMFD

AA 50MG A202640 003 Sep 17, 2012 Sep CMFD

AA WILSHIRE PHARMS INC 12.5MG A205136 001 Feb 22, 2019 May CAHN

AA 25MG A205136 002 Feb 22, 2019 May CAHN

AA 50MG A205136 003 Feb 22, 2019 May CAHN
RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - December 2023 1-94

MECLOFENAMATE SODIUM

CAPSULE;ORAL

MECLOFENAMATE SODIUM

@ CHARTWELL RX EQ 50MG BASE

@ EQ 100MG BASE

A072262

A072263

001

001

MEDROXYPROGESTERONE ACETATE

INJECTABLE;INJECTION

MEDROXYPROGESTERONE ACETATE

>D>

>A>

AB

AB

AB

AB

AMNEAL 150MG/ML

@ HIKMA 150MG/ML

HONG KONG 150MG/ML

150MG/ML

MEITHEAL 150MG/ML

A215397

A214309

A076553

A076553

A076553

001

001

001

001

001

MEGESTROL ACETATE

SUSPENSION;ORAL

MEGESTROL ACETATE

AB

@ BIONPHARMA 125MG/ML

@ BRECKENRIDGE 125MG/ML

@ NOVITIUM PHARMA 40MG/ML

@ XTTRIUM LABS INC 40MG/ML

40MG/ML

A204688

A204688

A077404

A076721

A076721

001

001

001

001

001

MELOXICAM

TABLET;ORAL

MELOXICAM

AB ASCENT PHARMS INC 7.5MG A217579 001

AB 15MG A217579 002

AB COREPHARMA 7.5MG A077882 001

AB 15MG A077882 002

@ SCIEGEN PHARMS INC 7.5MG

@ 15MG

A077920

A077920

001

002

MELPHALAN HYDROCHLORIDE

POWDER;INTRA-ARTERIAL

HEPZATO

+! DELCATH SYSTEMS INC EQ 50MG BASE/VIAL

SOLUTION;INTRAVENOUS

MELPHALAN HYDROCHLORIDE

N201848 001

+! APOTEX EQ 90MG BASE/ML (EQ 90MG BASE/ML) N217110 001

MEMANTINE HYDROCHLORIDE

CAPSULE, EXTENDED RELEASE;ORAL

MEMANTINE HYDROCHLORIDE

AB

@ ANI PHARMS 28MG

XIAMEN LP PHARM CO 7MG

A205365

A213985

004

001

AB

@ 7MG

14MG

A213985

A213985

001

002

AB

@ 14MG

28MG

A213985

A213985

002

003

@ 28MG

NAMENDA XR

A213985 003

AB

+ @ ABBVIE 7MG

+ 7MG

N022525

N022525

001

001

AB + 14MG N022525 002

AB + 21MG N022525 003

AB +! 28MG N022525 004

TABLET;ORAL

MEMANTINE HYDROCHLORIDE

AB

@ HIKMA 5MG

@ 10MG

WESTMINSTER PHARMS 5MG

A208173

A208173

A209527

001

002

001

AB 10MG A209527 002

@ YILING 5MG

@ 10MG

NAMENDA

A212947

A212947

001

002

AB + ABBVIE 5MG N021487 001

AB +! 10MG N021487 002

Nov 29, 1988 Jan CAHN

Nov 29, 1988 Jan CAHN

Jun 07, 2023 May NEWA

Jan 05, 2023 Jul DISC

Jul 28, 2004 Dec CAHN

Jul 28, 2004 Oct CAHN

Jul 28, 2004 Dec CAHN

Dec 01, 2017 Jun CAHN

Dec 01, 2017 Jan DISC

Feb 16, 2006 Nov CAHN

Nov 01, 2004 Jul DISC

Nov 01, 2004 Jan CAHN

Jun 07, 2023 May NEWA

Jun 07, 2023 May NEWA

Jul 20, 2006 Feb CAHN

Jul 20, 2006 Feb CAHN

Jul 19, 2006 Sep CAHN

Jul 19, 2006 Sep CAHN

Aug 14, 2023 Aug NEWA

Aug 18, 2023 Aug NEWA

Feb 28, 2020 Feb DISC

Oct 11, 2022 Nov CMFD

Oct 11, 2022 Apr DISC

Oct 11, 2022 Nov CMFD

Oct 11, 2022 Apr DISC

Oct 11, 2022 Nov CMFD

Oct 11, 2022 Apr DISC

Jun 21, 2010 Aug DISC

Jun 21, 2010 Feb CAHN

Jun 21, 2010 Feb CAHN

Jun 21, 2010 Feb CAHN

Jun 21, 2010 Feb CAHN

Feb 28, 2020 Oct DISC

Feb 28, 2020 Oct DISC

May 07, 2018 Aug CAHN

May 07, 2018 Aug CAHN

Apr 03, 2020 Mar CAHN

Apr 03, 2020 Mar CAHN

Oct 16, 2003 Feb CAHN

Oct 16, 2003 Feb CAHN
RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - December 2023 1-95

MEPIVACAINE HYDROCHLORIDE

INJECTABLE;INJECTION

SCANDONEST PLAIN

! DEPROCO 3% A088387 001 Oct 10, 1984 May CTEC

MEROPENEM

INJECTABLE;INJECTION

MEROPENEM

AP

AP

BROOKS STERISCIENCE

@

@

POWDER;INTRAVENOUS

MEROPENEM

500MG/VIAL

500MG/VIAL

1GM/VIAL

1GM/VIAL

A216154

A216154

A216154

A216154

001

001

002

002

Aug 18, 2022

Aug 18, 2022

Aug 18, 2022

Aug 18, 2022

Jul CMFD

Mar DISC

Jul CMFD

Mar DISC

+! HQ SPCLT PHARMA 2GM/VIAL N215212 001 Jul 26, 2023 Jul NEWA

MESALAMINE

CAPSULE, DELAYED RELEASE;ORAL

DELZICOL

AB +! ABBVIE 400MG

CAPSULE, EXTENDED RELEASE;ORAL

APRISO

N204412 001 Feb 01, 2013 Feb CAHN

AB +! SALIX

MESALAMINE

375MG N022301 001 Oct 31, 2008 Sep CAHN

AB

AB

AMTA

AUROBINDO PHARMA LTD

ENEMA;RECTAL

MESALAMINE

375MG

375MG

A217533

A214477

001

001

Jun 06, 2023

Mar 31, 2023

May NEWA

Mar NEWA

AB ENCUBE

SUPPOSITORY;RECTAL

CANASA

4GM/60ML A216941 001 May 30, 2023 May NEWA

AB

@ ABBVIE

+!

MESALAMINE

500MG

1GM

N021252

N021252

001

002

Jan 05, 2001

Nov 05, 2004

Feb CAHN

Feb CAHN

AB

AB

PHARM SOURCING 1GM

RISING 1GM

TABLET, DELAYED RELEASE;ORAL

MESALAMINE

A207448

A207448

001

001

Apr 19, 2019

Apr 19, 2019

Oct CAHN

Sep CAHN

AB SINOTHERAPEUTICS INC 1.2GM A217337 001 May 12, 2023 May NEWA

METAXALONE

TABLET;ORAL

METAXALONE

AB ! AMNEAL PHARMS

+ @ PRIMUS PHARMS

+!

SKELAXIN

800MG

640MG

640MG

A203399

N022503

N022503

001

001

001

Jun 21, 2013

Jun 01, 2015

Jun 01, 2015

Jul CHRS

Jun DISC

Feb CMFD

+ @ KING PHARMS 800MG N013217 003 Aug 30, 2002 Jul DISC

METFORMIN HYDROCHLORIDE

TABLET;ORAL

METFORMIN HYDROCHLORIDE

@ SUN PHARM INDS INC 500MG

@ 850MG

@ 1GM

TABLET, EXTENDED RELEASE;ORAL

METFORMIN HYDROCHLORIDE

A075967

A075967

A075967

001

002

003

Jan 29, 2002

Jan 29, 2002

Jan 29, 2002

Sep DISC

Sep DISC

Sep DISC

AB1

AB

AB3

AB3

AB3

AB3

LAURUS

RK PHARMA

VGYAAN

500MG

750MG

500MG

1GM

500MG

1GM

A217631

A217631

A215629

A215629

A215629

A215629

001

002

001

002

001

002

Oct 05, 2023

Oct 05, 2023

Jun 20, 2023

Jun 20, 2023

Jun 20, 2023

Jun 20, 2023

Sep NEWA

Sep NEWA

Jun CAHN

Jun CAHN

Jun NEWA

Jun NEWA

METFORMIN HYDROCHLORIDE; SAXAGLIPTIN HYDROCHLORIDE

TABLET, EXTENDED RELEASE;ORAL

KOMBIGLYZE XR

AB

+

+

+

@

@

ASTRAZENECA AB 500MG;EQ 5MG BASE

500MG;EQ 5MG BASE

1GM;EQ 2.5MG BASE

N200678

N200678

N200678

001

001

003

Nov 05, 2010

Nov 05, 2010

Nov 05, 2010

Oct DISC

Jul CFTG

Oct DISC
RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - December 2023 1-96

TABLET, EXTENDED RELEASE;ORAL

KOMBIGLYZE XR

AB

AB

AB

AB

AB

AB

+ 1GM;EQ 2.5MG BASE

+ @ 1GM;EQ 5MG BASE

+! 1GM;EQ 5MG BASE

METFORMIN HYDROCHLORIDE; SAXAGLIPTIN HYDROCHLORIDE

DR REDDYS LABS SA 500MG;EQ 5MG BASE

1GM;EQ 2.5MG BASE

! 1GM;EQ 5MG BASE

1GM;EQ 5MG BASE

SAXAGLIPTIN AND METFORMIN HYDROCHLORIDE

N200678

N200678

N200678

A207678

A207678

A207678

A207678

003 Nov 05, 2010

002 Nov 05, 2010

002 Nov 05, 2010

001 Aug 09, 2023

002 Aug 09, 2023

003 Aug 09, 2023

003 Aug 09, 2023

Jul CFTG

Oct DISC

Jul CFTG

Jul NEWA

Jul NEWA

Oct CHRS

Jul NEWA

AB

AB

AB

AB

AB

AB

MYLAN

SUN PHARM

500MG;EQ 5MG BASE

1GM;EQ 2.5MG BASE

1GM;EQ 5MG BASE

500MG;EQ 5MG BASE

1GM;EQ 2.5MG BASE

1GM;EQ 5MG BASE

A205981

A205981

A205981

A206081

A206081

A206081

001 Jul 31, 2023

002 Jul 31, 2023

003 Jul 31, 2023

001 Jul 31, 2023

002 Jul 31, 2023

003 Jul 31, 2023

Jul NFTG

Jul NFTG

Jul NFTG

Jul NFTG

Jul NFTG

Jul NFTG

METFORMIN HYDROCHLORIDE; SITAGLIPTIN

TABLET;ORAL

ZITUVIMET

+

+!

ZYDUS 500MG;50MG

1GM;50MG

N216743

N216743

001 Nov 03, 2023

002 Nov 03, 2023

Nov NEWA

Nov NEWA

METFORMIN HYDROCHLORIDE; SITAGLIPTIN PHOSPHATE

TABLET;ORAL

JANUMET

+ MSD SUB MERCK 500MG;EQ 50MG BASE

+! 1GM;EQ 50MG BASE

TABLET, EXTENDED RELEASE;ORAL

JANUMET XR

N022044

N022044

001 Mar 30, 2007

002 Mar 30, 2007

Mar CAHN

Mar CAHN

+

+

+!

MSD SUB MERCK 500MG;EQ 50MG BASE

1GM;EQ 50MG BASE

1GM;EQ 100MG BASE

N202270

N202270

N202270

001 Feb 02, 2012

002 Feb 02, 2012

003 Feb 02, 2012

Sep CAHN

Sep CAHN

Sep CAHN

METHADONE HYDROCHLORIDE

INJECTABLE;INJECTION

METHADONE HYDROCHLORIDE

AP LONG GROVE PHARMS

TABLET;ORAL

METHADONE HYDROCHLORIDE

10MG/ML A208306 001 Oct 27, 2017 Aug CAHN

@ SUN PHARM INDUSTRIES

@

5MG

10MG

A208305

A208305

001 Mar 30, 2018

002 Mar 30, 2018

Sep DISC

Sep DISC

METHAMPHETAMINE HYDROCHLORIDE

TABLET;ORAL

DESOXYN

>A> AA +! AJENAT PHARMS 5MG N005378 002 Dec CAHN

>D> AA +! KEY THERAP 5MG N005378 002 Dec CAHN

TABLET, EXTENDED RELEASE;ORAL

DESOXYN

>A>

>A>

>A>

>D>

>D>

>D>

@

@

@

@

@

@

AJENAT PHARMS

KEY THERAP

5MG

10MG

15MG

5MG

10MG

15MG

N005378

N005378

N005378

N005378

N005378

N005378

004

003

005

004

003

005

Dec CAHN

Dec CAHN

Dec CAHN

Dec CAHN

Dec CAHN

Dec CAHN

METHENAMINE HIPPURATE

TABLET;ORAL

HIPREX

>A> AB + SS PHARMA 1GM N017681 001 Dec CAHN

>D> AB + VALIDUS PHARMS 1GM N017681 001 Dec CAHN

METHENAMINE HIPPURATE

AB LYRUS LIFE SCIENCES 1GM A217675 001 Dec 01, 2023 Nov NEWA
RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - December 2023 1-97

METHIMAZOLE

TABLET;ORAL

METHIMAZOLE

AB

AB

AB

AB

AB

AB

@

BIONPHARMA

MACLEODS PHARMS LTD

QINGDAO BAHEAL PHARM

5MG

10MG

5MG

10MG

5MG

10MG

20MG

A218149

A218149

A209827

A209827

A040547

A040547

A040547

001

002

001

002

001

002

004

Sep 25, 2023

Sep 25, 2023

May 24, 2023

May 24, 2023

Feb 18, 2005

Feb 18, 2005

Feb 18, 2005

Sep NEWA

Sep NEWA

May NEWA

May NEWA

Sep CAHN

Sep CAHN

Sep CAHN

METHOCARBAMOL

SOLUTION;IM-IV

METHOCARBAMOL

AP

@ BAXTER HLTHCARE CORP

SLATE RUN PHARMA

TABLET;ORAL

METHOCARBAMOL

1GM/10ML (100MG/ML)

1GM/10ML (100MG/ML)

A215065

A208116

001

001

Jul 14, 2022

Jan 19, 2017

Feb DISC

Sep CAHN

AA

AA

AA

AA

AB

AA

AA

AB

!

ACME LABS

AUROBINDO PHARMA LTD

AUSTARPHARMA LLC

DBL PHARMS

MIKART

500MG

750MG

500MG

750MG

1GM

500MG

750MG

1GM

A203550

A203550

A213967

A213967

A200958

A203550

A203550

A212707

001

002

002

001

003

001

002

001

Feb 08, 2017

Feb 08, 2017

Feb 09, 2023

Aug 12, 2020

Dec 06, 2021

Feb 08, 2017

Feb 08, 2017

Jun 12, 2023

Sep CAHN

Sep CAHN

Feb NEWA

Feb CMFD

Jun CTEC

Feb CAHN

Feb CAHN

Jun NEWA

METHOTREXATE

SOLUTION;ORAL

JYLAMVO

+! SHORLA

+! THERAKIND

+ @

SOLUTION;SUBCUTANEOUS

REDITREX

2MG/ML

2MG/ML

2MG/ML

N212479

N212479

N212479

001

001

001

Nov 29, 2022

Nov 29, 2022

Nov 29, 2022

Oct CAHN

Oct CMFD

May DISC

+

+

+

@

@

@

NORDIC GRP 15MG/0.6ML (15MG/0.6ML)

20MG/0.8ML (20MG/0.8ML)

25MG/1ML (25MG/1ML)

N210737

N210737

N210737

004

006

008

Nov 27, 2019

Nov 27, 2019

Nov 27, 2019

Aug DISC

Aug DISC

Aug DISC

METHOTREXATE SODIUM

TABLET;ORAL

METHOTREXATE SODIUM

AB DAITO EQ 2.5MG BASE A213362 001 Aug 07, 2023 Jul NEWA

METHSUXIMIDE

CAPSULE;ORAL

CELONTIN

AB +! PARKE DAVIS

METHSUXIMIDE

300MG N010596 008 Apr CFTG

AB NOVITIUM PHARMA 300MG A217213 001 May 01, 2023 Apr NFTG

METHYLENE BLUE

SOLUTION;INTRAVENOUS

METHYLENE BLUE

AP

AP

ZYDUS

PROVAYBLUE

10MG/2ML (5MG/ML)

50MG/10ML (5MG/ML)

A215636

A215636

001

002

Dec 05, 2023

Dec 05, 2023

Nov NFTG

Nov NFTG

AP

AP

+!

+!

PROVEPHARM SAS 10MG/2ML (5MG/ML)

50MG/10ML (5MG/ML)

N204630

N204630

002

001

Jul 18, 2019

Apr 08, 2016

Nov CFTG

Nov CFTG

METHYLERGONOVINE MALEATE

TABLET;ORAL

METHYLERGONOVINE MALEATE

AB ! CHARTWELL RX 0.2MG A091577 001 May 02, 2011 Jun CAHN

METHYLPHENIDATE HYDROCHLORIDE

CAPSULE, EXTENDED RELEASE;ORAL

RITALIN LA

AB1 + SANDOZ 10MG N021284 004 Apr 10, 2004 Sep CAHN

AB1 + 20MG N021284 001 Jun 05, 2002 Sep CAHN

AB1 + 30MG N021284 002 Jun 05, 2002 Sep CAHN
RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - December 2023 1-98

CAPSULE, EXTENDED RELEASE;ORAL

RITALIN LA

AB1 + 40MG

+ @ 60MG

SOLUTION;ORAL

METHYLPHENIDATE HYDROCHLORIDE

N021284

N021284

003 Jun 05, 2002

005 Oct 27, 2014

Sep CAHN

Sep CAHN

>D>

>D>

>A>

>A>

AA

AA

AA

AA

AA

AA

EYWA

PATRIN

WES PHARMA INC

TABLET;ORAL

RITALIN

5MG/5ML

10MG/5ML

5MG/5ML

10MG/5ML

5MG/5ML

10MG/5ML

A210139

A210139

A210764

A210764

A210139

A210139

001 Oct 03, 2018

002 Oct 03, 2018

001 Apr 10, 2020

002 Apr 10, 2020

001 Oct 03, 2018

002 Oct 03, 2018

Dec CAHN

Dec CAHN

Sep CAHN

Sep CAHN

Dec CAHN

Dec CAHN

AB

AB

AB

+ SANDOZ 5MG

+ 10MG

+! 20MG

TABLET, EXTENDED RELEASE;ORAL

METHYLPHENIDATE HYDROCHLORIDE

N010187

N010187

N010187

003

006

010

Sep CAHN

Sep CAHN

Sep CAHN

AB

AB

AB

AB

AB

AB

AB

AB

AB

AB

!

@

@

@

@

ALKEM LABS LTD

AMNEAL PHARMS

OSMOTICA PHARM US

SUN PHARM INDS INC

18MG

27MG

36MG

54MG

18MG

27MG

36MG

54MG

18MG

27MG

36MG

54MG

72MG

72MG

A214447

A214447

A214447

A214447

A207515

A207515

A207515

A207515

A205327

A205327

A205327

A205327

A205327

A217229

001 May 23, 2023

002 May 23, 2023

003 May 23, 2023

004 May 23, 2023

001 Feb 01, 2018

002 Feb 01, 2018

003 Feb 01, 2018

004 Feb 01, 2018

001 Jul 28, 2017

002 Jul 28, 2017

003 Jul 28, 2017

004 Jul 28, 2017

005 Jul 28, 2017

001 Aug 25, 2023

May NEWA

May NEWA

May NEWA

May NEWA

Jun DISC

Jun DISC

Jun DISC

Jun DISC

Nov CAHN

Nov CAHN

Nov CAHN

Nov CAHN

Nov CAHN

Aug NEWA

METHYLPREDNISOLONE

TABLET;ORAL

MEDROL

+ PFIZER

METHYLPREDNISOLONE

2MG N011153 002 Apr CTEC

@ CHARTWELL RX

@

@

@

@

2MG

4MG

8MG

16MG

32MG

A209097

A209097

A209097

A209097

A209097

001 Feb 22, 2019

002 Feb 22, 2019

003 Feb 22, 2019

004 Feb 22, 2019

005 Feb 22, 2019

May CAHN

May CAHN

May CAHN

May CAHN

May CAHN

METHYLPREDNISOLONE ACETATE

INJECTABLE;INJECTION

METHYLPREDNISOLONE ACETATE

>D>

>D>

>A>

>A>

AB

AB

AB

AB

AB

AB

AB

AB

AB

AB

AB

AB

AMNEAL

EUGIA PHARMA

HONG KONG

MEITHEAL

PAR STERILE PRODUCTS

SLAYBACK PHARMA LLC

40MG/ML

80MG/ML

40MG/ML

80MG/ML

40MG/ML

40MG/ML

80MG/ML

80MG/ML

40MG/ML

80MG/ML

40MG/ML

40MG/ML

A216502

A216502

A211930

A211930

A040557

A040557

A040557

A040557

A040557

A040557

A214297

A214870

001 Nov 03, 2023

002 Nov 03, 2023

001 Apr 13, 2023

002 Apr 13, 2023

001 Feb 23, 2005

001 Feb 23, 2005

002 Feb 23, 2005

002 Feb 23, 2005

001 Feb 23, 2005

002 Feb 23, 2005

001 Jan 21, 2022

002 May 10, 2023

Oct NEWA

Oct NEWA

Apr NEWA

Apr NEWA

Dec CAHN

Sep CAHN

Dec CAHN

Sep CAHN

Dec CAHN

Dec CAHN

Jun CMFD

Apr NEWA

METOCLOPRAMIDE HYDROCHLORIDE

SOLUTION;ORAL

METOCLOPRAMIDE HYDROCHLORIDE

AA

AA

! PHARM ASSOC EQ 5MG BASE/5ML

@ PHARMOBEDIENT CNSLTG EQ 5MG BASE/5ML

@ VISTAPHARM EQ 5MG BASE/5ML

@ XTTRIUM LABS INC EQ 5MG BASE/5ML

! EQ 5MG BASE/5ML

TABLET;ORAL

METOCLOPRAMIDE HYDROCHLORIDE

A072744

A074703

A075051

A074703

A074703

001 May 28, 1991

001 Oct 31, 1997

001 Jan 26, 2001

001 Oct 31, 1997

001 Oct 31, 1997

Jul CHRS

Sep CAHN

Sep DISC

Jul DISC

Jan CAHN

>A> @ AIPING PHARM INC EQ 10MG BASE A072215 001 Jan 30, 1990 Dec CAHN
RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - December 2023 1-99

TABLET;ORAL

METOCLOPRAMIDE HYDROCHLORIDE

>D> @ CHARTWELL RX EQ 10MG BASE A072215 001 Jan 30, 1990 Dec CAHN

METOLAZONE

TABLET;ORAL

METOLAZONE

AB

AB

AB

AB

AB

AB

AACE PHARMS

@

@

@

NE RX PHARMA

MYKROX

2.5MG

2.5MG

5MG

5MG

10MG

10MG

2.5MG

5MG

10MG

A216216

A216216

A216216

A216216

A216216

A216216

A216216

A216216

A216216

001 Oct 25, 2022

001 Oct 25, 2022

002 Oct 25, 2022

002 Oct 25, 2022

003 Oct 25, 2022

003 Oct 25, 2022

001 Oct 25, 2022

002 Oct 25, 2022

003 Oct 25, 2022

Aug CMFD

Apr DISC

Aug CMFD

Apr DISC

Aug CMFD

Apr DISC

Sep CAHN

Sep CAHN

Sep CAHN

@ CHARTWELL MOLECULAR 0.5MG N019532 001 Oct 30, 1987 Jul CAHN

METOPROLOL SUCCINATE

TABLET, EXTENDED RELEASE;ORAL

METOPROLOL SUCCINATE

AB

AB

AB

AB

AB

AB

AB

AB

AB

AB

AB

AB

@

@

@

@

@

@

@

@

ACCORD HLTHCARE

GRANULES

LUPIN

EQ 25MG TARTRATE

EQ 50MG TARTRATE

EQ 100MG TARTRATE

EQ 200MG TARTRATE

EQ 25MG TARTRATE

EQ 25MG TARTRATE

EQ 50MG TARTRATE

EQ 50MG TARTRATE

EQ 100MG TARTRATE

EQ 100MG TARTRATE

EQ 200MG TARTRATE

EQ 200MG TARTRATE

EQ 25MG TARTRATE

EQ 25MG TARTRATE

EQ 50MG TARTRATE

EQ 50MG TARTRATE

EQ 100MG TARTRATE

EQ 100MG TARTRATE

EQ 200MG TARTRATE

EQ 200MG TARTRATE

A215637

A215637

A215637

A215637

A216509

A216916

A216509

A216916

A216509

A216916

A216509

A216916

A209272

A209272

A209272

A209272

A209272

A209272

A209272

A209272

001 Oct 18, 2022

002 Oct 18, 2022

003 Oct 18, 2022

004 Oct 18, 2022

001 Aug 07, 2023

001 Jun 12, 2023

002 Aug 07, 2023

002 Jun 12, 2023

003 Aug 07, 2023

003 Jun 12, 2023

004 Aug 07, 2023

004 Jun 12, 2023

001 Aug 15, 2023

001 Aug 15, 2023

002 Aug 15, 2023

002 Aug 15, 2023

003 Aug 15, 2023

003 Aug 15, 2023

004 Aug 15, 2023

004 Aug 15, 2023

Apr DISC

Apr DISC

Apr DISC

Apr DISC

Jul NEWA

Jun NEWA

Jul NEWA

Jun NEWA

Jul NEWA

Jun NEWA

Jul NEWA

Jun NEWA

Aug DISC

Aug NEWA

Aug DISC

Aug NEWA

Aug DISC

Aug NEWA

Aug DISC

Aug NEWA

METOPROLOL TARTRATE

INJECTABLE;INJECTION

METOPROLOL TARTRATE

@ HOSPIRA

TABLET;ORAL

METOPROLOL TARTRATE

1MG/ML A075160 001 Jul 06, 1998 Jun DISC

>A> AB

>A> AB

AB

AB

AB

AB

AB

AUROBINDO PHARMA

RENATA

@ ZYDUS PHARMS

@

@

37.5MG

75MG

50MG

100MG

25MG

25MG

50MG

50MG

100MG

100MG

A077739

A077739

A074453

A074453

A212402

A212402

A212402

A212402

A212402

A212402

004 Dec 07, 2023

005 Dec 07, 2023

001 Apr 27, 1995

002 Apr 27, 1995

001 Apr 19, 2023

001 Apr 19, 2023

002 Apr 19, 2023

002 Apr 19, 2023

003 Apr 19, 2023

003 Apr 19, 2023

Dec NEWA

Dec NEWA

Nov CMFD

Nov CMFD

Oct DISC

Apr NEWA

Oct DISC

Apr NEWA

Oct DISC

Apr NEWA

METRONIDAZOLE

CREAM;TOPICAL

METRONIDAZOLE

AB ZYDUS LIFESCIENCES

GEL;TOPICAL

METRONIDAZOLE

0.75% A217128 001 Apr 21, 2023 Apr NEWA

AB

@ CHARTWELL RX

COSETTE

@ TOLMAR

GEL;VAGINAL

METRONIDAZOLE

1%

1%

1%

A090903

A216692

A090903

001 Jul 22, 2011

001 Jan 23, 2023

001 Jul 22, 2011

Oct CAHN

Jan NEWA

Feb DISC

AB COSETTE 0.75% A216323 001 Jul 12, 2023 Jun NEWA
RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - December 2023 1-100

>D>

>D>

>A>

>A>

AB

AP

AB

AB

AB

AB

AB

AB

AB

GEL;VAGINAL

METRONIDAZOLE

@ ENCUBE 0.75%

0.75%

INJECTABLE;INJECTION

METRONIDAZOLE IN PLASTIC CONTAINER

AMNEAL 500MG/100ML

SUSPENSION;ORAL

LIKMEZ

+! SAPTALIS PHARMS 500MG/5ML

TABLET;ORAL

FLAGYL

+ @ PFIZER 250MG

+ @ 500MG

METRONIDAZOLE

ALEMBIC 250MG

500MG

AMICI 250MG

500MG

! AUROBINDO PHARMA LTD 500MG

INNOGENIX 250MG

500MG

A077264

A215610

A217665

N216755

N012623

N012623

A208681

A208681

A070772

A070772

A203974

A070772

A070772

001 Oct 31, 2006

001 Jun 16, 2023

001 May 24, 2023

001 Sep 22, 2023

001

003

001 Jun 20, 2017

002 Jun 20, 2017

001 Jul 16, 1986

002 Jul 16, 1986

002 May 29, 2015

001 Jul 16, 1986

002 Jul 16, 1986

Mar CAHN

Jun NEWA

Jun CMS1

Sep NEWA

Oct DISC

Oct DISC

Feb CAHN

Feb CAHN

Dec CAHN

Dec CAHN

Oct CHRS

Dec CAHN

Dec CAHN

METRONIDAZOLE IN PLASTIC CONTAINER

AP

INJECTABLE;INJECTION

METRONIDAZOLE IN PLASTIC CONTAINER

AMNEAL 500MG/100ML A217665 001 May 24, 2023 May NEWA

MEXILETINE HYDROCHLORIDE

AB

AB

AB

AB

AB

AB

AB

AB

AB

AB

AB

AB

CAPSULE;ORAL

MEXILETINE HYDROCHLORIDE

CARNEGIE 150MG

200MG

250MG

CHEMISTRY HLTH 150MG

200MG

250MG

LEADING 150MG

200MG

250MG

ZENARA 150MG

200MG

250MG

A215315

A215315

A215315

A215876

A215876

A215876

A215876

A215876

A215876

A215315

A215315

A215315

001 Aug 26, 2022

002 Aug 26, 2022

003 Aug 26, 2022

001 Feb 27, 2023

002 Feb 27, 2023

003 Feb 27, 2023

001 Feb 27, 2023

002 Feb 27, 2023

003 Feb 27, 2023

001 Aug 26, 2022

002 Aug 26, 2022

003 Aug 26, 2022

Sep CAHN

Sep CAHN

Sep CAHN

Sep CAHN

Sep CAHN

Sep CAHN

Feb NEWA

Feb NEWA

Feb NEWA

Feb CAHN

Feb CAHN

Feb CAHN

MICAFUNGIN SODIUM

AP

AP

INJECTABLE;INTRAVENOUS

MICAFUNGIN SODIUM

ZYDUS PHARMS EQ 50MG BASE/VIAL

@ EQ 50MG BASE/VIAL

EQ 100MG BASE/VIAL

@ EQ 100MG BASE/VIAL

SOLUTION;INTRAVENOUS

MICAFUNGIN IN SODIUM CHLORIDE 0.9%

+! BAXTER HLTHCARE CORP EQ 50MG BASE/50ML (EQ 1MG BASE/ML)

+! EQ 100MG BASE/100ML (EQ 1MG

BASE/ML)

+! EQ 150MG BASE/150ML (EQ 1MG

BASE/ML)

A215241

A215241

A215241

A215241

N216142

N216142

N216142

001 Oct 24, 2022

001 Oct 24, 2022

002 Oct 24, 2022

002 Oct 24, 2022

001 Sep 29, 2023

002 Sep 29, 2023

003 Sep 29, 2023

Aug CMFD

Mar DISC

Aug CMFD

Mar DISC

Sep NEWA

Sep NEWA

Sep NEWA

MIDAZOLAM

AP

AP

AP

AP

SOLUTION;INTRAVENOUS

MIDAZOLAM IN 0.9% SODIUM CHLORIDE

HIKMA 50MG/50ML (1MG/ML)

100MG/100ML (1MG/ML)

+! INFORLIFE 50MG/50ML (1MG/ML)

+! 100MG/100ML (1MG/ML)

A216159

A216159

N211844

N211844

001 Apr 17, 2023

002 Apr 17, 2023

001 Mar 22, 2021

002 Mar 22, 2021

Apr NFTG

Apr NFTG

Apr CFTG

Apr CFTG
RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - December 2023 1-101

MIDAZOLAM HYDROCHLORIDE

INJECTABLE;INJECTION

MIDAZOLAM HYDROCHLORIDE

>A>

>A>

>A>

>A>

>D>

>D>

>D>

>D>

AP

AP

MICRO LABS EQ 1MG BASE/ML

EQ 5MG BASE/ML

@ PAI HOLDINGS EQ 1MG BASE/ML

@ EQ 1MG BASE/ML

@ EQ 5MG BASE/ML

@ EQ 5MG BASE/ML

@ RISING EQ 5MG BASE/ML

@ WOCKHARDT BIO AG EQ 1MG BASE/ML

@ EQ 1MG BASE/ML

@ EQ 5MG BASE/ML

@ EQ 5MG BASE/ML

MIDAZOLAM HYDROCHLORIDE PRESERVATIVE FREE

A217504

A217504

A078141

A078511

A078141

A078511

A075481

A078141

A078511

A078141

A078511

001

002

001

001

002

002

001

001

001

002

002

Aug 21, 2023

Aug 21, 2023

May 30, 2008

Nov 10, 2008

May 30, 2008

Nov 10, 2008

Jun 30, 2000

May 30, 2008

Nov 10, 2008

May 30, 2008

Nov 10, 2008

Aug NEWA

Aug NEWA

Dec CAHN

Dec CAHN

Dec CAHN

Dec CAHN

Sep CAHN

Dec CAHN

Dec CAHN

Dec CAHN

Dec CAHN

>D>

>A>

>D>

>A>

AP

AP

@ STERISCIENCE

@

MIDOZALAM HYDROCHLORIDE

EQ 1MG BASE/ML

EQ 1MG BASE/ML

EQ 5MG BASE/ML

EQ 5MG BASE/ML

A090315

A090315

A090315

A090315

001

001

002

002

Nov 29, 2010

Nov 29, 2010

Nov 29, 2010

Nov 29, 2010

Dec CMFD

Dec CMFD

Dec CMFD

Dec CMFD

>D>

>A>

>D>

>A>

AP

AP

@

@

STERISCIENCE EQ 1MG BASE/ML

EQ 1MG BASE/ML

EQ 5MG BASE/ML

EQ 5MG BASE/ML

A090316

A090316

A090316

A090316

001

001

002

002

May 04, 2011

May 04, 2011

May 04, 2011

May 04, 2011

Dec CMFD

Dec CMFD

Dec CMFD

Dec CMFD

MIDODRINE HYDROCHLORIDE

TABLET;ORAL

MIDODRINE HYDROCHLORIDE

>A>

>A>

>A>

>D>

>D>

>D>

AB

AB

AB

AB

AB

AB

AB

AB

AB

AB

AB

AB

MANKIND PHARMA

NOVUGEN

THINQ PHARM-CRO PVT

UNIQUE

2.5MG

5MG

10MG

2.5MG

5MG

10MG

2.5MG

5MG

10MG

2.5MG

5MG

10MG

A217271

A217271

A217271

A211973

A211973

A211973

A207613

A207613

A207613

A207613

A207613

A207613

001

002

003

001

002

003

001

002

003

001

002

003

Nov 01, 2023

Nov 01, 2023

Nov 01, 2023

Oct 17, 2023

Oct 17, 2023

Oct 17, 2023

Nov 02, 2018

Nov 02, 2018

Nov 02, 2018

Nov 02, 2018

Nov 02, 2018

Nov 02, 2018

Oct NEWA

Oct NEWA

Oct NEWA

Oct NEWA

Oct NEWA

Oct NEWA

Dec CAHN

Dec CAHN

Dec CAHN

Dec CAHN

Dec CAHN

Dec CAHN

MIGLUSTAT

CAPSULE;ORAL

OPFOLDA

+! AMICUS THERAP US

YARGESA

65MG N215211 001 Sep 28, 2023 Sep NEWA

AB EDENBRIDGE PHARMS 100MG A209821 001 Aug 06, 2020 Jul CTNA

MILNACIPRAN HYDROCHLORIDE

TABLET;ORAL

SAVELLA

+

+

+!

+

ABBVIE 12.5MG

25MG

50MG

100MG

N022256

N022256

N022256

N022256

001

002

003

004

Jan 14, 2009

Jan 14, 2009

Jan 14, 2009

Jan 14, 2009

Jan CAHN

Jan CAHN

Jan CAHN

Jan CAHN

MILRINONE LACTATE

INJECTABLE;INJECTION

MILRINONE LACTATE

AP SHANDONG EQ 1MG BASE/ML

MILRINONE LACTATE IN DEXTROSE 5% IN PLASTIC CONTAINER

A216373 001 Jan 23, 2023 Jan NEWA

@

@

HOSPIRA EQ 20MG BASE/100ML (EQ 0.2MG

BASE/ML)

EQ 40MG BASE/200ML (EQ 0.2MG

BASE/ML)

A075885

A075885

001

002

May 28, 2002

May 28, 2002

Oct DISC

Oct DISC

MINOCYCLINE HYDROCHLORIDE

CAPSULE;ORAL

DYNACIN

@

@

@

ALVOGEN EQ 50MG BASE

EQ 75MG BASE

EQ 100MG BASE

A063067

A063067

A063067

003

002

001

Aug 14, 1990

Sep 15, 1999

Jul 31, 1990

Nov DISC

Nov DISC

Nov DISC
RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - December 2023

CAPSULE, EXTENDED RELEASE;ORAL

XIMINO

@ JOURNEY EQ 45MG BASE N201922

@ EQ 90MG BASE N201922

@ EQ 135MG BASE N201922

INJECTABLE;INJECTION

MINOCIN

001

003

005

+! REMPEX EQ 100MG BASE/VIAL N050444

TABLET, EXTENDED RELEASE;ORAL

MINOCYCLINE HYDROCHLORIDE

001

AB

AB

AB

ZYDUS PHARMS EQ 55MG BASE A203553

EQ 65MG BASE A203553

EQ 115MG BASE A203553

002

003

007

MIRABEGRON

TABLET, EXTENDED RELEASE;ORAL

MIRABEGRON

@ ZYDUS PHARMS 25MG A209488

@ 50MG A209488

001

002

MIRTAZAPINE

TABLET;ORAL

MIRTAZAPINE

AB PRASCO 7.5MG A216751 001

AB 15MG A216751 002

AB 30MG A216751 003

AB 45MG A216751 004

AB ! SUN PHARM INDS INC 7.5MG A076541 004

REMERON

AB +! ORGANON 15MG N020415 001

AB + 30MG N020415 002

AB + 30MG N020415 002

+ @ 45MG N020415

+ @ 45MG N020415

TABLET, ORALLY DISINTEGRATING;ORAL

REMERON SOLTAB

003

003

AB +! ORGANON USA ORGANON 15MG N021208 001

AB + 30MG N021208 002

AB + 45MG N021208 003

MISOPROSTOL

TABLET;ORAL

MISOPROSTOL

@ NOVEL LABS INC 0.1MG A091667

@ 0.2MG A091667

001

002

MITOMYCIN

INJECTABLE;INJECTION

MITOMYCIN

AP

AP

AP

EUGIA PHARMA 5MG/VIAL A216732

20MG/VIAL A216732

40MG/VIAL A216732

001

002

003

MITOXANTRONE HYDROCHLORIDE

INJECTABLE;INJECTION

MITOXANTRONE HYDROCHLORIDE

>D>

>D>

>D>

>A>

>A>

>A>

AP

AP

AP

AP

AP

AP

AP

AP

AP

HONG KONG EQ 20MG BASE/10ML (EQ 2MG BASE/ML) A077356

EQ 20MG BASE/10ML (EQ 2MG BASE/ML) A077356

EQ 25MG BASE/12.5ML (EQ 2MG A077356

BASE/ML)

EQ 25MG BASE/12.5ML (EQ 2MG A077356

BASE/ML)

EQ 30MG BASE/15ML (EQ 2MG BASE/ML) A077356

EQ 30MG BASE/15ML (EQ 2MG BASE/ML) A077356

MEITHEAL EQ 20MG BASE/10ML (EQ 2MG BASE/ML) A077356

EQ 25MG BASE/12.5ML (EQ 2MG A077356

BASE/ML)

EQ 30MG BASE/15ML (EQ 2MG BASE/ML) A077356

001

001

002

002

003

003

001

002

003

Jul 11, 2012

Jul 11, 2012

Jul 11, 2012

Jun 16, 2023

Jun 16, 2023

Jun 16, 2023

Sep 29, 2022

Sep 29, 2022

Jan 18, 2023

Jan 18, 2023

Jan 18, 2023

Jan 18, 2023

Apr 22, 2004

Jun 14, 1996

Jun 14, 1996

Jun 14, 1996

Mar 17, 1997

Mar 17, 1997

Jan 12, 2001

Jan 12, 2001

Jan 12, 2001

Jul 25, 2012

Jul 25, 2012

Oct 30, 2023

Oct 30, 2023

Oct 30, 2023

Apr 11, 2006

Apr 11, 2006

Apr 11, 2006

Apr 11, 2006

Apr 11, 2006

Apr 11, 2006

Apr 11, 2006

Apr 11, 2006

Apr 11, 2006

1-102

Oct DISC

Oct DISC

Oct DISC

May CTEC

Jun NEWA

Jun NEWA

Jun NEWA

Mar DISC

Mar DISC

Jan NEWA

Jan NEWA

Jan NEWA

Jan NEWA

Oct CHRS

Apr CAHN

Apr CAHN

May CAHN

Apr CAHN

May CAHN

May CAHN

May CAHN

May CAHN

Feb DISC

Feb DISC

Oct NEWA

Oct NEWA

Oct NEWA

Dec CAHN

Sep CAHN

Dec CAHN

Sep CAHN

Dec CAHN

Sep CAHN

Dec CAHN

Dec CAHN

Dec CAHN
RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - December 2023 1-103

MODAFINIL

TABLET;ORAL

PROVIGIL

AB

AB

+

+!

CEPHALON 100MG

200MG

N020717

N020717

001

002

Dec 24, 1998

Dec 24, 1998

Jul CAHN

Jul CAHN

MOLINDONE HYDROCHLORIDE

CAPSULE;ORAL

MOBAN

>A>

>A>

>A>

>D>

>D>

>D>

+ @ CHARTWELL RX

+ @

+ @

+ @ STRIDES PHARMA

+ @

+ @

TABLET;ORAL

MOBAN

5MG

10MG

25MG

5MG

10MG

25MG

N017111

N017111

N017111

N017111

N017111

N017111

001

002

003

001

002

003

Dec CAHN

Dec CAHN

Dec CAHN

Dec CAHN

Dec CAHN

Dec CAHN

>A>

>A>

>A>

>A>

>A>

>D>

>D>

>D>

>D>

>D>

+

+

+

+

+

+

+

+

+

+

@

@

@

@

@

@

@

@

@

@

CHARTWELL RX

STRIDES PHARMA

5MG

10MG

25MG

50MG

100MG

5MG

10MG

25MG

50MG

100MG

N017111

N017111

N017111

N017111

N017111

N017111

N017111

N017111

N017111

N017111

004

005

006

007

008

004

005

006

007

008

Dec CAHN

Dec CAHN

Dec CAHN

Dec CAHN

Dec CAHN

Dec CAHN

Dec CAHN

Dec CAHN

Dec CAHN

Dec CAHN

MOMELOTINIB DIHYDROCHLORIDE

TABLET;ORAL

OJJAARA

+

+

+!

GLAXOSMITHKLINE EQ 100MG BASE

EQ 150MG BASE

EQ 200MG BASE

N216873

N216873

N216873

001

002

003

Sep 15, 2023

Sep 15, 2023

Sep 15, 2023

Sep NEWA

Sep NEWA

Sep NEWA

MOMETASONE FUROATE

LOTION;TOPICAL

MOMETASONE FUROATE

AB ! PADAGIS ISRAEL 0.1% A077180 001 Apr 06, 2005 Mar CHRS

MONTELUKAST SODIUM

TABLET, CHEWABLE;ORAL

MONTELUKAST SODIUM

AB

AB

AB

AB

@

@

CHARTWELL MOLECULAR

RISING

UNICHEM

EQ 4MG BASE

EQ 5MG BASE

EQ 4MG BASE

EQ 5MG BASE

EQ 4MG BASE

EQ 5MG BASE

A207464

A207464

A209011

A209011

A208621

A208621

001

002

001

002

001

002

Dec 06, 2018

Dec 06, 2018

Apr 18, 2017

Apr 18, 2017

Jul 02, 2018

Jul 02, 2018

Jan CAHN

Jan CAHN

Aug CAHN

Aug CAHN

Aug DISC

Aug DISC

MORPHINE SULFATE

INJECTABLE;INJECTION

MORPHINE SULFATE

AP

AP

AP

AP

AP

AP

AP

AP

AP

HIKMA

+! HOSPIRA INC

SOLUTION;ORAL

MORPHINE SULFATE

2MG/ML

2MG/ML

4MG/ML

4MG/ML

8MG/ML

8MG/ML

10MG/ML

10MG/ML

15MG/ML

15MG/ML

2MG/ML

A211452

A211452

A211452

A211452

A211452

A211452

A211452

A211452

A211452

A211452

N202515

001

001

002

002

003

003

004

004

005

005

001

Jan 12, 2023

Jan 12, 2023

Jan 12, 2023

Jan 12, 2023

Jan 12, 2023

Jan 12, 2023

Jan 12, 2023

Jan 12, 2023

Jan 12, 2023

Jan 12, 2023

Nov 14, 2011

Sep CAHN

Jan NFTG

Sep CAHN

Jan NEWA

Sep CAHN

Jan NEWA

Sep CAHN

Jan NEWA

Sep CAHN

Jan NFTG

Jan CFTG

AA PHARM ASSOC

TABLET;ORAL

MORPHINE SULFATE

10MG/5ML A206573 002 Sep 12, 2023 Sep NEWA

AB

AB

SPECGX LLC 15MG

30MG

A215194

A215194

001

002

Aug 21, 2023

Aug 21, 2023

Aug NEWA

Aug NEWA
RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - December 2023 1-104

TABLET, EXTENDED RELEASE;ORAL

MORPHABOND ER

+

+

+

+

@

@

@

@

OHEMO LIFE 15MG

30MG

60MG

100MG

N206544

N206544

N206544

N206544

001 Oct 02, 2015

002 Oct 02, 2015

003 Oct 02, 2015

004 Oct 02, 2015

Jun CAHN

Jun CAHN

Jun CAHN

Jun CAHN

MOTIXAFORTIDE ACETATE

POWDER;SUBCUTANEOUS

APHEXDA

+! BIOLINERX LTD EQ 62MG BASE/VIAL N217159 001 Sep 08, 2023 Sep NEWA

MOXIFLOXACIN HYDROCHLORIDE

SOLUTION/DROPS;OPHTHALMIC

MOXEZA

AT2

+ @ HARROW EYE EQ 0.5% BASE

+! EQ 0.5% BASE

MOXIFLOXACIN HYDROCHLORIDE

N022428

N022428

001 Nov 19, 2010

001 Nov 19, 2010

Jun DISC

May CAHN

@ AKORN EQ 0.5% BASE

! LUPIN LTD EQ 0.5% BASE

EQ 0.5% BASE

TABLET;ORAL

MOXIFLOXACIN HYDROCHLORIDE

A202916

A204079

A204079

001 Nov 09, 2017

001 May 28, 2015

001 May 28, 2015

Jan DISC

Jun CHRS

Jun CTEC

AB

AB

@

CHARTWELL RX

HETERO LABS LTD V

TORRENT

EQ 400MG BASE

EQ 400MG BASE

EQ 400MG BASE

A207285

A204836

A200160

001 Feb 13, 2017

001 Mar 02, 2023

001 Apr 03, 2014

Apr CAHN

Feb NEWA

Feb DISC

MUPIROCIN CALCIUM

CREAM;TOPICAL

MUPIROCIN

@ PADAGIS ISRAEL EQ 2% BASE A212465 001 Aug 03, 2022 Oct DISC

MYCOPHENOLATE MOFETIL

CAPSULE;ORAL

MYCOPHENOLATE MOFETIL

>A> AB AUROBINDO PHARMA LTD

FOR SUSPENSION;ORAL

MYCOPHENOLATE MOFETIL

250MG A217828 001 Jan 05, 2024 Dec NEWA

AB

AB

AB

AIRIS PHARMA PVT LTD

HETERO LABS LTD V

STRIDES PHARMA

200MG/ML

200MG/ML

200MG/ML

A213955

A213955

A212634

001 Sep 11, 2023

001 Sep 11, 2023

001 Aug 29, 2023

Sep NEWA

Sep CAHN

Aug NEWA

MYCOPHENOLATE MOFETIL HYDROCHLORIDE

INJECTABLE;INJECTION

MYCOPHENOLATE MOFETIL HYDROCHLORIDE

AP BPI LABS 500MG/VIAL A214283 001 Jun 01, 2023 May NEWA

MYCOPHENOLIC SODIUM

TABLET, DELAYED RELEASE;ORAL

MYCOPHENOLIC SODIUM

AB

AB

AIRIS PHARMA PVT LTD EQ 180MG BASE

EQ 360MG BASE

A217031

A217031

001 Nov 29, 2023

002 Nov 29, 2023

Nov NEWA

Nov NEWA

NABUMETONE

TABLET;ORAL

NABUMETONE

@

@

AUROBINDO PHARMA USA 500MG

750MG

A090516

A090516

001 Jul 12, 2010

002 Jul 12, 2010

Apr CAHN

Apr CAHN

NADOLOL

TABLET;ORAL

NADOLOL

AB

AB

AB

AB

AB

AB

@

@

@

ALEMBIC

HERITAGE PHARMA

RK PHARMA

20MG

40MG

80MG

20MG

40MG

80MG

20MG

40MG

80MG

A211763

A211763

A211763

A074229

A074229

A074255

A212856

A212856

A212856

001 Jun 02, 2023

002 Jun 02, 2023

003 Jun 02, 2023

001 Aug 30, 1996

002 Aug 30, 1996

001 Jan 24, 1996

001 Sep 13, 2019

002 Sep 13, 2019

003 Sep 13, 2019

May NEWA

May NEWA

May NEWA

Oct DISC

Oct DISC

Oct DISC

Jun CAHN

Jun CAHN

Jun CAHN
RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 -

NAFCILLIN SODIUM

INJECTABLE;INJECTION

NAFCILLIN SODIUM

AP ! EUGIA PHARMA SPECLTS EQ 1GM BASE/VIAL

AP ! EQ 2GM BASE/VIAL

AP ! EQ 10GM BASE/VIAL

@ SANDOZ EQ 1GM BASE/VIAL

@ EQ 1GM BASE/VIAL

@ EQ 2GM BASE/VIAL

@ EQ 2GM BASE/VIAL

@ EQ 10GM BASE/VIAL

AP STERISCIENCE EQ 1GM BASE/VIAL

AP EQ 2GM BASE/VIAL

NAFTIFINE HYDROCHLORIDE

CREAM;TOPICAL

NAFTIFINE HYDROCHLORIDE

AB AMNEAL 2%

GEL;TOPICAL

NAFTIFINE HYDROCHLORIDE

AB AMNEAL 1%

AB TARO 2%

NAFTIN

AB +! SEBELA IRELAND LTD 2%

+! 2%

NALMEFENE HYDROCHLORIDE

SOLUTION;INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS

NALMEFENE HYDROCHLORIDE

CHENGDU SHUODE EQ 0.1MG BASE/ML (EQ 0.1MG

BASE/ML)

AP EQ 2MG BASE/2ML (EQ 1MG BASE/ML)

AP ! PURDUE PHARMA LP EQ 2MG BASE/2ML (EQ 1MG BASE/ML)

SPRAY;NASAL

OPVEE

+! INDIVIOR EQ 2.7MG BASE/SPRAY

+! OPIANT PHARMS EQ 2.7MG BASE/SPRAY

NALOXEGOL OXALATE

TABLET;ORAL

MOVANTIK

+ VALINOR EQ 12.5MG BASE

+! EQ 25MG BASE

NALOXONE HYDROCHLORIDE

INJECTABLE;INJECTION

NALOXONE HYDROCHLORIDE

AP BPI LABS 1MG/ML

@ CHARTWELL RX 0.4MG/ML

AP HIKMA 1MG/ML

SPRAY, METERED;NASAL

NALOXONE HYDROCHLORIDE

TEVA PHARMS USA 4MG/SPRAY

REXTOVY

+ @ AMPHASTAR PHARMS INC 4MG/SPRAY

+! 4MG/SPRAY

+! 4MG/SPRAY

NAPHAZOLINE HYDROCHLORIDE

SOLUTION/DROPS;OPHTHALMIC

NAPHAZOLINE HYDROCHLORIDE

@ RISING 0.1%

NAPROXEN

TABLET, DELAYED RELEASE;ORAL

NAPROXEN

@ AUROBINDO PHARMA USA 375MG

@ 500MG

AB TULEX PHARMS INC 375MG

AB 500MG

December 

A091613

A091613

A091614

A062527

A062732

A062527

A062732

A062527

A200002

A200002

A206960

A206165

A208201

N204286

N204286

A216007

A216007

A212955

N217470

N217470

N204760

N204760

A216977

A207846

A212300

A209522

N208969

N208969

N208969

A083590

A075390

A075390

A216908

A216908

2023

001

002

001

002

001

003

002

004

001

002

001

001

001

001

001

001

002

001

001

001

001

002

001

001

001

001

001

001

001

001

001

002

001

002

Dec 26, 2012

Dec 26, 2012

Dec 26, 2012

Aug 02, 1984

Dec 23, 1986

Aug 02, 1984

Dec 23, 1986

Aug 02, 1984

Apr 07, 2014

Apr 07, 2014

Apr 10, 2017

Mar 20, 2019

Apr 10, 2019

Jun 27, 2013

Jun 27, 2013

Nov 15, 2023

Nov 15, 2023

Feb 08, 2022

May 22, 2023

May 22, 2023

Sep 16, 2014

Sep 16, 2014

Oct 06, 2023

Dec 17, 2018

Jun 10, 2022

Apr 19, 2019

Mar 07, 2023

Mar 07, 2023

Mar 07, 2023

Apr 19, 2001

Apr 19, 2001

May 31, 2023

May 31, 2023

1-105

Jan CHRS

Jan CHRS

Jan CHRS

Jan DISC

Jan DISC

Jan DISC

Jan DISC

Jan DISC

Oct CMFD

Oct CMFD

Feb CAHN

Feb CAHN

Mar CMFD

May CTEC

Feb CTEC

Nov NFTG

Nov NEWA

Nov NEWA

Jun CAHN

May NEWA

Feb CAHN

Feb CAHN

Sep NEWA

Sep CAHN

Sep CAHN

Jul CTEC

Oct DISC

Jun CTNA

Mar NEWA

Sep CAHN

Apr CAHN

Apr CAHN

May NEWA

May NEWA
RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - December 2023 1-106

NAPROXEN SODIUM

TABLET, EXTENDED RELEASE;ORAL

NAPRELAN

AB

AB

AB

+

+

+!

TWI PHARMS EQ 375MG BASE

EQ 500MG BASE

EQ 750MG BASE

N020353

N020353

N020353

001

002

003

Jan 05, 1996

Jan 05, 1996

Jan 05, 1996

Nov CAHN

Nov CAHN

Nov CAHN

NARATRIPTAN HYDROCHLORIDE

TABLET;ORAL

AMERGE

+

+

@ GLAXOSMITHKLINE LLC

@

NARATRIPTAN

EQ 1MG BASE

EQ 2.5MG BASE

N020763

N020763

002

001

Feb 10, 1998

Feb 10, 1998

Nov DISC

Nov DISC

AB !

@

@

AUROBINDO PHARMA USA

HERITAGE PHARMS

EQ 1MG BASE

EQ 2.5MG BASE

EQ 2.5MG BASE

A202431

A202431

A200502

001

002

002

May 31, 2012

May 31, 2012

Feb 28, 2011

Apr CAHN

Apr CAHN

Nov CHRS

NATAMYCIN

SUSPENSION;OPHTHALMIC

NATACYN

+! HARROW EYE 5% N050514 001 Oct CAHN

NEBIVOLOL HYDROCHLORIDE

TABLET;ORAL

NEBIVOLOL HYDROCHLORIDE

AB

AB

AB

AB

BEXIMCO PHARMS USA EQ 2.5MG BASE

EQ 5MG BASE

EQ 10MG BASE

EQ 20MG BASE

A216568

A216568

A216568

A216568

001

002

003

004

Mar 30, 2023

Mar 30, 2023

Mar 30, 2023

Mar 30, 2023

Mar NEWA

Mar NEWA

Mar NEWA

Mar NEWA

NEDOSIRAN SODIUM

SOLUTION;INJECTION

RIVFLOZA

+!

+!

+!

NOVO EQ 80MG BASE/0.5ML (EQ 160MG

BASE/ML)

EQ 128MG BASE/0.8ML (EQ 160MG

BASE/ML)

EQ 160MG BASE/ML (EQ 160MG

BASE/ML)

N215842

N215842

N215842

001

002

003

Sep 29, 2023

Sep 29, 2023

Sep 29, 2023

Sep NEWA

Sep NEWA

Sep NEWA

NEFAZODONE HYDROCHLORIDE

TABLET;ORAL

NEFAZODONE HYDROCHLORIDE

@

@

@

@

AUROBINDO PHARMA USA 100MG

150MG

200MG

250MG

A076129

A076129

A076129

A076129

002

003

004

005

Sep 16, 2003

Sep 16, 2003

Sep 16, 2003

Sep 16, 2003

Apr CAHN

Apr CAHN

Apr CAHN

Apr CAHN

NELARABINE

INJECTABLE;INTRAVENOUS

ARRANON

AP +! SANDOZ

NELARABINE

250MG/50ML (5MG/ML) N021877 001 Oct 28, 2005 May CAHN

>A>

AP

AP

AP

AMNEAL

GLAND PHARMA LTD

SHORLA

250MG/50ML (5MG/ML)

250MG/50ML (5MG/ML)

250MG/50ML (5MG/ML)

A216346

A212605

A214809

001

001

001

Apr 04, 2023

Jan 03, 2024

Mar 03, 2023

Mar NEWA

Dec NEWA

Feb NEWA

NEOSTIGMINE METHYLSULFATE

SOLUTION;INTRAVENOUS

BLOXIVERZ

+! EXELA PHARMA 5MG/5ML (1MG/ML)

NEOSTIGMINE METHYLSULFATE

N204078 003 Oct 27, 2023 Nov NEWA

AP

AP

AP

AP

AP

AP

AP

AP

EUGIA PHARMA

HIKMA

SAGENT PHARMS INC

UMEDICA

5MG/10ML (0.5MG/ML)

10MG/10ML (1MG/ML)

5MG/10ML (0.5MG/ML)

10MG/10ML (1MG/ML)

5MG/10ML (0.5MG/ML)

10MG/10ML (1MG/ML)

5MG/10ML (0.5MG/ML)

10MG/10ML (1MG/ML)

A213244

A213244

A207042

A207042

A216542

A216542

A212627

A212627

001

002

001

002

001

002

001

002

Nov 02, 2023

Nov 02, 2023

Dec 28, 2015

Dec 28, 2015

Feb 17, 2023

Feb 17, 2023

Nov 03, 2022

Nov 03, 2022

Oct NEWA

Oct NEWA

May CAHN

May CAHN

Feb NEWA

Feb NEWA

Sep CAHN

Sep CAHN
RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - December 2023 1-107

NEPAFENAC

SUSPENSION/DROPS;OPHTHALMIC

ILEVRO

+! HARROW EYE

NEVANAC

0.3% N203491 001 Oct 16, 2012 May CAHN

+! HARROW EYE 0.1% N021862 001 Aug 19, 2005 May CAHN

NETARSUDIL MESYLATE

SOLUTION/DROPS;OPHTHALMIC

RHOPRESSA

+! ALCON LABS INC EQ 0.02% BASE N208254 001 Dec 18, 2017 May CAHN

NEVIRAPINE

TABLET, EXTENDED RELEASE;ORAL

NEVIRAPINE

@ AUROBINDO PHARMA

@

VIRAMUNE XR

100MG

400MG

A208616

A207698

001

001

Nov 23, 2016

Feb 28, 2017

Sep DISC

Sep DISC

+ BOEHRINGER INGELHEIM 100MG N201152 002 Nov 08, 2012 Sep CTEC

NIACIN

TABLET, EXTENDED RELEASE;ORAL

NIACIN

AB

AB

AB

EYWA 500MG

750MG

1GM

A213090

A213090

A213090

001

002

003

Aug 25, 2023

Aug 25, 2023

Aug 25, 2023

Aug NEWA

Aug NEWA

Aug NEWA

NICARDIPINE HYDROCHLORIDE

CAPSULE;ORAL

NICARDIPINE HYDROCHLORIDE

AB

AB

AB

AB

AB

AB

BIONPHARMA 20MG

30MG

SENORES PHARMS 20MG

30MG

SQUARE PHARMS 20MG

30MG

INJECTABLE;INJECTION

NICARDIPINE HYDROCHLORIDE

A217555

A217555

A215377

A215377

A217555

A217555

001

002

001

002

001

002

May 03, 2023

May 03, 2023

Jul 17, 2023

Jul 17, 2023

May 03, 2023

May 03, 2023

Sep CAHN

Sep CAHN

Jul NEWA

Jul NEWA

Apr NEWA

Apr NEWA

AP

AP

+!

@

HIKMA INTL PHARMS

MICRO LABS

SUN PHARM

25MG/10ML (2.5MG/ML)

25MG/10ML (2.5MG/ML)

25MG/10ML (2.5MG/ML)

N022276

A216420

N078405

001

001

001

Jul 24, 2008

Jul 07, 2023

Nov 17, 2009

Jun CTEC

Jun NEWA

Sep DISC

NIFEDIPINE

TABLET, EXTENDED RELEASE;ORAL

NIFEDIPINE

@

@

@

@

PHARMADAX INC

VITRUVIAS

30MG

60MG

30MG

60MG

A216019

A216019

A216019

A216019

001

002

001

002

Nov 18, 2022

Nov 18, 2022

Nov 18, 2022

Nov 18, 2022

Apr DISC

Apr DISC

Sep CAHN

Sep CAHN

NILOTINIB HYDROCHLORIDE

>A>

CAPSULE;ORAL

NILOTINIB HYDROCHLORIDE

>A>

>A>

>A>

AB

AB

AB

APOTEX

TASIGNA

EQ 50MG BASE

EQ 150MG BASE

EQ 200MG BASE

A203640

A203640

A203640

001

002

003

Jan 05, 2024

Jan 05, 2024

Jan 05, 2024

Dec NEWA

Dec NEWA

Dec NEWA

>D>

>A>

>D>

>A>

>D>

>A>

AB

AB

AB

+

+

+

+

+!

+!

NOVARTIS EQ 50MG BASE

EQ 50MG BASE

EQ 150MG BASE

EQ 150MG BASE

EQ 200MG BASE

EQ 200MG BASE

N022068

N022068

N022068

N022068

N022068

N022068

003

003

002

002

001

001

Mar 22, 2018

Mar 22, 2018

Jun 17, 2010

Jun 17, 2010

Oct 29, 2007

Oct 29, 2007

Dec CFTG

Dec CFTG

Dec CFTG

Dec CFTG

Dec CFTG

Dec CFTG

NIRAPARIB TOSYLATE

TABLET;ORAL

ZEJULA

+

+

+!

GLAXOSMITHKLINE EQ 100MG BASE

EQ 200MG BASE

EQ 300MG BASE

N214876

N214876

N214876

001

002

003

Apr 26, 2023

Apr 26, 2023

Apr 26, 2023

Apr NEWA

Apr NEWA

Apr NEWA
RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - December 2023 1-108

NIRMATRELVIR; RITONAVIR

TABLET;ORAL

PAXLOVID (COPACKAGED)

+ PFIZER

+!

150MG;100MG

300MG;100MG

N217188

N217188

001

002

May 25, 2023

May 25, 2023

May NEWA

May NEWA

NIROGACESTAT HYDROBROMIDE

TABLET;ORAL

OGSIVEO

+! SPRINGWORKS EQ 50MG BASE N217677 001 Nov 27, 2023 Nov NEWA

NISOLDIPINE

TABLET, EXTENDED RELEASE;ORAL

NISOLDIPINE

AB

@ AMTA 8.5MG

8.5MG

A216606

A216606

001

001

Apr 10, 2023

Apr 10, 2023

Sep DISC

Mar NEWA

NITISINONE

CAPSULE;ORAL

NITISINONE

AB

AB

AB

AB

AB

AB

AB

AB

AB

ETON

MEDUNIK

ZENARA

2MG

5MG

10MG

20MG

20MG

2MG

5MG

10MG

20MG

A216201

A216201

A216201

A216201

A212390

A216201

A216201

A216201

A216201

001

002

003

004

004

001

002

003

004

May 25, 2023

May 25, 2023

May 25, 2023

May 25, 2023

Apr 27, 2023

May 25, 2023

May 25, 2023

May 25, 2023

May 25, 2023

Oct CAHN

Oct CAHN

Oct CAHN

Oct CAHN

Apr NEWA

May NEWA

May NEWA

May NEWA

May NEWA

NITRIC OXIDE

GAS;INHALATION

GENOSYL

+! VERO BIOTECH INC

ULSPIRA

800PPM N202860 001 Dec 20, 2019 Jan CAHN

AA AIRGAS THERAP 800PPM A203144 001 Jul 27, 2023 Jul NEWA

NITROFURANTOIN

SUSPENSION;ORAL

FURADANTIN

AB + CASPER PHARMA LLC

+!

NITROFURANTOIN

25MG/5ML

50MG/5ML

N009175

N009175

001

002 Jun 09, 2023

Jun CHRS

Jun NEWA

AB

AB

AB

AMNEAL PHARMS

AUROBINDO PHARMA

NOVITIUM PHARMA

TABLET;ORAL

FURALAN

25MG/5ML

25MG/5ML

25MG/5ML

A201679

A212607

A216385

001

001

001

May 11, 2011

May 11, 2023

Apr 14, 2023

Nov CMFD

May NEWA

Apr NEWA

@ CHARTWELL MOLECULAR

@

50MG

100MG

A080017

A080017

001

002

Jul CAHN

Jul CAHN

NITROFURANTOIN, MACROCRYSTALLINE

CAPSULE;ORAL

NITROFURANTOIN

AB

AB

AB

AB

AB

AB

AUROBINDO PHARMA USA

MANKIND PHARMA

50MG

100MG

100MG

25MG

50MG

100MG

A074967

A074967

A077025

A217272

A217272

A217272

001

002

001

001

002

003

Jul 09, 1997

Jul 09, 1997

Aug 18, 2004

Mar 21, 2023

Mar 21, 2023

Mar 21, 2023

Apr CMFD

Apr CMFD

May CMFD

Mar NEWA

Mar NEWA

Mar NEWA

AB

AB

AB

NITROFURANTOIN; NITROFURANTOIN, MACROCRYSTALLINE

CAPSULE;ORAL

NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)

@ ALVOGEN 75MG;25MG

AUROBINDO PHARMA 75MG;25MG

MANKIND PHARMA 75MG;25MG

OMSAV PHARMA 75MG;25MG

A215002

A209225

A217357

A217073

001

001

001

001

Jul 20, 2022

Mar 30, 2023

Jul 11, 2023

Nov 03, 2023

Jan DISC

Mar NEWA

Jun NEWA

Oct NEWA
RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - December 2023 1-109

NITROGLYCERIN

INJECTABLE;INJECTION

NITROGLYCERIN IN DEXTROSE 5%

+! BAXTER HLTHCARE

+!

+!

OINTMENT;TRANSDERMAL

NITROGLYCERIN

10MG/100ML

20MG/100ML

40MG/100ML

N019970

N019970

N019970

001

002

003

Dec 29, 1989

Dec 29, 1989

Dec 29, 1989

May CTEC

May CTEC

May CTEC

+! FOUGERA PHARMS INC

TABLET;SUBLINGUAL

NITROGLYCERIN

2% A087355 001 Jul 08, 1988 May CRLD

AB

AB

AB

AB

AB

AB

AUROBINDO PHARMA

MANKIND PHARMA

0.3MG

0.4MG

0.6MG

0.3MG

0.4MG

0.6MG

A217879

A217879

A217879

A217970

A217970

A217970

001

002

003

001

002

003

Oct 26, 2023

Oct 26, 2023

Oct 26, 2023

Dec 05, 2023

Dec 05, 2023

Dec 05, 2023

Oct NEWA

Oct NEWA

Oct NEWA

Nov NEWA

Nov NEWA

Nov NEWA

NOREPINEPHRINE BITARTRATE

INJECTABLE;INJECTION

NOREPINEPHRINE BITARTRATE

>D>

>A>

AP

AP

AP

AP

CAPLIN EQ 1MG BASE/ML

HONG KONG EQ 1MG BASE/ML

EQ 1MG BASE/ML

MEITHEAL EQ 1MG BASE/ML

SOLUTION;INTRAVENOUS

NOREPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDE

A217575

A040455

A040455

A040455

001

001

001

001

Sep 15, 2023

Mar 03, 2003

Mar 03, 2003

Mar 03, 2003

Sep NEWA

Dec CAHN

Oct CAHN

Dec CAHN

+

+

+

+

+

+

@ LONG GROVE PHARMS EQ 4MG BASE/250 ML (EQ 16MCG

BASE/ML)

@ EQ 8MG BASE/250ML (EQ 32MCG

BASE/ML)

@ EQ 16MG BASE/250ML (EQ 64MCG

BASE/ML)

@ NEVAKAR INJECTABLES EQ 4MG BASE/250 ML (EQ 16MCG

BASE/ML)

@ EQ 8MG BASE/250ML (EQ 32MCG

BASE/ML)

@ EQ 16MG BASE/250ML (EQ 64MCG

BASE/ML)

NOREPINEPHRINE BITARTRATE IN 5% DEXTROSE

N214628

N214628

N214628

N214628

N214628

N214628

001

002

003

001

002

003

Oct 06, 2022

Oct 06, 2022

Oct 06, 2022

Oct 06, 2022

Oct 06, 2022

Oct 06, 2022

May CAHN

May CAHN

May CAHN

Apr DISC

Apr DISC

Apr DISC

+! BAXTER HLTHCARE CORP EQ 16MG BASE/250ML (EQ 64MCG

BASE/ML)

N214313 003 Nov 21, 2023 Nov NEWA

NORTRIPTYLINE HYDROCHLORIDE

SOLUTION;ORAL

NORTRIPTYLINE HYDROCHLORIDE

AA

AA

! PHARM ASSOC

RUBICON

EQ 10MG BASE/5ML

EQ 10MG BASE/5ML

A075606

A217731

001

001

Aug 23, 2000

Aug 15, 2023

Aug CTEC

Aug NEWA

NYSTATIN

OINTMENT;TOPICAL

NYSTATIN

@ TORRENT

POWDER;TOPICAL

NYSTATIN

100,000 UNITS/GM A211838 001 Jan 28, 2019 Mar DISC

AT BEOWULF ASSET

SUSPENSION;ORAL

NILSTAT

100,000 UNITS/GM A065175 001 Dec 17, 2004 Sep CAHN

+ @ CHARTWELL MOLECULES

NYSTATIN

100,000 UNITS/ML N050299 001 Apr CAHN

AA MLV

@ VISTAPHARM

@

100,000 UNITS/ML

100,000 UNITS/ML

100,000 UNITS/ML

A062832

A064142

A064142

001

001

002

Dec 27, 1991

Jun 25, 1998

Mar 07, 2011

Oct CAHN

Oct DISC

Oct DISC

NYSTATIN; TRIAMCINOLONE ACETONIDE

CREAM;TOPICAL

NYSTATIN AND TRIAMCINOLONE ACETONIDE

@ TORRENT 100,000 UNITS/GM;0.1%

OINTMENT;TOPICAL

NYSTATIN AND TRIAMCINOLONE ACETONIDE

A213142 001 Jul 14, 2020 Aug DISC

AT

@

EPIC PHARMA LLC

PAI HOLDINGS PHARM

100,000 UNITS/GM;0.1%

100,000 UNITS/GM;0.1%

A207217

A208287

001

001

Aug 04, 2017

Dec 30, 2016

Oct CAHN

Aug DISC
RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - December 2023 1-110

OBETICHOLIC ACID

TABLET;ORAL

OBETICHOLIC ACID

AB

AB

AB

AB

AB

AB

@ APOTEX

@

@ LUPIN LTD

@

@ MSN

@

OCALIVA

5MG

5MG

10MG

10MG

5MG

5MG

10MG

10MG

5MG

5MG

10MG

10MG

A214862

A214862

A214862

A214862

A214980

A214980

A214980

A214980

A215017

A215017

A215017

A215017

001

001

002

002

001

001

002

002

001

001

002

002

May 30, 2023

May 30, 2023

May 30, 2023

May 30, 2023

May 30, 2023

May 30, 2023

May 30, 2023

May 30, 2023

May 30, 2023

May 30, 2023

May 30, 2023

May 30, 2023

Sep DISC

May NFTG

Sep DISC

May NFTG

Oct DISC

May NFTG

Oct DISC

May NFTG

Jun DISC

May NFTG

Jun DISC

May NFTG

AB

AB

+

+

+!

+!

INTERCEPT PHARMS INC 5MG

5MG

10MG

10MG

N207999

N207999

N207999

N207999

001

001

002

002

May 27, 2016

May 27, 2016

May 27, 2016

May 27, 2016

Oct CTEC

May CFTG

Oct CTEC

May CFTG

OCTREOTIDE ACETATE

CAPSULE, DELAYED RELEASE;ORAL

MYCAPSSA

>D>

>A>

+! AMRYT

+! CHIESI

INJECTABLE;INJECTION

OCTREOTIDE ACETATE

EQ 20MG BASE

EQ 20MG BASE

N208232

N208232

001

001

Jun 26, 2020

Jun 26, 2020

Dec CAHN

Dec CAHN

>D>

>D>

>D>

>D>

>D>

>A>

>A>

>A>

>A>

>A>

AP

AP

AP

AP

AP

AP

AP

AP

AP

AP

AP

AP

AP

AP

AP

AP

AP

AP

AP

AP

AP

AP

GLAND PHARMA LTD

HONG KONG

MEITHEAL

TEVA PHARMS USA INC

SANDOSTATIN LAR

EQ 0.1MG BASE/ML

EQ 0.2MG BASE/ML

EQ 0.5MG BASE/ML

EQ 1MG BASE/ML

EQ 0.05MG BASE/ML

EQ 0.05MG BASE/ML

EQ 0.1MG BASE/ML

EQ 0.1MG BASE/ML

EQ 0.2MG BASE/ML

EQ 0.2MG BASE/ML

EQ 0.5MG BASE/ML

EQ 0.5MG BASE/ML

EQ 1MG BASE/ML

EQ 1MG BASE/ML

EQ 0.05MG BASE/ML

EQ 0.1MG BASE/ML

EQ 0.2MG BASE/ML

EQ 0.5MG BASE/ML

EQ 1MG BASE/ML

EQ 10MG BASE/VIAL

EQ 20MG BASE/VIAL

EQ 30MG BASE/VIAL

A216839

A216807

A216839

A216807

A075957

A075957

A075957

A075957

A075959

A075959

A075957

A075957

A075959

A075959

A075957

A075957

A075959

A075957

A075959

A210317

A210317

A210317

002

001

001

002

001

001

002

002

001

001

003

003

002

002

001

002

001

003

002

001

002

003

Jun 22, 2023

Jun 13, 2023

Jun 22, 2023

Jun 13, 2023

Oct 03, 2005

Oct 03, 2005

Oct 03, 2005

Oct 03, 2005

Nov 21, 2005

Nov 21, 2005

Oct 03, 2005

Oct 03, 2005

Nov 21, 2005

Nov 21, 2005

Oct 03, 2005

Oct 03, 2005

Nov 21, 2005

Oct 03, 2005

Nov 21, 2005

Dec 05, 2023

Dec 05, 2023

Dec 05, 2023

Jun NEWA

Jun NEWA

Jun NEWA

Jun NEWA

Dec CAHN

Oct CAHN

Dec CAHN

Oct CAHN

Dec CAHN

Oct CAHN

Dec CAHN

Oct CAHN

Dec CAHN

Oct CAHN

Dec CAHN

Dec CAHN

Dec CAHN

Dec CAHN

Dec CAHN

Nov NFTG

Nov NFTG

Nov NFTG

AP

AP

AP

+

+

+!

NOVARTIS EQ 10MG BASE/VIAL

EQ 20MG BASE/VIAL

EQ 30MG BASE/VIAL

N021008

N021008

N021008

001

002

003

Nov 25, 1998

Nov 25, 1998

Nov 25, 1998

Nov CFTG

Nov CFTG

Nov CFTG

OFLOXACIN

SOLUTION/DROPS;OPHTHALMIC

OFLOXACIN

AT SENTISS

SOLUTION/DROPS;OTIC

OFLOXACIN

0.3% A076407 001 Apr 15, 2008 Aug CAHN

>A> AT CAPLIN 0.3% A217903 001 Jan 05, 2024 Dec NEWA

OLANZAPINE

INJECTABLE;INTRAMUSCULAR

OLANZAPINE

AP ASPIRO

ZYPREXA

10MG/VIAL A217466 001 Mar 22, 2023 Mar NEWA

AP +! CHEPLAPHARM 10MG/VIAL N021253 001 Mar 29, 2004 Nov CAHN
RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - December 2023 1-111

TABLET;ORAL

OLANZAPINE

AB

AB

AB

AB

AB

AB

CADILA PHARMS LTD

ZYPREXA

2.5MG

5MG

7.5MG

10MG

15MG

20MG

A210022

A210022

A210022

A210022

A210022

A210022

001

002

003

004

005

006

Feb 24, 2023

Feb 24, 2023

Feb 24, 2023

Feb 24, 2023

Feb 24, 2023

Feb 24, 2023

Feb NEWA

Feb NEWA

Feb NEWA

Feb NEWA

Feb NEWA

Feb NEWA

AB

AB

AB

AB

AB

AB

+ CHEPLAPHARM 2.5MG

+! 5MG

+ 7.5MG

+ 10MG

+ 15MG

+ 20MG

TABLET, ORALLY DISINTEGRATING;ORAL

OLANZAPINE

N020592

N020592

N020592

N020592

N020592

N020592

001

002

003

004

005

006

Sep 30, 1996

Sep 30, 1996

Sep 30, 1996

Sep 30, 1996

Sep 09, 1997

Sep 09, 1997

Sep CAHN

Sep CAHN

Sep CAHN

Sep CAHN

Sep CAHN

Sep CAHN

AB

AB

AB

AB

AB

AB

AB

AB

HISUN PHARM HANGZHOU

@ ZYDUS PHARMS

@

@

@

ZYPREXA ZYDIS

5MG

10MG

15MG

20MG

5MG

5MG

10MG

10MG

15MG

15MG

20MG

20MG

A206892

A206892

A206892

A206892

A202889

A202889

A202889

A202889

A202889

A202889

A202889

A202889

001

002

003

004

001

001

002

002

003

003

004

004

Dec 31, 2020

Dec 31, 2020

Dec 31, 2020

Dec 31, 2020

Mar 09, 2023

Mar 09, 2023

Mar 09, 2023

Mar 09, 2023

Mar 09, 2023

Mar 09, 2023

Mar 09, 2023

Mar 09, 2023

Apr CMFD

Apr CMFD

Apr CMFD

Apr CMFD

Jul DISC

Mar NEWA

Jul DISC

Mar NEWA

Jul DISC

Mar NEWA

Jul DISC

Mar NEWA

AB

AB

AB

AB

+!

+

+

+

CHEPLAPHARM 5MG

10MG

15MG

20MG

N021086

N021086

N021086

N021086

001

002

003

004

Apr 06, 2000

Apr 06, 2000

Apr 06, 2000

Apr 06, 2000

Sep CAHN

Sep CAHN

Sep CAHN

Sep CAHN

OLANZAPINE PAMOATE

SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR

ZYPREXA RELPREVV

+

+

+

+

+!

+!

CHEPLAPHARM EQ 210MG BASE/VIAL

EQ 210MG BASE/VIAL

EQ 300MG BASE/VIAL

EQ 300MG BASE/VIAL

EQ 405MG BASE/VIAL

EQ 405MG BASE/VIAL

N022173

N022173

N022173

N022173

N022173

N022173

001

001

002

002

003

003

Dec 11, 2009

Dec 11, 2009

Dec 11, 2009

Dec 11, 2009

Dec 11, 2009

Dec 11, 2009

Sep CAHN

Aug CAHN

Sep CAHN

Aug CAHN

Sep CAHN

Aug CAHN

OLMESARTAN MEDOXOMIL

TABLET;ORAL

OLMESARTAN MEDOXOMIL

AB

AB

AB

AB

AB

AB

@

@

@

@

@

@

AMNEAL

MSN

TORRENT

5MG

5MG

20MG

20MG

40MG

40MG

5MG

20MG

40MG

5MG

20MG

40MG

A207480

A207480

A207480

A207480

A207480

A207480

A217399

A217399

A217399

A202375

A202375

A202375

001

001

002

002

003

003

001

002

003

001

002

003

Jul 11, 2023

Jul 11, 2023

Jul 11, 2023

Jul 11, 2023

Jul 11, 2023

Jul 11, 2023

Jan 18, 2023

Jan 18, 2023

Jan 18, 2023

Apr 24, 2017

Apr 24, 2017

Apr 24, 2017

Oct DISC

Jun NEWA

Oct DISC

Jun NEWA

Oct DISC

Jun NEWA

Jan NEWA

Jan NEWA

Jan NEWA

Aug DISC

Aug DISC

Aug DISC

OLOPATADINE HYDROCHLORIDE

SOLUTION/DROPS;OPHTHALMIC

OLOPATADINE HYDROCHLORIDE

@ FLORIDA EQ 0.7% BASE

SPRAY, METERED;NASAL

OLOPATADINE HYDROCHLORIDE

A208637 001 Feb 19, 2020 Nov CAHN

AB ! AMNEAL

PATANASE

0.665MG/SPRAY A210901 001 Jan 28, 2020 May CHRS

+ @ NOVARTIS 0.665MG/SPRAY N021861 001 Apr 15, 2008 May DISC
RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - December 2023 1-112

OMAVELOXOLONE

CAPSULE;ORAL

SKYCLARYS

+! REATA PHARMS 50MG N216718 001 Feb 28, 2023 Feb NEWA

OMEGA-3-ACID ETHYL ESTERS

CAPSULE;ORAL

OMEGA-3-ACID ETHYL ESTERS

>A> AB SLAYBACK PHARMA LLC 1GM CONTAINS AT LEAST 900MG OF THE

ETHYL ESTERS OF OMEGA-3 FATTY

A211345 001 Dec 07, 2023 Dec NEWA

ACIDS

OMEPRAZOLE; SODIUM BICARBONATE

CAPSULE;ORAL

OMEPRAZOLE AND SODIUM BICARBONATE

AB

AB

ANDA REPOSITORY 20MG;1.1GM

40MG;1.1GM

A212587

A212587

001

002

Apr 30, 2020

Apr 30, 2020

Sep CAHN

Sep CAHN

OMIDENEPAG ISOPROPYL

SOLUTION;OPHTHALMIC

OMLONTI

+

+

@

@

SANTEN

VISIOX PHARMA

0.002%

0.002%

N215092

N215092

001

001

Sep 22, 2022

Sep 22, 2022

May DISC

Nov CAHN

ONDANSETRON

TABLET, ORALLY DISINTEGRATING;ORAL

ONDANSETRON

AB

AB

!

!

CHARTWELL MOLECULES

IPCA LABS LTD

16MG

24MG

4MG

8MG

A077406

A077406

A209389

A209389

001

002

001

002

Dec 26, 2006

Dec 26, 2006

Oct 30, 2023

Oct 30, 2023

Mar CHRS

Mar CHRS

Oct NEWA

Oct NEWA

ONDANSETRON HYDROCHLORIDE

INJECTABLE;INJECTION

ZOFRAN

+ @ SANDOZ EQ 2MG BASE/ML

ZOFRAN PRESERVATIVE FREE

N020007 001 Jan 04, 1991 May CAHN

+ @ SANDOZ EQ 2MG BASE/ML

SOLUTION;ORAL

ONDANSETRON HYDROCHLORIDE

N020007 003 Dec 10, 1993 May CAHN

AA CHARTWELL MOLECULAR

ZOFRAN

EQ 4MG BASE/5ML A091342 001 Jan 27, 2011 Jul CAHN

+ @ SANDOZ EQ 4MG BASE/5ML

TABLET;ORAL

ONDANSETRON HYDROCHLORIDE

N020605 001 Jan 24, 1997 May CAHN

!

@ CASI PHARMS INC

@

CHARTWELL MOLECULES

ZOFRAN

EQ 4MG BASE

EQ 8MG BASE

EQ 24MG BASE

A077517

A077517

A077303

001

002

004

Jun 25, 2007

Jun 25, 2007

Jun 25, 2007

Nov DISC

Nov DISC

Feb CTEC

+

+

+

@

@

@

SANDOZ EQ 4MG BASE

EQ 8MG BASE

EQ 24MG BASE

N020103

N020103

N020103

001

002

003

Dec 31, 1992

Dec 31, 1992

Aug 27, 1999

May CAHN

May CAHN

May CAHN

ORPHENADRINE CITRATE

TABLET, EXTENDED RELEASE;ORAL

ORPHENADRINE CITRATE

AB

AB

AB

! LUPIN

RISING

SANDOZ

100MG

100MG

100MG

A040284

A040249

A040327

001

001

001

Jun 19, 1998

Jan 29, 1999

Feb 15, 2000

Nov CHRS

Jan CAHN

Nov CHRS

OSELTAMIVIR PHOSPHATE

CAPSULE;ORAL

OSELTAMIVIR PHOSPHATE

AB

AB

AB

AB

AB

@

@

@

ACCORD HLTHCARE

HAINAN POLY

INVAGEN PHARMS

SUNSHINE

EQ 30MG BASE

EQ 45MG BASE

EQ 75MG BASE

EQ 75MG BASE

EQ 30MG BASE

EQ 45MG BASE

EQ 75MG BASE

EQ 30MG BASE

A214726

A214726

A214726

A218009

A217467

A217467

A217467

A212739

001

002

003

001

001

002

003

001

Jul 25, 2022

Jul 25, 2022

Jul 25, 2022

Nov 24, 2023

Oct 03, 2023

Oct 03, 2023

Oct 03, 2023

Mar 04, 2020

Feb DISC

Feb DISC

Feb DISC

Nov NEWA

Sep NEWA

Sep NEWA

Sep NEWA

Jun CMFD
RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - December 2023 1-113

CAPSULE;ORAL

OSELTAMIVIR PHOSPHATE

AB

AB

EQ 45MG BASE

EQ 75MG BASE

A212739

A212739

002 Mar 04, 2020

003 Mar 04, 2020

Jun CMFD

Jun CMFD

FOR SUSPENSION;ORAL

OSELTAMIVIR PHOSPHATE

AB

@ CHEMISTRY HLTH

EPIC PHARMA LLC

EQ 6MG BASE/ML

EQ 6MG BASE/ML

A214949

A215538

001 Feb 28, 2022

001 Feb 14, 2023

Sep CAHN

Feb NEWA

OSILODROSTAT PHOSPHATE

TABLET;ORAL

ISTURISA

+ @ RECORDATI RARE EQ 10MG BASE N212801 003 Mar 06, 2020 Jul DISC

OXACILLIN SODIUM

INJECTABLE;INJECTION

OXACILLIN SODIUM

@ PIRAMAL CRITICAL EQ 10GM BASE/VIAL A206760 001 Oct 26, 2017 Sep DISC

OXAPROZIN

CAPSULE;ORAL

COXANTO

+! SOLUBIOMIX 300MG N217927 001 Oct 20, 2023 Oct NEWA

OXCARBAZEPINE

SUSPENSION;ORAL

OXCARBAZEPINE

>D>

>A>

AB

AB

AB

AB

AB

CHARTWELL RX

HETERO LABS LTD III

HIKMA

@

OAK TREE PHARMA

@ RENEW PHARMS

TABLET;ORAL

OXCARBAZEPINE

300MG/5ML

300MG/5ML

300MG/5ML

300MG/5ML

300MG/5ML

300MG/5ML

300MG/5ML

A212428

A216749

A201193

A201193

A211420

A211420

A211420

001 Jun 21, 2021

001 Oct 20, 2023

001 Oct 03, 2012

001 Oct 03, 2012

001 Jul 09, 2021

001 Jul 09, 2021

001 Jul 09, 2021

May CAHN

Oct NEWA

Dec DISC

Dec DISC

Aug CAHN

Sep DISC

Aug CAHN

AB

AB

AB

ZYDUS 150MG

300MG

600MG

A211747

A211747

A211747

001 Jul 03, 2023

002 Jul 03, 2023

003 Jul 03, 2023

Jun NEWA

Jun NEWA

Jun NEWA

TABLET, EXTENDED RELEASE;ORAL

OXCARBAZEPINE

AB

AB

AB

@ APOTEX

@

@

OXTELLAR XR

150MG

150MG

300MG

300MG

600MG

600MG

A213369

A213369

A213369

A213369

A213369

A213369

001 Jul 13, 2023

001 Jul 13, 2023

002 Jul 13, 2023

002 Jul 13, 2023

003 Jul 13, 2023

003 Jul 13, 2023

Sep DISC

Jul NFTG

Sep DISC

Jul NFTG

Sep DISC

Jul NFTG

AB

AB

AB

+

+

+

+

+!

+!

SUPERNUS PHARMS 150MG

150MG

300MG

300MG

600MG

600MG

N202810

N202810

N202810

N202810

N202810

N202810

001 Oct 19, 2012

001 Oct 19, 2012

002 Oct 19, 2012

002 Oct 19, 2012

003 Oct 19, 2012

003 Oct 19, 2012

Sep CTEC

Jul CFTG

Sep CTEC

Jul CFTG

Sep CTEC

Jul CFTG

OXYBUTYNIN CHLORIDE

GEL;TRANSDERMAL

GELNIQUE

+ @ ABBVIE

+!

SYRUP;ORAL

OXYBUTYNIN CHLORIDE

10% (100MG/PACKET)

10% (100MG/PACKET)

N022204

N022204

001 Jan 27, 2009

001 Jan 27, 2009

Sep DISC

Apr CAHN

AA CHARTWELL RX

@ PHARMOBEDIENT CNSLTG

@ XTTRIUM LABS INC

TABLET;ORAL

OXYBUTYNIN CHLORIDE

5MG/5ML

5MG/5ML

5MG/5ML

A075039

A074868

A074868

001 Jan 29, 1999

001 Feb 12, 1997

001 Feb 12, 1997

Mar CMFD

Sep CAHN

Mar CAHN

AB

AB

! APPCO

@ AVET LIFESCIENCES

! RISING

2.5MG

5MG

5MG

2.5MG

5MG

A209025

A211682

A211682

A209025

A209025

002 Feb 07, 2023

001 May 10, 2019

001 May 10, 2019

002 Feb 07, 2023

001 Dec 21, 2017

Jan NFTG

Nov DISC

Jun CTEC

Sep CAHN

Sep CAHN
RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - December 2023 1-114

TABLET, EXTENDED RELEASE;ORAL

DITROPAN XL

+

+

@

@

JANSSEN PHARMS 5MG

10MG

N020897

N020897

001

002

Dec 16, 1998

Dec 16, 1998

Sep DISC

Sep DISC

OXYCODONE HYDROCHLORIDE

SOLUTION;ORAL

OXYCODONE HYDROCHLORIDE

>D>

>D>

>D>

>A>

>D>

>A>

>A>

>A>

AA

AA

AA

AA

AA

AA

AA

EYWA

HIKMA

!

@ PHARMOBEDIENT CNSLTG

+! VISTAPHARM

+ @

@

WES PHARMA INC

TABLET;ORAL

OXAYDO

5MG/5ML

100MG/5ML

5MG/5ML

5MG/5ML

5MG/5ML

5MG/5ML

5MG/5ML

100MG/5ML

5MG/5ML

100MG/5ML

A207511

A209897

A204037

A204037

A206456

N201194

N201194

A202537

A207511

A209897

001

001

001

001

001

001

001

001

001

001

Nov 23, 2016

Sep 06, 2017

Jul 15, 2013

Jul 15, 2013

Jun 16, 2015

Jan 12, 2012

Jan 12, 2012

Jul 30, 2012

Nov 23, 2016

Sep 06, 2017

Dec CAHN

Dec CAHN

Dec CHRS

Dec CHRS

Sep CAHN

Dec DISC

Dec DISC

Sep DISC

Dec CAHN

Dec CAHN

+ @ ZYLA

+ @

ROXYBOND

5MG

7.5MG

N202080

N202080

001

002

Jun 17, 2011

Jun 17, 2011

Sep DISC

Sep DISC

>D>

>A>

>D>

>A>

>D>

>A>

PROTEGA PHARMS 5MG

5MG

15MG

15MG

30MG

30MG

N209777

N209777

N209777

N209777

N209777

N209777

001

001

002

002

003

003

Apr 20, 2017

Apr 20, 2017

Apr 20, 2017

Apr 20, 2017

Apr 20, 2017

Apr 20, 2017

Dec CAHN

Dec CAHN

Dec CAHN

Dec CAHN

Dec CAHN

Dec CAHN

OXYMETAZOLINE HYDROCHLORIDE

CREAM;TOPICAL

RHOFADE

+! MAYNE PHARMA 1% N208552 001 Jan 18, 2017 Sep CAHN

OXYMORPHONE HYDROCHLORIDE

TABLET;ORAL

OXYMORPHONE HYDROCHLORIDE

>D>

>A>

>D>

>A>

AB

AB

@

@

SPECGX LLC 5MG

5MG

10MG

10MG

A202321

A202321

A202321

A202321

001

001

002

002

Apr 25, 2013

Apr 25, 2013

Apr 25, 2013

Apr 25, 2013

Dec DISC

Dec DISC

Dec DISC

Dec DISC

PACLITAXEL

INJECTABLE;INJECTION

PACLITAXEL

@ DASH PHARMS

POWDER;INTRAVENOUS

PACLITAXEL

6MG/ML A091540 001 Sep 29, 2011 Feb CAHN

+! AM REGENT 100MG/VIAL N211875 001 Jul 27, 2022 Apr CAHN

PALBOCICLIB

TABLET;ORAL

IBRANCE

AB

AB

AB

+ PFIZER

+

+!

PALBOCICLIB

75MG

100MG

125MG

N212436

N212436

N212436

001

002

003

Nov 01, 2019

Nov 01, 2019

Nov 01, 2019

Aug CFTG

Aug CFTG

Aug CFTG

AB

AB

AB

SYNTHON PHARMS INC 75MG

100MG

125MG

A215570

A215570

A215570

001

002

003

Aug 28, 2023

Aug 28, 2023

Aug 28, 2023

Aug NFTG

Aug NFTG

Aug NFTG

PALIPERIDONE

TABLET, EXTENDED RELEASE;ORAL

PALIPERIDONE

AB

AB

AB

AB

ASCENT PHARMS INC 1.5MG

3MG

6MG

9MG

A216174

A216174

A216174

A216174

001

002

003

004

Aug 23, 2023

Aug 23, 2023

Aug 23, 2023

Aug 23, 2023

Aug NEWA

Aug NEWA

Aug NEWA

Aug NEWA
RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - December 2023 1-115

PALONOSETRON HYDROCHLORIDE

INJECTABLE;INTRAVENOUS

PALONOSETRON HYDROCHLORIDE

AP

AP

>A>

>A>

>D>

>D>

AP2

AP2

AP1

AP1

AP2

AP

AP2

AP

AP2

AP2

AP1

AP1

AB

AB

AB

AP

>A> AB

>A> AB

AA

CHARTWELL RX EQ 0.25MG BASE/5ML (EQ 0.05MG

BASE/ML)

@ CIPLA EQ 0.25MG BASE/5ML (EQ 0.05MG

BASE/ML)

@ INGENUS PHARMS LLC EQ 0.25MG BASE/5ML (EQ 0.05MG

BASE/ML)

NANJING KING-FRIEND EQ 0.25MG BASE/5ML (EQ 0.05MG

BASE/ML)

@ NOVAST LABS EQ 0.25MG BASE/5ML (EQ 0.05MG

BASE/ML)

SOLUTION;INTRAVENOUS

A209287

A206396

A208789

A215861

A208789

001

001

001

001

001

PALONOSETRON HYDROCHLORIDE

@ AVYXA PHARMA EQ 0.075MG BASE/1.5ML (EQ 0.05MG N203050 001

BASE/ML)

@ EQ 0.25MG BASE/5ML (EQ 0.05MG N203050 002

BASE/ML)

@ DR REDDYS EQ 0.075MG BASE/1.5ML (EQ 0.05MG N203050 001

BASE/ML)

@ EQ 0.25MG BASE/5ML (EQ 0.05MG N203050 002

BASE/ML)

@ HIKMA EQ 0.25MG BASE/2ML (EQ 0.125MG

BASE/ML)

PALOVAROTENE

N207963 001

CAPSULE;ORAL

SOHONOS

+ IPSEN INC 1MG N215559 001

+ 1.5MG N215559 002

+ 2.5MG N215559 003

+ 5MG N215559 004

+! 10MG

PAMIDRONATE DISODIUM

N215559 005

INJECTABLE;INJECTION

PAMIDRONATE DISODIUM

DR REDDYS 30MG/10ML (3MG/ML) A078156 001

90MG/10ML (9MG/ML) A078156 003

+! HIKMA 30MG/10ML (3MG/ML) N021113 001

+! 90MG/10ML (9MG/ML) N021113 002

HOSPIRA 30MG/10ML (3MG/ML) A075841 001

30MG/10ML (3MG/ML) A075841 001

90MG/10ML (9MG/ML) A075841 003

90MG/10ML (9MG/ML) A075841 003

MYLAN LABS LTD 30MG/10ML (3MG/ML) A078520 001

90MG/10ML (9MG/ML) A078520 002

SAGENT PHARMS INC 30MG/10ML (3MG/ML) A078373 001

90MG/10ML (9MG/ML) A078373 002

PANTOPRAZOLE SODIUM

FOR SUSPENSION, DELAYED RELEASE;ORAL

PANTOPRAZOLE SODIUM

AJANTA PHARMA LTD EQ 40MG BASE A217416 001

ANNORA PHARMA EQ 40MG BASE A216139 001

DEXCEL EQ 40MG BASE A216247 001

INJECTABLE;INTRAVENOUS

PANTOPRAZOLE SODIUM

KNACK EQ 40MG BASE/VIAL

TABLET, DELAYED RELEASE;ORAL

A214680 001

PANTOPRAZOLE SODIUM

GRANULES EQ 20MG BASE A217282 001

EQ 40MG BASE A217282 002

PAROMOMYCIN SULFATE

CAPSULE;ORAL

PAROMOMYCIN SULFATE

! HERITAGE PHARMS EQ 250MG BASE A065173 001

! EQ 250MG BASE A065173 001

@ SUN PHARM INDS INC EQ 250MG BASE A064171 001

Sep 19, 2018

Sep 19, 2018

May 22, 2020

Aug 14, 2023

May 22, 2020

Mar 01, 2016

Mar 01, 2016

Mar 01, 2016

Mar 01, 2016

Aug 22, 2016

Aug 16, 2023

Aug 16, 2023

Aug 16, 2023

Aug 16, 2023

Aug 16, 2023

Aug 19, 2008

Aug 19, 2008

Mar 04, 2002

Mar 04, 2002

Jun 27, 2002

Jun 27, 2002

Jun 27, 2002

Jun 27, 2002

Oct 31, 2008

Oct 31, 2008

Dec 23, 2008

Dec 23, 2008

Feb 09, 2023

Oct 27, 2023

Jun 16, 2023

May 19, 2022

Dec 11, 2023

Dec 11, 2023

Dec 14, 2007

Dec 14, 2007

Jun 30, 1997

Sep CAHN

Feb DISC

Feb DISC

Aug NEWA

Sep CAHN

Dec CAHN

Dec CAHN

Dec CAHN

Dec CAHN

Sep DISC

Aug NEWA

Aug NEWA

Aug NEWA

Aug NEWA

Aug NEWA

May CTEC

May CTEC

May CTEC

May CTEC

May CTEC

Apr CHRS

May CTEC

Apr CHRS

May CTEC

May CTEC

May CTEC

May CTEC

Feb NEWA

Oct NEWA

Jun NEWA

Sep CMFD

Dec NEWA

Dec NEWA

Nov CTEC

Nov CHRS

Nov DISC
RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - December 2023 1-116

PAROXETINE HYDROCHLORIDE

TABLET, EXTENDED RELEASE;ORAL

PAROXETINE HYDROCHLORIDE

>A>

>A>

AB

AB

@

@

@

EPIC PHARMA LLC

PRINSTON INC

EQ 12.5MG BASE

EQ 25MG BASE

EQ 37.5MG BASE

EQ 12.5MG BASE

EQ 25MG BASE

A213612

A213612

A213612

A209748

A209748

001

002

003

001

002

Aug 11, 2021

Aug 11, 2021

May 26, 2022

Jan 04, 2024

Jan 04, 2024

Jan CAHN

Jan CAHN

Jan CAHN

Dec NEWA

Dec NEWA

PAROXETINE MESYLATE

TABLET;ORAL

PEXEVA

+

+

+

@

@

@

SEBELA IRELAND LTD EQ 10MG BASE

EQ 20MG BASE

EQ 30MG BASE

N021299

N021299

N021299

001

002

003

Jul 03, 2003

Jul 03, 2003

Jul 03, 2003

May DISC

May DISC

May DISC

PATIROMER SORBITEX CALCIUM

POWDER;ORAL

VELTASSA

+ VIFOR PHARMA EQ 1GM BASE/PACKET N205739 004 Oct 02, 2023 Oct NEWA

PAZOPANIB HYDROCHLORIDE

TABLET;ORAL

PAZOPANIB HYDROCHLORIDE

AB

AB

AB

APOTEX

SUN PHARM

TEVA PHARMS INC

VOTRIENT

EQ 200MG BASE

EQ 200MG BASE

EQ 200MG BASE

A217713

A215837

A217517

001

001

001

Oct 19, 2023

Oct 19, 2023

Oct 19, 2023

Oct NEWA

Oct NFTG

Oct NEWA

AB +! NOVARTIS EQ 200MG BASE N022465 001 Oct 19, 2009 Oct CFTG

PEGCETACOPLAN

SOLUTION;INTRAVITREAL

SYFOVRE

+! APELLIS PHARMS 15MG/0.1ML (15MG/0.1ML) N217171 001 Feb 17, 2023 Feb NEWA

PEMETREXED DISODIUM

POWDER;INTRAVENOUS

PEMETREXED DISODIUM

>A>

AP

AP

AP

AP

AP

AP

AP

@ AMNEAL

@

MEITHEAL

@ MYLAN LABS LTD

PRINSTON INC

SOLUTION;INTRAVENOUS

PEMETREXED

EQ 100MG BASE/VIAL

EQ 100MG BASE/VIAL

EQ 500MG BASE/VIAL

EQ 100MG BASE/VIAL

EQ 500MG BASE/VIAL

EQ 750MG BASE/VIAL

EQ 1GM BASE/VIAL

EQ 500MG BASE/VIAL

EQ 500MG BASE/VIAL

EQ 100MG BASE/VIAL

A210047

A210047

A210047

A215479

A215479

A215479

A215479

A203628

A203628

A216582

002

002

001

001

002

003

004

001

001

001

May 08, 2023

May 08, 2023

Aug 04, 2022

Dec 13, 2022

Dec 13, 2022

Dec 13, 2022

Dec 13, 2022

Mar 10, 2023

Mar 10, 2023

Dec 11, 2023

Jun DISC

Apr NEWA

Jun DISC

Jan CAHN

Jan CAHN

Jan CAHN

Jan CAHN

Mar DISC

Mar NEWA

Dec NEWA

+! SHILPA

+!

+!

PEMETREXED DISODIUM

EQ 100MG/10ML BASE (10MG/ML)

EQ 500MG/50ML BASE (10MG/ML)

EQ 1GM/100ML BASE (10MG/ML)

N215179

N215179

N215179

001

002

003

May 22, 2023

May 22, 2023

May 22, 2023

May NEWA

May NEWA

May NEWA

+! SANDOZ EQ 100MG BASE/4ML (EQ 25MG

BASE/ML)

N214657 001 May 26, 2022 Jan CMS1

PENCICLOVIR

CREAM;TOPICAL

PENCICLOVIR

AB TORRENT 1% A216981 001 Aug 07, 2023 Jul NEWA

PENTAMIDINE ISETHIONATE

FOR SOLUTION;INHALATION

PENTAMIDINE ISETHIONATE

AN X-GEN PHARMS INC 300MG/VIAL A206983 001 Jan 20, 2023 Jan NEWA
RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - December 2023 1-117

PENTOBARBITAL SODIUM

>A>

>D>

AP

AP

AP

INJECTABLE;INJECTION

PENTOBARBITAL SODIUM

BPI LABS

PRAXGEN PHARMS

50MG/ML

50MG/ML

50MG/ML

A206677

A206677

A206677

001

001

001

Nov 27, 2017

Nov 27, 2017

Nov 27, 2017

Dec CAHN

Dec CAHN

Jul CAHN

PERAMPANEL

SUSPENSION;ORAL

FYCOMPA

+! CATALYST PHARMS

TABLET;ORAL

FYCOMPA

+ CATALYST PHARMS

+

+

+

+

+!

0.5MG/ML

2MG

4MG

6MG

8MG

10MG

12MG

N208277

N202834

N202834

N202834

N202834

N202834

N202834

001

001

002

003

004

005

006

Apr 29, 2016

Oct 22, 2012

Oct 22, 2012

Oct 22, 2012

Oct 22, 2012

Oct 22, 2012

Oct 22, 2012

Feb CAHN

Feb CAHN

Feb CAHN

Feb CAHN

Feb CAHN

Feb CAHN

Feb CAHN

PERFLUOROHEXYLOCTANE

SOLUTION/DROPS;OPHTHALMIC

MIEBO

+! BAUSCH AND LOMB INC 1.338GM/ML N216675 001 May 18, 2023 May NEWA

PERFLUTREN

INJECTABLE;INTRAVENOUS

DEFINITY

+! LANTHEUS MEDCL

DEFINITY RT

+! LANTHEUS MEDCL

13.04MG/2ML (6.52MG/ML)

13.04MG/2ML (6.52MG/ML)

N021064

N021064

001

002

Jul 31, 2001

Nov 17, 2020

Nov CPOT

Nov CPOT

PERMETHRIN

AB

AB

CREAM;TOPICAL

ELIMITE

+ AUROBINDO PHARMA USA

PERMETHRIN

DR REDDYS LABS EU

5%

5%

N019855

A209732

001

001

Aug 25, 1989

Aug 01, 2023

Oct CMFD

Jul NEWA

PEXIDARTINIB HYDROCHLORIDE

CAPSULE;ORAL

TURALIO

+ @ DAIICHI SANKYO INC EQ 200MG BASE N211810 001 Aug 02, 2019 Jun DISC

PHENOXYBENZAMINE HYDROCHLORIDE

>D>

>A>

>D>

>A>

AB

AB

AB

AB

CAPSULE;ORAL

PHENOXYBENZAMINE HYDROCHLORIDE

@ AUROBINDO PHARMA 10MG

10MG

@ 10MG

10MG

HIKMA 10MG

@ 10MG

RISING 10MG

A215600

A215600

A215600

A215600

A201050

A201050

A204551

001

001

001

001

001

001

001

May 08, 2023

May 08, 2023

May 08, 2023

May 08, 2023

Jul 16, 2012

Jul 16, 2012

Jun 20, 2023

Dec CMFD

Dec CMFD

Nov DISC

Apr NEWA

Dec DISC

Dec DISC

Jun NEWA

PHENTERMINE HYDROCHLORIDE

CAPSULE;ORAL

PHENTERMINE HYDROCHLORIDE

@ LANNETT 15MG

@ 30MG

@ SUN PHARM INDUSTRIES 30MG

A087022

A087022

A040525

002

001

001

Jan 20, 2012

Feb 03, 1983

Oct 23, 2003

Feb DISC

Feb DISC

Nov DISC

PHENTOLAMINE MESYLATE

SOLUTION;OPHTHALMIC

RYZUMVI

+! OCUPHIRE EQ 0.75% BASE N217064 001 Sep 25, 2023 Sep NEWA
RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - December 2023 1-118

PHENYLEPHRINE HYDROCHLORIDE

SOLUTION;INTRAVENOUS

IMMPHENTIV

+! HIKMA 0.5MG/5ML (0.1MG/ML)

+! 0.5MG/5ML (0.1MG/ML)

+! 1MG/10ML (0.1MG/ML)

+! 1MG/10ML (0.1MG/ML)

PHENYLEPHRINE HYDROCHLORIDE

N203826

N203826

N203826

N203826

004

004

005

005

Mar 09, 2023

Mar 09, 2023

Mar 09, 2023

Mar 09, 2023

May CAHN

Mar NEWA

May CAHN

Mar NEWA

AP2

AP2

AP2

AP2

AP2

AP2

AP2

AVET LIFESCIENCES 10MG/ML (10MG/ML)

BE PHARMS 10MG/ML (10MG/ML)

50MG/5ML (10MG/ML)

100MG/10ML (10MG/ML)

+! HIKMA 10MG/ML (10MG/ML)

+! 50MG/5ML (10MG/ML)

+! 50MG/5ML (10MG/ML)

+! 100MG/10ML (10MG/ML)

+! 100MG/10ML (10MG/ML)

SOLUTION/DROPS;OPHTHALMIC

PHENYLEPHRINE HYDROCHLORIDE

A209968

A217521

A217521

A217521

N203826

N203826

N203826

N203826

N203826

001

001

002

003

001

002

002

003

003

Feb 28, 2023

Jun 26, 2023

Jun 26, 2023

Jun 26, 2023

Dec 20, 2012

Jun 19, 2019

Jun 19, 2019

Jun 19, 2019

Jun 19, 2019

Feb NEWA

Jun NEWA

Jun NEWA

Jun NEWA

May CAHN

Jun CTEC

May CAHN

Jun CTEC

May CAHN

AT

AT

AT

AT

AT

AT

+

+

+

+

!

!

AKORN

ALCON

MANKIND PHARMA

2.5%

10%

2.5%

10%

2.5%

10%

N207926

N207926

N207926

N207926

A216859

A216496

001

002

001

002

001

001

Jan 15, 2015

Jan 15, 2015

Jan 15, 2015

Jan 15, 2015

Sep 29, 2022

Jan 11, 2023

Jul CHRS

Jul CHRS

Jul CAHN

Jul CAHN

Jul CHRS

Jul CHRS

PHENYLEPHRINE HYDROCHLORIDE; PROMETHAZINE HYDROCHLORIDE

SYRUP;ORAL

PROMETHAZINE VC PLAIN

@ XTTRIUM LABS INC 5MG/5ML;6.25MG/5ML A088897 001 Jan 04, 1985 Jan CAHN

PHENYLEPHRINE HYDROCHLORIDE; TROPICAMIDE

SPRAY, METERED;OPHTHALMIC

MYDCOMBI

+! EYENOVIA 2.5%;1% N215352 001 May 05, 2023 May NEWA

PHENYTOIN SODIUM

CAPSULE;ORAL

DIPHENYLAN SODIUM

@ CHARTWELL MOLECULAR 30MG PROMPT

@ 100MG PROMPT

EXTENDED PHENYTOIN SODIUM

A080857

A080857

001

002

Jul CAHN

Jul CAHN

@

@

MYLAN

UNICHEM

100MG EXTENDED

100MG EXTENDED

A040298

A213834

001

001

Dec 28, 1998

Oct 13, 2022

Mar DISC

Apr DISC

PHYTONADIONE

TABLET;ORAL

PHYTONADIONE

AB

AB

AB !

AGNITIO

SCIEGEN PHARMS INC

ZYDUS

5MG

5MG

5MG

A213336

A213329

A210189

001

001

001

Oct 12, 2023

Jul 28, 2023

Feb 20, 2019

Oct NEWA

Jul NEWA

Feb CHRS

PILOCARPINE

INSERT, EXTENDED RELEASE;OPHTHALMIC

OCUSERT PILO-20

@ EPIC PHARMA LLC

OCUSERT PILO-40

5MG N017431 001 Nov CAHN

@ EPIC PHARMA LLC 11MG N017548 001 Nov CAHN

PILOCARPINE HYDROCHLORIDE

SOLUTION;OPHTHALMIC

ISOPTO CARPINE

AT

AT

AT

+! SANDOZ

+!

+!

QLOSI

+! ORASIS PHARMS

TABLET;ORAL

1%

2%

4%

0.4%

N200890

N200890

N200890

N217836

001

002

003

001

Jun 22, 2010

Jun 22, 2010

Jun 22, 2010

Oct 17, 2023

Sep CAHN

Sep CAHN

Sep CAHN

Oct NEWA

PILOCARPINE HYDROCHLORIDE

>D> AB AMICI 5MG A076963 001 Dec 22, 2004 Dec CAHN

>D> AB 7.5MG A076963 002 Feb 27, 2007 Dec CAHN
RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 -

TABLET;ORAL

PILOCARPINE HYDROCHLORIDE

>A> AB INNOGENIX 5MG

>A> AB 7.5MG

PIOGLITAZONE HYDROCHLORIDE

TABLET;ORAL

PIOGLITAZONE HYDROCHLORIDE

@ ANDA REPOSITORY EQ 15MG BASE

@ EQ 30MG BASE

@ EQ 45MG BASE

AB CHARTWELL RX EQ 15MG BASE

@ EQ 15MG BASE

AB EQ 30MG BASE

@ EQ 30MG BASE

AB EQ 45MG BASE

@ EQ 45MG BASE

PIPERACILLIN SODIUM; TAZOBACTAM SODIUM

INJECTABLE;INJECTION

PIPERACILLIN AND TAZOBACTAM

AP EUGIA PHARMA EQ 12GM BASE/VIAL;EQ 1.5GM

BASE/VIAL

EQ 12GM BASE/VIAL;EQ 1.5GM

BASE/VIAL

! EQ 12GM BASE/VIAL;EQ 1.5GM

BASE/VIAL

AP EQ 36GM BASE/VIAL;EQ 4.5GM

BASE/VIAL

AP ! SANDOZ EQ 12GM BASE/VIAL;EQ 1.5GM

BASE/VIAL

AP SHANDONG EQ 2GM BASE/VIAL;EQ 250MG

BASE/VIAL

AP EQ 3GM BASE/VIAL;EQ 375MG

BASE/VIAL

AP EQ 4GM BASE/VIAL;EQ 500MG

BASE/VIAL

AP EQ 36GM BASE/VIAL;EQ 4.5GM

BASE/VIAL

ZOSYN IN PLASTIC CONTAINER

+! BAXTER HLTHCARE CORP EQ 40MG BASE/ML;EQ 5MG BASE/ML

+! EQ 60MG BASE/ML;EQ 7.5MG BASE/ML

+! EQ 4GM BASE/100ML;EQ 500MG

BASE/100ML

PIRFENIDONE

CAPSULE;ORAL

PIRFENIDONE

@ APOTEX 267MG

AB 267MG

>D> AB LUPIN LTD 267MG

>A> @ 267MG

AB 267MG

TABLET;ORAL

PIRFENIDONE

AB APOTEX 267MG

AB 801MG

>D> AB LUPIN LTD 267MG

>A> @ 267MG

AB 267MG

>D> AB 801MG

>A> @ 801MG

AB 801MG

PIROXICAM

CAPSULE;ORAL

PIROXICAM

>D> AB HIKMA 10MG

>A> @ 10MG

>D> AB 20MG

>A> @ 20MG

AB UNICHEM 10MG

AB 20MG

December 

A076963

A076963

A078383

A078383

A078383

A076798

A078383

A076798

A078383

A076798

A078383

A217409

A217409

A217409

A217409

A203557

A204959

A204959

A204959

A217243

N050750

N050750

N050750

A212687

A212687

A212404

A212404

A212404

A212709

A212709

A212403

A212403

A212403

A212403

A212403

A212403

A209256

A209256

A209256

A209256

A208340

A208340

2023

001

002

001

002

003

001

001

002

002

003

003

002

002

002

001

001

001

002

003

001

001

002

003

001

001

001

001

001

001

002

001

001

001

002

002

002

001

001

002

002

001

002

Dec 22, 2004

Feb 27, 2007

Mar 12, 2013

Mar 12, 2013

Mar 12, 2013

Oct 26, 2012

Mar 12, 2013

Oct 26, 2012

Mar 12, 2013

Oct 26, 2012

Mar 12, 2013

Oct 12, 2023

Oct 12, 2023

Oct 12, 2023

Oct 12, 2023

Oct 29, 2014

Aug 10, 2018

Aug 10, 2018

Aug 10, 2018

Apr 14, 2023

Feb 24, 1998

Feb 24, 1998

Feb 24, 1998

Jun 09, 2023

Jun 09, 2023

Aug 28, 2023

Aug 28, 2023

Aug 28, 2023

May 31, 2023

May 31, 2023

Aug 23, 2023

Aug 23, 2023

Aug 23, 2023

Aug 23, 2023

Aug 23, 2023

Aug 23, 2023

Aug 11, 2017

Aug 11, 2017

Aug 11, 2017

Aug 11, 2017

Apr 13, 2017

Apr 13, 2017

1-119

Dec CAHN

Dec CAHN

Sep CAHN

Sep CAHN

Sep CAHN

Nov CAHN

Nov CAHN

Nov CAHN

Nov CAHN

Nov CAHN

Nov CAHN

Nov CTEC

Nov CHRS

Oct NEWA

Oct NEWA

Nov CHRS

Apr CAHN

Apr CAHN

Apr CAHN

Apr NEWA

Mar CAHN

Mar CAHN

Mar CAHN

Sep DISC

Jun NEWA

Dec DISC

Dec DISC

Aug NEWA

May NEWA

May NEWA

Dec DISC

Dec DISC

Aug NEWA

Dec DISC

Dec DISC

Aug NEWA

Dec DISC

Dec DISC

Dec DISC

Dec DISC

Aug CTEC

Aug CTEC
RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - December 2023 1-120

PIRTOBRUTINIB

TABLET;ORAL

JAYPIRCA

+

+!

LOXO ONCOL 50MG

100MG

N216059

N216059

001

002

Jan 27, 2023

Jan 27, 2023

Jan NEWA

Jan NEWA

PITAVASTATIN CALCIUM

TABLET;ORAL

PITAVASTATIN CALCIUM

AB

AB

AB

AB

AB

AB

AB

AB

AB

LUPIN LTD

MYLAN

ZYDUS PHARMS

EQ 1MG BASE

EQ 2MG BASE

EQ 4MG BASE

EQ 1MG BASE

EQ 2MG BASE

EQ 4MG BASE

EQ 1MG BASE

EQ 2MG BASE

EQ 4MG BASE

A206029

A206029

A206029

A206070

A206070

A206070

A206047

A206047

A206047

001

002

003

001

002

003

001

002

003

Nov 20, 2023

Nov 20, 2023

Nov 20, 2023

Apr 04, 2019

Apr 04, 2019

Apr 04, 2019

Feb 22, 2023

Feb 22, 2023

Feb 22, 2023

Nov NEWA

Nov NEWA

Nov NEWA

Sep CMFD

Sep CMFD

Sep CMFD

Feb NEWA

Feb NEWA

Feb NEWA

PLERIXAFOR

SOLUTION;SUBCUTANEOUS

MOZOBIL

AP +! GENZYME

PLERIXAFOR

24MG/1.2ML (20MG/ML) N022311 001 Dec 15, 2008 Jul CFTG

AP

AP

AP

AP

AP

AP

AP

AMNEAL

DR REDDYS

EUGIA PHARMA

KINDOS

MSN

TEVA PHARMS USA INC

ZYDUS PHARMS

24MG/1.2ML (20MG/ML)

24MG/1.2ML (20MG/ML)

24MG/1.2ML (20MG/ML)

24MG/1.2ML (20MG/ML)

24MG/1.2ML (20MG/ML)

24MG/1.2ML (20MG/ML)

24MG/1.2ML (20MG/ML)

A215334

A205182

A213672

A215698

A211901

A205197

A208980

001

001

001

001

001

001

001

Jul 24, 2023

Jul 24, 2023

Jul 24, 2023

Jul 24, 2023

Jul 24, 2023

Jul 24, 2023

Jul 26, 2023

Jul NFTG

Jul NFTG

Jul NFTG

Jul NFTG

Jul NFTG

Jul NFTG

Jul NEWA

PODOFILOX

GEL;TOPICAL

CONDYLOX

AB +! ALLERGAN

PODOFILOX

0.5% N020529 001 Mar 13, 1997 Nov CFTG

AB PADAGIS US 0.5% A211871 001 Nov 22, 2023 Nov NFTG

POLYMYXIN B SULFATE

INJECTABLE;INJECTION

POLYMYXIN B SULFATE

AP BEOWULF ASSET EQ 500,000 UNITS BASE/VIAL A063000 001 Sep 30, 1994 Sep CAHN

POLYMYXIN B SULFATE; TRIMETHOPRIM SULFATE

SOLUTION/DROPS;OPHTHALMIC

POLYTRIM

+ @ ALLERGAN 10,000 UNITS/ML;EQ 1MG BASE/ML

TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE

N050567 001 Oct 20, 1988 Feb DISC

AT ! SANDOZ 10,000 UNITS/ML;EQ 1MG BASE/ML A064211 001 Apr 13, 1998 Feb CHRS

POMALIDOMIDE

CAPSULE;ORAL

POMALYST

+

+

+

+!

BRISTOL 1MG

2MG

3MG

4MG

N204026

N204026

N204026

N204026

001

002

003

004

Feb 08, 2013

Feb 08, 2013

Feb 08, 2013

Feb 08, 2013

Jan CAHN

Jan CAHN

Jan CAHN

Jan CAHN

PONATINIB HYDROCHLORIDE

TABLET;ORAL

ICLUSIG

AB

AB

+ TAKEDA PHARMS USA

+

+!

+!

PONATINIB HYDROCHLORIDE

EQ 15MG BASE

EQ 15MG BASE

EQ 45MG BASE

EQ 45MG BASE

N203469

N203469

N203469

N203469

001

001

002

002

Dec 14, 2012

Dec 14, 2012

Dec 14, 2012

Dec 14, 2012

Sep CTEC

Jul CFTG

Sep CTEC

Jul CFTG

AB

AB

@ APOTEX

@

EQ 15MG BASE

EQ 15MG BASE

EQ 45MG BASE

EQ 45MG BASE

A215893

A215893

A215893

A215893

001

001

002

002

Jul 14, 2023

Jul 14, 2023

Jul 14, 2023

Jul 14, 2023

Sep DISC

Jul NFTG

Sep DISC

Jul NFTG
RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - December 2023 1-121

POSACONAZOLE

SOLUTION;INTRAVENOUS

POSACONAZOLE

>A>

>A>

>A>

>A>

AP

AP

AP

AP

EUGIA PHARMA 300MG/16.7ML (18MG/ML)

FRESENIUS KABI USA 300MG/16.7ML (18MG/ML)

GLAND PHARMA LTD 300MG/16.7ML (18MG/ML)

MYLAN LABS LTD 300MG/16.7ML (18MG/ML)

TABLET, DELAYED RELEASE;ORAL

POSACONAZOLE

A214842

A209983

A217553

A211500

001

001

001

001

Dec 26, 2023

Dec 26, 2023

Dec 26, 2023

Dec 26, 2023

Dec NEWA

Dec NEWA

Dec NEWA

Dec NEWA

AB

AB

AB

@ ACTAVIS LABS FL INC

I 3 PHARMS

WELDING

WESTMINSTER PHARMS

100MG

100MG

100MG

100MG

A207355

A216488

A216326

A216326

001

001

001

001

Nov 30, 2022

Aug 28, 2023

Jun 20, 2023

Jun 20, 2023

May DISC

Aug NEWA

Jun NEWA

Jul CAHN

POTASSIUM ACETATE

INJECTABLE;INJECTION

POTASSIUM ACETATE

AP EXELA PHARMA 2MEQ/ML A212692 001 Oct 20, 2021 Feb CMFD

POTASSIUM CHLORIDE

CAPSULE, EXTENDED RELEASE;ORAL

POTASSIUM CHLORIDE

@ CHARTWELL MOLECULAR

@

FOR SOLUTION;ORAL

POKONZA

8MEQ

10MEQ

A204210

A204210

001

002

Mar 28, 2016

Mar 28, 2016

Jul CAHN

Jul CAHN

+ PHARMA RES SOFTWARE

POTASSIUM CHLORIDE

10MEQ N208019 002 Aug 25, 2023 Sep NEWA

AA

AA

AA

GRANULES

NOVITIUM PHARMA

+ PHARMA RES SOFTWARE

+!

INJECTABLE;INJECTION

POTASSIUM CHLORIDE

20MEQ

20MEQ

20MEQ

40MEQ

A213467

A212816

N208019

N208019

001

001

001

003

Jan 27, 2022

Jul 12, 2023

Aug 19, 2015

Aug 25, 2023

Jul CMFD

Jun NEWA

Sep CHRS

Sep NEWA

AP NEXUS PHARMS

SOLUTION;ORAL

POTASSIUM CHLORIDE

2MEQ/ML A217704 001 Aug 14, 2023 Aug NEWA

AA

AA

AA

AA

ANDA REPOSITORY 20MEQ/15ML

40MEQ/15ML

BELCHER 20MEQ/15ML

40MEQ/15ML

@ STRIDES PHARMA 40MEQ/15ML

TABLET, EXTENDED RELEASE;ORAL

POTASSIUM CHLORIDE

A214892

A214892

A216156

A216156

A211665

001

002

001

002

001

Dec 30, 2022

Dec 30, 2022

Mar 07, 2023

Mar 07, 2023

Nov 17, 2022

Sep CAHN

Sep CAHN

Feb NEWA

Feb NEWA

May DISC

>A>

>A>

AB2

AB2

AB1

AB1

AB1

AB3

AB3

AB3

!

!

@ CHARTWELL RX

RISING

RUBICON

TWI PHARMS

VITRUVIAS THERAP

20MEQ

8MEQ

10MEQ

10MEQ

15MEQ

20MEQ

10MEQ

20MEQ

20MEQ

A210098

A217412

A217412

A216321

A216321

A216321

A209688

A209688

A209688

001

001

002

001

002

003

001

002

002

Apr 26, 2019

Dec 19, 2023

Dec 19, 2023

Jun 16, 2023

Jun 16, 2023

Jun 16, 2023

Jan 12, 2018

Jan 12, 2018

Jan 12, 2018

Oct CAHN

Dec NEWA

Dec NEWA

Jun NEWA

Jun NEWA

Jun NEWA

Apr CAHN

Apr CAHN

Feb CHRS

POTASSIUM PHOSPHATE, DIBASIC; POTASSIUM PHOSPHATE, MONOBASIC

SOLUTION;INTRAVENOUS

POTASSIUM PHOSPHATES

AP

AP

AP

AP

AP

AP

AP

AP

+!

+!

AM REGENT

AMNEAL

FRESENIUS KABI USA

1.18GM/5ML (236MG/ML);1.12GM/5ML

(224MG/ML)

3.54GM/15ML (236MG/ML);3.36GM/15ML

(224MG/ML)

11.8GM/50ML (236MG/ML);11.2GM/50ML

(224MG/ML)

1.18GM/5ML (236MG/ML);1.12GM/5ML

(224MG/ML)

3.54GM/15ML (236MG/ML);3.36GM/15ML

(224MG/ML)

11.8GM/50ML (236MG/ML);11.2GM/50ML

(224MG/ML)

1.18GM/5ML (236MG/ML);1.12GM/5ML

(224MG/ML)

3.54GM/15ML (236MG/ML);3.36GM/15ML

(224MG/ML)

A216274

A216274

A216274

A216344

A216344

A216344

N212832

N212832

001

002

003

001

002

003

001

002

Oct 02, 2023

Oct 02, 2023

Oct 02, 2023

Oct 10, 2023

Oct 10, 2023

Oct 10, 2023

Nov 26, 2019

Nov 26, 2019

Sep NFTG

Sep NFTG

Sep NFTG

Sep NEWA

Sep NEWA

Sep NEWA

Sep CFTG

Sep CFTG
RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - December 2023 1-122

SOLUTION;INTRAVENOUS

POTASSIUM PHOSPHATES

AP +! 11.8GM/50ML (236MG/ML);11.2GM/50ML

(224MG/ML)

N212832 003 Nov 26, 2019 Sep CFTG

PRASUGREL HYDROCHLORIDE

TABLET;ORAL

PRASUGREL

AB

AB

AMNEAL PHARMS

@ LUPIN LTD

@

PRASUGREL HYDROCHLORIDE

EQ 5MG BASE

EQ 10MG BASE

EQ 5MG BASE

EQ 10MG BASE

A205913

A205913

A205930

A205930

001 Jun 19, 2018

002 Jun 19, 2018

001 Jan 09, 2023

002 Jan 09, 2023

Mar CTEC

Mar CTEC

Feb DISC

Feb DISC

AB

AB

UNICHEM EQ 5MG BASE

EQ 10MG BASE

A213315

A213315

001 Aug 28, 2023

002 Aug 28, 2023

Aug NEWA

Aug NEWA

PRAVASTATIN SODIUM

TABLET;ORAL

PRAVASTATIN SODIUM

AB

AB

AB

AB

CHARTWELL RX 10MG

20MG

40MG

80MG

A077917

A077917

A077917

A077917

001 Jan 08, 2008

002 Jan 08, 2008

003 Jan 08, 2008

004 Jan 08, 2008

May CAHN

May CAHN

May CAHN

May CAHN

PRAZOSIN HYDROCHLORIDE

CAPSULE;ORAL

PRAZOSIN HYDROCHLORIDE

AB

AB

AB

AB

AB

AB

>A> AB

>A> AB

>A> AB

ALEMBIC

AUROBINDO PHARMA LTD

LANNETT CO INC

EQ 1MG BASE

EQ 2MG BASE

EQ 5MG BASE

EQ 1MG BASE

EQ 2MG BASE

EQ 5MG BASE

EQ 1MG BASE

EQ 2MG BASE

EQ 5MG BASE

A217268

A217268

A217268

A213052

A213052

A213052

A214083

A214083

A214083

001 Mar 06, 2023

002 Mar 06, 2023

003 Mar 06, 2023

001 Mar 31, 2023

002 Mar 31, 2023

003 Mar 31, 2023

001 Jan 03, 2024

002 Jan 03, 2024

003 Jan 03, 2024

Feb NEWA

Feb NEWA

Feb NEWA

Mar NEWA

Mar NEWA

Mar NEWA

Dec NEWA

Dec NEWA

Dec NEWA

PREDNISOLONE

SYRUP;ORAL

PREDNISOLONE

AA

AA

AA

! CHARTWELL RX

PHARM ASSOC

@ PHARMOBEDIENT CNSLTG

@ XTTRIUM LABS INC

TABLET;ORAL

PREDNISOLONE

15MG/5ML

15MG/5ML

15MG/5ML

15MG/5ML

15MG/5ML

A040323

A040571

A040313

A040313

A040313

001 May 13, 1999

001 Aug 25, 2005

001 Sep 10, 2003

001 Sep 10, 2003

001 Sep 10, 2003

Jun CHRS

Sep CMFD

Sep CAHN

Jul DISC

Jan CAHN

AB

BX

AB +!

AUROBINDO PHARMA LTD

CHARTWELL MOLECULAR

WATSON LABS

5MG

5MG

5MG

A215673

A080531

A080354

001 Mar 17, 2023

002

001

Mar NEWA

May CMFD

Mar CTEC

PREDNISOLONE ACETATE

SUSPENSION/DROPS;OPHTHALMIC

ECONOPRED

@ HARROW EYE

OMNIPRED

0.125% N017468 001 Oct CAHN

AB +! SANDOZ

PRED FORTE

1% N017469 001 Sep CAHN

AB +! ABBVIE 1% N017011 001 Jan CAHN

PRED MILD

+! ABBVIE 0.12% N017100 001 Feb CAHN

PREDNISOLONE SODIUM PHOSPHATE

SOLUTION;ORAL

PREDNISOLONE SODIUM PHOSPHATE

AA

AA

AA

AA

AA

!

!

@

@

EDENBRIDGE PHARMS

MISSION PHARMA

PHARM ASSOC

PHARMOBEDIENT CNSLTG

XTTRIUM LABS INC

EQ 15MG BASE/5ML

EQ 25MG BASE/5ML

EQ 25MG BASE/5ML

EQ 15MG BASE/5ML

EQ 5MG BASE/5ML

EQ 5MG BASE/5ML

EQ 5MG BASE/5ML

A203559

A203559

A091396

A076913

A075099

A075099

A075099

003 Feb 06, 2023

004 Feb 06, 2023

001 Sep 13, 2010

001 Apr 25, 2005

001 Jun 28, 2002

001 Jun 28, 2002

001 Jun 28, 2002

Jan NEWA

Jan NEWA

Jan CTEC

Jul CHRS

Sep CAHN

Jul DISC

Jan CAHN
RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - December 2023 1-123

SOLUTION;ORAL

PREDNISOLONE SODIUM PHOSPHATE

AA

@

!

EQ 15MG BASE/5ML

EQ 15MG BASE/5ML

A076895

A076895

001

001

Oct 04, 2004

Oct 04, 2004

Jul DISC

Jan CAHN

PREDNISONE

SOLUTION;ORAL

PREDNISONE

@ XTTRIUM LABS INC

TABLET;ORAL

PREDNISONE

5MG/5ML A089726 001 Aug 02, 1988 Jan CAHN

AB

AB

AB

AB

AB

AB

AB

+!

+!

GENEYORK PHARMS

GRANULATION TECH

HIKMA

2.5MG

5MG

5MG

10MG

20MG

2.5MG

5MG

A210525

A210525

A212629

A212629

A212629

A087801

A080352

004

005

001

002

003

001

001

Dec 07, 2018

Dec 07, 2018

Dec 05, 2023

Dec 05, 2023

Dec 05, 2023

Apr 22, 1982

Sep CMS1

Sep CMS1

Nov NEWA

Nov NEWA

Nov NEWA

Jan CRLD

Jan CRLD

AB +! 50MG A084283 001 Jan CRLD

AB

AB

JUBILANT CADISTA 2.5MG

50MG

A040362

A040362

004

005

Apr 17, 2023

Apr 17, 2023

Apr NEWA

Apr NEWA

PREGABALIN

CAPSULE;ORAL

PREGABALIN

AB

AB

AB

AB

AB

AB

AB

AB

AB

AB

AB

AB

AB

AB

AB

AB

AB

AB

AB

AB

AB

AB

AB

AB

AB

AB

AB

AB

AB

AB

AB

AB

AB

AB

AB

AB

AB

AB

@

@

@

@

@

@

@

@

@

@

ACI

ADAPTIS

AUROBINDO PHARMA

CHARTWELL RX

CREEKWOOD PHARMS

YILING

ZYDUS PHARMS

25MG

25MG

50MG

50MG

75MG

75MG

100MG

100MG

150MG

150MG

200MG

200MG

225MG

225MG

300MG

300MG

25MG

50MG

75MG

100MG

150MG

200MG

225MG

300MG

25MG

50MG

75MG

100MG

150MG

200MG

225MG

300MG

50MG

75MG

100MG

150MG

25MG

50MG

75MG

100MG

150MG

200MG

225MG

300MG

75MG

300MG

25MG

50MG

A215755

A215755

A215755

A215755

A215755

A215755

A215755

A215755

A215755

A215755

A215755

A215755

A215755

A215755

A215755

A215755

A216197

A216197

A216197

A216197

A216197

A216197

A216197

A216197

A205321

A205321

A205321

A205321

A205321

A205321

A205321

A205321

A212865

A212865

A212865

A212865

A213423

A213423

A213423

A213423

A213423

A213423

A213423

A213423

A210891

A210891

A206752

A206752

001

001

002

002

003

003

004

004

005

005

006

006

007

007

008

008

001

002

003

004

005

006

007

008

001

002

003

004

005

006

007

008

001

002

003

004

001

002

003

004

005

006

007

008

001

002

001

002

Apr 26, 2023

Apr 26, 2023

Apr 26, 2023

Apr 26, 2023

Apr 26, 2023

Apr 26, 2023

Apr 26, 2023

Apr 26, 2023

Apr 26, 2023

Apr 26, 2023

Apr 26, 2023

Apr 26, 2023

Apr 26, 2023

Apr 26, 2023

Apr 26, 2023

Apr 26, 2023

Jul 18, 2022

Jul 18, 2022

Jul 18, 2022

Jul 18, 2022

Jul 18, 2022

Jul 18, 2022

Jul 18, 2022

Jul 18, 2022

Mar 29, 2023

Mar 29, 2023

Mar 29, 2023

Mar 29, 2023

Mar 29, 2023

Mar 29, 2023

Mar 29, 2023

Mar 29, 2023

Mar 20, 2020

Mar 20, 2020

Mar 20, 2020

Mar 20, 2020

Mar 23, 2020

Mar 23, 2020

Mar 23, 2020

Mar 23, 2020

Mar 23, 2020

Mar 23, 2020

Mar 23, 2020

Mar 23, 2020

Sep 30, 2019

Sep 30, 2019

Dec 09, 2022

Dec 09, 2022

Oct DISC

Apr NEWA

Oct DISC

Apr NEWA

Oct DISC

Apr NEWA

Oct DISC

Apr NEWA

Oct DISC

Apr NEWA

Oct DISC

Apr NEWA

Oct DISC

Apr NEWA

Oct DISC

Apr NEWA

Sep CAHN

Sep CAHN

Sep CAHN

Sep CAHN

Sep CAHN

Sep CAHN

Sep CAHN

Sep CAHN

Mar NEWA

Mar NEWA

Mar NEWA

Mar NEWA

Mar NEWA

Mar NEWA

Mar NEWA

Mar NEWA

Mar CAHN

Mar CAHN

Mar CAHN

Mar CAHN

Aug CAHN

Aug CAHN

Aug CAHN

Aug CAHN

Aug CAHN

Aug CAHN

Aug CAHN

Aug CAHN

Mar CAHN

Mar CAHN

May DISC

May DISC
RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - December 2023 1-124

CAPSULE;ORAL

PREGABALIN

@

@

@

@

@

@

SOLUTION;ORAL

PREGABALIN

75MG

100MG

150MG

200MG

225MG

300MG

A206752

A206752

A206752

A206752

A206752

A206752

003 Dec 09, 2022

004 Dec 09, 2022

005 Dec 09, 2022

006 Dec 09, 2022

007 Dec 09, 2022

008 Dec 09, 2022

May DISC

May DISC

May DISC

May DISC

May DISC

May DISC

AA PATRIN 20MG/ML

TABLET, EXTENDED RELEASE;ORAL

PREGABALIN

A212604 001 Feb 18, 2022 Jan CAHN

AB

AB

AB

AB

AB

AB

@

@

@

@

@

@

EPIC PHARMA LLC

SCIEGEN PHARMS INC

SINOTHERAPEUTICS INC

ZYDUS PHARMS

82.5MG

165MG

330MG

82.5MG

165MG

330MG

82.5MG

165MG

330MG

82.5MG

165MG

330MG

A214496

A214496

A214496

A215675

A215675

A215675

A214496

A214496

A214496

A215577

A215577

A215577

001 Jun 01, 2023

002 Jun 01, 2023

003 Jun 01, 2023

001 Sep 14, 2022

002 Sep 14, 2022

003 Sep 14, 2022

001 Jun 01, 2023

002 Jun 01, 2023

003 Jun 01, 2023

001 Aug 26, 2022

002 Aug 26, 2022

003 Aug 26, 2022

Aug CAHN

Aug CAHN

Aug CAHN

May DISC

May DISC

May DISC

May NEWA

May NEWA

May NEWA

Jan DISC

Jan DISC

Jan DISC

PRIMIDONE

TABLET;ORAL

PRIMIDONE

RUBICON 125MG A214896 003 Dec 28, 2022 May CTEC

PROBENECID

TABLET;ORAL

PROBENECID

AB RISING 500MG A217020 001 Nov 20, 2023 Nov NEWA

PROCAINAMIDE HYDROCHLORIDE

INJECTABLE;INJECTION

PROCAINAMIDE HYDROCHLORIDE

AP ! HOSPIRA 500MG/ML A089070 001 Feb 12, 1986 Feb CTEC

PROCHLORPERAZINE EDISYLATE

INJECTABLE;INJECTION

PROCHLORPERAZINE EDISYLATE

AP

AP

HIKMA

SAGENT

EQ 5MG BASE/ML

EQ 5MG BASE/ML

A213630

A040540

001 Nov 22, 2022

001 May 28, 2004

Sep CAHN

Jul CAHN

PROCHLORPERAZINE MALEATE

TABLET;ORAL

PROCHLORPERAZINE MALEATE

AB

AB

AB

AB

AB

AB

AMNEAL

BIONPHARMA

GLENMARK PHARMS LTD

EQ 5MG BASE

EQ 10MG BASE

EQ 5MG BASE

EQ 10MG BASE

EQ 5MG BASE

EQ 10MG BASE

A216598

A216598

A217478

A217478

A216595

A216595

001 Apr 17, 2023

002 Apr 17, 2023

001 Apr 04, 2023

002 Apr 04, 2023

001 Mar 17, 2023

002 Mar 17, 2023

Apr NEWA

Apr NEWA

Mar NEWA

Mar NEWA

Mar NEWA

Mar NEWA

PROGESTERONE

CAPSULE;ORAL

PROGESTERONE

>D> BX

>A> AB

>D> BX

>A> AB

SOFGEN PHARMS

INJECTABLE;INJECTION

PROGESTERONE

100MG

100MG

200MG

200MG

A200456

A200456

A200456

A200456

001 Sep 28, 2012

001 Sep 28, 2012

002 Sep 28, 2012

002 Sep 28, 2012

Dec CTEC

Dec CTEC

Dec CTEC

Dec CTEC

AO ACCORD HLTHCARE 50MG/ML A217707 001 Nov 21, 2023 Nov NEWA
RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - December 2023 1-125

PROMETHAZINE HYDROCHLORIDE

SYRUP;ORAL

PROMETHAZINE HYDROCHLORIDE

AA

@ AMNEAL PHARMS 6.25MG/5ML

CHARTWELL RX 6.25MG/5ML

@ PHARM ASSOC 6.25MG/5ML

TABLET;ORAL

PROMETHAZINE HYDROCHLORIDE

A040882

A040026

A040643

001

001

001

Dec 30, 2009

Sep 25, 1998

Apr 26, 2006

Jun DISC

Sep CAHN

Sep DISC

>D>

>A>

>D>

>A>

>D>

>A>

AB

AB

AB

@

@

@

@

@

@

AUROBINDO PHARMA USA

SUN PHARM INDS INC

12.5MG

25MG

50MG

12.5MG

12.5MG

25MG

25MG

50MG

50MG

A091054

A091054

A091054

A040863

A040863

A040863

A040863

A040863

A040863

001

002

003

001

001

002

002

003

003

Aug 30, 2011

Aug 30, 2011

Aug 30, 2011

Dec 30, 2008

Dec 30, 2008

Dec 30, 2008

Dec 30, 2008

Dec 30, 2008

Dec 30, 2008

Apr CAHN

Apr CAHN

Apr CAHN

Dec DISC

Dec DISC

Dec DISC

Dec DISC

Dec DISC

Dec DISC

PROPAFENONE HYDROCHLORIDE

CAPSULE, EXTENDED RELEASE;ORAL

PROPAFENONE HYDROCHLORIDE

AB

AB

AB

AB

AB

AB

AB !

AUROBINDO PHARMA LTD

SCINOPHARM TAIWAN

STRIDES PHARMA

RYTHMOL SR

225MG

325MG

425MG

225MG

325MG

425MG

425MG

A213096

A213096

A213096

A212928

A212928

A212928

A078540

001

002

003

001

002

003

003

Feb 21, 2023

Feb 21, 2023

Feb 21, 2023

Jun 18, 2020

Jun 18, 2020

Jun 18, 2020

Oct 18, 2010

Feb NEWA

Feb NEWA

Feb NEWA

Sep CAHN

Sep CAHN

Sep CAHN

Nov CHRS

+

+

+

@

@

@

GLAXOSMITHKLINE LLC 225MG

325MG

425MG

N021416

N021416

N021416

001

002

003

Sep 04, 2003

Sep 04, 2003

Sep 04, 2003

Nov DISC

Nov DISC

Nov DISC

PROPARACAINE HYDROCHLORIDE

SOLUTION/DROPS;OPHTHALMIC

PROPARACAINE HYDROCHLORIDE

AT ! BAUSCH AND LOMB 0.5% A040074 001 Sep 29, 1995 Jul CHRS

PROPOFOL

INJECTABLE;INJECTION

PROPOFOL

AB

@

AVET LIFESCIENCES

WATSON LABS INC

10MG/ML

10MG/ML

A206408

A205307

001

001

Oct 12, 2021

Dec 22, 2015

Jan CAHN

Oct DISC

PROPRANOLOL HYDROCHLORIDE

TABLET;ORAL

PROPRANOLOL HYDROCHLORIDE

>D>

>D>

>D>

>D>

>D>

>A>

>A>

>A>

>A>

>A>

AB

AB

AB

AB

AB

AB

AB

AB

AB

AB

AB

AB

AB

AB

AB

AB

AB

!

AMICI

IMPAX LABS INC

INNOGENIX

WATSON LABS

10MG

10MG

20MG

20MG

40MG

40MG

60MG

60MG

80MG

80MG

80MG

10MG

20MG

40MG

60MG

80MG

80MG

A070322

A070322

A070322

A070322

A070322

A070322

A070322

A070322

A070322

A070322

A071976

A070322

A070322

A070322

A070322

A070322

A070178

002

002

003

003

004

004

005

005

001

001

001

002

003

004

005

001

001

Oct 22, 1985

Oct 22, 1985

Oct 22, 1985

Oct 22, 1985

Oct 22, 1985

Oct 22, 1985

Sep 24, 1986

Sep 24, 1986

Aug 04, 1986

Aug 04, 1986

Apr 06, 1988

Oct 22, 1985

Oct 22, 1985

Oct 22, 1985

Sep 24, 1986

Aug 04, 1986

May 13, 1986

Dec CAHN

Sep CAHN

Dec CAHN

Sep CAHN

Dec CAHN

Sep CAHN

Dec CAHN

Sep CAHN

Dec CAHN

Sep CAHN

Jun CHRS

Dec CAHN

Dec CAHN

Dec CAHN

Dec CAHN

Dec CAHN

Jun CHRS

PROPYLTHIOURACIL

TABLET;ORAL

PROPYLTHIOURACIL

AB

AB

+! DAVA PHARMS INC

MACLEODS PHARMS LTD

50MG

50MG

N006188

A208867

001

001 May 10, 2023

Apr CTEC

Apr NEWA
RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - December 2023 1-126

PYRIDOSTIGMINE BROMIDE

AA

AA

SYRUP;ORAL

PYRIDOSTIGMINE BROMIDE

MSN

RISING

60MG/5ML

60MG/5ML

A216512

A208797

001

001

Sep 21, 2023

Jan 09, 2020

Sep NEWA

Sep CAHN

PYRIMETHAMINE

AB

TABLET;ORAL

DARAPRIM

+! TILDE SCIENCES 25MG N008578 001 Oct CAHN

QUININE SULFATE

CAPSULE;ORAL

QUININE SULFATE

@ AUROBINDO PHARMA USA 324MG A202581 001 Dec 14, 2012 May CAHN

QUIZARTINIB DIHYDROCHLORIDE

TABLET;ORAL

VANFLYTA

+ DAIICHI SANKYO INC

+!

EQ 17.7MG BASE

EQ 26.5MG BASE

N216993

N216993

001

002

Jul 20, 2023

Jul 20, 2023

Jul NEWA

Jul NEWA

RAMELTEON

AB

AB

AB

AB

TABLET;ORAL

RAMELTEON

AUROBINDO PHARMA LTD

INNOGENIX

@

MICRO LABS

8MG

8MG

8MG

8MG

8MG

A215972

A215435

A215435

A215435

A215243

001

001

001

001

001

Jul 10, 2023

Aug 24, 2022

Aug 24, 2022

Aug 24, 2022

Feb 09, 2023

Jun NEWA

May CMFD

Mar DISC

Jan CAHN

Feb NEWA

RAMIPRIL

AB

AB

AB

AB

CAPSULE;ORAL

RAMIPRIL

COREPHARMA 1.25MG

2.5MG

5MG

10MG

A079116

A079116

A079116

A079116

001

002

003

004

Jun 20, 2008

Jun 20, 2008

Jun 20, 2008

Jun 20, 2008

Feb CAHN

Feb CAHN

Feb CAHN

Feb CAHN

RANITIDINE HYDROCHLORIDE

INJECTABLE;INJECTION

RANITIDINE HYDROCHLORIDE

@ HIKMA EQ 25MG BASE/ML

@ EQ 25MG BASE/ML

@ ZYDUS PHARMS USA INC EQ 25MG BASE/ML

ZANTAC

+ @ PAI HOLDINGS PHARM EQ 25MG BASE/ML

SYRUP;ORAL

RANITIDINE HYDROCHLORIDE

@ EPIC PHARMA LLC EQ 15MG BASE/ML

A074777

A077458

A091534

N019090

A091078

001

001

001

001

001

Mar 02, 2005

Feb 16, 2006

Feb 22, 2013

Oct 19, 1984

Mar 22, 2011

May DISC

May DISC

May DISC

May DISC

Oct CAHN

RANOLAZINE

>D>

>D>

>A>

>A>

>D>

>A>

AB

AB

AB

AB

AB

AB

AB

AB

TABLET, EXTENDED RELEASE;ORAL

RANEXA

+ @ GILEAD 500MG

+ @ 500MG

+ @ 1GM

+ @ 1GM

+ @ MENARINI INTL 500MG

+ @ 1GM

RANOLAZINE

NOVAST LABS 500MG

1GM

PIRAMAL HLTHCARE UK 500MG

1GM

RISING 500MG

1GM

! SUN PHARM 1GM

@ UNICHEM 500MG

500MG

@ 500MG

N021526

N021526

N021526

N021526

N021526

N021526

A210668

A210668

A213085

A213085

A212889

A212889

A211707

A213083

A213083

A213083

002

002

001

001

002

001

001

002

001

002

001

002

002

001

001

001

Jan 27, 2006

Jan 27, 2006

Feb 12, 2007

Feb 12, 2007

Jan 27, 2006

Feb 12, 2007

Sep 27, 2023

Sep 27, 2023

Jul 25, 2023

Jul 25, 2023

Jan 28, 2021

Jan 28, 2021

May 28, 2019

Mar 16, 2023

Mar 16, 2023

Mar 16, 2023

Dec CAHN

Jan DISC

Dec CAHN

Jan DISC

Dec CAHN

Dec CAHN

Sep NEWA

Sep NEWA

Jul NEWA

Jul NEWA

Aug CAHN

Aug CAHN

Jan CHRS

Dec CMFD

Dec CMFD

Sep DISC
RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - December 2023 1-127

TABLET, EXTENDED RELEASE;ORAL

RANOLAZINE

>D>

>A>

AB

AB

AB

@

@

500MG

1GM

1GM

1GM

1GM

A213083

A213083

A213083

A213083

A213083

001

002

002

002

002

Mar 16, 2023

Mar 16, 2023

Mar 16, 2023

Mar 16, 2023

Mar 16, 2023

Mar NEWA

Dec CMFD

Dec CMFD

Sep DISC

Mar NEWA

RASAGILINE MESYLATE

TABLET;ORAL

RASAGILINE MESYLATE

>A>

>A>

>D>

>D>

@

@

@

@

CARNEGIE

DR REDDYS

EQ 0.5MG BASE

EQ 1MG BASE

EQ 0.5MG BASE

EQ 1MG BASE

A201942

A201942

A201942

A201942

001

002

001

002

Nov 18, 2021

Nov 18, 2021

Nov 18, 2021

Nov 18, 2021

Dec CAHN

Dec CAHN

Dec CAHN

Dec CAHN

REGADENOSON

SOLUTION;INTRAVENOUS

REGADENOSON

AP

AP

AP

BAXTER HLTHCARE CORP

HIKMA

IMS LTD

0.4MG/5ML (0.08MG/ML)

0.4MG/5ML (0.08MG/ML)

0.4MG/5ML (0.08MG/ML)

A217455

A215827

A214252

001

001

001

May 23, 2023

Feb 02, 2023

May 23, 2022

May NEWA

Jan NEWA

Apr CMFD

RELUGOLIX

TABLET;ORAL

ORGOVYX

+! SUMITOMO PHARMA 120MG N214621 001 Dec 18, 2020 Nov CAHN

REPAGLINIDE

TABLET;ORAL

REPAGLINIDE

AB

AB

AB

@

@

@

KENTON

MACLEODS PHARMS LTD

0.5MG

1MG

2MG

0.5MG

1MG

2MG

A091517

A091517

A091517

A207209

A207209

A207209

001

002

003

001

002

003

Apr 24, 2015

Apr 24, 2015

Apr 24, 2015

Mar 22, 2023

Mar 22, 2023

Mar 22, 2023

Oct CAHN

Oct CAHN

Oct CAHN

Mar NEWA

Mar NEWA

Mar NEWA

REPOTRECTINIB

CAPSULE;ORAL

AUGTYRO

+! BRISTOL 40MG N218213 001 Nov 15, 2023 Nov NEWA

REZAFUNGIN ACETATE

POWDER;INTRAVENOUS

REZZAYO

+! CIDARA THERAPS EQ 200MG BASE/VIAL N217417 001 Mar 22, 2023 Mar NEWA

RIBOFLAVIN 5'-PHOSPHATE

SOLUTION/DROPS;OPHTHALMIC

PHOTREXA

+! GLAUKOS 0.146%

PHOTREXA VISCOUS IN DEXTRAN 20%

N203324 001 Apr 15, 2016 Jun CAIN

+! GLAUKOS 0.146% N203324 002 Apr 15, 2016 Jun CAIN

RIFAMPIN

CAPSULE;ORAL

RIFAMPIN

AB

AB

HIKMA

INJECTABLE;INJECTION

RIFAMPIN

150MG

300MG

A065028

A065028

001

002

Mar 14, 2001

Mar 14, 2001

Sep CAHN

Sep CAHN

AP EPIC PHARMA LLC 600MG/VIAL A065502 001 Sep 21, 2010 Sep CAHN

RIMANTADINE HYDROCHLORIDE

TABLET;ORAL

FLUMADINE

+ @ SUN PHARM INDS INC 100MG

RIMANTADINE HYDROCHLORIDE

N019649 001 Sep 17, 1993 Nov DISC

AB

!

!

IMPAX LABS 100MG

100MG

A076132

A076132

001

001

Aug 30, 2002

Aug 30, 2002

Nov CTEC

Nov CHRS
RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - December 2023 1-128

RIMEGEPANT SULFATE

TABLET, ORALLY DISINTEGRATING;ORAL

NURTEC ODT

+! PFIZER EQ 75MG BASE N212728 001 Feb 27, 2020 Feb CAHN

RIMEXOLONE

SUSPENSION/DROPS;OPHTHALMIC

VEXOL

@ HARROW EYE 1% N020474 001 Dec 30, 1994 Oct CAHN

RISPERIDONE

FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR

RYKINDO

+! SHANDONG LUYE

+!

+!

+!

INJECTABLE;INTRAMUSCULAR

RISPERDAL CONSTA

12.5MG

25MG

37.5MG

50MG

N212849

N212849

N212849

N212849

001

002

003

004

Jan 13, 2023

Jan 13, 2023

Jan 13, 2023

Jan 13, 2023

Jan NEWA

Jan NEWA

Jan NEWA

Jan NEWA

>D>

>A>

>D>

>A>

>D>

>A>

>D>

>A>

>A>

AP

AP

AP

AP

+ JANSSEN PHARMS

+

+!

+!

+

+

+

+

RISPERIDONE

12.5MG/VIAL

12.5MG/VIAL

25MG/VIAL

25MG/VIAL

37.5MG/VIAL

37.5MG/VIAL

50MG/VIAL

50MG/VIAL

N021346

N021346

N021346

N021346

N021346

N021346

N021346

N021346

004

004

001

001

002

002

003

003

Apr 12, 2007

Apr 12, 2007

Oct 29, 2003

Oct 29, 2003

Oct 29, 2003

Oct 29, 2003

Oct 29, 2003

Oct 29, 2003

Dec CFTG

Dec CFTG

Dec CFTG

Dec CFTG

Dec CFTG

Dec CFTG

Dec CFTG

Dec CFTG

>A>

>A>

>A>

>A>

AP

AP

AP

AP

TEVA PHARMS USA INC 12.5MG/VIAL

25MG/VIAL

37.5MG/VIAL

50MG/VIAL

SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS

UZEDY

A214068

A214068

A214068

A214068

001

002

003

004

Dec 05, 2023

Dec 05, 2023

Dec 05, 2023

Dec 05, 2023

Dec NFTG

Dec NFTG

Dec NFTG

Dec NFTG

+ TEVA

+

+

+

+

+

+!

TABLET;ORAL

RISPERIDONE

50MG/0.14ML (50MG/0.14ML)

75MG/0.21ML (75MG/0.21ML)

100MG/0.28ML (100MG/0.28ML)

125MG/0.35ML (125MG/0.35ML)

150MG/0.42ML (150MG/0.42ML)

200MG/0.56ML (200MG/0.56ML)

250MG/0.7ML (250MG/0.7ML)

N213586

N213586

N213586

N213586

N213586

N213586

N213586

001

002

003

004

005

006

007

Apr 28, 2023

Apr 28, 2023

Apr 28, 2023

Apr 28, 2023

Apr 28, 2023

Apr 28, 2023

Apr 28, 2023

Apr NEWA

Apr NEWA

Apr NEWA

Apr NEWA

Apr NEWA

Apr NEWA

Apr NEWA

AB

AB

AB

AB

AB

AB

@ DASH PHARMS 0.25MG

@ 0.5MG

@ 1MG

@ 2MG

@ 3MG

@ 4MG

WESTMINSTER PHARMS 0.25MG

0.5MG

1MG

2MG

3MG

4MG

TABLET, ORALLY DISINTEGRATING;ORAL

RISPERIDONE

A076288

A076288

A076288

A076288

A076288

A076288

A078707

A078707

A078707

A078707

A078707

A078707

001

002

003

004

005

006

001

002

003

004

005

006

Sep 15, 2008

Sep 15, 2008

Sep 15, 2008

Sep 15, 2008

Sep 15, 2008

Sep 15, 2008

Dec 29, 2008

Dec 29, 2008

Dec 29, 2008

Dec 29, 2008

Dec 29, 2008

Dec 29, 2008

Feb CAHN

Feb CAHN

Feb CAHN

Feb CAHN

Feb CAHN

Feb CAHN

Aug CAHN

Aug CAHN

Aug CAHN

Aug CAHN

Aug CAHN

Aug CAHN

@

@

@

@

@

@

DASH PHARMS 0.25MG

0.5MG

1MG

2MG

3MG

4MG

A091537

A091537

A091537

A091537

A091537

A091537

006

001

002

003

004

005

Feb 12, 2013

Mar 30, 2011

Mar 30, 2011

Mar 30, 2011

Mar 30, 2011

Mar 30, 2011

Feb CAHN

Feb CAHN

Feb CAHN

Feb CAHN

Feb CAHN

Feb CAHN

RITLECITINIB TOSYLATE

CAPSULE;ORAL

LITFULO

+! PFIZER EQ 50MG BASE N215830 001 Jun 23, 2023 Jun NEWA
RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - December 2023 1-129

RITONAVIR

SOLUTION;ORAL

NORVIR

+ @ ABBVIE 80MG/ML N020659 001 Mar 01, 1996 Feb DISC

RIVASTIGMINE

FILM, EXTENDED RELEASE;TRANSDERMAL

EXELON

AB

AB

AB

+

+!

+

SANDOZ 4.6MG/24HR

9.5MG/24HR

13.3MG/24HR

N022083

N022083

N022083

001

002

005

Jul 06, 2007

Jul 06, 2007

Aug 31, 2012

Sep CAHN

Sep CAHN

Sep CAHN

RIZATRIPTAN BENZOATE

FILM;ORAL

RIZAFILM

+! GENSCO

+! INTELGENX CORP

TABLET;ORAL

RIZATRIPTAN BENZOATE

EQ 10MG BASE

EQ 10MG BASE

N205394

N205394

001

001

Apr 14, 2023

Apr 14, 2023

Sep CAHN

Apr NEWA

AB

AB

AB

AB

CHARTWELL RX EQ 5MG BASE

EQ 10MG BASE

CREEKWOOD PHARMS EQ 5MG BASE

EQ 10MG BASE

TABLET, ORALLY DISINTEGRATING;ORAL

RIZATRIPTAN BENZOATE

A077526

A077526

A202047

A202047

001

002

001

002

Mar 26, 2013

Mar 26, 2013

Dec 31, 2012

Dec 31, 2012

May CAHN

May CAHN

Aug CAHN

Aug CAHN

@

@

UNICHEM EQ 5MG BASE

EQ 10MG BASE

A207835

A207835

001

002

Mar 07, 2017

Mar 07, 2017

Oct DISC

Oct DISC

ROCURONIUM BROMIDE

INJECTABLE;INJECTION

ROCURONIUM BROMIDE

AP

AP

AP

AP

AP

AP

AP

CAPLIN

HIKMA

HONG KONG

MEITHEAL

50MG/5ML (10MG/ML)

100MG/10ML (10MG/ML)

50MG/5ML (10MG/ML)

50MG/5ML (10MG/ML)

100MG/10ML (10MG/ML)

50MG/5ML (10MG/ML)

100MG/10ML (10MG/ML)

A216234

A216234

A217034

A213453

A213453

A213453

A213453

001

002

001

001

002

001

002

Mar 02, 2023

Mar 02, 2023

May 24, 2023

May 08, 2023

May 08, 2023

May 08, 2023

May 08, 2023

Feb NEWA

Feb NEWA

May NEWA

Apr NEWA

Apr NEWA

Aug CAHN

Aug CAHN

ROFLUMILAST

>A>

FOAM;TOPICAL

ZORYVE

>A> +! ARCUTIS

TABLET;ORAL

ROFLUMILAST

0.3% N217242 001 Dec 15, 2023 Dec NEWA

AB

AB

AB

AB

AB

AB

AB

AB

ALKEM LABS LTD

AUROBINDO PHARMA LTD

BRECKENRIDGE

HETERO LABS LTD III

MICRO LABS

STRIDES PHARMA

@ TORRENT

ZYDUS PHARMS

250MCG

500MCG

500MCG

250MCG

250MCG

250MCG

250MCG

500MCG

250MCG

A212490

A212490

A213298

A208236

A208213

A208180

A208247

A208272

A208303

001

002

001

002

002

002

002

001

002

Apr 18, 2023

Apr 18, 2023

Apr 17, 2023

Oct 19, 2023

Apr 18, 2023

Apr 18, 2023

Jun 20, 2023

Aug 06, 2018

Apr 18, 2023

Apr NEWA

Apr NEWA

Apr NEWA

Oct NEWA

Apr NEWA

Apr NEWA

Jun NEWA

Oct DISC

Apr NEWA

ROMIDEPSIN

POWDER;INTRAVENOUS

ISTODAX

AP +! BRISTOL-MYERS 10MG/VIAL N022393 001 Nov 05, 2009 Jul CAHN

ROPINIROLE HYDROCHLORIDE

TABLET;ORAL

ROPINIROLE HYDROCHLORIDE

AB

AB

AB

AB

AB

AB

AB

@

CHARTWELL RX

MYLAN

EQ 0.25MG BASE

EQ 0.5MG BASE

EQ 1MG BASE

EQ 2MG BASE

EQ 3MG BASE

EQ 4MG BASE

EQ 5MG BASE

EQ 0.25MG BASE

A079050

A079050

A079050

A079050

A079050

A079050

A079050

A078881

001

002

003

004

005

006

007

001

May 29, 2008

May 29, 2008

May 29, 2008

May 29, 2008

May 29, 2008

May 29, 2008

May 29, 2008

May 05, 2008

Jun CAHN

Jun CAHN

Jun CAHN

Jun CAHN

Jun CAHN

Jun CAHN

Jun CAHN

May DISC
RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - December 2023 1-130

TABLET;ORAL

ROPINIROLE HYDROCHLORIDE

@ EQ 0.5MG BASE

@ EQ 1MG BASE

@ EQ 2MG BASE

@ EQ 3MG BASE

@ EQ 4MG BASE

@ EQ 5MG BASE

TABLET, EXTENDED RELEASE;ORAL

ROPINIROLE HYDROCHLORIDE

A078881

A078881

A078881

A078881

A078881

A078881

002 May 05, 2008

003 May 05, 2008

004 May 05, 2008

005 May 05, 2008

006 May 05, 2008

007 May 19, 2008

May DISC

May DISC

May DISC

May DISC

May DISC

Mar DISC

AB

AB

AB

AB

AB

CHARTWELL RX EQ 2MG BASE

EQ 4MG BASE

EQ 6MG BASE

EQ 8MG BASE

EQ 12MG BASE

A091395

A091395

A091395

A091395

A091395

001 Aug 27, 2012

002 Aug 27, 2012

003 Aug 27, 2012

004 Aug 27, 2012

005 Aug 27, 2012

Jun CAHN

Jun CAHN

Jun CAHN

Jun CAHN

Jun CAHN

ROPIVACAINE HYDROCHLORIDE

SOLUTION;INJECTION

ROPIVACAINE HYDROCHLORIDE

AP

AP

AP

AP

AP

AP

AMNEAL

MYLAN LABS LTD

200MG/100ML (2MG/ML)

400MG/200ML (2MG/ML)

500MG/100ML (5MG/ML)

1GM/200ML (5MG/ML)

200MG/100ML (2MG/ML)

400MG/200ML (2MG/ML)

A216605

A216605

A216605

A216605

A206091

A206091

001 Mar 08, 2023

002 Mar 08, 2023

003 Mar 07, 2023

004 Mar 07, 2023

001 Oct 26, 2023

002 Oct 26, 2023

Feb NEWA

Feb NEWA

Feb NEWA

Feb NEWA

Oct NEWA

Oct NEWA

ROSIGLITAZONE MALEATE

TABLET;ORAL

AVANDIA

+

+

@

@

WOODWARD EQ 2MG BASE

EQ 4MG BASE

N021071

N021071

002 May 25, 1999

003 May 25, 1999

Jun DISC

Jun DISC

ROSUVASTATIN CALCIUM

CAPSULE;ORAL

EZALLOR SPRINKLE

>D>

>A>

>D>

>A>

>D>

>A>

>D>

>A>

+ SUN PHARM

+ @

+

+ @

+

+ @

+!

+ @

TABLET;ORAL

ROSUVASTATIN CALCIUM

EQ 5MG BASE

EQ 5MG BASE

EQ 10MG BASE

EQ 10MG BASE

EQ 20MG BASE

EQ 20MG BASE

EQ 40MG BASE

EQ 40MG BASE

N208647

N208647

N208647

N208647

N208647

N208647

N208647

N208647

001 Dec 18, 2018

001 Dec 18, 2018

002 Dec 18, 2018

002 Dec 18, 2018

003 Dec 18, 2018

003 Dec 18, 2018

004 Dec 18, 2018

004 Dec 18, 2018

Dec DISC

Dec DISC

Dec DISC

Dec DISC

Dec DISC

Dec DISC

Dec DISC

Dec DISC

AB

AB

AB

AB

UMEDICA EQ 5MG BASE

EQ 10MG BASE

EQ 20MG BASE

EQ 40MG BASE

A207626

A207626

A207626

A207626

001 Apr 09, 2019

002 Apr 09, 2019

003 Apr 09, 2019

004 Apr 09, 2019

Jul CMFD

Jul CMFD

Jul CMFD

Jul CMFD

RUCAPARIB CAMSYLATE

TABLET;ORAL

RUBRACA

+

+

+!

ZR PHARMA EQ 200MG BASE

EQ 250MG BASE

EQ 300MG BASE

N209115

N209115

N209115

001 Dec 19, 2016

003 May 01, 2017

002 Dec 19, 2016

May CAHN

May CAHN

May CAHN

RUFINAMIDE

SUSPENSION;ORAL

RUFINAMIDE

AB

AB

CHARTWELL RX

HETERO LABS LTD III

TABLET;ORAL

RUFINAMIDE

40MG/ML

40MG/ML

A214009

A216841

001 Nov 07, 2022

001 Dec 05, 2023

May CAHN

Nov NEWA

AB

AB

AB

AB

AUROBINDO PHARMA

MICRO LABS

200MG

400MG

200MG

400MG

A217230

A217230

A216688

A216688

001 Jun 16, 2023

002 Jun 16, 2023

001 May 15, 2023

002 May 15, 2023

Jun NEWA

Jun NEWA

May NEWA

May NEWA
RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - December 2023 1-131

SAFINAMIDE MESYLATE

TABLET;ORAL

XADAGO

AB

AB

+

+

+!

+!

MDD US EQ 50MG BASE

EQ 50MG BASE

EQ 100MG BASE

EQ 100MG BASE

N207145

N207145

N207145

N207145

001

001

002

002

Mar 21, 2017

Mar 21, 2017

Mar 21, 2017

Mar 21, 2017

Jun CTEC

Jun CFTG

Jun CTEC

Jun CFTG

SAXAGLIPTIN HYDROCHLORIDE

TABLET;ORAL

ONGLYZA

AB

AB

+ @ ASTRAZENECA AB

+

+ @

+!

SAXAGLIPTIN

EQ 2.5MG BASE

EQ 2.5MG BASE

EQ 5MG BASE

EQ 5MG BASE

N022350

N022350

N022350

N022350

001

001

002

002

Jul 31, 2009

Jul 31, 2009

Jul 31, 2009

Jul 31, 2009

Oct DISC

Jul CFTG

Oct DISC

Jul CFTG

AB

AB

AB

AB

AB

AB

AB

AB

AB

AB

AB

!

AMNEAL

AUROBINDO PHARMA

GLENMARK PHARMS LTD

MYLAN

SUN PHARM

EQ 2.5MG BASE

EQ 5MG BASE

EQ 2.5MG BASE

EQ 5MG BASE

EQ 2.5MG BASE

EQ 5MG BASE

EQ 2.5MG BASE

EQ 5MG BASE

EQ 5MG BASE

EQ 2.5MG BASE

EQ 5MG BASE

A205941

A205941

A205972

A205972

A205994

A205994

A205980

A205980

A205980

A206078

A206078

001

002

001

002

001

002

001

002

002

001

002

Jul 31, 2023

Jul 31, 2023

Jul 31, 2023

Jul 31, 2023

Jul 31, 2023

Jul 31, 2023

Jul 31, 2023

Jul 31, 2023

Jul 31, 2023

Jul 31, 2023

Jul 31, 2023

Jul NFTG

Jul NFTG

Jul NFTG

Jul NFTG

Jul NFTG

Jul NFTG

Jul NFTG

Oct CHRS

Jul NFTG

Jul NFTG

Jul NFTG

SELEGILINE HYDROCHLORIDE

TABLET;ORAL

SELEGILINE HYDROCHLORIDE

@

@

BAYSHORE PHARMS LLC

DASH PHARMS NATCO

5MG

5MG

A074912

A074866

001

001

Apr 30, 1998

Nov 26, 1997

Sep CAHN

Mar CAHN

SELENIUM SULFIDE

LOTION/SHAMPOO;TOPICAL

SELENIUM SULFIDE

@

@

PHARMOBEDIENT CNSLTG

XTTRIUM LABS INC

2.5%

2.5%

A088228

A088228

001

001

Sep 01, 1983

Sep 01, 1983

Sep CAHN

Mar CAHN

SELEXIPAG

TABLET;ORAL

SELEXIPAG

AB

AB

AB

AB

AB

AB

ALEMBIC

@ ZYDUS

@

@

@

@

@

@

@

UPTRAVI

0.2MG

0.4MG

0.6MG

0.8MG

1.4MG

1.6MG

0.2MG

0.4MG

0.6MG

0.8MG

1MG

1.2MG

1.4MG

1.6MG

A214414

A214414

A214414

A214414

A214414

A214414

A214302

A214302

A214302

A214302

A214302

A214302

A214302

A214302

001

002

003

004

005

006

001

002

003

004

005

006

007

008

Oct 11, 2023

Oct 11, 2023

Oct 11, 2023

Oct 11, 2023

Oct 11, 2023

Oct 11, 2023

Dec 21, 2022

Dec 21, 2022

Dec 21, 2022

Dec 21, 2022

Dec 21, 2022

Dec 21, 2022

Dec 21, 2022

Dec 21, 2022

Sep NEWA

Sep NEWA

Sep NEWA

Sep NEWA

Sep NEWA

Sep NEWA

May DISC

May DISC

May DISC

May DISC

May DISC

May DISC

May DISC

May DISC

AB

AB

AB

AB

AB

AB

+

+

+!

+!

+

+

+

+

+

+

+

+

+

+

ACTELION 0.2MG

0.2MG

0.4MG

0.4MG

0.6MG

0.6MG

0.8MG

0.8MG

1MG

1.2MG

1.4MG

1.4MG

1.6MG

1.6MG

N207947

N207947

N207947

N207947

N207947

N207947

N207947

N207947

N207947

N207947

N207947

N207947

N207947

N207947

001

001

002

002

003

003

004

004

005

006

007

007

008

008

Dec 21, 2015

Dec 21, 2015

Dec 21, 2015

Dec 21, 2015

Dec 21, 2015

Dec 21, 2015

Dec 21, 2015

Dec 21, 2015

Dec 21, 2015

Dec 21, 2015

Dec 21, 2015

Dec 21, 2015

Dec 21, 2015

Dec 21, 2015

Sep CTEC

May CTEC

Sep CTEC

May CTEC

Sep CTEC

May CTEC

Sep CTEC

May CTEC

May CTEC

May CTEC

Sep CTEC

May CTEC

Sep CTEC

May CTEC
RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - December 2023 1-132

SERTACONAZOLE NITRATE

CREAM;TOPICAL

ERTACZO

+! LACER PHARMA

SERTRALINE HYDROCHLORIDE

CAPSULE;ORAL

SERTRALINE HYDROCHLORIDE

+! ALMATICA

+

TABLET;ORAL

SERTRALINE HYDROCHLORIDE

AB HERITAGE PHARMA AVET

AB

AB

@ ZYDUS

@

@

SETMELANOTIDE ACETATE

SOLUTION;SUBCUTANEOUS

IMCIVREE

+! RHYTHM

SEVELAMER CARBONATE

FOR SUSPENSION;ORAL

SEVELAMER CARBONATE

AB CHARTWELL RX

AB

AB HANGZHOU ANPRIME

AB

AB STRIDES PHARMA

AB

TABLET;ORAL

SEVELAMER CARBONATE

AB MACLEODS PHARMS LTD

SEVELAMER HYDROCHLORIDE

TABLET;ORAL

SEVELAMER HYDROCHLORIDE

AB AUROBINDO PHARMA LTD

AB

AB MACLEODS PHARMS LTD

AB

SEVOFLURANE

LIQUID;INHALATION

SEVOFLURANE

AN SHANDONG

SILDENAFIL CITRATE

FOR SUSPENSION;ORAL

SILDENAFIL CITRATE

AB GRANULES

SUSPENSION;ORAL

LIQREV

+! CMP DEV LLC

TABLET;ORAL

SILDENAFIL CITRATE

AB CADILA PHARMS LTD

AB

AB

AB MACLEODS PHARMS LTD

AB

AB

AB NOVITIUM PHARMA

AB

AB

2%

EQ 150MG BASE

EQ 200MG BASE

EQ 25MG BASE

EQ 50MG BASE

EQ 100MG BASE

EQ 25MG BASE

EQ 50MG BASE

EQ 100MG BASE

EQ 10MG BASE/ML (EQ 10MG BASE/ML)

800MG/PACKET

2.4GM/PACKET

800MG/PACKET

2.4GM/PACKET

800MG/PACKET

2.4GM/PACKET

800MG

400MG

800MG

400MG

800MG

100%

EQ 10MG BASE/ML

EQ 10MG BASE/ML

EQ 25MG BASE

EQ 50MG BASE

EQ 100MG BASE

EQ 25MG BASE

EQ 50MG BASE

EQ 100MG BASE

EQ 25MG BASE

EQ 50MG BASE

EQ 100MG BASE

N021385

N215133

N215133

A076465

A076465

A076465

A077106

A077106

A077106

N213793

A217319

A217319

A217319

A217319

A211917

A211917

A206100

A212599

A212599

A206883

A206883

A214382

A214556

N214952

A218045

A218045

A218045

A202255

A202255

A202255

A216383

A216383

A216383

001 Dec 10, 2003 Aug CAHN

001 Oct 04, 2021 Nov CHRS

002 Oct 04, 2021 Nov CHRS

001 Aug 11, 2006 Mar CMFD

002 Aug 11, 2006 Mar CMFD

003 Aug 11, 2006 Mar CMFD

001 Feb 06, 2007 May CAHN

002 Feb 06, 2007 May CAHN

003 Feb 06, 2007 May CAHN

001 Nov 25, 2020 Aug CPOT

001 Mar 02, 2023 Aug CAHN

002 Mar 02, 2023 Aug CAHN

001 Mar 02, 2023 Feb NEWA

002 Mar 02, 2023 Feb NEWA

001 Sep 08, 2023 Sep NEWA

002 Sep 08, 2023 Sep NEWA

001 Apr 19, 2023 Apr NEWA

001 Jul 11, 2023 Jun NEWA

002 Jul 11, 2023 Jun NEWA

001 May 26, 2023 May NEWA

002 May 26, 2023 May NEWA

001 Aug 18, 2023 Aug NEWA

001 Dec 01, 2023 Nov NEWA

001 Apr 28, 2023 Apr NEWA

001 Nov 28, 2023 Nov NEWA

002 Nov 28, 2023 Nov NEWA

003 Nov 28, 2023 Nov NEWA

001 Apr 19, 2023 Apr NEWA

002 Apr 19, 2023 Apr NEWA

003 Apr 19, 2023 Apr NEWA

001 Aug 29, 2023 Aug NEWA

002 Aug 29, 2023 Aug NEWA

003 Aug 29, 2023 Aug NEWA
RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - December 2023 1-133

SILODOSIN

CAPSULE;ORAL

SILODOSIN

AB

AB

@

@

@

@

CREEKWOOD PHARMS

ZYDUS PHARMS

4MG

4MG

8MG

8MG

4MG

8MG

A213230

A213230

A213230

A213230

A204816

A204816

001

001

002

002

001

002

Jan 03, 2022

Jan 03, 2022

Jan 03, 2022

Jan 03, 2022

Dec 08, 2022

Dec 08, 2022

Nov CMFD

Sep CAHN

Nov CMFD

Sep CAHN

May DISC

May DISC

SIMVASTATIN

TABLET;ORAL

SIMVASTATIN

AB

AB

AB

AB

@

@

@

@

@

INVAGEN PHARMS

WATSON LABS TEVA

10MG

20MG

40MG

80MG

5MG

10MG

20MG

40MG

80MG

A206557

A206557

A206557

A206557

A076685

A076685

A076685

A076685

A076685

001

002

003

004

001

002

003

004

005

Nov 13, 2017

Nov 13, 2017

Nov 13, 2017

Nov 13, 2017

Dec 20, 2006

Dec 20, 2006

Dec 20, 2006

Dec 20, 2006

Dec 20, 2006

Nov CAHN

Nov CAHN

Nov CAHN

Nov CAHN

Sep DISC

Sep DISC

Sep DISC

Sep DISC

Sep DISC

SIPONIMOD

TABLET;ORAL

MAYZENT

+

+

+!

NOVARTIS EQ 0.25MG BASE

EQ 1MG BASE

EQ 2MG BASE

N209884

N209884

N209884

001

003

002

Mar 26, 2019

Aug 24, 2021

Mar 26, 2019

May CAIN

May CAIN

May CAIN

SIROLIMUS

SOLUTION;ORAL

SIROLIMUS

AA MSN

TABLET;ORAL

SIROLIMUS

1MG/ML A216728 001 Jan 19, 2023 Jan NEWA

AB

AB

ZYDUS PHARMS 1MG

2MG

A201676

A201676

001

002

Feb 15, 2023

Feb 15, 2023

Feb NEWA

Feb NEWA

SITAGLIPTIN

TABLET;ORAL

ZITUVIO

+

+

+!

ZYDUS 25MG

50MG

100MG

N211566

N211566

N211566

001

002

003

Oct 18, 2023

Oct 18, 2023

Oct 18, 2023

Oct NEWA

Oct NEWA

Oct NEWA

SODIUM ACETATE

INJECTABLE;INJECTION

SODIUM ACETATE

AP

AP

FRESENIUS KABI USA

MILLA PHARMS

4MEQ/ML

4MEQ/ML

A206687

A214805

001

002

Oct 30, 2017

Aug 25, 2023

Aug CTEC

Aug NEWA

SODIUM BENZOATE; SODIUM PHENYLACETATE

SOLUTION;INTRAVENOUS

SODIUM PHENYLACETATE AND SODIUM BENZOATE

AP

AP

+! MAIA PHARMS INC

NAVINTA LLC

10%;10% (2GM/20ML;2GM/20ML)

10%;10% (2GM/20ML; 2GM/20ML)

N215025

A217526

001

001

Jun 10, 2021

Jul 14, 2023

Jul CFTG

Jul NFTG

SODIUM BICARBONATE

INJECTABLE;INJECTION

SODIUM BICARBONATE

AP

AP

OMNIVIUM PHARMS

STERISCIENCE

1MEQ/ML

1MEQ/ML

A216364

A217594

001

001

Jun 15, 2023

Jun 28, 2023

Jun NEWA

Jun NEWA

SODIUM CHLORIDE

INJECTABLE;INJECTION

SODIUM CHLORIDE 0.9%

+ B BRAUN 9MG/ML

SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER

N019635 005 Aug 08, 2016 Mar CPOT

+

+

@ LIEBEL-FLARSHEIM 450MG/50ML (9MG/ML)

1.125GM/125ML (9MG/ML)

N021569

N021569

001

002

Jul 27, 2006

Jul 27, 2006

Mar CPOT

Mar CPOT
RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - December 

INJECTABLE;INJECTION

SODIUM CHLORIDE 0.9% IN PLASTIC THERMOJECT KIT FOR CARDIAC OUTPUT USE

+ @ ICU MEDICAL INC 9MG/ML N019217

SODIUM CHLORIDE 23.4%

AP FRESENIUS KABI USA 234MG/ML A212248

AP 234MG/ML A217796

SOLUTION;INJECTION

BACTERIOSTATIC SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER

@ ABRAXIS PHARM 9MG/ML A088909

@ 90MG/10ML (9MG/ML) A088909

@ 270MG/30ML (9MG/ML) A088909

AP FRESENIUS KABI USA 9MG/ML A088911

AP 90MG/10ML (9MG/ML) A088911

AP 270MG/30ML (9MG/ML) A088911

AP +! HOSPIRA 9MG/ML N018800

AP +! 90MG/10ML (9MG/ML) N018800

AP +! 180MG/20ML (9MG/ML) N018800

AP +! 270MG/30ML (9MG/ML) N018800

SODIUM CHLORIDE 0.9%

+ B BRAUN 9MG/ML N019635

+ 90MG/10ML (9MG/ML) N019635

HIKMA 9MG/ML A201833

AP 9MG/ML A201850

18MG/2ML (9MG/ML) A201833

AP 90MG/10ML (9MG/ML) A201833

AP 90MG/10ML (9MG/ML) A201850

AP NEXUS PHARMS 90MG/10ML (9MG/ML) A217535

AP 180MG/20ML (9MG/ML) A217535

AP SPECTRA MDCL DEVICES 9MG/ML A206171

AP 45MG/5ML (9MG/ML) A206171

AP 90MG/10ML (9MG/ML) A206171

SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER

@ ABBOTT 9MG/ML N019218

@ 90MG/10ML (9MG/ML) N019218

@ 180MG/20ML (9MG/ML) N019218

AP +! BAXTER HLTHCARE 9MG/ML N016677

AP + 9MG/ML N020178

+! 225MG/25ML (9MG/ML) N016677

AP +! 225MG/25ML (9MG/ML) N016677

AP +! 450MG/50ML (9MG/ML) N016677

AP + 450MG/50ML (9MG/ML) N020178

AP +! 900MG/100ML N016677

AP +! 900MG/100ML N020178

AP ! FRESENIUS KABI USA 9MG/ML A088912

! 18MG/2ML (9MG/ML) A088912

AP ! 90MG/10ML (9MG/ML) A088912

AP ! 180MG/20ML (9MG/ML) A088912

AP ! 270MG/30ML (9MG/ML) A088912

AP +! HOSPIRA 90MG/10ML (9MG/ML) N018803

AP +! 9MG/ML N018803

AP + 9MG/ML N019465

+ @ 18MG/2ML (9MG/ML) N018803

+ @ 27MG/3ML (9MG/ML) N018803

+ @ 45MG/5ML (9MG/ML) N018803

AP +! 180MG/20ML (9MG/ML) N018803

AP +! 450MG/50ML (9MG/ML) N018803

AP + 450MG/50ML (9MG/ML) N019465

AP +! 900MG/100ML N019465

+ @ ICU MEDICAL INC 45MG/5ML (9MG/ML) N019217

+ @ 90MG/10ML (9MG/ML) N019217

+ @ 360MG/40ML (9MG/ML) N019217

@ JUBILANT CADISTA 9MG/ML A203352

@ 27MG/3ML (9MG/ML) A203352

@ 90MG/10ML (9MG/ML) A203352

@ MILES 450MG/50ML (9MG/ML) N018502

@ 900MG/100ML N018502

AP NEPHRON 9MG/ML A211968

AP 450MG/50ML (9MG/ML) A211968

AP 900MG/100ML A211968

AP ! TARO 9MG/ML A077407

AP ! 45MG/5ML (9MG/ML) A077407

AP ! 90MG/10ML (9MG/ML) A077407

2023

001

001

001

001

002

001

001

002

001

001

001

002

003

005

005

001

001

001

002

001

001

002

001

001

002

001

001

002

004

002

004

004

003

002

001

001

001

004

001

002

003

001

001

002

004

005

006

002

003

002

001

002

003

004

001

002

001

002

001

001

001

002

001

001

002

1-134

Jul 13, 1984 Jun CTNA

Apr 28, 2021 Jun CTEC

Jul 11, 2023 Jun NEWA

Feb 07, 1985 Jun CDFR

May 15, 1985 Jun CMS1

Feb 07, 1985 Jun CPOT

Feb 07, 1985 Jun CDFR

May 17, 1985 Jun CMS1

Feb 07, 1985 Jun CPOT

Oct 29, 1982 Jun CDFR

Oct 29, 1982 Jun CPOT

Oct 29, 1982 Jun CMS1

Oct 29, 1982 Jun CMS1

Aug 08, 2016 Jun CDFR

Aug 08, 2016 Jun CPOT

Sep 24, 2013 Jun CDFR

Jan 20, 2012 Jun CDFR

Sep 24, 2013 Jun CPOT

Jan 07, 2015 Jun CMS1

Jan 20, 2012 Jun CPOT

Aug 23, 2023 Aug NEWA

Aug 23, 2023 Aug NEWA

Jul 21, 2017 Jun CDFR

Jul 21, 2017 Jun CPOT

Jul 21, 2017 Jun CMS1

Jul 13, 1984 Jun CDFR

Jul 13, 1984 Jun CPOT

Apr 30, 1985 Jun CMS1

Oct 30, 1985 Jun CDFR

Dec 07, 1992 Jun CDFR

Oct 30, 1985 Jun CTEC

Oct 30, 1985 Jun CPOT

Jun CMS1

Dec 07, 1992 Jun CPOT

Jun CDFR

Dec 07, 1992 Jun CDFR

Jan 10, 1985 Jun CDFR

Nov 29, 1985 Jun CMS1

Jan 10, 1985 Jun CPOT

Jan 10, 1985 Jun CMS1

Jan 10, 1985 Jun CMS1

Oct 29, 1982 Jun CPOT

Oct 29, 1982 Jun CDFR

Jul 15, 1985 Jun CDFR

Jan 22, 2015 Jun CMS1

Jan 22, 2015 Jun CMS1

Jan 22, 2015 Jun CMS1

Oct 29, 1982 Jun CMS1

Oct 29, 1982 Jun CMS1

Jul 15, 1985 Jun CPOT

Jul 15, 1985 Jun CDFR

Nov 18, 1998 Jun CMS1

Nov 18, 1998 Jun CMS1

Apr 01, 1999 Jun CMS1

May 18, 2016 Jun CDFR

May 18, 2016 Jun CMS1

May 18, 2016 Jun CPOT

Jun CMS1

Jun CDFR

Apr 23, 2020 Jun CDFR

Apr 23, 2020 Jun CPOT

Apr 23, 2020 Jun CMS1

Aug 11, 2006 Jun CDFR

Aug 11, 2006 Jun CPOT

Aug 11, 2006 Jun CMS1
RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - December 2023 1-135

SOLUTION;INJECTION

SODIUM CHLORIDE 0.9% IN PLASTIC THERMOJECT KIT FOR CARDIAC OUTPUT USE

+ @ ICU MEDICAL INC 9MG/ML N019217 001 Jul 13, 1984 Jun CDFR

+ @ 90MG/10ML (9MG/ML) N019217 001 Jul 13, 1984 Jun CPOT

SODIUM FLUORIDE F-18

INJECTABLE;INTRAVENOUS

SODIUM FLUORIDE F-18

>D> AP SHERTECH LABS LLC 10-200mCi/ML A204315 001 Sep 22, 2014 Dec DISC

>A> @ 10-200mCi/ML A204315 001 Sep 22, 2014 Dec DISC

SODIUM NITROPRUSSIDE

INJECTABLE;INJECTION

SODIUM NITROPRUSSIDE

@ CHARTWELL RX 25MG/ML A209834 001 Jun 26, 2018 Sep CAHN

AP MYLAN 25MG/ML A209584 001 Aug 10, 2018 Sep CAHN

@ VIRTUS 25MG/ML A209834 001 Jun 26, 2018 Sep CAHN

SODIUM OXYBATE

FOR SUSPENSION, EXTENDED RELEASE;ORAL

LUMRYZ

+! AVADEL CNS 4.5GM/PACKET N214755 001 May 01, 2023 Jun CHRS

+ 4.5GM/PACKET N214755 001 May 01, 2023 May NEWA

+ 6GM/PACKET N214755 002 May 01, 2023 May NEWA

+ 7.5GM/PACKET N214755 003 May 01, 2023 May NEWA

+ 9GM/PACKET N214755 004 May 01, 2023 May NEWA

SODIUM PHENYLBUTYRATE

POWDER;ORAL

BUPHENYL

AB +! HORIZON THERAP US 3GM/TEASPOONFUL N020573 001 Apr 30, 1996 Jan CAHN

TABLET;ORAL

BUPHENYL

AB +! HORIZON THERAP US 500MG N020572 001 May 13, 1996 Jan CAHN

SODIUM PHOSPHATE, DIBASIC, ANHYDROUS; SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE

TABLET;ORAL

MONOBASIC SODIUM PHOSPHATE AND DIBASIC SODIUM PHOSPHATE

! NOVEL LABS INC 0.398GM;1.102GM A079247 001 Dec 30, 2011 Jul CTEC

AB ! 0.398GM;1.102GM A079247 001 Dec 30, 2011 Jul CHRS

OSMOPREP

+ @ SALIX PHARMS 0.398GM;1.102GM N021892 001 Mar 16, 2006 Jul DISC

SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE; SODIUM PHOSPHATE, MONOBASIC, ANHYDROUS

INJECTABLE;INJECTION

SODIUM PHOSPHATES

AP ! FRESENIUS KABI USA 142MG/ML;276MG/ML A209997 001 Mar 30, 2022 Mar CHRS

SODIUM POLYSTYRENE SULFONATE

POWDER;ORAL, RECTAL

SODIUM POLYSTYRENE SULFONATE

AA UPSHER SMITH LABS 453.6GM/BOT A090313 001 Dec 21, 2011 Sep CAHN

SOLIFENACIN SUCCINATE

TABLET;ORAL

SOLIFENACIN SUCCINATE

AB CHARTWELL RX 5MG A210582 001 May 20, 2019 May CAHN

AB 10MG A210582 002 May 20, 2019 May CAHN

@ CIPLA 5MG A209839 001 May 20, 2019 Jul DISC

@ 10MG A209839 002 May 20, 2019 Jul DISC

>D> AB LANNETT CO INC 5MG A211622 001 Jun 06, 2023 Dec DISC

>A> @ 5MG A211622 001 Jun 06, 2023 Dec DISC

AB 5MG A211622 001 Jun 06, 2023 May NEWA

>D> AB 10MG A211622 002 Jun 06, 2023 Dec DISC

>A> @ 10MG A211622 002 Jun 06, 2023 Dec DISC

AB 10MG A211622 002 Jun 06, 2023 May NEWA

AB RISING 5MG A211423 001 Dec 11, 2019 Aug CAHN

AB 10MG A211423 002 Dec 11, 2019 Aug CAHN
RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - December 2023 1-136

SORAFENIB TOSYLATE

TABLET;ORAL

SORAFENIB TOSYLATE

AB TORRENT EQ 200MG BASE A217095 001 Apr 12, 2023 Mar NEWA

SOTAGLIFLOZIN

TABLET;ORAL

INPEFA

+

+!

LEXICON PHARMS INC 200MG

400MG

N216203

N216203

001

002

May 26, 2023

May 26, 2023

May NEWA

May NEWA

SOTALOL HYDROCHLORIDE

TABLET;ORAL

SORINE

AB

AB

AB

AB

AIPING PHARM INC

SOTALOL HYDROCHLORIDE

80MG

120MG

160MG

240MG

A075500

A075500

A075500

A075500

001

004

002

003

Apr 27, 2001

Apr 27, 2001

Apr 27, 2001

Apr 27, 2001

Oct CAHN

Oct CAHN

Oct CAHN

Oct CAHN

AB

AB

AB

AUROBINDO PHARMA USA

@ NATCO PHARMA USA

@

@

@

80MG

120MG

160MG

80MG

120MG

160MG

240MG

A077616

A077616

A077616

A075237

A075237

A075237

A075237

001

002

003

001

002

003

004

Feb 07, 2007

Feb 07, 2007

Feb 07, 2007

May 01, 2000

May 01, 2000

May 01, 2000

May 01, 2000

Jul CMFD

Jul CMFD

Jul CMFD

Aug CAHN

Aug CAHN

Aug CAHN

Aug CAHN

SOTORASIB

TABLET;ORAL

LUMAKRAS

+

+!

+

AMGEN INC 120MG

320MG

320MG

N214665

N214665

N214665

001

002

002

May 28, 2021

Jan 20, 2023

Jan 20, 2023

Mar CHRS

Mar CHRS

Feb NEWA

SOYBEAN OIL

INJECTABLE;INJECTION

INTRALIPID 10%

+ @ FRESENIUS

NUTRILIPID 10%

10% N017643 001 Nov DISC

+! B BRAUN 10% N019531 001 May 28, 1993 Nov CTEC

SPARSENTAN

TABLET;ORAL

FILSPARI

+

+!

TRAVERE 200MG

400MG

N216403

N216403

001

002

Feb 17, 2023

Feb 17, 2023

Feb NEWA

Feb NEWA

SPIRONOLACTONE

SUSPENSION;ORAL

CAROSPIR

AB +! CMP DEV LLC

SPIRONOLACTONE

25MG/5ML N209478 001 Aug 04, 2017 Aug CFTG

AB AMNEAL 25MG/5ML A215572 001 Sep 05, 2023 Aug NFTG

STERILE WATER FOR INJECTION

LIQUID;N/A

STERILE WATER FOR INJECTION

AP

AP

AP

AP +!

+ @

+!

AM REGENT

HIKMA

HOSPIRA

100% (10ML)

100% (20ML)

100%

100% (20ML)

100% (5.2ML)

100% (5.2ML)

A217341

A217341

A212735

N018801

N018801

N018801

001

002

001

003

006

006

Aug 29, 2023

Aug 29, 2023

Jan 31, 2023

Oct 27, 1982

May 02, 2023

May 02, 2023

Aug NEWA

Aug NEWA

Jan NEWA

Jun CFTG

Jun DISC

May NEWA

SUCCINYLCHOLINE CHLORIDE

INJECTABLE;INJECTION

SUCCINYLCHOLINE CHLORIDE

>D>

>A> AP

AP

@

@

BE PHARMS

BRECKENRIDGE

EUGIA PHARMA

20MG/ML

20MG/ML

20MG/ML

20MG/ML

A216003

A216003

A212638

A217808

001

001

001

001

Feb 07, 2022

Feb 07, 2022

Oct 09, 2019

Oct 16, 2023

Dec CMFD

Dec CMFD

Apr DISC

Oct NEWA
RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - December 2023 1-137

INJECTABLE;INJECTION

SUCCINYLCHOLINE CHLORIDE

AP

AP

@ MANKIND PHARMA

UMEDICA

20MG/ML

20MG/ML

20MG/ML

A216127

A216127

A211625

001 Feb 02, 2023

001 Feb 02, 2023

001 May 19, 2020

Aug DISC

Jan NEWA

Sep CAHN

SUCRALFATE

TABLET;ORAL

SUCRALFATE

AB ZYDUS LIFESCIENCES 1GM A215705 001 May 03, 2023 Apr NEWA

SUFENTANIL CITRATE

INJECTABLE;INJECTION

SUFENTA PRESERVATIVE FREE

AP +! RISING

TABLET;SUBLINGUAL

DSUVIA

EQ 0.05MG BASE/ML N019050 001 May 04, 1984 Sep CAHN

+! VERTICAL PHARMS EQ 0.03MG BASE N209128 001 Nov 02, 2018 Apr CAHN

SUGAMMADEX SODIUM

SOLUTION;INTRAVENOUS

BRIDION

AP

AP

AP

AP

+ MSD SUB MERCK

+!

+ ORGANON SUB MERCK

+!

SUGAMMADEX SODIUM

EQ 200MG BASE/2ML (EQ 100MG

BASE/ML)

EQ 500MG BASE/5ML (EQ 100MG

BASE/ML)

EQ 200MG BASE/2ML (EQ 100MG

BASE/ML)

EQ 500MG BASE/5ML (EQ 100MG

BASE/ML)

N022225

N022225

N022225

N022225

002 Dec 15, 2015

001 Dec 15, 2015

002 Dec 15, 2015

001 Dec 15, 2015

Jul CAHN

Jul CAHN

Jun CFTG

Jun CFTG

AP

AP

AP

AP

ASPIRO

ZYDUS PHARMS

EQ 200MG BASE/2ML (EQ 100MG

BASE/ML)

EQ 500MG BASE/5ML (EQ 100MG

BASE/ML)

EQ 200MG BASE/2ML (EQ 100MG

BASE/ML)

EQ 500MG BASE/5ML (EQ 100MG

BASE/ML)

A214337

A214337

A214290

A214290

001 Jun 09, 2023

002 Jun 09, 2023

001 Oct 04, 2023

002 Oct 04, 2023

Jun NFTG

Jun NFTG

Sep NEWA

Sep NEWA

SULFACETAMIDE SODIUM

SOLUTION/DROPS;OPHTHALMIC

BLEPH-10

+ @ ALLERGAN

SULFACETAMIDE SODIUM

10% A080028 001 Nov DISC

@ AKORN

@ EPIC PHARMA LLC

10%

30%

A040215

A040216

001 May 25, 1999

001 May 25, 1999

Jan DISC

Sep CAHN

SULFADIAZINE

TABLET;ORAL

SULFADIAZINE

>A>

>D>

@

@

CHARTWELL MOLECULAR

LANNETT

500MG

500MG

A080084

A080084

001

001

Dec CAHN

Dec CAHN

SULFAMETHOXAZOLE; TRIMETHOPRIM

SUSPENSION;ORAL

SULFAMETHOXAZOLE AND TRIMETHOPRIM

AB CHARTWELL MOLECULAR 200MG/5ML;40MG/5ML A077785 001 Jan 24, 2007 Jul CAHN

SULINDAC

TABLET;ORAL

SULINDAC

@

@

CHARTWELL RX 150MG

200MG

A072712

A072713

001 Aug 30, 1991

001 Aug 30, 1991

Jan CAHN

Jan CAHN

SUMATRIPTAN

SPRAY;NASAL

TOSYMRA

+! TONIX MEDS 10MG/SPRAY N210884 001 Jan 25, 2019 Jul CAHN
RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - December 2023 1-138

SUMATRIPTAN SUCCINATE

INJECTABLE;SUBCUTANEOUS

IMITREX STATDOSE

>D> AB +! GLAXOSMITHKLINE

>A> +!

SUMATRIPTAN SUCCINATE

>D> AB ANTARES PHARMA INC

>A> @

>D> AB

>A> @

@ BAXTER HLTHCARE CORP

AP

AP SOMERSET

SOLUTION;SUBCUTANEOUS

ZEMBRACE SYMTOUCH

+ TONIX MEDS

TABLET;ORAL

SUMATRIPTAN SUCCINATE

@ SUN PHARM INDS LTD

@

@

SUNITINIB MALATE

CAPSULE;ORAL

SUNITINIB MALATE

AB NATCO PHARMA

AB

AB

AB

AB NOVUGEN

AB

AB

AB

TACROLIMUS

CAPSULE;ORAL

TACROLIMUS

BX ACCORD HLTHCARE

BX

BX

AB HANGZHOU ZHONGMEI

AB

AB

OINTMENT;TOPICAL

TACROLIMUS

AB ENCUBE

AB GLENMARK PHARMS LTD

TADALAFIL

TABLET;ORAL

ALYQ

AB2 TEVA PHARMS INC

@

TADALAFIL

AB2 CHARTWELL RX

AB1 NOVITIUM PHARMA

AB1

AB1

AB1 UNICHEM

AB1

AB1

AB1

AB1 WATSON LABS INC

AB1

AB1

AB1

@ ZYDUS PHARMS

EQ 4MG BASE/0.5ML (EQ 8MG BASE/ML)

EQ 4MG BASE/0.5ML (EQ 8MG BASE/ML)

EQ 4MG BASE/0.5ML (EQ 8MG BASE/ML)

EQ 4MG BASE/0.5ML (EQ 8MG BASE/ML)

EQ 6MG BASE/0.5ML (EQ 12MG

BASE/ML)

EQ 6MG BASE/0.5ML (EQ 12MG

BASE/ML)

EQ 6MG BASE/0.5ML (EQ 12MG

BASE/ML)

EQ 6MG BASE/0.5ML EQ 12MG BASE/ML

EQ 6MG BASE/0.5ML (EQ 12MG

BASE/ML)

EQ 3MG BASE/0.5ML (EQ 3MG

BASE/0.5ML)

EQ 25MG BASE

EQ 50MG BASE

EQ 100MG BASE

EQ 12.5MG BASE

EQ 25MG BASE

EQ 37.5MG BASE

EQ 50MG BASE

EQ 12.5MG BASE

EQ 25MG BASE

EQ 37.5MG BASE

EQ 50MG BASE

EQ 0.5MG BASE

EQ 1MG BASE

EQ 5MG BASE

EQ 0.5MG BASE

EQ 1MG BASE

EQ 5MG BASE

0.1%

0.03%

20MG

20MG

20MG

5MG

10MG

20MG

2.5MG

5MG

10MG

20MG

2.5MG

5MG

10MG

20MG

20MG

N020080

N020080

A078319

A078319

A078319

A078319

A207101

A207101

A213998

N208223

A076554

A076554

A076572

A218024

A218024

A218024

A218024

A218012

A218012

A218012

A218012

A091195

A091195

A091195

A210929

A210929

A210929

A212387

A210393

A216932

A216932

A210572

A215949

A215949

A215949

A209250

A209250

A209250

A209250

A205885

A205885

A205885

A205885

A212515

002

002

001

001

002

002

001

001

001

001

001

002

001

001

002

003

004

001

002

003

004

001

002

003

001

002

003

001

002

001

001

001

001

002

003

001

002

003

004

001

002

003

004

001

Feb 01, 2006

Feb 01, 2006

Dec 10, 2015

Dec 10, 2015

Dec 10, 2015

Dec 10, 2015

Jan 19, 2023

Jan 19, 2023

Jul 13, 2021

Jan 28, 2016

Aug 10, 2009

Aug 10, 2009

Feb 09, 2009

Oct 24, 2023

Oct 24, 2023

Oct 24, 2023

Oct 24, 2023

Aug 21, 2023

Aug 21, 2023

Aug 21, 2023

Aug 21, 2023

Aug 31, 2011

Aug 31, 2011

Aug 31, 2011

Apr 17, 2023

Apr 17, 2023

Apr 17, 2023

Oct 10, 2023

Aug 16, 2023

Oct 12, 2022

Oct 12, 2022

Feb 05, 2019

Mar 03, 2023

Mar 03, 2023

Mar 03, 2023

Mar 26, 2019

Mar 26, 2019

Mar 26, 2019

Mar 26, 2019

Mar 29, 2019

Mar 29, 2019

Mar 29, 2019

Mar 29, 2019

Jun 06, 2023

Dec CTEC

Dec CTEC

Dec DISC

Dec DISC

Dec DISC

Dec DISC

Aug DISC

Jan NEWA

Sep CAHN

Jul CAHN

Aug DISC

Aug DISC

Aug DISC

Oct NEWA

Oct NEWA

Oct NEWA

Oct NEWA

Aug NEWA

Aug NEWA

Aug NEWA

Aug NEWA

Sep CTEC

Sep CTEC

Sep CTEC

Apr NEWA

Apr NEWA

Apr NEWA

Sep NEWA

Aug NEWA

Oct CMFD

Apr DISC

May CAHN

Feb NEWA

Feb NEWA

Feb NEWA

Jan CTEC

Jan CTEC

Jan CTEC

Jan CTEC

Oct CMFD

Oct CMFD

Oct CMFD

Oct CMFD

Oct DISC
RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - December 2023 1-139

TABLET;ORAL

TADALAFIL

AB2 20MG A212515 001 Jun 06, 2023 May NEWA

TALAZOPARIB TOSYLATE

CAPSULE;ORAL

TALZENNA

+

+

PFIZER EQ 0.1MG BASE

EQ 0.35MG BASE

N211651

N211651

005

006

Jun 20, 2023

Jun 20, 2023

Jul NEWA

Jul NEWA

TAMOXIFEN CITRATE

SOLUTION;ORAL

SOLTAMOX

+! MAYNE PHARMA COMMRCL EQ 20MG BASE/10ML N021807 001 Oct 29, 2005 Feb CAHN

TAMSULOSIN HYDROCHLORIDE

CAPSULE;ORAL

TAMSULOSIN HYDROCHLORIDE

AB

@ ASCENT PHARMS INC

CHARTWELL RX

0.4MG

0.4MG

A214730

A211885

001

001

May 04, 2022

Oct 17, 2019

Sep CAHN

Sep CAHN

TASIMELTEON

CAPSULE;ORAL

TASIMELTEON

AB

AB

APOTEX

MSN

20MG

20MG

A211607

A211654

001

001

Dec 20, 2022

Jan 12, 2023

Jan CAHN

Jan NEWA

TAVABOROLE

SOLUTION;TOPICAL

TAVABOROLE

AB ZYDUS LIFESCIENCES 5% A212294 001 Apr 10, 2023 Mar NEWA

TAZAROTENE

GEL;TOPICAL

TAZAROTENE

AB

AB

AB

AB

PADAGIS ISRAEL

SOLARIS PHARMA CORP

0.05%

0.1%

0.05%

0.1%

A213079

A213079

A213644

A213644

001

002

001

002

Apr 25, 2023

Apr 25, 2023

Mar 20, 2023

Mar 20, 2023

Apr NEWA

Apr NEWA

Mar NEWA

Mar NEWA

TECHNETIUM TC-99M LABELED CARBON

AEROSOL;INHALATION

TECHNEGAS KIT

+! CYCLOMEDICA N/A N022335 001 Sep 29, 2023 Sep NEWA

TECHNETIUM TC-99M MERTIATIDE KIT

POWDER;INTRAVENOUS

TECHNETIUM TC 99M MERTIATIDE KIT

+! JUBILANT DRAXIMAGE N/A N216820 001 Jan 30, 2023 Jan NEWA

TECHNETIUM TC-99M SODIUM PERTECHNETATE GENERATOR

SOLUTION;INTRAVENOUS, INTRAVESICULAR, OPHTHALMIC

RADIOGENIX SYSTEM

+ @ NORTHSTAR MEDICAL 30-1153mCi/GENERATOR N202158 001 Feb 08, 2018 Oct DISC

TECHNETIUM TC-99M SULFUR COLLOID KIT

SOLUTION;INJECTION, ORAL

AN-SULFUR COLLOID

AP +! SUN PHARM INDS INC N/A

TECHNETIUM TC-99M SULFUR COLLOID KIT

N017858 001 Nov CFTG

AP JUBILANT N/A A213516 001 Nov 09, 2023 Nov NFTG

TELMISARTAN

TABLET;ORAL

TELMISARTAN

AB

AB

AB

CHARTWELL RX 20MG

40MG

80MG

A078710

A078710

A078710

001

002

003

Jan 08, 2014

Jan 08, 2014

Jan 08, 2014

May CAHN

May CAHN

May CAHN
RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - December 2023 1-140

TEMAZEPAM

CAPSULE;ORAL

TEMAZEPAM

AB

AB

AB

AB

@

ALKEM LABS LTD

SUN PHARM INDUSTRIES

7.5MG

15MG

22.5MG

30MG

22.5MG

A217875

A217875

A217875

A217875

A071175

001

002

003

004

002

Aug 24, 2023

Aug 24, 2023

Aug 24, 2023

Aug 24, 2023

Sep 14, 2009

Aug NEWA

Aug NEWA

Aug NEWA

Aug NEWA

Nov DISC

TEMOZOLOMIDE

CAPSULE;ORAL

TEMOZOLOMIDE

@

@

@

@

@

@

@

@

@

@

@

@

CHARTWELL MOLECULAR

HERITAGE

5MG

20MG

100MG

140MG

180MG

250MG

5MG

20MG

100MG

140MG

180MG

250MG

A203898

A203898

A203898

A203898

A203898

A203898

A078879

A078879

A078879

A078879

A078879

A078879

001

002

003

004

005

006

001

002

003

005

006

004

Feb 10, 2016

Feb 10, 2016

Feb 10, 2016

Feb 10, 2016

Feb 10, 2016

Feb 10, 2016

Mar 01, 2010

Mar 01, 2010

Mar 01, 2010

Mar 01, 2010

Mar 01, 2010

Mar 01, 2010

Jul CAHN

Jul CAHN

Jul CAHN

Jul CAHN

Jul CAHN

Jul CAHN

Aug DISC

Aug DISC

Aug DISC

Aug DISC

Aug DISC

Aug DISC

TENAPANOR HYDROCHLORIDE

TABLET;ORAL

XPHOZAH

+

+

+!

ARDELYX INC EQ 10MG BASE

EQ 20MG BASE

EQ 30MG BASE

N213931

N213931

N213931

001

002

003

Oct 17, 2023

Oct 17, 2023

Oct 17, 2023

Oct NEWA

Oct NEWA

Oct NEWA

TENOFOVIR ALAFENAMIDE FUMARATE

TABLET;ORAL

TENOFOVIR ALAFENAMIDE

AB LUPIN LTD

VEMLIDY

EQ 25MG BASE A214226 001 Mar 30, 2023 Mar NFTG

AB +! GILEAD SCIENCES INC EQ 25MG BASE N208464 001 Nov 10, 2016 Mar CFTG

TENOFOVIR DISOPROXIL FUMARATE

TABLET;ORAL

TENOFOVIR DISOPROXIL FUMARATE

AB

AB

@ CASI PHARMS INC

REYOUNG

REYOUNG PHARM

300MG

300MG

300MG

A209550

A211337

A211337

001

001

001

Feb 26, 2018

Mar 02, 2023

Mar 02, 2023

Nov DISC

Aug CAHN

Feb NEWA

TERAZOSIN HYDROCHLORIDE

CAPSULE;ORAL

TERAZOSIN HYDROCHLORIDE

@ BIONPHARMA

@

@

@

TABLET;ORAL

TERAZOSIN HYDROCHLORIDE

EQ 1MG BASE

EQ 2MG BASE

EQ 5MG BASE

EQ 10MG BASE

A075667

A075667

A075667

A075667

001

002

003

004

Jul 28, 2000

Jul 28, 2000

Jul 28, 2000

Jul 28, 2000

Apr CAHN

Apr CAHN

Apr CAHN

Apr CAHN

@ CHARTWELL RX

@

@

@

EQ 1MG BASE

EQ 2MG BASE

EQ 5MG BASE

EQ 10MG BASE

A074657

A074657

A074657

A074657

001

002

003

004

Apr 28, 2000

Apr 28, 2000

Apr 28, 2000

Apr 28, 2000

May CAHN

May CAHN

May CAHN

May CAHN

TERIFLUNOMIDE

TABLET;ORAL

TERIFLUNOMIDE

AB

AB

AB

AB

AB

AB

AB

AB

AMNEAL PHARMS CO

APOTEX

AUROBINDO PHARMA

BIOCON PHARMA

7MG

14MG

7MG

14MG

7MG

14MG

7MG

14MG

A209613

A209613

A209601

A209601

A209638

A209638

A209639

A209639

001

002

001

002

001

002

001

002

Sep 28, 2018

Sep 28, 2018

Nov 02, 2018

Nov 02, 2018

Oct 26, 2018

Oct 26, 2018

Mar 13, 2023

Mar 13, 2023

Feb CMFD

Feb CMFD

Jan CMFD

Jan CMFD

Jan CMFD

Jan CMFD

Mar NEWA

Mar NEWA
RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - December 2023 1-141

TABLET;ORAL

TERIFLUNOMIDE

AB

AB

AB

AB

AB

AB

AB

AB

AB

AB

AB

AB

AB

AB

HETERO LABS LTD V

MSN

MYLAN

NATCO

SOLA PHARMS

TEVA PHARMS USA

ZYDUS PHARMS

7MG

14MG

7MG

14MG

7MG

14MG

7MG

14MG

7MG

14MG

7MG

14MG

7MG

14MG

A209598

A209598

A209623

A209623

A209702

A209702

A209555

A209555

A209677

A209677

A209700

A209700

A209668

A209668

001

002

001

002

001

002

001

002

002

001

001

002

001

002

Mar 13, 2023

Mar 13, 2023

Apr 24, 2019

Apr 24, 2019

Feb 28, 2020

Feb 28, 2020

May 15, 2023

May 15, 2023

Sep 28, 2023

Jun 17, 2020

Sep 04, 2018

Sep 04, 2018

Nov 30, 2018

Nov 30, 2018

Mar NEWA

Mar NEWA

Feb CMFD

Feb CMFD

Feb CMFD

Feb CMFD

May NEWA

May NEWA

Sep NEWA

Feb CMFD

Feb CMFD

Feb CMFD

Jan CMFD

Jan CMFD

TERIPARATIDE

SOLUTION;SUBCUTANEOUS

FORTEO

AP +! LILLY

TERIPARATIDE

0.6MG/2.4ML (0.25MG/ML) N021318 002 Jun 25, 2008 Nov CFTG

AP

AP

APOTEX

TEVA PHARMS USA

0.6MG/2.4ML (0.25MG/ML)

0.6MG/2.4ML (0.25MG/ML)

A211097

A208569

001

001

Nov 16, 2023

Nov 16, 2023

Nov NFTG

Nov NFTG

TESTOSTERONE

GEL, METERED;NASAL

NATESTO

+! ACERUS

+

GEL, METERED;TRANSDERMAL

ANDROGEL

5.5MG/0.122GM ACTUATION

5.5MG/0.122GM ACTUATION

N205488

N205488

001

001

May 28, 2014

May 28, 2014

Jan CHRS

Jan CRLD

AB +! BESINS HLTHCARE

+ @

TESTOSTERONE

1.62% (20.25MG/1.25GM ACTUATION)

12.5MG/1.25GM ACTUATION

N022309

N021015

001

003

Apr 29, 2011

Sep 26, 2003

Feb CAHN

Feb CAHN

AB ENCUBE 1.62% (20.25MG/1.25GM ACTUATION) A208620 001 Apr 10, 2019 Jan CAHN

TESTOSTERONE CYPIONATE

INJECTABLE;INJECTION

TESTOSTERONE CYPIONATE

AO

AO

AO

AO

EUGIA PHARMA

XIROMED

100MG/ML

200MG/ML

100MG/ML

200MG/ML

A211817

A211817

A215351

A215351

001

002

001

002

Oct 20, 2023

Oct 20, 2023

Apr 13, 2023

Apr 13, 2023

Oct NEWA

Oct NEWA

Mar NEWA

Mar NEWA

TETRABENAZINE

TABLET;ORAL

TETRABENAZINE

AB

AB

@

@

CHARTWELL RX

SUN PHARM

12.5MG

25MG

12.5MG

25MG

A210544

A210544

A206129

A206129

001

002

001

002

Apr 20, 2018

Apr 20, 2018

Aug 17, 2015

Aug 17, 2015

May CAHN

May CAHN

Jan DISC

Jan DISC

TETRACYCLINE HYDROCHLORIDE

CAPSULE;ORAL

ACHROMYCIN V

+

+

@ AVET 250MG

@ 500MG

TETRACYCLINE HYDROCHLORIDE

N050278

N050278

003

001

Sep DISC

Sep DISC

AB !

@

@

AMNEAL PHARMS NY

AUROBINDO PHARMA USA

500MG

250MG

500MG

A210674

A060783

A060783

002

001

002

Sep 18, 2018 Sep CHRS

Apr CAHN

Apr CAHN

THALIDOMIDE

CAPSULE;ORAL

THALIDOMIDE

AB

@ NATCO

THALOMID

150MG

150MG

A213267

A213267

001

001

Apr 27, 2023

Apr 27, 2023

Oct DISC

Apr NFTG

+

+

+

BRISTOL-MYERS 50MG

100MG

150MG

N020785

N020785

N020785

001

002

004

Jul 16, 1998

Jan 17, 2003

Jan 10, 2007

Sep CAHN

Sep CAHN

Oct CTEC
RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - December 2023 1-142

CAPSULE;ORAL

THALOMID

AB

AB

+

+!

+ CELGENE

150MG

200MG

150MG

N020785

N020785

N020785

004 Jan 10, 2007

003 Jan 17, 2003

004 Jan 10, 2007

Sep CAHN

Sep CAHN

Apr CFTG

THALLOUS CHLORIDE TL-201

INJECTABLE;INJECTION

THALLOUS CHLORIDE TL 201

+!

+ @

CURIUM

LANTHEUS MEDCL

1mCi/ML

1mCi/ML

N018150

N017806

001

001

Aug CTEC

Aug DISC

THEOPHYLLINE

CAPSULE, EXTENDED RELEASE;ORAL

THEO-24

AUXILIUM PHARMS LLC 100MG

300MG

! 400MG

INJECTABLE;INJECTION

THEOPHYLLINE 0.04% AND DEXTROSE 5% IN PLASTIC CONTAINER

A087943

A087943

A087943

002 Aug 22, 1983

003 Aug 22, 1983

004 Feb 28, 1992

Oct CMS1

Oct CMS1

Oct CMS1

+ @ B BRAUN 40MG/100ML

THEOPHYLLINE 0.08% AND DEXTROSE 5% IN PLASTIC CONTAINER

N019826 001 Aug 14, 1992 Oct DISC

+ @ B BRAUN 80MG/100ML

THEOPHYLLINE 0.16% AND DEXTROSE 5% IN PLASTIC CONTAINER

N019826 002 Aug 14, 1992 Oct DISC

+ @ B BRAUN 160MG/100ML

THEOPHYLLINE 0.32% AND DEXTROSE 5% IN PLASTIC CONTAINER

N019826 003 Aug 14, 1992 Oct DISC

+ @ B BRAUN 320MG/100ML

TABLET, EXTENDED RELEASE;ORAL

THEO-DUR

N019826 006 Aug 14, 1992 Oct DISC

>D>

>A> +

@ SCHERING

@

THEOCHRON

100MG

100MG

A085328

A085328

001

001

Dec CRLD

Dec CRLD

AB

AB

NOSTRUM PHARMS LLC

THEOPHYLLINE

100MG

200MG

300MG

450MG

A087400

A087400

A087400

A087400

003 Feb 21, 1985

004 Feb 21, 1985

002 Jan 11, 1983

005 Aug 09, 2023

Aug CMFD

Aug CMFD

Aug CMFD

Aug NEWA

AB

AB

AB

AB

AB

AB

AB

AB

AB

AB

AB

AMNEAL

ANNORA PHARMA

BIONPHARMA

HARMAN FINOCHEM

LEADING

RHODES PHARMS

300MG

450MG

300MG

450MG

300MG

450MG

300MG

450MG

300MG

450MG

300MG

A216276

A216276

A217422

A217422

A216300

A216300

A214806

A214806

A214950

A214950

A214113

001 Mar 20, 2023

002 Mar 20, 2023

001 Sep 08, 2023

002 Sep 08, 2023

001 Apr 26, 2023

002 Apr 26, 2023

001 Oct 24, 2023

002 Oct 24, 2023

001 Jan 30, 2023

002 Jan 30, 2023

001 May 11, 2023

Mar NEWA

Mar NEWA

Sep NEWA

Sep NEWA

Apr NEWA

Apr NEWA

Oct NEWA

Oct NEWA

Jan NEWA

Jan NEWA

May NEWA

THIAMINE HYDROCHLORIDE

INJECTABLE;INJECTION

THIAMINE HYDROCHLORIDE

AP

AP

!

CAPLIN

DR REDDYS

100MG/ML

100MG/ML

200MG/ML

A215692

A080571

A080571

001 Mar 06, 2023

001

002

Feb NEWA

Mar CMFD

Mar CMFD

THIOGUANINE

TABLET;ORAL

THIOGUANINE

+! WAYLIS THERAP 40MG N012429 001 Sep CAHN

THIORIDAZINE HYDROCHLORIDE

TABLET;ORAL

THIORIDAZINE HYDROCHLORIDE

@

@

@

@

@

@

@

CHARTWELL RX 10MG

15MG

25MG

50MG

100MG

150MG

200MG

A088131

A088132

A088133

A088134

A088135

A088136

A088137

001 Aug 30, 1983

001 Aug 30, 1983

001 Aug 30, 1983

001 Aug 30, 1983

001 Nov 20, 1984

001 Sep 17, 1986

001 Sep 17, 1986

Jan CAHN

Jan CAHN

Jan CAHN

Jan CAHN

Jan CAHN

Jan CAHN

Jan CAHN
RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - December 2023 1-143

THIOTEPA

INJECTABLE;INJECTION

THIOTEPA

AP PENN LIFE 15MG/VIAL

POWDER;INTRACAVITARY, INTRAVENOUS, INTRAVESICAL

THIOTEPA

A208242 001 Jan 10, 2020 May CAHN

AP

>A> AP

>A> AP

HIKMA

KINDOS

100MG/VIAL

15MG/VIAL

100MG/VIAL

A211755

A216037

A216037

001

001

002

Sep 05, 2023

Dec 26, 2023

Dec 26, 2023

Aug NEWA

Dec NEWA

Dec NEWA

THIOTHIXENE

CAPSULE;ORAL

THIOTHIXENE

AB

AB

AB

AB

RISING 1MG

2MG

5MG

10MG

A071093

A071093

A071093

A071093

002

003

004

001

Jun 23, 1987

Jun 23, 1987

Jun 23, 1987

Jun 23, 1987

Feb CAHN

Feb CAHN

Feb CAHN

Feb CAHN

TICAGRELOR

TABLET;ORAL

TICAGRELOR

AB ALKEM LABS LTD 90MG A208567 001 Apr 21, 2023 Apr NEWA

TICLOPIDINE HYDROCHLORIDE

TABLET;ORAL

TICLOPIDINE HYDROCHLORIDE

!

@

APOTEX

TEVA

250MG

250MG

250MG

A075089

A075089

A075149

001

001

001

Jul 01, 1999

Jul 01, 1999

Aug 20, 1999

Sep CHRS

Sep CTEC

Sep DISC

TIMOLOL

SOLUTION/DROPS;OPHTHALMIC

BETIMOL

+! THEA PHARMA

+!

TIMOLOL

EQ 0.25% BASE

EQ 0.5% BASE

N020439

N020439

001

002

Mar 31, 1995

Mar 31, 1995

Jan CTEC

Jan CTEC

@ AKORN

@

@ EPIC PHARMA LLC

@

EQ 0.25% BASE

EQ 0.5% BASE

EQ 0.25% BASE

EQ 0.5% BASE

A205309

A205309

A205309

A205309

001

002

001

002

Sep 30, 2016

Sep 30, 2016

Sep 30, 2016

Sep 30, 2016

Jan DISC

Jan DISC

Oct CAHN

Oct CAHN

TIMOLOL MALEATE

SOLUTION, GEL FORMING/DROPS;OPHTHALMIC

TIMOLOL MALEATE

AB

AB

EUGIA PHARMA

GLAND PHARMA LTD

EQ 0.5% BASE

EQ 0.5% BASE

A213540

A214645

001

002

Mar 23, 2023

Feb 14, 2023

Mar NEWA

Feb NEWA

SOLUTION/DROPS;OPHTHALMIC

TIMOLOL MALEATE

AT1

AT1

AT3

@ AKORN

MICRO LABS

SENTISS PHARMA

TABLET;ORAL

TIMOLOL MALEATE

EQ 0.5% BASE

EQ 0.25% BASE

EQ 0.5% BASE

EQ 0.5% BASE

A074466

A217343

A217343

A217195

001

001

002

001

Mar 25, 1997

May 26, 2023

May 26, 2023

May 08, 2023

Jan DISC

May NEWA

May NEWA

Apr NEWA

AB

AB

AB

RISING 5MG

10MG

20MG

A207556

A207556

A207556

001

002

003

May 02, 2019

May 02, 2019

May 02, 2019

Aug CAHN

Aug CAHN

Aug CAHN

TINIDAZOLE

TABLET;ORAL

TINIDAZOLE

AB

AB

>A> AB

>A> AB

>D> AB

>D> AB

CHARTWELL RX

THINQ PHARM-CRO PVT

UNIQUE

250MG

500MG

250MG

500MG

250MG

500MG

A202044

A202044

A202489

A202489

A202489

A202489

001

002

001

002

001

002

Apr 30, 2012

Apr 30, 2012

Oct 09, 2013

Oct 09, 2013

Oct 09, 2013

Oct 09, 2013

Apr CAHN

Apr CAHN

Dec CAHN

Dec CAHN

Dec CAHN

Dec CAHN
RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - December 2023 1-144

TIOPRONIN

TABLET, DELAYED RELEASE;ORAL

THIOLA EC

AB

AB

AB

+ MISSION PHARMACAL

+!

+ MISSION PHARMACAL CO

+!

+!

TIOPRONIN

100MG

300MG

100MG

300MG

300MG

N211843

N211843

N211843

N211843

N211843

001

002

001

002

002

Jun 28, 2019

Jun 28, 2019

Jun 28, 2019

Jun 28, 2019

Jun 28, 2019

Apr CTEC

Aug CTEC

Feb CFTG

Apr CTEC

Feb CFTG

AB

AB

AB

AMNEAL

@ PAR PHARM

@

300MG

100MG

100MG

300MG

300MG

A216278

A217219

A217219

A217219

A217219

001

001

001

002

002

Aug 15, 2023

Feb 24, 2023

Feb 24, 2023

Feb 24, 2023

Feb 24, 2023

Aug NEWA

Apr DISC

Feb NFTG

Apr DISC

Feb NFTG

TIOTROPIUM BROMIDE

POWDER;INHALATION

SPIRIVA

AB +! BOEHRINGER INGELHEIM

TIOTROPIUM BROMIDE

EQ 0.018MG BASE/INH N021395 001 Jan 30, 2004 Jun CFTG

AB LUPIN EQ 0.018MG BASE/INH A211287 001 Jun 20, 2023 Jun NFTG

TIPIRACIL HYDROCHLORIDE; TRIFLURIDINE

TABLET;ORAL

LONSURF

AB

AB

+ TAIHO ONCOLOGY EQ 6.14MG BASE;15MG

+! EQ 8.19MG BASE;20MG

TIPIRACIL HYDROCHLORIDE AND TRIFLURIDINE

N207981

N207981

001

002

Sep 22, 2015

Sep 22, 2015

Jun CFTG

Jun CFTG

AB

AB

NATCO EQ 6.14MG BASE;15MG

EQ 8.19MG BASE;20MG

A214008

A214008

001

002

Jun 13, 2023

Jun 13, 2023

Jun NFTG

Jun NFTG

TIROFIBAN HYDROCHLORIDE

SOLUTION;INTRAVENOUS

AGGRASTAT

AP + MEDICURE

TIROFIBAN HYDROCHLORIDE

EQ 5MG BASE/100ML (EQ 0.05MG

BASE/ML)

N020913 002 May 17, 2002 Jan CFTG

AP

AP

EUGIA PHARMA EQ 5MG BASE/100ML (EQ 0.05MG

BASE/ML)

EQ 12.5MG BASE/250ML (EQ 0.05MG

BASE/ML)

A216379

A216379

001

002

May 01, 2023

May 01, 2023

Apr NEWA

Apr NEWA

TIRZEPATIDE

SOLUTION;SUBCUTANEOUS

ZEPBOUND

+!

+!

+!

+!

+!

+!

ELI LILLY AND CO 2.5MG/0.5ML (2.5MG/0.5ML)

5MG/0.5ML (5MG/0.5ML)

7.5MG/0.5ML (7.5MG/0.5ML)

10MG/0.5ML (10MG/0.5ML)

12.5MG/0.5ML (12.5MG/0.5ML)

15MG/0.5ML (15MG/0.5ML)

N217806

N217806

N217806

N217806

N217806

N217806

001

002

003

004

005

006

Nov 08, 2023

Nov 08, 2023

Nov 08, 2023

Nov 08, 2023

Nov 08, 2023

Nov 08, 2023

Nov NEWA

Nov NEWA

Nov NEWA

Nov NEWA

Nov NEWA

Nov NEWA

TIZANIDINE HYDROCHLORIDE

CAPSULE;ORAL

ZANAFLEX

AB

AB

AB

+ LEGACY PHARMA USA EQ 2MG BASE

+ EQ 4MG BASE

+! EQ 6MG BASE

TABLET;ORAL

TIZANIDINE HYDROCHLORIDE

N021447

N021447

N021447

001

002

003

Aug 29, 2002

Aug 29, 2002

Aug 29, 2002

Jul CAHN

Jul CAHN

Jul CAHN

@ AUROBINDO PHARMA USA

@

ZANAFLEX

EQ 2MG BASE

EQ 4MG BASE

A076282

A076282

001

002

Dec 16, 2003

Dec 16, 2003

Apr CAHN

Apr CAHN

AB

+ @ LEGACY PHARMA USA

+!

EQ 2MG BASE

EQ 4MG BASE

N020397

N020397

002

001

Feb 04, 2000

Nov 27, 1996

Jul CAHN

Jul CAHN
RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - December 2023 1-145

TOBRAMYCIN

SOLUTION;INHALATION

TOBRAMYCIN

AN

AN

MANKIND PHARMA

MICRO LABS

SOLUTION/DROPS;OPHTHALMIC

AKTOB

300MG/5ML

300MG/5ML

A214478

A217344

001

001

Jun 30, 2023

Jul 27, 2023

Jun NEWA

Jul NEWA

@ AKORN

@ EPIC PHARMA LLC

TOBRAMYCIN

0.3%

0.3%

A064096

A064096

001

001

Jan 31, 1996

Jan 31, 1996

Feb DISC

Nov CAHN

AT CHARTWELL RX 0.3% A065026 001 Sep 11, 2001 Oct CAHN

TOBRAMYCIN SULFATE

INJECTABLE;INJECTION

TOBRAMYCIN SULFATE

AP

AP

AP

!

@ EPIC PHARMA LLC EQ 40MG BASE/ML A205179

EUGIA PHARMA EQ 1.2GM BASE/VIAL A217519

FRESENIUS KABI USA EQ 10MG BASE/ML A065122

HAINAN POLY EQ 1.2GM BASE/VIAL A217029

@ HOSPIRA EQ 10MG BASE/ML A063112

TOBRAMYCIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER

001

001

001

001

001

Sep 16, 2014

Jun 21, 2023

Nov 29, 2002

Feb 01, 2023

Apr 30, 1991

Oct CAHN

Jun NEWA

Sep CHRS

Jan NEWA

Sep DISC

@

@

@

HOSPIRA EQ 1.2MG BASE/ML

EQ 1.6MG BASE/ML

EQ 80MG BASE/100ML

A063081

A063081

A063081

003

006

001

Jul 31, 1990

Jun 02, 1993

Jul 31, 1990

Sep DISC

Sep DISC

Sep DISC

TOFACITINIB CITRATE

SOLUTION;ORAL

TOFACITINIB CITRATE

AA SLAYBACK PHARMA LLC

XELJANZ

EQ 1MG BASE/ML A216878 001 Sep 25, 2023 Sep NFTG

AA +! PFIZER

+!

TABLET;ORAL

TOFACITINIB CITRATE

EQ 1MG BASE/ML

EQ 1MG BASE/ML

N213082

N213082

001

001

Sep 25, 2020

Sep 25, 2020

Sep CFTG

Aug CPOT

AB

AB

@ MICRO LABS

@ ZYDUS PHARMS

XELJANZ

EQ 5MG BASE

EQ 5MG BASE

EQ 5MG BASE

EQ 5MG BASE

A209738

A209738

A209829

A209829

001

001

001

001

Mar 13, 2023

Mar 13, 2023

Mar 13, 2023

Mar 13, 2023

Mar DISC

Mar NFTG

Sep DISC

Mar NEWA

AB

+

+

PF PRISM CV EQ 5MG BASE

EQ 5MG BASE

N203214

N203214

001

001

Nov 06, 2012

Nov 06, 2012

Sep CTEC

Mar CFTG

TOFERSEN

SOLUTION;INTRATHECAL

QALSODY

+! BIOGEN MA 100MG/15ML (6.7MG/ML) N215887 001 Apr 25, 2023 Apr NEWA

TOLMETIN SODIUM

CAPSULE;ORAL

TOLMETIN SODIUM

RISING

TABLET;ORAL

TOLMETIN SODIUM

EQ 400MG BASE A073393 001 May 27, 1993 Jul CMFD

! RISING EQ 600MG BASE A074473 001 Aug 30, 1994 May CMFD

TOLTERODINE TARTRATE

TABLET;ORAL

TOLTERODINE TARTRATE

AB

AB

ELYSIUM 1MG

2MG

A210775

A210775

001

002

Dec 30, 2019

Dec 30, 2019

Sep CAHN

Sep CAHN

TOLVAPTAN

TABLET;ORAL

TOLVAPTAN

AB

AB

MSN 15MG

30MG

A216949

A216949

001

002

Jun 21, 2023

Jun 21, 2023

Jun NEWA

Jun NEWA
RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 -

TOPIRAMATE

CAPSULE;ORAL

TOPIRAMATE

AB AUROBINDO PHARMA LTD 15MG

AB 25MG

AB TWI PHARMS 15MG

AB 25MG

@ WATSON LABS 15MG

@ 25MG

CAPSULE, EXTENDED RELEASE;ORAL

TOPIRAMATE

AB1 ACTAVIS LABS FL 25MG

AB1 50MG

AB1 100MG

AB1 200MG

AB1 AJANTA PHARMA LTD 25MG

AB1 50MG

AB1 100MG

AB1 200MG

AB1 ALKEM LABS LTD 25MG

AB1 50MG

AB1 100MG

AB1 200MG

AB1 DR REDDYS 25MG

AB1 50MG

AB1 100MG

AB1 200MG

AB1 PAR PHARM 25MG

AB1 50MG

AB1 100MG

AB1 200MG

AB1 ZYDUS 25MG

AB2 25MG

AB1 50MG

AB2 50MG

AB1 100MG

AB2 100MG

AB2 150MG

AB1 200MG

AB2 200MG

@ ZYDUS PHARMS 200MG

AB1 200MG

TROKENDI XR

AB1 +! SUPERNUS PHARMS 200MG

TABLET;ORAL

TOPIRAMATE

@ TEVA 25MG

@ 50MG

@ 100MG

@ 200MG

TOPOTECAN HYDROCHLORIDE

CAPSULE;ORAL

HYCAMTIN

+ SANDOZ EQ 0.25MG BASE

+! EQ 1MG BASE

INJECTABLE;INJECTION

HYCAMTIN

AP +! SANDOZ EQ 4MG BASE/VIAL

SOLUTION;INTRAVENOUS

TOPOTECAN HYDROCHLORIDE

@ DASH PHARMS EQ 4MG BASE/4ML (EQ 1MG BASE/ML)

>D> AP HONG KONG EQ 4MG BASE/4ML (EQ 1MG BASE/ML)

AP EQ 4MG BASE/4ML (EQ 1MG BASE/ML)

>A> AP MEITHEAL EQ 4MG BASE/4ML (EQ 1MG BASE/ML)

December 

A215449

A215449

A217694

A217694

A077868

A077868

A206210

A206210

A206210

A206210

A215663

A215663

A215663

A215663

A217248

A217248

A217248

A217248

A217231

A217231

A217231

A217231

A205976

A205976

A205976

A205976

A207382

A208949

A207382

A208949

A207382

A208949

A208949

A207382

A208949

A216167

A216167

N201635

A076317

A076317

A076317

A076317

N020981

N020981

N020671

A206074

N022453

N022453

N022453

2023

001

002

001

002

001

002

001

002

003

004

001

002

003

004

001

002

003

004

001

002

003

004

002

003

004

001

001

001

002

002

003

003

004

004

005

001

001

004

001

002

003

004

001

002

001

001

001

001

001

1-146

Sep 27, 2023 Sep NEWA

Sep 27, 2023 Sep NEWA

Dec 05, 2023 Nov NEWA

Dec 05, 2023 Nov NEWA

Apr 15, 2009 Sep DISC

Apr 15, 2009 Sep DISC

Mar 10, 2023 Mar NEWA

Mar 10, 2023 Mar NEWA

Mar 10, 2023 Mar NEWA

Mar 10, 2023 Mar NEWA

Aug 15, 2023 Aug NEWA

Aug 15, 2023 Aug NEWA

Aug 15, 2023 Aug NEWA

Aug 15, 2023 Aug NEWA

Jun 20, 2023 Jun NEWA

Jun 20, 2023 Jun NEWA

Jun 20, 2023 Jun NEWA

Jun 20, 2023 Jun NEWA

Nov 17, 2023 Nov NEWA

Nov 17, 2023 Nov NEWA

Nov 17, 2023 Nov NEWA

Nov 17, 2023 Nov NEWA

May 04, 2023 Apr NEWA

May 04, 2023 Apr NEWA

May 04, 2023 Apr NEWA

Mar 01, 2023 Feb NEWA

Nov 24, 2017 Jan CAHN

Nov 29, 2022 Jan CAHN

Nov 24, 2017 Jan CAHN

Nov 29, 2022 Jan CAHN

Nov 24, 2017 Jan CAHN

Nov 29, 2022 Jan CAHN

Nov 29, 2022 Jan CAHN

Oct 30, 2023 Oct NEWA

Nov 29, 2022 Jan CAHN

Feb 09, 2023 Aug DISC

Feb 09, 2023 Jan NFTG

Aug 16, 2013 Jan CFTG

Mar 27, 2009 Sep DISC

Mar 27, 2009 Sep DISC

Mar 27, 2009 Sep DISC

Mar 27, 2009 Sep DISC

Oct 11, 2007 May CAHN

Oct 11, 2007 May CAHN

May 28, 1996 May CAHN

Nov 24, 2017 Mar CAHN

Dec 20, 2012 Dec CAHN

Dec 20, 2012 Oct CAHN

Dec 20, 2012 Dec CAHN
RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - December 2023 1-147

TORSEMIDE

TABLET;ORAL

SOAANZ

+ @ SARFE PHARMS

+ @

TORSEMIDE

@ TEVA

@

@

@

20MG

60MG

5MG

10MG

20MG

100MG

N213218

N213218

A076110

A076110

A076110

A076110

001

002

001

002

003

004

Jun 14, 2021

Jun 14, 2021

May 14, 2002

May 14, 2002

May 14, 2002

May 14, 2002

Jun DISC

Jun DISC

Sep DISC

Sep DISC

Sep DISC

Sep DISC

TRAMADOL HYDROCHLORIDE

>D>

>A>

TABLET;ORAL

TRAMADOL HYDROCHLORIDE

@ PLIVA 50MG

RUBICON 25MG

TABLET, EXTENDED RELEASE;ORAL

TRAMADOL HYDROCHLORIDE

@ ACTAVIS ELIZABETH 100MG

@ 200MG

@ 300MG

! SUN PHARM 100MG

200MG

@ 200MG

200MG

300MG

A075982

A208708

A091609

A091609

A091609

A091607

A091607

A091607

A091607

A091607

001

003

001

002

003

001

002

002

002

003

Jul 01, 2002

Nov 27, 2023

Jun 27, 2012

Jun 27, 2012

Jun 27, 2012

Dec 30, 2011

Dec 30, 2011

Dec 30, 2011

Dec 30, 2011

Dec 30, 2011

Sep DISC

Nov NFTG

Sep DISC

Sep DISC

Sep DISC

Sep CTEC

Dec DISC

Dec DISC

Sep CTEC

Sep CTEC

TRAMETINIB DIMETHYL SULFOXIDE

SOLUTION;ORAL

MEKINIST

+! NOVARTIS EQ 0.05MG BASE/ML N217513 001 Mar 16, 2023 Mar NEWA

TRANDOLAPRIL

TABLET;ORAL

TRANDOLAPRIL

@ TEVA PHARMS

@

@

1MG

2MG

4MG

A077489

A077489

A077489

001

002

003

Dec 12, 2006

Dec 12, 2006

Dec 12, 2006

Sep DISC

Sep DISC

Sep DISC

TRANEXAMIC ACID

>D>

>A>

AP

AP

AP

AB

INJECTABLE;INJECTION

TRANEXAMIC ACID

@ CHARTWELL RX

EPIC PHARMA LLC

@ VIRTUS

SOLUTION;INTRAVENOUS

TRANEXAMIC ACID

AMNEAL

+! EXELA PHARMA

TABLET;ORAL

TRANEXAMIC ACID

@ AUROBINDO PHARMA USA

100MG/ML

100MG/ML

100MG/ML

1GM/100ML (10MG/ML)

1GM/100ML (10MG/ML)

650MG

650MG

A202755

A202373

A202755

A217155

N212020

A205133

A205133

001

001

001

001

001

001

001

Feb 25, 2016

Nov 17, 2011

Feb 25, 2016

Oct 16, 2023

Apr 15, 2019

Sep 21, 2015

Sep 21, 2015

Sep CAHN

Oct CAHN

Sep CAHN

Oct NFTG

Oct CFTG

Dec CMFD

Dec CMFD

TRAVOPROST

>A>

>A>

AT

IMPLANT;INTRACAMERAL

IDOSE TR

+! GLAUKOS

SOLUTION/DROPS;OPHTHALMIC

TRAVATAN Z

+! SANDOZ

75MCG

0.004%

N218010

N021994

001

001

Dec 13, 2023

Sep 21, 2006

Dec NEWA

Sep CAHN

TRAZODONE HYDROCHLORIDE

AB

AB

AB

AB

TABLET;ORAL

TRAZODONE HYDROCHLORIDE

AUROBINDO PHARMA 50MG

100MG

150MG

300MG

A204852

A204852

A204852

A204852

001

002

003

004

Feb 05, 2020

Feb 05, 2020

Feb 05, 2020

Feb 05, 2020

Jan CAHN

Jan CAHN

Jan CAHN

Jan CAHN
RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - December 2023 1-148

TREPROSTINIL

INJECTABLE;IV (INFUSION), SUBCUTANEOUS

REMODULIN

+! UNITED THERAP

+!

+!

TREPROSTINIL

0.1MG/ML

0.2MG/ML

0.4MG/ML

N021272

N021272

N021272

006

007

008

Sep 28, 2023

Sep 28, 2023

Sep 28, 2023

Oct NEWA

Oct NEWA

Oct NEWA

AP

AP

AP

AP

DR REDDYS 1MG/ML

2.5MG/ML

5MG/ML

10MG/ML

A210214

A210214

A210214

A210214

001

002

003

004

May 22, 2020

May 22, 2020

May 22, 2020

May 22, 2020

Feb CMFD

Feb CMFD

Feb CMFD

Feb CMFD

TRETINOIN

CREAM;TOPICAL

RETIN-A

AB +! BAUSCH

GEL;TOPICAL

AVITA

0.025% N019049 001 Sep 16, 1988 Jan CAHN

@ MYLAN

RETIN-A MICRO

0.025% N020400 001 Jan 29, 1998 May DISC

>A>

>A>

>D>

>D>

+! BAUSCH

+!

+! VALEANT INTL

+!

RETIN-A-MICRO

0.04%

0.1%

0.04%

0.1%

N020475

N020475

N020475

N020475

002

001

002

001

May 10, 2002

Feb 07, 1997

May 10, 2002

Feb 07, 1997

Dec CAHN

Dec CAHN

Dec CAHN

Dec CAHN

>A>

>A>

>D>

>D>

AB

AB

AB

+! BAUSCH

+!

+! VALEANT INTL

+!

+!

TRETINOIN MICROSPHERE

0.06%

0.08%

0.06%

0.08%

0.08%

N020475

N020475

N020475

N020475

N020475

004

003

004

003

003

Oct 23, 2017

Jan 28, 2014

Oct 23, 2017

Jan 28, 2014

Jan 28, 2014

Dec CAHN

Dec CAHN

Dec CAHN

Dec CAHN

Aug CFTG

AB ENCUBE 0.08% A215609 001 Aug 22, 2023 Aug NFTG

TRIAMCINOLONE ACETONIDE

CREAM;TOPICAL

TRIAMCINOLONE ACETONIDE

AT

AT

AT

AT

CHARTWELL RX

ENCUBE

INJECTABLE;INTRAVITREAL

TRIESENCE

0.025%

0.1%

0.5%

0.1%

A208763

A208763

A208763

A208848

001

002

003

001

Feb 01, 2017

Feb 01, 2017

Feb 01, 2017

Sep 18, 2017

May CAHN

May CAHN

May CAHN

Oct CAHN

>A>

>D>

+! HARROW EYE

+! NOVARTIS

LOTION;TOPICAL

TRIAMCINOLONE ACETONIDE

40MG/ML (40MG/ML)

40MG/ML (40MG/ML)

N022048

N022048

001

001

Nov 29, 2007

Nov 29, 2007

Dec CAHN

Dec CAHN

AT

AT

EPIC PHARMA LLC

@ PAI HOLDINGS PHARM

@

OINTMENT;TOPICAL

TRIAMCINOLONE ACETONIDE

0.025%

0.1%

0.025%

0.1%

A202374

A202374

A204608

A204606

001

002

001

001

May 08, 2013

May 08, 2013

Jul 07, 2016

Jul 07, 2016

Oct CAHN

Oct CAHN

Aug DISC

Aug DISC

AT

AT

AT

AT

AT

AT

!

CHARTWELL RX

ENCUBE

GLASSHOUSE PHARMS

MACLEODS PHARMS LTD

@ PAI HOLDINGS PHARM

TRIANEX

0.05%

0.1%

0.05%

0.1%

0.05%

0.05%

0.5%

A214532

A207365

A212384

A205373

A214532

A216625

A208590

001

001

001

001

001

001

001

Jan 27, 2023

Oct 12, 2018

Nov 29, 2019

May 13, 2016

Jan 27, 2023

Aug 18, 2023

Mar 03, 2017

May CAHN

Apr CAHN

Nov CHRS

Oct CAHN

Jan NEWA

Aug NEWA

Aug DISC

@ CMP PHARMA INC 0.05% A089595 001 Mar 23, 1995 Nov DISC

SPRAY;TOPICAL

KENALOG

+ @ SUN PHARM INDS INC

TRIAMCINOLONE ACETONIDE

0.147MG/GM N012104 001 Jun DISC

AT ! PADAGIS ISRAEL 0.147MG/GM A205782 001 Apr 13, 2015 Jun CHRS
RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - December 2023 1-149

TRIAMTERENE

CAPSULE;ORAL

TRIAMTERENE

@

@

EYWA 50MG

100MG

A214768

A214768

001

002

Jul 06, 2022

Jul 06, 2022

Jan DISC

Jan DISC

TRIENTINE HYDROCHLORIDE

CAPSULE;ORAL

TRIENTINE HYDROCHLORIDE

AB MSN

RISING

250MG

500MG

A211134

A212238

001

002

May 22, 2019

Sep 22, 2023

Mar CTEC

Sep NEWA

TRIMETHOBENZAMIDE HYDROCHLORIDE

CAPSULE;ORAL

TRIMETHOBENZAMIDE HYDROCHLORIDE

AB AVET LIFESCIENCES 300MG A205950 001 Nov 21, 2023 Nov NEWA

TROFINETIDE

SOLUTION;ORAL

DAYBUE

+! ACADIA PHARMS INC 200MG/ML N217026 001 Mar 10, 2023 Mar NEWA

TROPICAMIDE

SOLUTION/DROPS;OPHTHALMIC

TROPICACYL

AT EPIC PHARMA LLC 0.5% A040314 001 Sep 29, 2000 Sep CAHN

TROSPIUM CHLORIDE

TABLET;ORAL

TROSPIUM CHLORIDE

AB CHARTWELL RX 20MG A215781 001 Feb 16, 2022 Sep CAHN

UBROGEPANT

TABLET;ORAL

UBRELVY

+

+!

ABBVIE 50MG

100MG

N211765

N211765

001

002

Dec 23, 2019

Dec 23, 2019

Jan CAHN

Jan CAHN

UREA, C-14

CAPSULE;ORAL

PYTEST KIT

+ @ AVENT 1uCi N020617 002 May 09, 1997 Sep DISC

URIDINE TRIACETATE

GRANULE;ORAL

VISTOGARD

+! BTG INTL

XURIDEN

10GM/PACKET N208159 001 Dec 11, 2015 Jul CAHN

+! BTG INTL 2GM/PACKET N208169 001 Sep 04, 2015 Jul CAHN

URSODIOL

CAPSULE;ORAL

URSODIOL

AB

AB

@

@

MYLAN

RK PHARMA

TEVA PHARMS

VGYAAN

300MG

300MG

300MG

300MG

A090530

A214329

A075592

A214329

001

001

001

001

Feb 17, 2010

Jul 28, 2021

May 25, 2000

Jul 28, 2021

Jan DISC

Jun CAHN

Sep DISC

Apr CMFD

VALACYCLOVIR HYDROCHLORIDE

TABLET;ORAL

VALACYCLOVIR HYDROCHLORIDE

AB

AB

AB

AB

AB

AB

ADAPTIS

CHARTWELL RX

YAMPA

EQ 500MG BASE

EQ 1GM BASE

EQ 500MG BASE

EQ 1GM BASE

EQ 500MG BASE

EQ 1GM BASE

A079012

A079012

A090216

A090216

A079012

A079012

001

002

001

002

001

002

May 24, 2010

May 24, 2010

May 24, 2010

May 24, 2010

May 24, 2010

May 24, 2010

Oct CAHN

Oct CAHN

Jan CAHN

Jan CAHN

Sep CAHN

Sep CAHN
RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - December 2023 1-150

VALGANCICLOVIR HYDROCHLORIDE

FOR SOLUTION;ORAL

VALCYTE

AB +! CHEPLAPHARM 50MG/ML

VALGANCICLOVIR HYDROCHLORIDE

N022257 001 Aug 28, 2009 Mar CAHN

AB APPCO

TABLET;ORAL

VALCYTE

50MG/ML A216317 001 Apr 11, 2023 Mar NEWA

AB +! CHEPLAPHARM EQ 450MG BASE

VALGANCICLOVIR HYDROCHLORIDE

N021304 001 Mar 29, 2001 Mar CAHN

@ CIPLA EQ 450MG BASE A209672 001 Nov 09, 2018 Aug DISC

VALPROATE SODIUM

INJECTABLE;INJECTION

VALPROATE SODIUM

AP SAGENT EQ 100MG BASE/ML A076295 001 Nov 14, 2002 Aug CAHN

VALPROIC ACID

SYRUP;ORAL

VALPROIC ACID

>D>

>A> AA

AA

@

@

@

ANI PHARMS

HIKMA

PHARMOBEDIENT CNSLTG

XTTRIUM LABS INC

250MG/5ML

250MG/5ML

250MG/5ML

250MG/5ML

250MG/5ML

A073178

A073178

A074060

A070868

A070868

001

001

001

001

001

Aug 25, 1992

Aug 25, 1992

Jan 13, 1995

Jul 01, 1986

Jul 01, 1986

Dec CMFD

Dec CMFD

Sep CAHN

Sep CAHN

Mar CAHN

VALSARTAN

SOLUTION;ORAL

VALSARTAN

! NOVITIUM PHARMA

TABLET;ORAL

VALSARTAN

20MG/5ML A214102 001 Nov 02, 2021 Jan CHRS

@ IVAX PHARMS

@

@

@

40MG

80MG

160MG

320MG

A077530

A077530

A077530

A077530

001

002

003

004

Jan 04, 2016

Jan 04, 2016

Jan 04, 2016

Jan 04, 2016

Sep DISC

Sep DISC

Sep DISC

Sep DISC

VAMOROLONE

SUSPENSION;ORAL

AGAMREE

+!

+!

CATALYST PHARMS

SANTHERA PHARMS

40MG/ML

40MG/ML

N215239

N215239

001

001

Oct 26, 2023

Oct 26, 2023

Oct CAHN

Oct NEWA

VANCOMYCIN

SOLUTION;INTRAVENOUS, ORAL

VANCOMYCIN

+ @ XELLIA PHARMS APS 5GM/100ML (50MG/ML) N213895 001 Aug 26, 2021 Oct DISC

VANCOMYCIN HYDROCHLORIDE

CAPSULE;ORAL

VANCOMYCIN HYDROCHLORIDE

AB

AB

PAI HOLDINGS PHARM

@ WATSON LABS

@

FOR SOLUTION;ORAL

VANCOCIN HYDROCHLORIDE

EQ 125MG BASE

EQ 250MG BASE

EQ 125MG BASE

EQ 250MG BASE

A065478

A065478

A065510

A065510

001

002

001

002

Apr 09, 2012

Apr 09, 2012

Apr 09, 2012

Apr 09, 2012

Oct CAHN

Oct CAHN

Sep DISC

Sep DISC

AA ! ANI PHARMS EQ 250MG BASE/5ML

VANCOMYCIN HYDROCHLORIDE

A061667 002 Jul 13, 1983 Jun CTEC

AA AMNEAL EQ 250MG BASE/5ML

INJECTABLE;INJECTION

VANCOMYCIN HYDROCHLORIDE

A215338 001 Jun 23, 2023 Jun NEWA

AP

AP

AP

GLAND PHARMA LTD EQ 5GM BASE/VIAL

EQ 10GM BASE/VIAL

HIKMA EQ 1GM BASE/VIAL

POWDER;INTRAVENOUS

VANCOMYCIN HYDROCHLORIDE

A205694

A205694

A203300

003

004

002

Jun 06, 2023

Jun 06, 2023

Aug 11, 2020

May NEWA

May NEWA

Jan CMFD

AP

AP

AP

EUGIA PHARMA

HIKMA

EQ 1.25GM BASE/VIAL

EQ 1.5GM BASE/VIAL

EQ 1.25GM BASE/VIAL

A217401

A217401

A217489

001

002

001

Aug 04, 2023

Aug 04, 2023

Jun 29, 2023

Jul NEWA

Jul NEWA

Jun NFTG
RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - December 2023 1-151

POWDER;INTRAVENOUS

VANCOMYCIN HYDROCHLORIDE

AP

AP

AP

EQ 1.5GM BASE/VIAL

+! MYLAN LABS LTD EQ 1.25GM BASE/VIAL

+! EQ 1.5GM BASE/VIAL

POWDER;INTRAVENOUS, ORAL

VANCOMYCIN HYDROCHLORIDE

A217489

N209481

N209481

002 Jun 29, 2023

003 Jul 10, 2018

004 Jul 10, 2018

Jun NFTG

Jun CFTG

Jun CFTG

+!

+!

+!

+!

ZHEJIANG NOVUS PHARM EQ 500MG BASE/VIAL

EQ 1GM BASE/VIAL

EQ 5GM BASE/VIAL

EQ 10GM BASE/VIAL

N210274

N210274

N210274

N210274

001 Jan 20, 2023

002 Jan 20, 2023

003 Jan 20, 2023

004 Jan 20, 2023

Jan NEWA

Jan NEWA

Jan NEWA

Jan NEWA

VARDENAFIL HYDROCHLORIDE

TABLET;ORAL

VARDENAFIL HYDROCHLORIDE

>D>

>D>

>D>

>A>

>A>

>A>

@

@

@

@

@

@

AMNEAL PHARMS CO

STEVENS J

EQ 5MG BASE

EQ 10MG BASE

EQ 20MG BASE

EQ 5MG BASE

EQ 10MG BASE

EQ 20MG BASE

A210738

A210738

A210738

A210738

A210738

A210738

001 Oct 31, 2018

002 Oct 31, 2018

003 Oct 31, 2018

001 Oct 31, 2018

002 Oct 31, 2018

003 Oct 31, 2018

Dec CAHN

Dec CAHN

Dec CAHN

Dec CAHN

Dec CAHN

Dec CAHN

VARENICLINE TARTRATE

TABLET;ORAL

VARENICLINE TARTRATE

AB

AB

AB

AB

AB

AB

AB

AB

AB

AB

AB

AB

AB

AB

AB

AB

AB

AB

AB

AB

!

ALKEM LABS LTD

APOTEX

HETERO LABS LTD III

LEADING PHARMA

LUPIN LTD

MANKIND PHARMA

MEDLEY PHARMS

PAR PHARM INC

ZYDUS

ZYDUS PHARMS

EQ 0.5MG BASE

EQ 1MG BASE

EQ 0.5MG BASE

EQ 1MG BASE

EQ 0.5MG BASE

EQ 1MG BASE

EQ 0.5MG BASE

EQ 1MG BASE

EQ 0.5MG BASE

EQ 1MG BASE

EQ 0.5MG BASE

EQ 1MG BASE

EQ 0.5MG BASE

EQ 1MG BASE

EQ 0.5MG BASE

EQ 1MG BASE

EQ 0.5MG BASE

EQ 1MG BASE

EQ 0.5MG BASE

EQ 1MG BASE

A214557

A214557

A201962

A201962

A214571

A214571

A217151

A217151

A211862

A211862

A214255

A214255

A217151

A217151

A201785

A201785

A216723

A216723

A216723

A216723

001 Aug 23, 2023

002 Aug 23, 2023

001 Jan 25, 2023

002 Jan 25, 2023

001 Oct 23, 2023

002 Oct 23, 2023

001 Jul 25, 2023

002 Jul 25, 2023

001 Dec 04, 2023

002 Dec 04, 2023

001 Aug 01, 2023

002 Aug 01, 2023

001 Jul 25, 2023

002 Jul 25, 2023

001 Aug 11, 2021

002 Aug 11, 2021

001 Jun 12, 2023

002 Jun 12, 2023

001 Jun 12, 2023

002 Jun 12, 2023

Aug NEWA

Aug NEWA

Jan NEWA

Jan NEWA

Oct NEWA

Oct NEWA

Sep CAHN

Sep CAHN

Nov NEWA

Nov NEWA

Jul NEWA

Jul NEWA

Jul NEWA

Jul NEWA

Jan CTEC

Jan CTEC

Jun CAHN

Jun CAHN

Jun NEWA

Jun NEWA

VASOPRESSIN

SOLUTION;INTRAVENOUS

VASOPRESSIN

AP

AP

+! AM REGENT 200UNITS/10ML (20UNITS/ML)

CIPLA 20UNITS/100ML (0.2UNITS/ML)

FRESENIUS KABI USA 20UNITS/ML (20UNITS/ML)

VASOPRESSIN IN SODIUM CHLORIDE 0.9%

N212593

A217987

A213206

002 Jun 09, 2023

001 Dec 06, 2023

001 May 26, 2023

Jul NEWA

Nov NFTG

May NEWA

+! BAXTER HLTHCARE CORP

+!

VASOSTRICT

20UNITS/100ML (0.2UNITS/ML)

40UNITS/100ML (0.4UNITS/ML)

N217569

N217569

001 Sep 29, 2023

002 Sep 29, 2023

Sep NEWA

Sep NEWA

>D>

>A>

>D>

>A>

AP +! PAR STERILE PRODUCTS

+!

+ @

+!

+!

+ @

20UNITS/100ML (0.2UNITS/ML)

50UNITS/50ML (1UNITS/ML)

50UNITS/50ML (1UNITS/ML)

50UNITS/50ML (1UNITS/ML)

60UNITS/100ML (0.6UNITS/ML)

60UNITS/100ML (0.6UNITS/ML)

N204485

N204485

N204485

N204485

N204485

N204485

005 Apr 21, 2021

006 Apr 12, 2023

006 Apr 12, 2023

006 Apr 12, 2023

004 Apr 15, 2020

004 Apr 15, 2020

Nov CFTG

Dec DISC

Dec DISC

Apr NEWA

Dec DISC

Dec DISC

VECURONIUM BROMIDE

INJECTABLE;INJECTION

VECURONIUM BROMIDE

>D>

>D>

>A>

>A>

AP

AP

AP

AP

AP

AP

HONG KONG

MEITHEAL

10MG/VIAL

10MG/VIAL

20MG/VIAL

20MG/VIAL

10MG/VIAL

20MG/VIAL

A074688

A074688

A074688

A074688

A074688

A074688

001 Aug 25, 1999

001 Aug 25, 1999

002 Aug 25, 1999

002 Aug 25, 1999

001 Aug 25, 1999

002 Aug 25, 1999

Dec CAHN

Oct CAHN

Dec CAHN

Oct CAHN

Dec CAHN

Dec CAHN
RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - December 2023 1-152

VENLAFAXINE HYDROCHLORIDE

CAPSULE, EXTENDED RELEASE;ORAL

VENLAFAXINE HYDROCHLORIDE

AB

AB

AB

AB

AB

AB

GRANULES EQ 37.5MG BASE

EQ 75MG BASE

EQ 150MG BASE

NOSTRUM PHARMS LLC EQ 37.5MG BASE

EQ 75MG BASE

EQ 150MG BASE

@ TORRENT EQ 37.5MG BASE

@ EQ 75MG BASE

@ EQ 150MG BASE

TABLET;ORAL

VENLAFAXINE HYDROCHLORIDE

A217390

A217390

A217390

A200430

A200430

A200430

A090899

A090899

A090899

001

002

003

001

002

003

001

002

003

May 18, 2023

May 18, 2023

May 18, 2023

Apr 04, 2023

Apr 04, 2023

Apr 04, 2023

Jun 01, 2011

Jun 01, 2011

Jun 01, 2011

May NEWA

May NEWA

May NEWA

Mar NEWA

Mar NEWA

Mar NEWA

Aug DISC

Aug DISC

Aug DISC

@ CHARTWELL RX EQ 25MG BASE

@ EQ 37.5MG BASE

@ EQ 50MG BASE

@ EQ 75MG BASE

@ EQ 100MG BASE

TABLET, EXTENDED RELEASE;ORAL

VENLAFAXINE HYDROCHLORIDE

A077515

A077515

A077515

A077515

A077515

001

002

003

004

005

Jun 13, 2008

Jun 13, 2008

Jun 13, 2008

Jun 13, 2008

Jun 13, 2008

Jan CAHN

Jan CAHN

Jan CAHN

Jan CAHN

Jan CAHN

AB

AB

AB

AB

AB

AB

AB

AB

+

+

+!

+

AJANTA PHARMA LTD

OSMOTICA PHARM US

EQ 37.5MG BASE

EQ 75MG BASE

EQ 150MG BASE

EQ 225MG BASE

EQ 37.5MG BASE

EQ 75MG BASE

EQ 150MG BASE

EQ 225MG BASE

A214691

A214691

A214691

A214691

N022104

N022104

N022104

N022104

001

002

003

004

001

002

003

004

Apr 12, 2023

Apr 12, 2023

Apr 12, 2023

Apr 12, 2023

May 20, 2008

May 20, 2008

May 20, 2008

May 20, 2008

Mar NEWA

Mar NEWA

Mar NEWA

Mar NEWA

Nov CAHN

Nov CAHN

Nov CAHN

Nov CAHN

VERAPAMIL HYDROCHLORIDE

TABLET, EXTENDED RELEASE;ORAL

CALAN SR

+

+

@ PFIZER

@

VERAPAMIL HYDROCHLORIDE

120MG

240MG

N019152

N019152

003

001

Mar 06, 1991

Dec 16, 1986

Mar DISC

Mar DISC

>D>

>A>

>D>

>A>

>D>

>A>

AB

AB

AB

AB

AB

AB

!

!

@

@

@

@

@

@

CADILA PHARMS LTD

GLENMARK GENERICS

IVAX SUB TEVA PHARMS

SUN PHARM INDS INC

120MG

120MG

240MG

120MG

180MG

240MG

120MG

120MG

180MG

180MG

240MG

240MG

A206173

A090700

A078906

A073568

A074330

A073568

A090529

A090529

A090529

A090529

A090529

A090529

003

001

001

002

001

001

001

001

002

002

003

003

Nov 14, 2022

Aug 03, 2011

Sep 17, 2009

Oct 10, 1997

Jan 31, 1994

Jul 31, 1992

Dec 30, 2011

Dec 30, 2011

Dec 30, 2011

Dec 30, 2011

Dec 30, 2011

Dec 30, 2011

Mar NEWA

Mar CHRS

Mar CHRS

Sep DISC

Sep DISC

Sep DISC

Dec DISC

Dec DISC

Dec DISC

Dec DISC

Dec DISC

Dec DISC

VIGABATRIN

FOR SOLUTION;ORAL

VIGABATRIN

>D>

>A>

AA

AA

@ ACCORD HLTHCARE

@ CHARTWELL RX

PYROS PHARMS

@ ZYDUS

VIGPODER

500MG/PACKET

500MG/PACKET

500MG/PACKET

500MG/PACKET

500MG/PACKET

A214425

A211790

A214961

A214671

A214671

001

001

001

001

001

Nov 13, 2020

Mar 10, 2022

Jun 24, 2022

Mar 02, 2023

Mar 02, 2023

Mar DISC

May CAHN

Dec CTNA

Jul DISC

Feb NEWA

>A> AA PYROS PHARMS

TABLET;ORAL

VIGABATRIN

500MG/PACKET A214961 001 Jun 24, 2022 Dec CTNA

AB

AB

AB

PROPEL PHARMA

UPSHER SMITH LABS

ZENARA

500MG

500MG

500MG

A215519

A214749

A214749

001

001

001

Apr 28, 2023

Jun 29, 2023

Jun 29, 2023

Apr NEWA

Sep CAHN

Jun NEWA

VILAZODONE HYDROCHLORIDE

TABLET;ORAL

VIIBRYD

AB

AB

AB

+!

+

+

ABBVIE 10MG

20MG

40MG

N022567

N022567

N022567

001

002

003

Jan 21, 2011

Jan 21, 2011

Jan 21, 2011

Jan CAHN

Jan CAHN

Jan CAHN
RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - December 2023 1-153

TABLET;ORAL

VILAZODONE HYDROCHLORIDE

AB

AB

AB

APOTEX 10MG

20MG

40MG

A208228

A208228

A208228

001 Jul 07, 2023

002 Jul 07, 2023

003 Jul 07, 2023

Jun NEWA

Jun NEWA

Jun NEWA

VINCRISTINE SULFATE

INJECTABLE;INJECTION

VINCRISTINE SULFATE PFS

!

@

HOSPIRA

TEVA PHARMS USA

1MG/ML

1MG/ML

A071484

A075493

001 Apr 19, 1988

001 Sep 01, 1999

Sep CTEC

Sep DISC

VONOPRAZAN FUMARATE

TABLET;ORAL

VOQUEZNA

+ PHATHOM

+!

EQ 10MG BASE

EQ 20MG BASE

N215151

N215151

001 Nov 01, 2023

002 Nov 01, 2023

Nov NEWA

Nov NEWA

VORICONAZOLE

FOR SUSPENSION;ORAL

VORICONAZOLE

>A> AB HAINAN POLY

INJECTABLE;INTRAVENOUS

VORICONAZOLE

200MG/5ML A216805 001 Jan 02, 2024 Dec NEWA

AP

AP

AP

AP

@ EUGIA PHARMA

SLATE RUN PHARMA

UBI

XELLIA PHARMS APS

TABLET;ORAL

VORICONAZOLE

200MG/VIAL

200MG/VIAL

200MG/VIAL

200MG/VIAL

200MG/VIAL

A212162

A212162

A211661

A211264

N208562

001 Feb 02, 2023

001 Feb 02, 2023

001 Nov 30, 2018

001 Mar 09, 2023

001 Mar 09, 2017

Aug DISC

Jan NEWA

Sep CAHN

Mar NEWA

Mar CDFR

AB

AB

AB

AB

CHARTWELL RX

EPIC PHARMA LLC

50MG

200MG

50MG

200MG

A207371

A207371

A207049

A207049

001 May 24, 2016

002 May 24, 2016

001 Sep 07, 2016

002 Sep 07, 2016

Apr CAHN

Apr CAHN

Nov CAHN

Nov CAHN

VUTRISIRAN SODIUM

SOLUTION;SUBCUTANEOUS

AMVUTTRA

+!

+!

ALNYLAM PHARMS INC EQ 25MG BASE/0.5ML (EQ 25MG

BASE/0.5ML)

25MG/0.5ML (25MG/0.5ML)

N215515

N215515

001 Jun 13, 2022

001 Jun 13, 2022

Feb CPOT

Feb CAIN

WARFARIN SODIUM

TABLET;ORAL

WARFARIN SODIUM

@

@

@

@

@

@

@

@

@

AUROBINDO PHARMA USA 1MG

2MG

2.5MG

3MG

4MG

5MG

6MG

7.5MG

10MG

A040415

A040415

A040415

A040415

A040415

A040415

A040415

A040415

A040415

001 Sep 27, 2004

002 Sep 27, 2004

003 Sep 29, 2004

004 Sep 27, 2004

005 Sep 27, 2004

006 Sep 27, 2004

007 Sep 27, 2004

008 Sep 27, 2004

009 Sep 27, 2004

May CAHN

May CAHN

May CAHN

May CAHN

May CAHN

May CAHN

May CAHN

May CAHN

May CAHN

XENON XE-129 HYPERPOLARIZED

GAS;INHALATION

XENOVIEW

+! POLAREAN N/A N214375 001 Dec 23, 2022 Jan NEWA

ZAFIRLUKAST

TABLET;ORAL

ZAFIRLUKAST

AB

AB

AUROBINDO PHARMA 10MG

20MG

A213163

A213163

001 Nov 27, 2023

002 Nov 27, 2023

Nov NEWA

Nov NEWA
RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - December 2023 1-154

ZAVEGEPANT HYDROCHLORIDE

SPRAY, METERED;NASAL

ZAVZPRET

+! PFIZER EQ 10MG BASE/SPRAY N216386 001 Mar 09, 2023 Mar NEWA

ZILEUTON

TABLET, EXTENDED RELEASE;ORAL

ZILEUTON

AB

AB !

AIZANT

RISING

600MG

600MG

A211390

A204929

001

001

Oct 23, 2020

Mar 17, 2017

Aug CAHN

Jan CHRS

ZILUCOPLAN SODIUM

SOLUTION;SUBCUTANEOUS

ZILBRYSQ

+! UCB INC

+!

+!

EQ 16.6MG BASE/0.416ML (EQ 16.6MG

BASE/0.416ML)

EQ 23MG BASE/0.574ML (EQ 23MG

BASE/0.574ML)

EQ 32.4MG BASE/0.81ML (EQ 32.4

BASE/0.81ML)

N216834

N216834

N216834

001

002

003

Oct 17, 2023

Oct 17, 2023

Oct 17, 2023

Oct NEWA

Oct NEWA

Oct NEWA

ZINC SULFATE

SOLUTION;INTRAVENOUS

ZINC SULFATE

AP

AP

AP

AP

AP

AP

AP

FRESENIUS KABI USA

GLAND PHARMA LTD

ZYDUS PHARMS

EQ 10MG BASE/10ML (EQ 1MG BASE/ML)

EQ 25MG BASE/5ML (EQ 5MG BASE/ML)

EQ 30MG BASE/10ML (EQ 3MG BASE/ML)

EQ 10MG BASE/10ML (EQ 1MG BASE/ML)

EQ 30MG BASE/10ML (EQ 3MG BASE/ML)

EQ 10MG BASE/10ML (EQ 1MG BASE/ML)

EQ 25MG BASE/5ML (EQ 5MG BASE/ML)

A216145

A216145

A216145

A216249

A217074

A217074

A217074

001

002

003

003

003

001

002

Dec 27, 2022

Dec 27, 2022

Dec 27, 2022

Sep 01, 2023

Aug 22, 2023

Aug 22, 2023

Aug 22, 2023

May CAIN

May CAIN

May CAIN

Aug NEWA

Aug NEWA

Aug NEWA

Aug NEWA

ZOLEDRONIC ACID

INJECTABLE;INTRAVENOUS

RECLAST

AP +! SANDOZ

ZOLEDRONIC

EQ 5MG BASE/100ML N021817 001 Apr 16, 2007 May CAHN

>D>

>A>

AP

AP

GLAND PHARMA LTD

!

ZOLEDRONIC ACID

EQ 4MG BASE/100ML

EQ 4MG BASE/100ML

A205749

A205749

001

001

Jun 29, 2018

Jun 29, 2018

Dec CHRS

Dec CHRS

>D>

>A>

>D>

AP

AP

AP

AP

AP

AP

AP

AP

AP

AP

AP

AVET LIFESCIENCES

@ BRECKENRIDGE

CHARTWELL RX

DR REDDYS LABS LTD

!

HONG KONG

+! INFORLIFE

+

@ INGENUS PHARMS LLC

MEITHEAL

@ NOVAST LABS

PII

ZOMETA

EQ 4MG BASE/5ML

EQ 4MG BASE/5ML

EQ 4MG BASE/5ML

EQ 5MG BASE/100ML

EQ 4MG BASE/5ML

EQ 4MG BASE/5ML

EQ 5MG BASE/100ML

EQ 4MG BASE/100ML

EQ 4MG BASE/100ML

EQ 4MG BASE/5ML

EQ 5MG BASE/100ML

EQ 4MG BASE/5ML

EQ 4MG BASE/5ML

EQ 5MG BASE/100ML

A201783

A091170

A202571

A202163

A091186

A091186

A213371

N203231

N203231

A208968

A213371

A208968

A202571

A202163

001

001

001

001

001

001

001

001

001

001

001

001

001

001

Mar 12, 2013

Mar 04, 2013

May 07, 2013

Aug 05, 2013

Mar 04, 2013

Mar 04, 2013

Jun 05, 2023

Aug 02, 2013

Aug 02, 2013

Feb 19, 2020

Jun 05, 2023

Feb 19, 2020

May 07, 2013

Aug 05, 2013

Sep CMFD

Sep DISC

Aug CAHN

Aug CAHN

Dec CHRS

Dec CHRS

May NEWA

Nov CHRS

Jul CRLD

Jun DISC

Aug CAHN

Sep CAHN

Jul CAHN

Jul CAHN

>D>

>A>

>D>

>A>

AP

AP

+! NOVARTIS

+ @

+!

+ @

EQ 4MG BASE/5ML

EQ 4MG BASE/5ML

EQ 4MG BASE/100ML

EQ 4MG BASE/100ML

N021223

N021223

N021223

N021223

002

002

003

003

Mar 07, 2003

Mar 07, 2003

Jun 17, 2011

Jun 17, 2011

Dec DISC

Dec DISC

Dec DISC

Dec DISC

ZOLMITRIPTAN

SPRAY;NASAL

ZOMIG

AB

AB

+ AMNEAL

+!

TABLET;ORAL

ZOLMITRIPTAN

2.5MG/SPRAY

5MG/SPRAY

N021450

N021450

003

004

Sep 16, 2013

Sep 30, 2003

Jan CAHN

Jan CAHN

>D>

>D>

>A>

>A>

AB ! AJANTA PHARMA LTD

@ MYLAN PHARMS INC

@

@ NATCO PHARMA USA

@

5MG

2.5MG

5MG

2.5MG

5MG

A204041

A203186

A203186

A203186

A203186

002

001

002

001

002

May 20, 2016

May 14, 2013

May 14, 2013

May 14, 2013

May 14, 2013

Jun CHRS

Dec CAHN

Dec CAHN

Dec CAHN

Dec CAHN
RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - December 2023 1-155

AB

TABLET;ORAL

ZOMIG

+ @ IPR 2.5MG

+ @ 5MG

TABLET, ORALLY DISINTEGRATING;ORAL

ZOLMITRIPTAN

! ZYDUS PHARMS USA INC 5MG

ZOMIG-ZMT

+ @ ASTRAZENECA 2.5MG

+ @ 5MG

N020768

N020768

A202890

N021231

N021231

001

002

002

001

002

Nov 25, 1997

Nov 25, 1997

May 15, 2013

Feb 13, 2001

Sep 17, 2001

Jun DISC

Jun DISC

Jun CHRS

Jun DISC

Jun DISC

ZOLPIDEM TARTRATE

CAPSULE;ORAL

ZOLPIDEM TARTRATE

+! ALMATICA 7.5MG

TABLET, EXTENDED RELEASE;ORAL

ZOLPIDEM TARTRATE

@ ACTAVIS LABS FL INC 6.25MG

@ 12.5MG

@ ANCHEN PHARMS 6.25MG

@ 12.5MG

@ BRECKENRIDGE 6.25MG

@ 12.5MG

N215721

A090153

A090153

A078148

A078148

A213592

A213592

001

001

002

002

001

001

002

May 09, 2023

Mar 25, 2013

Mar 25, 2013

Apr 14, 2011

Dec 03, 2010

Jun 04, 2020

Jun 04, 2020

May NEWA

Sep DISC

Sep DISC

May DISC

May DISC

Aug DISC

Aug DISC

ZURANOLONE

CAPSULE;ORAL

ZURZUVAE

+ BIOGEN INC

+

+!

20MG

25MG

30MG

N217369

N217369

N217369

001

002

003

Oct 31, 2023

Oct 31, 2023

Oct 31, 2023

Oct NEWA

Oct NEWA

Oct NEWA
OTC DRUG PRODUCT LIST - 43RD EDITION

OTC DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - December 2023 2-1

ACETAMINOPHEN; ASPIRIN; CAFFEINE

TABLET;ORAL

EXCEDRIN (MIGRAINE RELIEF)

+! GLAXOSMITHKLINE CONS 250MG;250MG;65MG N020802 001 Jan 14, 1998 Apr CTNA

ACETAMINOPHEN; IBUPROFEN

TABLET;ORAL

ACETAMINOPHEN AND IBUPROFEN

BIONPHARMA

GRANULES

L PERRIGO CO

MARKSANS PHARMA

250MG;125MG

250MG;125MG

250MG;125MG

250MG;125MG

A216999

A216592

A214836

A216994

001

001

001

001

Aug 01, 2023

Jul 13, 2023

Feb 28, 2023

Jul 10, 2023

Jul NEWA

Jul NEWA

Feb NEWA

Jun NEWA

ALCAFTADINE

>D>

SOLUTION/DROPS;OPHTHALMIC

ALCAFTADINE

>D>

>A> @

EUGIA PHARMA 0.25%

0.25%

0.25%

A210659

A210659

A210659

001

001

001

Jun 23, 2023

Jun 23, 2023

Jun 23, 2023

Dec DISC

Dec DISC

Jun NEWA

CALCIUM CARBONATE; FAMOTIDINE; MAGNESIUM HYDROXIDE

TABLET, CHEWABLE;ORAL

FAMOTIDINE, CALCIUM CARBONATE, AND MAGNESIUM HYDROXIDE

@ PERRIGO R AND D 800MG;10MG;165MG A204782 001 Aug 29, 2016 Aug DISC

CETIRIZINE HYDROCHLORIDE

CAPSULE;ORAL

CETIRIZINE HYDROCHLORIDE ALLERGY

@ APOTEX 10MG

TABLET, CHEWABLE;ORAL

CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY

A207235 001 Aug 12, 2016 Aug DISC

>D>

>A>

SUN PHARM 10MG

@ 10MG

CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF

A090142

A090142

002

002

Aug 30, 2011

Aug 30, 2011

Dec DISC

Dec DISC

>D>

>A> @

SUN PHARM 10MG

10MG

A090142

A090142

004

004

Aug 30, 2011

Aug 30, 2011

Dec DISC

Dec DISC

CETIRIZINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE

TABLET, EXTENDED RELEASE;ORAL

CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE

@ AUROBINDO PHARMA LTD 5MG;120MG

5MG;120MG

A212409

A212409

001

001

Mar 08, 2023

Mar 08, 2023

Sep DISC

Feb NEWA

CHLORHEXIDINE GLUCONATE; ISOPROPYL ALCOHOL

SOLUTION;TOPICAL

SOLUPREP S

+! 3M HEALTH CARE 2%;70% N208288 001 Aug 08, 2018 Mar CTNA

CIMETIDINE

TABLET;ORAL

CIMETIDINE

@ IVAX SUB TEVA PHARMS 200MG A075345 001 Jun 16, 1999 Sep DISC

DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN

TABLET, EXTENDED RELEASE;ORAL

GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE

DR REDDYS 30MG;600MG

60MG;1.2GM

A217340

A217340

001

002

Aug 01, 2023

Aug 01, 2023

Jul NEWA

Jul NEWA

DIPHENHYDRAMINE HYDROCHLORIDE; NAPROXEN SODIUM

TABLET;ORAL

NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE

COREPHARMA 25MG;220MG A211830 001 Aug 22, 2019 Feb CAHN
OTC DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - December 2023 2-2

DOCOSANOL

CREAM;TOPICAL

DOCOSANOL

TARO 10% A214454 001 Oct 26, 2023 Oct NEWA

ESOMEPRAZOLE MAGNESIUM

CAPSULE, DELAYED RELEASE;ORAL

ESOMEPRAZOLE MAGNESIUM

ANDA REPOSITORY

GUARDIAN DRUG

EQ 20MG BASE

EQ 20MG BASE

A216149

A216149

001

001

Mar 15, 2023

Mar 15, 2023

Sep CAHN

Mar NEWA

FAMOTIDINE

TABLET;ORAL

FAMOTIDINE

MARKSANS PHARMA 10MG

20MG

A217543

A217543

001

002

Mar 08, 2023

Mar 08, 2023

Feb NEWA

Feb NEWA

FEXOFENADINE HYDROCHLORIDE

SUSPENSION;ORAL

FEXOFENADINE HYDROCHLORIDE

AUROBINDO PHARMA LTD 30MG/5ML

TABLET;ORAL

CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY

A213466 001 May 23, 2023 May NEWA

AUROBINDO PHARMA LTD 30MG

AUROBINDO PHARMA USA 30MG

FEXOFENADINE HYDROCHLORIDE ALLERGY

A202039

A202039

001

001

Nov 19, 2014

Nov 19, 2014

Oct CAHN

Apr CAHN

AUROBINDO PHARMA LTD

AUROBINDO PHARMA USA

60MG

180MG

60MG

180MG

A202039

A202039

A202039

A202039

002

003

002

003

Nov 19, 2014

Nov 19, 2014

Nov 19, 2014

Nov 19, 2014

Oct CAHN

Oct CAHN

Apr CAHN

Apr CAHN

GUAIFENESIN

TABLET, EXTENDED RELEASE;ORAL

GUAIFENESIN

MARKSANS PHARMA 600MG

1.2GM

A217780

A217780

001

002

Aug 21, 2023

Aug 21, 2023

Aug NEWA

Aug NEWA

GUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE

TABLET, EXTENDED RELEASE;ORAL

GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE

@

@

GRANULES 600MG;60MG

1.2GM;120MG

A216082

A216082

001

002

Aug 22, 2022

Aug 22, 2022

Feb DISC

Feb DISC

IBUPROFEN

CAPSULE;ORAL

IBUPROFEN

AUROBINDO PHARMA LTD

SUSPENSION;ORAL

IBUPROFEN

EQ 200MG FREE ACID AND POTASSIUM

SALT

A215777 001 Sep 14, 2023 Sep NEWA

@ ARISE

SUSPENSION/DROPS;ORAL

IBUPROFEN

100MG/5ML A200457 001 Aug 18, 2011 Jun DISC

TARO

TABLET;ORAL

IBUPROFEN

40MG/ML A217261 001 Aug 08, 2023 Jul NEWA

@ OHM 200MG A071163 001 Jul 15, 1986 Nov DISC

IBUPROFEN; PSEUDOEPHEDRINE HYDROCHLORIDE

TABLET;ORAL

IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE

@ AUROBINDO PHARMA LTD 200MG;30MG

200MG;30MG

A213565

A213565

001

001

Mar 10, 2023

Mar 10, 2023

Sep DISC

Mar NEWA

KETOTIFEN FUMARATE

SOLUTION/DROPS;OPHTHALMIC

KETOTIFEN FUMARATE

SENTISS EQ 0.025% BASE A077958 001 Jul 26, 2007 Aug CAHN
OTC DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - December 2023 2-3

LANSOPRAZOLE

CAPSULE, DELAYED REL PELLETS;ORAL

LANSOPRAZOLE

@ MYLAN 15MG A203187 001 Jun 01, 2016 Aug DISC

LOPERAMIDE HYDROCHLORIDE; SIMETHICONE

TABLET;ORAL

LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE

@ GRANULES 2MG;125MG A215981 001 Aug 29, 2022 Feb DISC

LORATADINE

CAPSULE;ORAL

LORATADINE

@ AUROBINDO PHARMA

TABLET;ORAL

LORATADINE

10MG

10MG

A211900

A211900

001

001

Mar 24, 2023

Mar 24, 2023

Sep DISC

Mar NEWA

GUARDIAN DRUG

HETERO LABS LTD V

10MG

10MG

A207569

A211718

001

001

Mar 12, 2019

Jul 28, 2023

Sep CAHN

Jul NEWA

MINOXIDIL

SOLUTION;TOPICAL

MINOXIDIL (FOR MEN)

AUROBINDO PHARMA LTD 2%

MINOXIDIL EXTRA STRENGTH (FOR MEN)

AUROBINDO PHARMA LTD 5%

A074767

A075438

001

001

Feb 28, 1997

Feb 27, 2003

Sep CAHN

Sep CAHN

MOMETASONE FUROATE

SPRAY, METERED;NASAL

MOMETASONE FUROATE

@ AMNEAL 0.05MG/SPRAY

0.05MG/SPRAY

A217460

A217460

001

001

Jun 14, 2023

Jun 14, 2023

Sep DISC

Jun NFTG

NALOXONE HYDROCHLORIDE

SPRAY, METERED;NASAL

NALOXONE HYDROCHLORIDE

PADAGIS ISRAEL

NARCAN

4MG/SPRAY A211951 001 Jun 21, 2022 Jul CMKT

+! EMERGENT

RIVIVE

4MG/SPRAY N208411 001 Nov 18, 2015 Mar CMKT

+! HARM REDUCTION THERP 3MG/SPRAY N217722 001 Jul 28, 2023 Jul NEWA

NAPROXEN SODIUM

CAPSULE;ORAL

NAPROXEN SODIUM

@ STRIDES PHARMA EQ 200MG BASE A215472 001 Aug 17, 2022 Feb DISC

NICOTINE POLACRILEX

GUM, CHEWING;BUCCAL

NICOTINE POLACRILEX

@ FERTIN PHARMA EQ 4MG BASE A214354 001 Dec 21, 2022 Jun DISC

NORGESTREL

TABLET;ORAL

OPILL

+ @ LABORATOIRE HRA 0.075MG N017031 001 Jul CMKT

OLOPATADINE HYDROCHLORIDE

SOLUTION/DROPS;OPHTHALMIC

OLOPATADINE HYDROCHLORIDE

>A>

>D>

@

@

@

@

AKORN

BAUSCH AND LOMB INC

CIPLA

EQ 0.1% BASE

EQ 0.2% BASE

EQ 0.2% BASE

EQ 0.2% BASE

A204532

A204723

A206087

A206087

001

001

001

001

Jan 10, 2017

Dec 05, 2017

Dec 05, 2017

Dec 05, 2017

Jan DISC

Jan DISC

Dec CAHN

Dec CAHN
OTC DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - December 2023 2-4

>D>

>A>

OMEPRAZOLE MAGNESIUM

CAPSULE, DELAYED RELEASE;ORAL

OMEPRAZOLE MAGNESIUM

@ AUROBINDO PHARMA LTD EQ 20MG BASE

EQ 20MG BASE

OMEPRAZOLE; SODIUM BICARBONATE

CAPSULE;ORAL

OMEPRAZOLE AND SODIUM BICARBONATE

AUROBINDO PHARMA 20MG;1.1GM

ZYDUS 20MG;1.1GM

POLYETHYLENE GLYCOL 3350

FOR SOLUTION;ORAL

POLYETHYLENE GLYCOL 3350

ELYSIUM 17GM/SCOOPFUL

RANITIDINE HYDROCHLORIDE

TABLET;ORAL

RANITIDINE HYDROCHLORIDE

THINQ PHARM-CRO PVT EQ 150MG BASE

@ EQ 150MG BASE

A213201

A213201

A204923

A203345

A202071

A210228

A210228

001 Apr 28, 2023

001 Apr 28, 2023

001 Nov 07, 2016

001 Mar 16, 2018

001 Dec 28, 2012

001 Aug 30, 2019

001 Aug 30, 2019

Oct DISC

Apr NEWA

Jun CAHN

May CAHN

Sep CAHN

Dec DISC

Dec DISC
 

 

3-1 

DRUG PRODUCTS WITH APPROVAL UNDER SECTION 505 OF THE ACT 

ADMINISTERED BY THE CENTER FOR BIOLOGICS EVALUATION AND 

RESEARCH LIST 

CUMULATIVE SUPPLEMENT NUMBER 12 DECEMBER 2023 

NO DECEMBER 2023 APPROVALS 
 

4-1 

ORPHAN PRODUCT DESIGNATIONS AND APPROVALS LIST 

The list of Orphan Designations and Approvals is available at: 

https://www.fda.gov/industry/developing-products-rare-diseasesconditions/designating-orphan-product-drugs-and-biological-products. 
5-1 

DRUG PRODUCTS WHICH MUST DEMONSTRATE IN VIVO BIOAVAILABILITY 

ONLY IF PRODUCT FAILS TO ACHIEVE ADEQUATE DISSOLUTION 

NO DECEMBER 2023 APPROVALS 
PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST - 43RD EDITION

A - 1

PATENT AND EXCLUSIVITY DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - December 2023

APPL/PROD PATENT PATENT EXCLUSIVITY

NO PATENT NO EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION

DATE CODES REQUESTED CODE(S) DATE

ABACAVIR SULFATE; DOLUTEGRAVIR SODIUM; LAMIVUDINE - TRIUMEQ

N 205551 001 8129385 Oct 05, 2027 DS DP M-294 Jun 15, 2026

8129385*PED Apr 05, 2028 PED Dec 15, 2026

9242986 Dec 08, 2029 DS DP

9242986*PED Jun 08, 2030

ABACAVIR SULFATE; DOLUTEGRAVIR SODIUM; LAMIVUDINE - TRIUMEQ PD

N 215413 001 8129385 Oct 05, 2027 DS DP NPP Jun 15, 2026

8129385*PED Apr 05, 2028 PED Dec 15, 2026

9242986 Dec 08, 2029 DS DP

9242986*PED Jun 08, 2030

ABALOPARATIDE - TYMLOS

N 208743 001 11680942 Jan 10, 2040 U-3322 I-907 Dec 19, 2025

11782041 Apr 30, 2038 DP U-2009

11782041 Apr 30, 2038 DP U-3543

8748382 Oct 03, 2027 U-2009

8748382 Oct 03, 2027 U-3543

RE49444 Apr 28, 2031 U-2009

RE49444 Apr 28, 2031 U-3543

ABEMACICLIB - VERZENIO

N 208716 001 7855211 Dec 15, 2029 DS DP U-2132

7855211 Dec 15, 2029 DS DP U-2135

7855211 Dec 15, 2029 DS DP U-2251

7855211 Dec 15, 2029 DS DP U-3241

7855211 Dec 15, 2029 DS DP U-3242

7855211 Dec 15, 2029 DS DP U-3243

7855211 Dec 15, 2029 DS DP U-3265

7855211 Dec 15, 2029 DS DP U-3546

ABEMACICLIB - VERZENIO

N 208716 002 7855211 Dec 15, 2029 DS DP U-2132

7855211 Dec 15, 2029 DS DP U-2135

7855211 Dec 15, 2029 DS DP U-2251

7855211 Dec 15, 2029 DS DP U-3241

7855211 Dec 15, 2029 DS DP U-3242

7855211 Dec 15, 2029 DS DP U-3243

7855211 Dec 15, 2029 DS DP U-3265

7855211 Dec 15, 2029 DS DP U-3546

ABEMACICLIB - VERZENIO

N 208716 003 7855211 Dec 15, 2029 DS DP U-2132

7855211 Dec 15, 2029 DS DP U-2135

7855211 Dec 15, 2029 DS DP U-2251

7855211 Dec 15, 2029 DS DP U-3241

7855211 Dec 15, 2029 DS DP U-3242

7855211 Dec 15, 2029 DS DP U-3243

7855211 Dec 15, 2029 DS DP U-3265

7855211 Dec 15, 2029 DS DP U-3546

ABIRATERONE ACETATE; NIRAPARIB TOSYLATE - AKEEGA

N 216793 001 11091459 Mar 27, 2038 DS DP NP Aug 11, 2026

11207311 Jul 28, 2037 U-2830

11673877 Mar 27, 2038 DS DP

8071579 Aug 12, 2027 U-2830

8071623 Mar 27, 2031 DS DP

8143241 Aug 12, 2027 U-2830

8436185 Apr 24, 2029 DS DP

8859562 Aug 04, 2031 U-2830

ABIRATERONE ACETATE; NIRAPARIB TOSYLATE - AKEEGA

N 216793 002 11091459 Mar 27, 2038 DS DP NP Aug 11, 2026

11207311 Jul 28, 2037 U-2830

11673877 Mar 27, 2038 DS DP
A - 2

PATENT AND EXCLUSIVITY DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - December 2023

APPL/PROD PATENT PATENT EXCLUSIVITY

NO PATENT NO EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION

DATE CODES REQUESTED CODE(S) DATE

ABIRATERONE ACETATE; NIRAPARIB TOSYLATE - AKEEGA

N 216793 002 8071579 Aug 12, 2027 U-2830

8071623 Mar 27, 2031 DS DP

8143241 Aug 12, 2027 U-2830

8436185 Apr 24, 2029 DS DP

8859562 Aug 04, 2031 U-2830

ABROCITINIB - CIBINQO

N 213871 001 NPP Feb 09, 2026

ABROCITINIB - CIBINQO

N 213871 002 NPP Feb 09, 2026

ABROCITINIB - CIBINQO

N 213871 003 NPP Feb 09, 2026

ACALABRUTINIB - CALQUENCE

N 210259 001 11771696 Jan 21, 2035 U-3710

ACALABRUTINIB MALEATE - CALQUENCE

N 216387 001 11771696 Jan 21, 2035 U-3710

ACETAMINOPHEN; IBUPROFEN - COMBOGESIC

N 209471 001 10532036 Sep 22, 2025 U-3553 NP Mar 01, 2026

11197830 Feb 27, 2039 DP U-3553

11534407 Feb 27, 2039 DP U-3553

ACETAMINOPHEN; IBUPROFEN SODIUM - COMBOGESIC IV

N 215320 001 11213498 Jan 14, 2036 DP NP Oct 17, 2026

11389416 Jul 17, 2035 DP

11446266 Oct 26, 2031 U-3744

11446266 Oct 26, 2031 U-3745

ADAGRASIB - KRAZATI

N 216340 001 NCE Dec 12, 2027

ODE-352 Dec 12, 2029

ADAPALENE; BENZOYL PEROXIDE; CLINDAMYCIN PHOSPHATE - CABTREO

N 216632 001 10220049 Jun 03, 2029 DP U-3713 NP Oct 20, 2026

10624918 Jun 03, 2029 U-3713

11389467 Dec 28, 2040 DP U-3713

8288434 Aug 05, 2029 DP U-3713

9561208 Jun 03, 2029 DP U-3713

ALBUTEROL SULFATE; BUDESONIDE - AIRSUPRA

N 214070 001 9415009 May 28, 2030 U-3509 NP Jan 10, 2026

ALENDRONATE SODIUM - ALENDRONATE SODIUM

A 214512 001 CGT Nov 20, 2023

ALOGLIPTIN BENZOATE - NESINA

N 022271 001 M-300 Jul 27, 2026

ALOGLIPTIN BENZOATE - NESINA

N 022271 002 M-300 Jul 27, 2026

ALOGLIPTIN BENZOATE - NESINA

N 022271 003 M-300 Jul 27, 2026

ALOGLIPTIN BENZOATE; METFORMIN HYDROCHLORIDE - KAZANO

N 203414 001 M-300 Jul 27, 2026
A - 3

PATENT AND EXCLUSIVITY DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - December 2023

APPL/PROD PATENT PATENT EXCLUSIVITY

NO PATENT NO EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION

DATE CODES REQUESTED CODE(S) DATE

ALOGLIPTIN BENZOATE; METFORMIN HYDROCHLORIDE - KAZANO

N 203414 002 M-300 Jul 27, 2026

ALPELISIB - PIQRAY

N 212526 001 8227462 Apr 29, 2033 DS DP U-2539

ALPELISIB - PIQRAY

N 212526 002 8227462 Apr 29, 2033 DS DP U-2539

ALPELISIB - PIQRAY

N 212526 003 8227462 Apr 29, 2033 DS DP U-2539

ALPELISIB - VIJOICE

N 215039 001 8227462 Apr 29, 2033 DS DP ODE-396 Apr 05, 2029

ALPELISIB - VIJOICE

N 215039 002 8227462 Apr 29, 2033 DS DP ODE-396 Apr 05, 2029

ALPELISIB - VIJOICE

N 215039 003 8227462 Apr 29, 2033 DS DP ODE-396 Apr 05, 2029

AMINOLEVULINIC ACID HYDROCHLORIDE - LEVULAN

N 020965 001 11571478 Jan 12, 2038

11690914 Jan 12, 2038

U-3163

U-3163

AMINOLEVULINIC ACID HYDROCHLORIDE - AMELUZ

N 208081 001 11540981 Feb 07, 2028 DP

AMLODIPINE BENZOATE - KATERZIA

N 211340 001 11701326 Oct 06, 2037 DP

AMLODIPINE BESYLATE - NORLIQVA

N 214439 001 11723866

11723866

11723866

Feb 24, 2041

Feb 24, 2041

Feb 24, 2041

DP U-3309

DP U-3310

DP U-3311

AMOXICILLIN; OMEPRAZOLE MAGNESIUM; RIFABUTIN - TALICIA

N 213004 001 NP

GAIN

Nov 01, 2022

Nov 01, 2027

AMPHETAMINE; AMPHETAMINE ASPARTATE/DEXTROAMPHETAMINE SULFATE - DYANAVEL XR

N 208147 001 11590228 Sep 07, 2036 DP U-3538

AMPHETAMINE; AMPHETAMINE ASPARTATE/DEXTROAMPHETAMINE SULFATE - DYANAVEL XR 5

N 210526 001 11590081 Sep 24, 2038 DP U-3538

AMPHETAMINE; AMPHETAMINE ASPARTATE/DEXTROAMPHETAMINE SULFATE - DYANAVEL XR 10

N 210526 002 11590081 Sep 24, 2038 DP U-3538

AMPHETAMINE; AMPHETAMINE ASPARTATE/DEXTROAMPHETAMINE SULFATE - DYANAVEL XR 15

N 210526 003 11590081 Sep 24, 2038 DP U-3538

AMPHETAMINE; AMPHETAMINE ASPARTATE/DEXTROAMPHETAMINE SULFATE - DYANAVEL XR 20

N 210526 004 11590081 Sep 24, 2038 DP U-3538

AMPICILLIN/AMPICILLIN TRIHYDRATE - AMPICILLIN TRIHYDRATE

A 216554 001 >A> CGT Jun 03, 2024

AMPICILLIN/AMPICILLIN TRIHYDRATE - AMPICILLIN TRIHYDRATE

A 216554 002 >A> CGT Jun 03, 2024
A - 4

PATENT AND EXCLUSIVITY DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - December 2023

APPL/PROD PATENT PATENT EXCLUSIVITY

NO PATENT NO EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION

DATE CODES REQUESTED CODE(S) DATE

ANGIOTENSIN II ACETATE - GIAPREZA

N 209360 001 11559559 Dec 18, 2034 U-3514

ANGIOTENSIN II ACETATE - GIAPREZA

N 209360 002 11559559 Dec 18, 2034 U-3514

ANGIOTENSIN II ACETATE - GIAPREZA

N 209360 003 11559559 Dec 18, 2034 U-3514

APALUTAMIDE - ERLEADA

N 210951 001 10052314

10052314

9481663

9481663

RE49353

Sep 23, 2033

Sep 23, 2033

Jun 04, 2033

Jun 04, 2033

Sep 23, 2033

U-2381

U-2382

DS DP U-2237

DS DP U-2624

U-2381

Y

Y

APALUTAMIDE - ERLEADA

N 210951 002 10702508

10849888

8445507

8445507

8802689

8802689

9388159

9481663

9481663

9884054

9987261

RE49353

Apr 30, 2038

Sep 23, 2033

Sep 15, 2030

Sep 15, 2030

Mar 27, 2027

Mar 27, 2027

Mar 27, 2027

Jun 04, 2033

Jun 04, 2033

Sep 23, 2033

Mar 27, 2027

Sep 23, 2033

U-3012

U-3013

DS DP U-2237

DS DP U-2624

U-2237

U-2624

DS DP

DS DP U-2237

DS DP U-2624

U-2237

DP

U-2381

APREMILAST - OTEZLA

N 205437 001 M-299 Jul 20, 2026

APREMILAST - OTEZLA

N 205437 002 M-299 Jul 20, 2026

APREMILAST - OTEZLA

N 205437 003 M-299 Jul 20, 2026

APREPITANT - CINVANTI

N 209296 001 11744800 Sep 18, 2035 DP

APREPITANT - APONVIE

N 216457 001 11744800 Sep 18, 2035 DP U-3690

ARIPIPRAZOLE - ABILIFY MAINTENA KIT

N 202971 001 11648347 Apr 06, 2034 DP

ARIPIPRAZOLE - ABILIFY MAINTENA KIT

N 202971 002 11648347 Apr 06, 2034 DP

ARIPIPRAZOLE - ABILIFY MAINTENA KIT

N 202971 003 11648347 Apr 06, 2034 DP

ARIPIPRAZOLE - ABILIFY MAINTENA KIT

N 202971 004 11648347 Apr 06, 2034 DP

ARIPIPRAZOLE - ABILIFY ASIMTUFII

N 217006 001 10517951

10517951

11097007

11097007

11638757

11638757

Apr 23, 2033

Apr 23, 2033

Apr 23, 2033

Apr 23, 2033

Apr 23, 2033

Apr 23, 2033

DP U-3245

DP U-814

DP U-3245

DP U-814

DP U-3245

DP U-814
A - 5

PATENT AND EXCLUSIVITY DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - December 2023

APPL/PROD PATENT

NO PATENT NO EXPIRATION PATENT

DATE CODES

ARIPIPRAZOLE - ABILIFY ASIMTUFII

N 217006 001 8338427 Mar 15, 2025 DP U-1530

8338428 Aug 06, 2023 DP U-1530

8399469 Jun 29, 2025 DS

8759351 Aug 06, 2023 DP U-1530

ARIPIPRAZOLE - ABILIFY ASIMTUFII

N 217006 002 10517951 Apr 23, 2033 DP U-3245

10517951 Apr 23, 2033 DP U-814

11097007 Apr 23, 2033 DP U-3245

11097007 Apr 23, 2033 DP U-814

11638757 Apr 23, 2033 DP U-3245

11638757 Apr 23, 2033 DP U-814

8338427 Mar 15, 2025 DP U-1530

8338428 Aug 06, 2023 DP U-1530

8399469 Jun 29, 2025 DS

8759351 Aug 06, 2023 DP U-1530

ASENAPINE - SECUADO

N 212268 001 >A> 11813364 Sep 22, 2033 DP

ASENAPINE - SECUADO

N 212268 002 >A> 11813364 Sep 22, 2033 DP

ASENAPINE - SECUADO

N 212268 003 >A> 11813364 Sep 22, 2033 DP

ASPIRIN - VAZALORE

N 203697 001 10646431 Sep 29, 2032 DP

10786444 Sep 29, 2032 U-3559

ASPIRIN - VAZALORE

N 203697 002 10646431 Sep 29, 2032 DP

10786444 Sep 29, 2032 U-3559

ATOGEPANT - QULIPTA

N 215206 001 8754096 Jul 19, 2032 DS DP U-3534

9499545 Nov 10, 2031 DS DP U-3534

ATOGEPANT - QULIPTA

N 215206 002 8754096 Jul 19, 2032 DS DP U-3534

9499545 Nov 10, 2031 DS DP U-3534

ATOGEPANT - QULIPTA

N 215206 003 8754096 Jul 19, 2032 DS DP U-3534

9499545 Nov 10, 2031 DS DP U-3534

ATORVASTATIN CALCIUM - ATORVALIQ

N 213260 001 11369567 Jun 07, 2037 DP

11654106 Jun 07, 2037 DP U-3612

11654106 Jun 07, 2037 DP U-3613

AVACINCAPTAD PEGOL SODIUM - IZERVAY

N 217225 001 10947544 Feb 14, 2025 DS U-3673

11273171 Jul 11, 2034 U-3673

11491176 Jul 11, 2034 U-3673

7538211 Feb 14, 2025 DS

7579456 Feb 14, 2025 DS

7803931 Feb 14, 2025 DS

8236773 Nov 11, 2026 U-3673

9617546 Feb 14, 2025 DS U-3673

PATENT EXCLUSIVITY

DELIST EXCLUSIVITY EXPIRATION

REQUESTED CODE(S) DATE

I-909 Apr 17, 2026

I-909 Apr 17, 2026

I-909 Apr 17, 2026
A - 6

PATENT AND EXCLUSIVITY DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - December 2023

APPL/PROD PATENT PATENT EXCLUSIVITY

NO PATENT NO EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION

DATE CODES REQUESTED CODE(S) DATE

AVACOPAN - TAVNEOS

N 214487 001 11603356 May 29, 2041 DS DP U-3558

AVAPRITINIB - AYVAKIT

N 212608 001 ODE-434 May 22, 2030

AVAPRITINIB - AYVAKIT

N 212608 002 ODE-434 May 22, 2030

AVAPRITINIB - AYVAKIT

N 212608 003 ODE-434 May 22, 2030

AVAPRITINIB - AYVAKIT

N 212608 004 >A> 11827642

9200002

9200002

9944651

9944651

9994575

9994575

Oct 15, 2034

Oct 15, 2034

Oct 15, 2034

Oct 15, 2034

Oct 15, 2034

Oct 15, 2034

Oct 15, 2034

DS DP U-3506

DS DP U-3168

DS DP U-3506

DS DP U-3168

DS DP U-3506

DS DP U-3168

DS DP U-3506

I-912

ODE-434

May 22, 2026

May 22, 2030

AVAPRITINIB - AYVAKIT

N 212608 005 ODE-434 May 22, 2030

AVIBACTAM SODIUM; CEFTAZIDIME - AVYCAZ

N 206494 001 NPP Dec 20, 2025

AZACITIDINE - VIDAZA

N 050794 001 ODE-399 May 20, 2029

AZACITIDINE - ONUREG

N 214120 001 11571436 May 14, 2029 DP

AZACITIDINE - ONUREG

N 214120 002 11571436 May 14, 2029 DP

BACLOFEN - BACLOFEN

A 217252 001 PC Dec 16, 2023

BACLOFEN - LYVISPAH

N 215422 001 11654124 Jul 29, 2039 DP

BACLOFEN - LYVISPAH

N 215422 002 11654124 Jul 29, 2039 DP

BACLOFEN - LYVISPAH

N 215422 003 11654124 Jul 29, 2039 DP

BARICITINIB - OLUMIANT

N 207924 001 11806555

9737469

Nov 02, 2031

Nov 02, 2031

U-3500

U-3500

BARICITINIB - OLUMIANT

N 207924 002 11806555

9737469

Nov 02, 2031

Nov 02, 2031

U-3500

U-3500

BARICITINIB - OLUMIANT

N 207924 003 11806555

9737469

Nov 02, 2031

Nov 02, 2031

U-3500

U-3500
A - 7

PATENT AND EXCLUSIVITY DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - December 2023

APPL/PROD PATENT PATENT EXCLUSIVITY

NO PATENT NO EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION

DATE CODES REQUESTED CODE(S) DATE

BECLOMETHASONE DIPROPIONATE - QVAR REDIHALER

N 207921 001 11559637 Jul 21, 2039 DP

11583643 Aug 19, 2041 DP

11793953 Jan 26, 2038 DP

BECLOMETHASONE DIPROPIONATE - QVAR REDIHALER

N 207921 002 11559637 Jul 21, 2039 DP

11583643 Aug 19, 2041 DP

11793953 Jan 26, 2038 DP

BELZUTIFAN - WELIREG

N 215383 001 >A> 9908845 Sep 05, 2034 DS DP U-3201

>A> 9908845 Sep 05, 2034 DS DP U-3780

>A> 9969689 Sep 05, 2034 DS DP U-3201

>A> 9969689 Sep 05, 2034 DS DP U-3780

BEMPEDOIC ACID - NEXLETOL

N 211616 001 11613511 Jun 19, 2040 DS

11760714 Jun 19, 2040 DP

BEMPEDOIC ACID; EZETIMIBE - NEXLIZET

N 211617 001 11613511 Jun 19, 2040 DS

11744816 Mar 14, 2036 U-3692

11760714 Jun 19, 2040 DP

BENDAMUSTINE HYDROCHLORIDE - TREANDA

N 022249 001 9533955 Mar 26, 2029 DP U-1949

9533955 Mar 26, 2029 DP U-1952

9533955*PED Sep 26, 2029

BENDAMUSTINE HYDROCHLORIDE - TREANDA

N 022249 002 9533955 Mar 26, 2029 DP U-1949

9533955 Mar 26, 2029 DP U-1952

9533955*PED Sep 26, 2029

BENDAMUSTINE HYDROCHLORIDE - BELRAPZO

N 205580 001 >A> 11844783 Jan 28, 2031 U-1542

>A> 11844783 Jan 28, 2031 U-1971

>A> 11844783 Jan 28, 2031 U-1972

BENDAMUSTINE HYDROCHLORIDE - BENDEKA

N 208194 001 >A> 11844783 Jan 28, 2031 U-1542

>A> 11844783 Jan 28, 2031 U-1971

>A> 11844783 Jan 28, 2031 U-1972

BENDAMUSTINE HYDROCHLORIDE - VIVIMUSTA

N 212209 001 >A> 11844784 Jul 29, 2042 DP

BENZOYL PEROXIDE - EPSOLAY

N 214510 001 11541026 Feb 19, 2040 U-3356

11628155 Dec 27, 2040 U-3356

BENZOYL PEROXIDE; CLINDAMYCIN PHOSPHATE - CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE

A 208683 001 PC Mar 30, 2024

BEROTRALSTAT HYDROCHLORIDE - ORLADEYO

N 214094 001 11618733 Nov 01, 2039 U-3300

11708333 Mar 09, 2035 U-3300

BEROTRALSTAT HYDROCHLORIDE - ORLADEYO

N 214094 002 11618733 Nov 01, 2039 U-3300

11708333 Mar 09, 2035 U-3300
A - 8

PATENT AND EXCLUSIVITY DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - December 2023

APPL/PROD PATENT PATENT EXCLUSIVITY

NO PATENT NO EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION

DATE CODES REQUESTED CODE(S) DATE

BETAMETHASONE DIPROPIONATE; CALCIPOTRIENE - WYNZORA

N 213422 001 11696919 Mar 18, 2039 DP

BEXAGLIFLOZIN - BRENZAVVY

N 214373 001 10533032 Jul 03, 2031 U-2214 NCE Jan 20, 2028

10981942 Jun 13, 2031 DS DP

7838499 Jan 30, 2029 DS DP U-2214

8106021 Aug 22, 2028 U-2214

8802637 Aug 22, 2028 DS DP U-2214

8987323 May 14, 2032 DS DP

BICTEGRAVIR SODIUM; EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE - BIKTARVY

N 210251 001 11744802 Nov 08, 2036 DP

BINIMETINIB - MEKTOVI

N 210498 001 10005761 Aug 27, 2030 U-2331 >A> I-928 Oct 11, 2026

10005761 Aug 27, 2030 U-3737

7777050 Mar 13, 2024 DS DP

9314464 Jul 04, 2031 U-2332

9314464 Jul 04, 2031 U-3737

BISMUTH SUBCITRATE POTASSIUM; METRONIDAZOLE; TETRACYCLINE HYDROCHLORIDE - BISMUTH SUBCITRATE POTASSIUM,

METRONIDAZOLE AND TETRACYCLINE HYDROCHLORIDE

A 217511 001 CGT Dec 29, 2023

BORTEZOMIB - BORTEZOMIB

N 215331 001 11679119 Sep 23, 2042 U-3632

11679119 Sep 23, 2042 U-3633

11752164 Sep 23, 2042 U-3632

11752164 Sep 23, 2042 U-3633

BORTEZOMIB - BORTEZOMIB

N 215331 002 11679119 Sep 23, 2042 U-3632

11679119 Sep 23, 2042 U-3633

11752164 Sep 23, 2042 U-3632

11752164 Sep 23, 2042 U-3633

BOSUTINIB MONOHYDRATE - BOSULIF

N 203341 001 11103497 Feb 28, 2034 U-3216 I-923 Sep 26, 2026

11103497 Feb 28, 2034 U-3217 ODE-163 Dec 19, 2024

11103497*PED Aug 28, 2034 ODE-444 Sep 26, 2030

7417148 Dec 11, 2025 U-1283 PED Jun 19, 2025

7417148 Dec 11, 2025 U-3707 PED Mar 26, 2027

7417148 Dec 11, 2025 U-3708 PED Mar 26, 2031

7417148*PED Jun 11, 2026

7767678 Nov 23, 2026 DS DP

7767678*PED May 23, 2027

7919625 Dec 11, 2025 DP

7919625*PED Jun 11, 2026

RE42376 Apr 13, 2024 DS

RE42376*PED Oct 13, 2024

BOSUTINIB MONOHYDRATE - BOSULIF

N 203341 002 11103497 Feb 28, 2034 U-3216 I-923 Sep 26, 2026

11103497 Feb 28, 2034 U-3217 ODE-163 Dec 19, 2024

11103497*PED Aug 28, 2034 ODE-444 Sep 26, 2030

7417148 Dec 11, 2025 U-1283 PED Jun 19, 2025

7417148 Dec 11, 2025 U-3707 PED Mar 26, 2027

7417148 Dec 11, 2025 U-3708 PED Mar 26, 2031

7417148*PED Jun 11, 2026

7767678 Nov 23, 2026 DS DP

7767678*PED May 23, 2027

7919625 Dec 11, 2025 DP

7919625*PED Jun 11, 2026

RE42376 Apr 13, 2024 DS

RE42376*PED Oct 13, 2024
A - 9

PATENT AND EXCLUSIVITY DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - December 2023

APPL/PROD PATENT PATENT EXCLUSIVITY

NO PATENT NO EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION

DATE CODES REQUESTED CODE(S) DATE

BOSUTINIB MONOHYDRATE - BOSULIF

N 203341 002 11103497

11103497

11103497*PED

7417148

7417148

7417148

7417148*PED

7767678

7767678*PED

7919625

7919625*PED

RE42376

RE42376*PED

Feb 28, 2034

Feb 28, 2034

Aug 28, 2034

Dec 11, 2025

Dec 11, 2025

Dec 11, 2025

Jun 11, 2026

Nov 23, 2026

May 23, 2027

Dec 11, 2025

Jun 11, 2026

Apr 13, 2024

Oct 13, 2024

U-3216

U-3217

U-1283

U-3707

U-3708

DS DP

DP

DS

I-923

ODE-163

ODE-444

PED

PED

PED

Sep 26, 2026

Dec 19, 2024

Sep 26, 2030

Jun 19, 2025

Mar 26, 2027

Mar 26, 2031

BOSUTINIB MONOHYDRATE - BOSULIF

N 203341 003 11103497

11103497

11103497*PED

7417148

7417148

7417148

7417148*PED

7767678

7767678*PED

7919625

7919625*PED

RE42376

RE42376*PED

Feb 28, 2034

Feb 28, 2034

Aug 28, 2034

Dec 11, 2025

Dec 11, 2025

Dec 11, 2025

Jun 11, 2026

Nov 23, 2026

May 23, 2027

Dec 11, 2025

Jun 11, 2026

Apr 13, 2024

Oct 13, 2024

U-3216

U-3217

U-1283

U-3707

U-3708

DS DP

DP

DS

I-923

ODE-163

ODE-444

PED

PED

PED

Sep 26, 2026

Dec 19, 2024

Sep 26, 2030

Jun 19, 2025

Mar 26, 2027

Mar 26, 2031

BOSUTINIB MONOHYDRATE - BOSULIF

N 217729 001 11103497

11103497

11103497*PED

7417148

7417148

7417148*PED

7767678

7767678*PED

7919625

7919625*PED

RE42376

RE42376*PED

Feb 28, 2034

Feb 28, 2034

Aug 28, 2034

Dec 11, 2025

Dec 11, 2025

Jun 11, 2026

Nov 23, 2026

May 23, 2027

Dec 11, 2025

Jun 11, 2026

Apr 13, 2024

Oct 13, 2024

U-3216

U-3217

U-3707

U-3708

DS DP

DP

DS DP

NP

ODE-444

PED

PED

Sep 26, 2026

Sep 26, 2030

Mar 26, 2027

Mar 26, 2031

BOSUTINIB MONOHYDRATE - BOSULIF

N 217729 002 11103497

11103497

11103497*PED

7417148

7417148

7417148*PED

7767678

7767678*PED

7919625

7919625*PED

RE42376

RE42376*PED

Feb 28, 2034

Feb 28, 2034

Aug 28, 2034

Dec 11, 2025

Dec 11, 2025

Jun 11, 2026

Nov 23, 2026

May 23, 2027

Dec 11, 2025

Jun 11, 2026

Apr 13, 2024

Oct 13, 2024

U-3216

U-3217

U-3707

U-3708

DS DP

DP

DS DP

NP

ODE-444

PED

PED

Sep 26, 2026

Sep 26, 2030

Mar 26, 2027

Mar 26, 2031

BREMELANOTIDE ACETATE - VYLEESI (AUTOINJECTOR)

N 210557 001 11590209 Apr 29, 2041 U-3539

BREXPIPRAZOLE - REXULTI

N 205422 001 I-913 May 10, 2026

BREXPIPRAZOLE - REXULTI

N 205422 002 I-913 May 10, 2026
A - 10

PATENT AND EXCLUSIVITY DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - December 2023

APPL/PROD PATENT PATENT EXCLUSIVITY

NO PATENT NO EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION

DATE CODES REQUESTED CODE(S) DATE

BREXPIPRAZOLE - REXULTI

N 205422 003 I-913 May 10, 2026

BREXPIPRAZOLE - REXULTI

N 205422 004 I-913 May 10, 2026

BREXPIPRAZOLE - REXULTI

N 205422 005 I-913 May 10, 2026

BREXPIPRAZOLE - REXULTI

N 205422 006 I-913 May 10, 2026

BRIMONIDINE TARTRATE - LUMIFY

N 208144 001 11596600

>A> 11833245

Jul 27, 2029

Jul 27, 2029

U-2222

U-2222

BRINZOLAMIDE - BRINZOLAMIDE

A 211914 001 CGT Apr 07, 2024

BUDESONIDE - BUDESONIDE

A 215328 001 CGT Oct 24, 2023

BUDESONIDE - TARPEYO

N 215935 001 ODE-389 Dec 15, 2028

BUDESONIDE; FORMOTEROL FUMARATE - SYMBICORT AEROSPHERE

N 216579 001 10716753 May 28, 2030

9415009 May 28, 2030

DP U-3203

U-3203

BUDESONIDE; FORMOTEROL FUMARATE; GLYCOPYRROLATE - BREZTRI AEROSPHERE

N 212122 001 11331442 Oct 05, 2038 DP

>A> 11833292 Oct 05, 2038 DP

BUPIVACAINE - EXPAREL

N 022496 001 >A> 11819574

11819575

Jan 22, 2041

Jan 22, 2041

DP U-3250

DP U-3250

BUPIVACAINE - EXPAREL

N 022496 002 >A> 11819574

11819575

Jan 22, 2041

Jan 22, 2041

DP U-3250

DP U-3250

BUPIVACAINE - POSIMIR

N 204803 001 11771624 Jan 12, 2041 U-3724

BUPIVACAINE HYDROCHLORIDE - XARACOLL

N 209511 001 11746141 Jan 09, 2033 DP

BUPIVACAINE; MELOXICAM - ZYNRELEF KIT

N 211988 001 >A> 11844837 Apr 21, 2036 U-3417

BUPIVACAINE; MELOXICAM - ZYNRELEF KIT

N 211988 002 >A> 11844837 Apr 21, 2036 U-3417

BUPIVACAINE; MELOXICAM - ZYNRELEF KIT

N 211988 003 >A> 11844837 Apr 21, 2036 U-3417

BUPIVACAINE; MELOXICAM - ZYNRELEF KIT

N 211988 004 >A> 11844837 Apr 21, 2036 U-3417

BUPRENORPHINE - SUBLOCADE

N 209819 001 >A> 11839611 Nov 06, 2035 U-3111
A - 11

PATENT AND EXCLUSIVITY DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - December 2023

APPL/PROD PATENT PATENT EXCLUSIVITY

NO PATENT NO EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION

DATE CODES REQUESTED CODE(S) DATE

BUPRENORPHINE - SUBLOCADE

N 209819 002 >A> 11839611 Nov 06, 2035 U-3111

BUPRENORPHINE - BRIXADI

N 210136 001 10912772

11110084

11135215

8236292

8236755

8545832

9937164

Jul 26, 2032

Jul 26, 2032

Jul 26, 2032

Jan 10, 2027

Jul 31, 2026

Jun 06, 2025

Jul 26, 2032

U-3617

DP U-3616

DP

DP U-3619

DP U-3620

DP U-3619

DP U-3618

NP May 23, 2026

BUPRENORPHINE - BRIXADI

N 210136 002 10912772

11110084

11135215

8236292

8236755

8545832

9937164

Jul 26, 2032

Jul 26, 2032

Jul 26, 2032

Jan 10, 2027

Jul 31, 2026

Jun 06, 2025

Jul 26, 2032

U-3617

DP U-3616

DP

DP U-3619

DP U-3620

DP U-3619

DP U-3618

NP May 23, 2026

BUPRENORPHINE - BRIXADI

N 210136 003 10912772

11110084

11135215

8236292

8236755

8545832

9937164

Jul 26, 2032

Jul 26, 2032

Jul 26, 2032

Jan 10, 2027

Jul 31, 2026

Jun 06, 2025

Jul 26, 2032

U-3617

DP U-3616

DP

DP U-3619

DP U-3620

DP U-3619

DP U-3618

NP May 23, 2026

BUPRENORPHINE - BRIXADI

N 210136 004 10912772

11110084

11135215

8236292

8236755

8545832

9937164

Jul 26, 2032

Jul 26, 2032

Jul 26, 2032

Jan 10, 2027

Jul 31, 2026

Jun 06, 2025

Jul 26, 2032

U-3617

DP U-3616

DP

DP U-3619

DP U-3620

DP U-3619

DP U-3618

NP May 23, 2026

BUPRENORPHINE - BRIXADI

N 210136 005 10912772

11110084

11135215

8236292

8236755

8545832

9937164

Jul 26, 2032

Jul 26, 2032

Jul 26, 2032

Jan 10, 2027

Jul 31, 2026

Jun 06, 2025

Jul 26, 2032

U-3617

DP U-3616

DP

DP U-3619

DP U-3620

DP U-3619

DP U-3618

NP May 23, 2026

BUPRENORPHINE - BRIXADI

N 210136 006 10912772

11110084

11135215

8236292

8236755

8545832

9937164

Jul 26, 2032

Jul 26, 2032

Jul 26, 2032

Jan 10, 2027

Jul 31, 2026

Jun 06, 2025

Jul 26, 2032

U-3617

DP U-3616

DP

DP U-3619

DP U-3620

DP U-3619

DP U-3618

NP May 23, 2026

BUPRENORPHINE - BRIXADI

N 210136 007 10912772

11110084

11135215

8236292

8236755

8545832

9937164

Jul 26, 2032

Jul 26, 2032

Jul 26, 2032

Jan 10, 2027

Jul 31, 2026

Jun 06, 2025

Jul 26, 2032

U-3617

DP U-3616

DP

DP U-3619

DP U-3620

DP U-3619

DP U-3618

NP May 23, 2026
A - 12

PATENT AND EXCLUSIVITY DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - December 2023

APPL/PROD PATENT PATENT EXCLUSIVITY

NO PATENT NO EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION

DATE CODES REQUESTED CODE(S) DATE

BUPROPION HYDROCHLORIDE; DEXTROMETHORPHAN HYDROBROMIDE - AUVELITY

N 215430 001 11534414 Nov 05, 2034 DP U-3419

11541021 Nov 05, 2034 U-3419

11541048 Nov 05, 2034 U-3419

11596627 Nov 05, 2034 U-3419

11617728 Nov 05, 2034 U-3419

11617747 Nov 05, 2034 U-3563

11717518 Jan 20, 2043 U-3419

11730706 Jan 23, 2043 U-3419

11752144 Feb 23, 2043 U-3419

11779579 Nov 05, 2034 U-3419

>A> 11839612 Mar 02, 2043 U-3419

>A> 11844797 Apr 20, 2043 U-3778

CALCIFEDIOL - RAYALDEE

N 208010 001 11801253

11801253

11801253

Sep 07, 2030

Sep 07, 2030

Sep 07, 2030

DP U-3721

DP U-3722

DP U-3723

CALCIUM GLUCONATE - CALCIUM GLUCONATE

A 216541 001 CGT Apr 30, 2024

CALCIUM GLUCONATE - CALCIUM GLUCONATE IN SODIUM CHLORIDE

A 217174 001 CGT Mar 10, 2024

CALCIUM GLUCONATE - CALCIUM GLUCONATE IN SODIUM CHLORIDE

A 217174 002 CGT Mar 10, 2024

CALCIUM GLUCONATE - CALCIUM GLUCONATE

A 217689 001 CGT Apr 17, 2024

CALCIUM OXYBATE; MAGNESIUM OXYBATE; POTASSIUM OXYBATE; SODIUM OXYBATE - XYWAV

N 212690 001 11554102 Jan 11, 2033 DP

CANAGLIFLOZIN; METFORMIN HYDROCHLORIDE - INVOKAMET

N 204353 001 11576894 Jul 06, 2030 DP

CANAGLIFLOZIN; METFORMIN HYDROCHLORIDE - INVOKAMET

N 204353 002 11576894 Jul 06, 2030 DP

CANAGLIFLOZIN; METFORMIN HYDROCHLORIDE - INVOKAMET

N 204353 003 11576894 Jul 06, 2030 DP

CANAGLIFLOZIN; METFORMIN HYDROCHLORIDE - INVOKAMET

N 204353 004 11576894 Jul 06, 2030 DP

CANNABIDIOL - EPIDIOLEX

N 210365 001 11633369

11633369

11633369

11701330

11701330

11766411

Jun 17, 2035

Jun 17, 2035

Jun 17, 2035

Jun 17, 2035

Jun 17, 2035

Jun 17, 2035

DP U-2780

DP U-2781

DP U-3071

U-2780

U-2781

U-2781

M-270 Oct 20, 2026

CANTHARIDIN - YCANTH

N 212905 001 11052064

11052064

11147790

11147790

May 28, 2035

May 28, 2035

Aug 22, 2038

Aug 22, 2038

DP U-3663

DP U-3665

DP U-3663

DP U-3664

CAPIVASERTIB - TRUQAP

N 218197 001 >A> 10039766

>A> 10059714

>A> 10654855

Apr 16, 2033

Oct 10, 2028

Oct 10, 2028

U-3762

DS DP

U-3762

>A> NCE Nov 16, 2028
A - 13

PATENT AND EXCLUSIVITY DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - December 2023

APPL/PROD PATENT PATENT EXCLUSIVITY

NO PATENT NO EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION

DATE CODES REQUESTED CODE(S) DATE

CAPIVASERTIB - TRUQAP

N 218197 001 >A> 11760760 Oct 10, 2028 U-3762

>A> 8101623 Mar 10, 2030 DS DP U-3762

>A> 8809336 Oct 25, 2025 U-3762

>A> 9006430 Oct 25, 2025 DP

>A> 9487525 Apr 16, 2033 DS DP

CAPIVASERTIB - TRUQAP

N 218197 002 >A> 10039766 Apr 16, 2033 U-3762 >A> NCE Nov 16, 2028

>A> 10059714 Oct 10, 2028 DS DP

>A> 10654855 Oct 10, 2028 U-3762

>A> 11760760 Oct 10, 2028 U-3762

>A> 8101623 Mar 10, 2030 DS DP U-3762

>A> 8809336 Oct 25, 2025 U-3762

>A> 9006430 Oct 25, 2025 DP

>A> 9487525 Apr 16, 2033 DS DP

CARBAMAZEPINE - CARNEXIV

N 206030 001 11529357 Jan 31, 2040 DP

CARBIDOPA; LEVODOPA - DHIVY

N 214869 001 11439613 Mar 28, 2039 U-3557

>A> 11819485 Mar 28, 2039 U-3557

CARIPRAZINE HYDROCHLORIDE - VRAYLAR

N 204370 001 7737142 Sep 17, 2029 DS DP U-1750 I-904 Dec 16, 2025

7737142 Sep 17, 2029 DS DP U-2543

7737142 Sep 17, 2029 DS DP U-2544

7737142 Sep 17, 2029 DS DP U-2545

7737142 Sep 17, 2029 DS DP U-3503

RE47350 Jul 16, 2029 U-1750

RE47350 Jul 16, 2029 U-2543

RE47350 Jul 16, 2029 U-2544

RE47350 Jul 16, 2029 U-2545

RE47350 Jul 16, 2029 U-3503

RE49110 Jul 16, 2029 U-2543

RE49110 Jul 16, 2029 U-2544

RE49110 Jul 16, 2029 U-2545

RE49110 Jul 16, 2029 U-3503

RE49302 Jul 16, 2029 U-2543

RE49302 Jul 16, 2029 U-2544

RE49302 Jul 16, 2029 U-2545

RE49302 Jul 16, 2029 U-3503

CARIPRAZINE HYDROCHLORIDE - VRAYLAR

N 204370 002 7737142 Sep 17, 2029 DS DP U-1750 I-904 Dec 16, 2025

7737142 Sep 17, 2029 DS DP U-2543

7737142 Sep 17, 2029 DS DP U-2544

7737142 Sep 17, 2029 DS DP U-2545

7737142 Sep 17, 2029 DS DP U-3503

RE49110 Jul 16, 2029 U-2543

RE49110 Jul 16, 2029 U-2544

RE49110 Jul 16, 2029 U-2545

RE49110 Jul 16, 2029 U-3503

RE49302 Jul 16, 2029 U-2543

RE49302 Jul 16, 2029 U-2544

RE49302 Jul 16, 2029 U-2545

RE49302 Jul 16, 2029 U-3503

CARIPRAZINE HYDROCHLORIDE - VRAYLAR

N 204370 003 RE49302 Jul 16, 2029 U-2543 I-904 Dec 16, 2025

RE49302 Jul 16, 2029 U-2544

RE49302 Jul 16, 2029 U-2545

RE49302 Jul 16, 2029 U-3503
A - 14

PATENT AND EXCLUSIVITY DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - December 2023

APPL/PROD PATENT PATENT EXCLUSIVITY

NO PATENT NO EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION

DATE CODES REQUESTED CODE(S) DATE

CARIPRAZINE HYDROCHLORIDE - VRAYLAR

N 204370 004 RE49302 Jul 16, 2029

RE49302 Jul 16, 2029

RE49302 Jul 16, 2029

RE49302 Jul 16, 2029

U-2543

U-2544

U-2545

U-3503

I-904 Dec 16, 2025

CENOBAMATE - XCOPRI

N 212839 001 11654133

7598279

Jun 16, 2039

Oct 30, 2032 DS

U-3610

CENOBAMATE - XCOPRI

N 212839 002 11654133

7598279

Jun 16, 2039

Oct 30, 2032 DS

U-3610

CENOBAMATE - XCOPRI

N 212839 003 11654133

7598279

Jun 16, 2039

Oct 30, 2032 DS

U-3610

CENOBAMATE - XCOPRI

N 212839 004 11654133

7598279

Jun 16, 2039

Oct 30, 2032 DS

U-3610

CENOBAMATE - XCOPRI

N 212839 005 11654133

7598279

Jun 16, 2039

Oct 30, 2032 DS

U-3610

CENOBAMATE - XCOPRI

N 212839 006 11654133

7598279

Jun 16, 2039

Oct 30, 2032 DS

U-3610

CHLORHEXIDINE GLUCONATE; ISOPROPYL ALCOHOL - SOLUPREP S

N 208288 001 M-292 Jan 20, 2026

CHLOROPROCAINE HYDROCHLORIDE - IHEEZO

N 216227 001 NP Sep 27, 2025

CITRIC ACID; LACTIC ACID; POTASSIUM BITARTRATE - PHEXXI

N 208352 001 6706276 Mar 06, 2024 DP

CLASCOTERONE - WINLEVI

N 213433 001 >A> 8143240

8865690

9211295

Jan 12, 2025

Jul 24, 2024

Jul 24, 2024

U-2942

U-2942

DP

CLOBAZAM - SYMPAZAN

N 210833 001 11541002 Jan 31, 2040 DP U-724

CLOBAZAM - SYMPAZAN

N 210833 002 11541002 Jan 31, 2040 DP U-724

CLOBAZAM - SYMPAZAN

N 210833 003 11541002 Jan 31, 2040 DP U-724

COBIMETINIB FUMARATE - COTELLIC

N 206192 001 11597699 Oct 05, 2026 U-3554 ODE-416 Oct 28, 2029

COCAINE HYDROCHLORIDE - NUMBRINO

N 209575 001 10016407

10016407

10016407

10149843

10149843

10231961

10413505

Feb 07, 2037

Feb 07, 2037

Feb 07, 2037

Feb 07, 2037

Feb 07, 2037

Feb 07, 2037

Feb 07, 2037

U-2225

U-2226

U-2329

U-2478

U-2479

DP

U-3014
A - 15

PATENT AND EXCLUSIVITY DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - December 2023

APPL/PROD

NO PATENT NO

COCAINE HYDROCHLORIDE - NUMBRINO

N 209575 001 10420760

10857095

10894012

10933060

10933060

10973811

11040032

9867815

9867815

9867815

9867815

COLCHICINE - COLCHICINE

A 208678 001

COLCHICINE - LODOCO

N 215727 001 10130585

10206891

10265281

10842762

11026899

11026900

11026901

9744144

CORTICOTROPIN - ACTHAR GEL

N 008372 008 11752199

11752199

11752199

CRISABOROLE - EUCRISA

N 207695 001

CRIZOTINIB - XALKORI

N 202570 001

CRIZOTINIB - XALKORI

N 202570 002

CRIZOTINIB - XALKORI

N 217581 001 7230098

7825137

7825137

7825137

7858643

8217057

8785632

CRIZOTINIB - XALKORI

N 217581 002 7230098

7825137

7825137

7825137

7858643

8217057

8785632

PATENT

EXPIRATION

DATE

Feb 07, 2037

Feb 07, 2037

Feb 07, 2037

Feb 07, 2037

Feb 07, 2037

Feb 07, 2037

Feb 07, 2037

Feb 07, 2037

Feb 07, 2037

Feb 07, 2037

Feb 07, 2037

Dec 31, 2034

Jan 22, 2035

Jan 22, 2035

Jan 22, 2035

Jan 22, 2035

Jan 22, 2035

Jan 22, 2035

Jan 22, 2035

Feb 25, 2041

Feb 25, 2041

Feb 25, 2041

Aug 26, 2025

May 12, 2027

May 12, 2027

May 12, 2027

Oct 08, 2029

Nov 06, 2029

Mar 01, 2025

Aug 26, 2025

May 12, 2027

May 12, 2027

May 12, 2027

Oct 08, 2029

Nov 06, 2029

Mar 01, 2025

PATENT

PATENT DELIST

CODES REQUESTED

U-2478

U-3014

U-3014

U-2478

U-3014

U-3680

DP

U-2225

U-2226

U-2227

U-2329

U-3642

U-3641

U-3639

U-3640

U-3639

U-3639

U-3638

U-3643

U-3686

U-3687

U-3688

DS

U-3057

U-3058

U-3403

DS DP

DS

DS DP

DS

U-3057

U-3058

U-3403

DS DP

DS

DS DP

EXCLUSIVITY

CODE(S)

PC

D-191

ODE-407

ODE-407

I-852

I-897

I-852

I-897

EXCLUSIVITY

EXPIRATION

DATE

Apr 29, 2024

Apr 03, 2026

Jul 14, 2029

Jul 14, 2029

Jan 14, 2024

Jul 14, 2025

Jan 14, 2024

Jul 14, 2025

CRIZOTINIB - XALKORI

N 217581 003 7230098

7825137

7825137

7825137

7858643

8217057

8785632

Aug 26, 2025

May 12, 2027

May 12, 2027

May 12, 2027

Oct 08, 2029

Nov 06, 2029

Mar 01, 2025

DS

U-3057

U-3058

U-3403

DS DP

DS

DS DP

I-852

I-897

Jan 14, 2024

Jul 14, 2025
A - 16

PATENT AND EXCLUSIVITY DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - December 2023

APPL/PROD PATENT PATENT EXCLUSIVITY

NO PATENT NO EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION

DATE CODES REQUESTED CODE(S) DATE

CRIZOTINIB - XALKORI

N 217581 003 7230098 Aug 26, 2025 DS I-852 Jan 14, 2024

7825137 May 12, 2027 U-3057 I-897 Jul 14, 2025

7825137 May 12, 2027 U-3058

7825137 May 12, 2027 U-3403

7858643 Oct 08, 2029 DS DP

8217057 Nov 06, 2029 DS

8785632 Mar 01, 2025 DS DP

CUPRIC SULFATE; MANGANESE SULFATE; SELENIOUS ACID; ZINC SULFATE - TRALEMENT

N 209376 001 11786548 Jul 01, 2041 DP

CUPRIC SULFATE; MANGANESE SULFATE; SELENIOUS ACID; ZINC SULFATE - TRALEMENT

N 209376 002 11786548 Jul 01, 2041 DP

CUPRIC SULFATE; MANGANESE SULFATE; SELENIOUS ACID; ZINC SULFATE - MULTRYS

N 209376 003 11786548 Jul 01, 2041 DP

CYCLOPHOSPHAMIDE - CYCLOPHOSPHAMIDE

N 210735 003 9662342 Jun 26, 2035 DP

CYCLOPHOSPHAMIDE - CYCLOPHOSPHAMIDE

N 210852 001 10849916 Jul 13, 2035 DP

11382923 Dec 01, 2035 DP

CYCLOPHOSPHAMIDE - CYCLOPHOSPHAMIDE

N 210852 002 10849916 Jul 13, 2035 DP

11382923 Dec 01, 2035 DP

CYCLOPHOSPHAMIDE - CYCLOPHOSPHAMIDE

N 210852 003 10849916 Jul 13, 2035 DP

11382923 Dec 01, 2035 DP

CYCLOSPORINE - VERKAZIA

N 214965 001 11612658 Jan 27, 2026 U-3560 NP Jun 23, 2024

CYCLOSPORINE - VEVYE

N 217469 001 10813976 Sep 22, 2037 DP NP May 30, 2026

11154513 Nov 20, 2038 DP U-1900

11413323 Oct 11, 2039 U-3627

8614178 Dec 13, 2030 DP

CYSTEINE HYDROCHLORIDE - ELCYS

N 210660 001 11642370 Jan 15, 2039 DP

11648262 Jan 15, 2039 DP

11679125 Jan 15, 2039 DP

11684636 Jan 15, 2039 DP

11826383 Jan 15, 2039 DP

CYSTEINE HYDROCHLORIDE - NOURESS

N 212535 001 11510941 Mar 02, 2039 DP

11510942 Jan 15, 2039 DP U-2752

CYTARABINE; DAUNORUBICIN - VYXEOS

N 209401 001 10028912 Oct 15, 2032 DP U-3149

10028912 Oct 15, 2032 DP U-3150

DABRAFENIB MESYLATE - TAFINLAR

N 202806 001 10869869 Aug 30, 2033 U-3185 I-894 Jun 22, 2025

10869869*PED Mar 02, 2034 I-908 Mar 16, 2026

7994185 Jan 20, 2030 DS DP U-1406 ODE-147 Jun 22, 2024

7994185 Jan 20, 2030 DS DP U-2031 ODE-182 Apr 30, 2025

7994185 Jan 20, 2030 DS DP U-2032 ODE-183 May 04, 2025

7994185 Jan 20, 2030 DS DP U-2296 ODE-428 Mar 16, 2030
A - 17

PATENT AND EXCLUSIVITY DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - December 2023

APPL/PROD PATENT PATENT EXCLUSIVITY

NO PATENT NO EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION

DATE CODES REQUESTED CODE(S) DATE

DABRAFENIB MESYLATE - TAFINLAR

N 202806 001 7994185*PED Jul 20, 2030 PED Dec 22, 2024

8415345 Jan 20, 2030 DS DP U-1406 PED Oct 30, 2025

8415345 Jan 20, 2030 DS DP U-2031 PED Nov 04, 2025

8415345 Jan 20, 2030 DS DP U-2032 PED Dec 22, 2025

8415345 Jan 20, 2030 DS DP U-2296

8415345*PED Jul 20, 2030

8703781 Oct 15, 2030 DS DP U-1713

8703781 Oct 15, 2030 DS DP U-2032

8703781 Oct 15, 2030 DS DP U-2296

8703781 Oct 15, 2030 DS DP U-2298

8703781*PED Apr 15, 2031

8835443 Jun 10, 2025 U-2026

8835443 Jun 10, 2025 U-2027

8835443 Jun 10, 2025 U-2296

8835443 Jun 10, 2025 U-2298

8835443*PED Dec 10, 2025

8952018 Oct 15, 2030 U-2027

8952018*PED Apr 15, 2031

9233956 May 04, 2029 U-1811

9233956 May 04, 2029 U-2031

9233956 May 04, 2029 U-2032

9233956 May 04, 2029 U-2296

9233956*PED Nov 04, 2029

DABRAFENIB MESYLATE - TAFINLAR

N 202806 002 10869869 Aug 30, 2033 U-3185 I-894 Jun 22, 2025

10869869*PED Mar 02, 2034 I-908 Mar 16, 2026

7994185 Jan 20, 2030 DS DP U-1406 ODE-147 Jun 22, 2024

7994185 Jan 20, 2030 DS DP U-2031 ODE-182 Apr 30, 2025

7994185 Jan 20, 2030 DS DP U-2032 ODE-183 May 04, 2025

7994185 Jan 20, 2030 DS DP U-2296 ODE-428 Mar 16, 2030

7994185*PED Jul 20, 2030 PED Dec 22, 2024

8415345 Jan 20, 2030 DS DP U-1406 PED Oct 30, 2025

8415345 Jan 20, 2030 DS DP U-2031 PED Nov 04, 2025

8415345 Jan 20, 2030 DS DP U-2032 PED Dec 22, 2025

8415345 Jan 20, 2030 DS DP U-2296

8415345*PED Jul 20, 2030

8703781 Oct 15, 2030 DS DP U-1713

8703781 Oct 15, 2030 DS DP U-2032

8703781 Oct 15, 2030 DS DP U-2296

8703781 Oct 15, 2030 DS DP U-2298

8703781*PED Apr 15, 2031

8835443 Jun 10, 2025 U-2026

8835443 Jun 10, 2025 U-2027

8835443 Jun 10, 2025 U-2296

8835443 Jun 10, 2025 U-2298

8835443*PED Dec 10, 2025

8952018 Oct 15, 2030 U-2027

8952018*PED Apr 15, 2031

9233956 May 04, 2029 U-1811

9233956 May 04, 2029 U-2031

9233956 May 04, 2029 U-2032

9233956 May 04, 2029 U-2296

9233956*PED Nov 04, 2029

DABRAFENIB MESYLATE - TAFINLAR

N 217514 001 11504333 Jun 29, 2038 DP NP Mar 16, 2026

7994185 Jan 20, 2030 DS DP ODE-428 Mar 16, 2030

8415345 Jan 20, 2030 DS DP

8703781 Oct 15, 2030 DS DP U-3565

8835443 Jun 10, 2025 U-3565

DALBAVANCIN HYDROCHLORIDE - DALVANCE

N 021883 001 6900175 May 23, 2028 U-3499
A - 18

PATENT AND EXCLUSIVITY DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - December 2023

APPL/PROD PATENT PATENT EXCLUSIVITY

NO PATENT NO EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION

DATE CODES REQUESTED CODE(S) DATE

DAPAGLIFLOZIN - FARXIGA

N 202293 001 M-298 May 08, 2026

DAPAGLIFLOZIN - FARXIGA

N 202293 002 >A> 11826376 Jul 18, 2039 U-3766 M-298 May 08, 2026

DAPRODUSTAT - JESDUVROQ

N 216951 001 11117871

11643397

11649217

8324208

8557834

8815884

Mar 13, 2038

Jun 22, 2027

Mar 13, 2038

Dec 11, 2028

Jun 22, 2027

Jun 22, 2027

DS DP U-3535

DS U-3535

DP U-3535

DS DP

U-1238

DP U-1238

NCE Feb 01, 2028

DAPRODUSTAT - JESDUVROQ

N 216951 002 11117871

11643397

11649217

8324208

8557834

8815884

Mar 13, 2038

Jun 22, 2027

Mar 13, 2038

Dec 11, 2028

Jun 22, 2027

Jun 22, 2027

DS DP U-3535

DS U-3535

DP U-3535

DS DP

U-1238

DP U-1238

NCE Feb 01, 2028

DAPRODUSTAT - JESDUVROQ

N 216951 003 11117871

11643397

11649217

8324208

8557834

8815884

Mar 13, 2038

Jun 22, 2027

Mar 13, 2038

Dec 11, 2028

Jun 22, 2027

Jun 22, 2027

DS DP U-3535

DS U-3535

DP U-3535

DS DP

U-1238

DP U-1238

NCE Feb 01, 2028

DAPRODUSTAT - JESDUVROQ

N 216951 004 11117871

11643397

11649217

8324208

8557834

8815884

Mar 13, 2038

Jun 22, 2027

Mar 13, 2038

Dec 11, 2028

Jun 22, 2027

Jun 22, 2027

DS DP U-3535

DS U-3535

DP U-3535

DS DP

U-1238

DP U-1238

NCE Feb 01, 2028

DAPRODUSTAT - JESDUVROQ

N 216951 005 11117871

11643397

11649217

8324208

8557834

8815884

Mar 13, 2038

Jun 22, 2027

Mar 13, 2038

Dec 11, 2028

Jun 22, 2027

Jun 22, 2027

DS DP U-3535

DS U-3535

DP U-3535

DS DP

U-1238

DP U-1238

NCE Feb 01, 2028

DAPTOMYCIN - DAPTOMYCIN

N 217415 001 11759497 Aug 28, 2038 DP

DAPTOMYCIN - DAPTOMYCIN

N 217415 002 11759497 Aug 28, 2038 DP

DAROLUTAMIDE - NUBEQA

N 212099 001 8975254 Mar 25, 2033 DS DP U-2605

DARUNAVIR - DARUNAVIR

A 202073 002 PC Nov 28, 2023

DASATINIB - PHYRAGO

N 216099 001 >A>

>A>

>A>

>A>

>A>

>A>

11202778

11202778

11202778

11298356

11324745

11324745

Jan 22, 2041

Jan 22, 2041

Jan 22, 2041

Jan 22, 2041

Jan 22, 2041

Jan 22, 2041

U-3770

U-3771

U-3772

DP

U-3767

U-3768
A - 19

PATENT AND EXCLUSIVITY DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - December 2023

APPL/PROD PATENT PATENT EXCLUSIVITY

NO PATENT NO EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION

DATE CODES REQUESTED CODE(S) DATE

DASATINIB - PHYRAGO

N 216099 001 >A> 11324745 Jan 22, 2041 U-3769

DASATINIB - PHYRAGO

N 216099 002 >A> 11202778 Jan 22, 2041 U-3770

>A> 11202778 Jan 22, 2041 U-3771

>A> 11202778 Jan 22, 2041 U-3772

>A> 11298356 Jan 22, 2041 DP

>A> 11324745 Jan 22, 2041 U-3767

>A> 11324745 Jan 22, 2041 U-3768

>A> 11324745 Jan 22, 2041 U-3769

DASATINIB - PHYRAGO

N 216099 003 >A> 11202778 Jan 22, 2041 U-3770

>A> 11202778 Jan 22, 2041 U-3771

>A> 11202778 Jan 22, 2041 U-3772

>A> 11298356 Jan 22, 2041 DP

>A> 11324745 Jan 22, 2041 U-3767

>A> 11324745 Jan 22, 2041 U-3768

>A> 11324745 Jan 22, 2041 U-3769

DASATINIB - PHYRAGO

N 216099 004 >A> 11202778 Jan 22, 2041 U-3770

>A> 11202778 Jan 22, 2041 U-3771

>A> 11202778 Jan 22, 2041 U-3772

>A> 11298356 Jan 22, 2041 DP

>A> 11324745 Jan 22, 2041 U-3767

>A> 11324745 Jan 22, 2041 U-3768

>A> 11324745 Jan 22, 2041 U-3769

DASATINIB - PHYRAGO

N 216099 005 >A> 11202778 Jan 22, 2041 U-3770

>A> 11202778 Jan 22, 2041 U-3771

>A> 11202778 Jan 22, 2041 U-3772

>A> 11298356 Jan 22, 2041 DP

>A> 11324745 Jan 22, 2041 U-3767

>A> 11324745 Jan 22, 2041 U-3768

>A> 11324745 Jan 22, 2041 U-3769

DASATINIB - PHYRAGO

N 216099 006 >A> 11202778 Jan 22, 2041 U-3770

>A> 11202778 Jan 22, 2041 U-3771

>A> 11202778 Jan 22, 2041 U-3772

>A> 11298356 Jan 22, 2041 DP

>A> 11324745 Jan 22, 2041 U-3767

>A> 11324745 Jan 22, 2041 U-3768

>A> 11324745 Jan 22, 2041 U-3769

DASIGLUCAGON HYDROCHLORIDE - ZEGALOGUE

N 214231 001 11795204 Jan 06, 2034 U-3752

DASIGLUCAGON HYDROCHLORIDE - ZEGALOGUE (AUTOINJECTOR)

N 214231 002 11795204 Jan 06, 2034 U-3752

DEFERIPRONE - FERRIPROX

N 021825 001 ODE-417 Apr 30, 2028

ODE-420 Apr 30, 2028

ODE-421 Apr 30, 2028

DEFERIPRONE - FERRIPROX

N 021825 002 ODE-417 Apr 30, 2028

ODE-420 Apr 30, 2028

ODE-421 Apr 30, 2028
A - 20

PATENT AND EXCLUSIVITY DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - December 2023

APPL/PROD PATENT PATENT EXCLUSIVITY

NO PATENT NO EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION

DATE CODES REQUESTED CODE(S) DATE

DEFERIPRONE - FERRIPROX

N 208030 001 ODE-417

ODE-418

ODE-419

Apr 30, 2028

Apr 30, 2028

Apr 30, 2028

DEFERIPRONE - FERRIPROX

N 208030 002 ODE-417

ODE-418

ODE-419

Apr 30, 2028

Apr 30, 2028

Apr 30, 2028

DEFERIPRONE - FERRIPROX

N 212269 001 11723874 Oct 25, 2038 U-3083 ODE-417

ODE-420

ODE-421

Apr 30, 2028

Apr 30, 2028

Apr 30, 2028

DEFIBROTIDE SODIUM - DEFITELIO

N 208114 001 11746348 Jun 22, 2032 DP

DEGARELIX ACETATE - FIRMAGON

N 022201 001 11766468

>A> 11826397

Apr 27, 2032

Apr 27, 2032

U-1978

U-1978

DEGARELIX ACETATE - FIRMAGON

N 022201 002 11766468

>A> 11826397

Apr 27, 2032

Apr 27, 2032

U-1978

U-1978

DEUTETRABENAZINE - AUSTEDO

N 208082 001 11446291

11446291*PED

11564917

11564917*PED

11648244

11648244*PED

>A> 11666566

>A> 11666566*PED

>A> 11813232

>A> 11813232*PED

Mar 07, 2036

Sep 07, 2036

Mar 07, 2036

Sep 07, 2036

Mar 07, 2036

Sep 07, 2036

Sep 18, 2033

Mar 18, 2034

Mar 15, 2038

Sep 15, 2038

U-1995

U-1995

U-1995

DP

DP

DEUTETRABENAZINE - AUSTEDO

N 208082 002 11446291

11446291*PED

11564917

11564917*PED

11648244

11648244*PED

>A> 11666566

>A> 11666566*PED

>A> 11813232

>A> 11813232*PED

Mar 07, 2036

Sep 07, 2036

Mar 07, 2036

Sep 07, 2036

Mar 07, 2036

Sep 07, 2036

Sep 18, 2033

Mar 18, 2034

Mar 15, 2038

Sep 15, 2038

U-1995

U-1995

U-1995

DP

DP

DEUTETRABENAZINE - AUSTEDO

N 208082 003 11446291

11446291*PED

11564917

11564917*PED

11648244

11648244*PED

>A> 11666566

>A> 11666566*PED

>A> 11813232

>A> 11813232*PED

Mar 07, 2036

Sep 07, 2036

Mar 07, 2036

Sep 07, 2036

Mar 07, 2036

Sep 07, 2036

Sep 18, 2033

Mar 18, 2034

Mar 15, 2038

Sep 15, 2038

U-1995

U-1995

U-1995

DP

DP

DEUTETRABENAZINE - AUSTEDO XR

N 216354 001 10959996

10959996*PED

11179386

Mar 07, 2036

Sep 07, 2036

Mar 15, 2038

U-3055

DP U-1995
A - 21

PATENT AND EXCLUSIVITY DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - December 2023

APPL/PROD

NO PATENT NO

PATENT

EXPIRATION

DATE

PATENT

CODES

PATENT

DELIST

REQUESTED

EXCLUSIVITY

CODE(S)

EXCLUSIVITY

EXPIRATION

DATE

DEUTETRABENAZINE - AUSTEDO XR

N 216354 001 11179386

11179386*PED

11311488

11311488

11357772

11357772

11357772*PED

11446291

11446291*PED

11564917

11564917*PED

11648244

11648244*PED

>A> 11813232

>A> 11813232*PED

8524733

8524733*PED

9550780

9550780

9550780*PED

Mar 15, 2038

Sep 15, 2038

Jun 10, 2041

Jun 10, 2041

Mar 07, 2036

Mar 07, 2036

Sep 07, 2036

Mar 07, 2036

Sep 07, 2036

Mar 07, 2036

Sep 07, 2036

Mar 07, 2036

Sep 07, 2036

Mar 15, 2038

Sep 15, 2038

Apr 03, 2031

Oct 03, 2031

Sep 18, 2033

Sep 18, 2033

Mar 18, 2034

DP U-3055

DP U-1995

DP U-3055

U-1995

U-3055

U-1995

U-1995

U-1995

DP

DS DP

DS DP U-1995

DS DP U-3055

DEUTETRABENAZINE - AUSTEDO XR

N 216354 002 10959996

10959996*PED

11179386

11179386

11179386*PED

11311488

11311488

11357772

11357772

11357772*PED

11446291

11446291*PED

11564917

11564917*PED

11648244

11648244*PED

>A> 11813232

>A> 11813232*PED

8524733

8524733*PED

9550780

9550780

9550780*PED

Mar 07, 2036

Sep 07, 2036

Mar 15, 2038

Mar 15, 2038

Sep 15, 2038

Jun 10, 2041

Jun 10, 2041

Mar 07, 2036

Mar 07, 2036

Sep 07, 2036

Mar 07, 2036

Sep 07, 2036

Mar 07, 2036

Sep 07, 2036

Mar 07, 2036

Sep 07, 2036

Mar 15, 2038

Sep 15, 2038

Apr 03, 2031

Oct 03, 2031

Sep 18, 2033

Sep 18, 2033

Mar 18, 2034

U-3055

DP U-1995

DP U-3055

DP U-1995

DP U-3055

U-1995

U-3055

U-1995

U-1995

U-1995

DP

DS DP

DS DP U-1995

DS DP U-3055

DEUTETRABENAZINE - AUSTEDO XR

N 216354 003 10959996

10959996*PED

11179386

11179386

11179386*PED

11311488

11311488

11357772

11357772

11357772*PED

11446291

11446291*PED

11564917

11564917*PED

11648244

11648244*PED

>A> 11813232

>A> 11813232*PED

8524733

8524733*PED

9550780

Mar 07, 2036

Sep 07, 2036

Mar 15, 2038

Mar 15, 2038

Sep 15, 2038

Jun 10, 2041

Jun 10, 2041

Mar 07, 2036

Mar 07, 2036

Sep 07, 2036

Mar 07, 2036

Sep 07, 2036

Mar 07, 2036

Sep 07, 2036

Mar 07, 2036

Sep 07, 2036

Mar 15, 2038

Sep 15, 2038

Apr 03, 2031

Oct 03, 2031

Sep 18, 2033

U-3055

DP U-1995

DP U-3055

DP U-1995

DP U-3055

U-1995

U-3055

U-1995

U-1995

U-1995

DP

DS DP

DS DP U-1995
A - 22

PATENT AND EXCLUSIVITY DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - December 2023

APPL/PROD PATENT PATENT EXCLUSIVITY

NO PATENT NO EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION

DATE CODES REQUESTED CODE(S) DATE

DEUTETRABENAZINE - AUSTEDO XR

N 216354 003 9550780

9550780*PED

Sep 18, 2033

Mar 18, 2034

DS DP U-3055

DEXAMETHASONE - DEXAMETHASONE

A 217695 003 CGT Apr 29, 2024

DEXMEDETOMIDINE HYDROCHLORIDE - PRECEDEX

N 021038 001 NPP Dec 16, 2025

DEXMEDETOMIDINE HYDROCHLORIDE - PRECEDEX

N 021038 002 NPP Dec 16, 2025

DEXMEDETOMIDINE HYDROCHLORIDE - PRECEDEX

N 021038 003 NPP Dec 16, 2025

DEXMEDETOMIDINE HYDROCHLORIDE - PRECEDEX

N 021038 004 NPP Dec 16, 2025

DEXMEDETOMIDINE HYDROCHLORIDE - PRECEDEX

N 021038 005 NPP Dec 16, 2025

DEXMEDETOMIDINE HYDROCHLORIDE - IGALMI

N 215390 001 11497711 Jun 26, 2039

11517524 Jun 26, 2039

11786508 Dec 29, 2037

11806334 Jan 12, 2043

>A> 11839604 Dec 29, 2037

DP U-3645

DP U-3645

U-3698

U-3725

U-3756

DEXMEDETOMIDINE HYDROCHLORIDE - IGALMI

N 215390 002 11497711 Jun 26, 2039

11517524 Jun 26, 2039

11786508 Dec 29, 2037

11806334 Jan 12, 2043

>A> 11839604 Dec 29, 2037

DP U-3645

DP U-3645

U-3698

U-3725

U-3756

DEXTROAMPHETAMINE - XELSTRYM

N 215401 001 11559501 Jan 06, 2042 DP

DEXTROAMPHETAMINE - XELSTRYM

N 215401 002 11559501 Jan 06, 2042 DP

DEXTROAMPHETAMINE - XELSTRYM

N 215401 003 11559501 Jan 06, 2042 DP

DEXTROAMPHETAMINE - XELSTRYM

N 215401 004 11559501 Jan 06, 2042 DP

DIAZEPAM - VALTOCO

N 211635 001 11793786 Mar 27, 2029 DP

DIAZEPAM - VALTOCO

N 211635 002 11793786 Mar 27, 2029 DP

DIAZEPAM - VALTOCO

N 211635 003 11793786 Mar 27, 2029 DP

DOCETAXEL - DOCETAXEL

N 215813 001 10398785 Mar 14, 2036 DP
A - 23

PATENT AND EXCLUSIVITY DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - December 2023

APPL/PROD

NO PATENT NO

PATENT

EXPIRATION

DATE

PATENT

CODES

PATENT

DELIST

REQUESTED

EXCLUSIVITY

CODE(S)

EXCLUSIVITY

EXPIRATION

DATE

DOCETAXEL - DOCETAXEL

N 215813 002 10398785 Mar 14, 2036 DP

DOCETAXEL - DOCETAXEL

N 215813 003 10398785 Mar 14, 2036 DP

DOLUTEGRAVIR SODIUM - TIVICAY

N 204790 001 8129385

8129385*PED

9242986

9242986*PED

Oct 05, 2027

Apr 05, 2028

Dec 08, 2029

Jun 08, 2030

DS DP

DS DP

DOLUTEGRAVIR SODIUM - TIVICAY

N 204790 002 8129385

8129385*PED

9242986

9242986*PED

Oct 05, 2027

Apr 05, 2028

Dec 08, 2029

Jun 08, 2030

DS DP

DS DP

DOLUTEGRAVIR SODIUM - TIVICAY

N 204790 003 8129385

8129385*PED

9242986

9242986*PED

Oct 05, 2027

Apr 05, 2028

Dec 08, 2029

Jun 08, 2030

DS DP

DS DP

DOLUTEGRAVIR SODIUM - TIVICAY PD

N 213983 001 8129385

8129385*PED

9242986

9242986*PED

Oct 05, 2027

Apr 05, 2028

Dec 08, 2029

Jun 08, 2030

DS DP

DS DP

DOLUTEGRAVIR SODIUM; LAMIVUDINE - DOVATO

N 211994 001 8129385 Oct 05, 2027

8129385*PED Apr 05, 2028

9242986 Dec 08, 2029

9242986*PED Jun 08, 2030

DS DP

DS DP

DOLUTEGRAVIR SODIUM; RILPIVIRINE HYDROCHLORIDE - JULUCA

N 210192 001 8129385 Oct 05, 2027 DS DP

8129385*PED Apr 05, 2028

9242986 Dec 08, 2029 DS DP

9242986*PED Jun 08, 2030

DONEPEZIL HYDROCHLORIDE - ADLARITY

N 212304 001 11648214

11679086

Sep 23, 2037

May 26, 2037

DP U-3334

U-3334

DONEPEZIL HYDROCHLORIDE - ADLARITY

N 212304 002 11648214

11679086

Sep 23, 2037

May 26, 2037

DP U-3334

U-3334

DOXEPIN HYDROCHLORIDE - DOXEPIN HYDROCHLORIDE

A 215408 001 CGT Aug 16, 2023

DROSPIRENONE; ESTETROL - NEXTSTELLIS

N 214154 001 11793760 Jun 17, 2036 DP

DROSPIRENONE; ETHINYL ESTRADIOL; LEVOMEFOLATE CALCIUM - BEYAZ

N 022532 001 11617751 Jul 17, 2030 DP U-1

11617751 Jul 17, 2030 DP U-3572

11617751 Jul 17, 2030 DP U-3573

11617751 Jul 17, 2030 DP U-3574
A - 24

PATENT AND EXCLUSIVITY DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - December 2023

APPL/PROD PATENT PATENT EXCLUSIVITY

NO PATENT NO EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION

DATE CODES REQUESTED CODE(S) DATE

DROSPIRENONE; ETHINYL ESTRADIOL; LEVOMEFOLATE CALCIUM - SAFYRAL

N 022574 001 11617751 Jul 17, 2030 DP U-1

11617751 Jul 17, 2030 DP U-3572

DURLOBACTAM SODIUM; DURLOBACTAM SODIUM; SULBACTAM SODIUM - XACDURO (COPACKAGED)

N 216974 001 10376499 Nov 17, 2035 DP U-2840 NCE May 23, 2028

9309245 Apr 02, 2033 DS GAIN May 23, 2033

9623014 Apr 02, 2033 U-2840

9968593 Nov 17, 2035 DP U-2840

EDARAVONE - RADICAVA ORS

N 215446 001 11826352 Nov 01, 2039 DP

EDETATE CALCIUM DISODIUM - EDETATE CALCIUM DISODIUM

A 216435 001 CGT Jan 08, 2024

EFINACONAZOLE - JUBLIA

N 203567 001 11654139 Oct 02, 2034 U-1969

ELACESTRANT DIHYDROCHLORIDE - ORSERDU

N 217639 001 10071066 Oct 10, 2034 U-3524 NCE Jan 27, 2028

10385008 Jan 05, 2038 DS DP

10420734 Oct 10, 2034 U-3524

10745343 Jan 05, 2038 U-3523

11779552 Oct 10, 2034 U-3524

>A> 11819480 Nov 29, 2036 U-3523

7612114 Aug 18, 2026 DS DP U-3523

8399520 Dec 25, 2024 DS DP U-3523

ELACESTRANT DIHYDROCHLORIDE - ORSERDU

N 217639 002 10071066 Oct 10, 2034 U-3524 NCE Jan 27, 2028

10385008 Jan 05, 2038 DS DP

10420734 Oct 10, 2034 U-3524

10745343 Jan 05, 2038 U-3523

11779552 Oct 10, 2034 U-3524

>A> 11819480 Nov 29, 2036 U-3523

7612114 Aug 18, 2026 DS DP U-3523

8399520 Dec 25, 2024 DS DP U-3523

ELAGOLIX SODIUM - ORILISSA

N 210450 001 11542239 Jul 23, 2039 DS DP

11690845 Aug 27, 2040 U-3654

11690854 Apr 19, 2038 U-3653

11707464 Mar 14, 2034 U-3672

ELAGOLIX SODIUM - ORILISSA

N 210450 002 11542239 Jul 23, 2039 DS DP

11690845 Aug 27, 2040 U-3654

ELAGOLIX SODIUM,ESTRADIOL,NORETHINDRONE ACETATE; ELAGOLIX SODIUM - ORIAHNN (COPACKAGED)

N 213388 001 11542239 Jul 23, 2039 DS DP

11690845 Aug 27, 2040 U-3655

ELEXACAFTOR, IVACAFTOR, TEZACAFTOR; IVACAFTOR - TRIKAFTA (COPACKAGED)

N 212273 001 11564916 Aug 13, 2029 U-3525

11578062 Mar 25, 2031 DP U-3544

11639347 Apr 09, 2027 DS DP U-3587

ELEXACAFTOR, IVACAFTOR, TEZACAFTOR; IVACAFTOR - TRIKAFTA (COPACKAGED)

N 212273 002 11564916 Aug 13, 2029 U-3525

11578062 Mar 25, 2031 DP U-3544

11639347 Apr 09, 2027 DS DP U-3587
A - 25

PATENT AND EXCLUSIVITY DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - December 2023

APPL/PROD PATENT PATENT EXCLUSIVITY

NO PATENT NO EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION

DATE CODES REQUESTED CODE(S) DATE

ELEXACAFTOR, IVACAFTOR, TEZACAFTOR; IVACAFTOR - TRIKAFTA (COPACKAGED)

N 217660 001 10022352 Apr 09, 2027 DP U-3596 NCE Oct 21, 2024

10081621 Mar 25, 2031 DP U-3600 NP Apr 26, 2026

10239867 Apr 09, 2027 DS DP U-3590 ODE-433 Apr 26, 2030

10272046 Feb 27, 2033 DP U-3599

10646481 Aug 13, 2029 DP

10758534 Oct 06, 2035 DS DP U-3589

10793547 Dec 08, 2037 DS DP U-3588

11147770 Feb 27, 2033 DP U-3598

11179367 Dec 08, 2037 DP U-3597

11426407 Oct 06, 2035 DS DP U-3595

11453655 Dec 08, 2037 DS DP

11517564 Dec 08, 2037 DP U-3586

11564916 Aug 13, 2029 U-3585

11578062 Mar 25, 2031 DP U-3584

11639347 Apr 09, 2027 DS DP U-3583

11752106 Feb 27, 2033 DP U-3696

7495103 May 20, 2027 DS DP

7645789 May 01, 2027 DS DP

7776905 Jun 03, 2027 DS DP

8324242 Aug 05, 2027 U-3589

8354427 Jul 06, 2026 U-3593

8410274 Dec 28, 2026 DP

8415387 Nov 12, 2027 U-3589

8598181 May 01, 2027 U-3589

8623905 May 01, 2027 DS DP

8629162 Jun 24, 2025 U-3592

8754224 Dec 28, 2026 DS DP

8883206 Feb 27, 2033 DP

9670163 Dec 28, 2026 DP U-3591

9931334 Dec 28, 2026 DP U-3591

9974781 Apr 09, 2027 DP U-3589

ELEXACAFTOR, IVACAFTOR, TEZACAFTOR; IVACAFTOR - TRIKAFTA (COPACKAGED)

N 217660 002 10022352 Apr 09, 2027 DP U-3596 NCE Oct 21, 2024

10081621 Mar 25, 2031 DP U-3600 NP Apr 26, 2026

10239867 Apr 09, 2027 DS DP U-3590 ODE-433 Apr 26, 2030

10272046 Feb 27, 2033 DP U-3599

10646481 Aug 13, 2029 DP

10758534 Oct 06, 2035 DS DP U-3589

10793547 Dec 08, 2037 DS DP U-3588

11147770 Feb 27, 2033 DP U-3598

11179367 Dec 08, 2037 DP U-3597

11426407 Oct 06, 2035 DS DP U-3595

11453655 Dec 08, 2037 DS DP

11517564 Dec 08, 2037 DP U-3586

11564916 Aug 13, 2029 U-3585

11578062 Mar 25, 2031 DP U-3584

11639347 Apr 09, 2027 DS DP U-3583

11752106 Feb 27, 2033 DP U-3696

7495103 May 20, 2027 DS DP

7645789 May 01, 2027 DS DP

7776905 Jun 03, 2027 DS DP

8324242 Aug 05, 2027 U-3589

8354427 Jul 06, 2026 U-3593

8410274 Dec 28, 2026 DP

8415387 Nov 12, 2027 U-3589

8598181 May 01, 2027 U-3589

8623905 May 01, 2027 DS DP

8629162 Jun 24, 2025 U-3592

8754224 Dec 28, 2026 DS DP

8883206 Feb 27, 2033 DP

9670163 Dec 28, 2026 DP U-3591

9931334 Dec 28, 2026 DP U-3591

9974781 Apr 09, 2027 DP U-3589
A - 26

PATENT AND EXCLUSIVITY DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - December 2023

APPL/PROD PATENT PATENT EXCLUSIVITY

NO PATENT NO EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION

DATE CODES REQUESTED CODE(S) DATE

EMPAGLIFLOZIN - JARDIANCE

N 204629 001 10258637

10258637*PED

11090323

11090323*PED

11666590

>A> 11813275

>A> 11813275

>A> 11833166

>A> 11833166

7579449

7579449*PED

7713938

7713938*PED

8551957

8551957*PED

9949997

9949997

9949997

9949997*PED

9949998

9949998*PED

Apr 03, 2034

Oct 03, 2034

Apr 03, 2034

Oct 03, 2034

Apr 03, 2034

Apr 03, 2034

Apr 03, 2034

Apr 03, 2034

Apr 03, 2034

Aug 01, 2028

Feb 01, 2029

Apr 15, 2027

Oct 15, 2027

Oct 14, 2029

Apr 14, 2030

May 17, 2034

May 17, 2034

May 17, 2034

Nov 17, 2034

Jun 11, 2034

Dec 11, 2034

U-2290

U-3191

U-3691

U-3759

U-3760

U-3776

U-3777

DS

DS DP

U-1651

U-2292

U-3199

U-3325

U-2290

I-869

I-922

M-82

NPP

PED

PED

Aug 18, 2024

Sep 21, 2026

Feb 24, 2025

Jun 20, 2026

Aug 24, 2025

Dec 20, 2026

EMPAGLIFLOZIN - JARDIANCE

N 204629 002 10258637

10258637*PED

11090323

11090323*PED

>A> 11833166

>A> 11833166

7579449

7579449*PED

7713938

7713938*PED

8551957

8551957*PED

9949997

9949997*PED

9949998

9949998*PED

Apr 03, 2034

Oct 03, 2034

Apr 03, 2034

Oct 03, 2034

Apr 03, 2034

Apr 03, 2034

Aug 01, 2028

Feb 01, 2029

Apr 15, 2027

Oct 15, 2027

Oct 14, 2029

Apr 14, 2030

May 17, 2034

Nov 17, 2034

Jun 11, 2034

Dec 11, 2034

U-2290

U-3191

U-3776

U-3777

DS

DS DP

U-1651

U-2292

U-2290

NPP

PED

Jun 20, 2026

Dec 20, 2026

EMPAGLIFLOZIN; LINAGLIPTIN - GLYXAMBI

N 206073 001 10258637 Apr 03, 2034

10258637*PED Oct 03, 2034

11033552 May 04, 2027

11033552*PED Nov 04, 2027

11090323 Apr 03, 2034

11090323*PED Oct 03, 2034

>A> 11833166 Apr 03, 2034

>A> 11833166 Apr 03, 2034

7407955 May 02, 2025

7407955*PED Nov 02, 2025

7579449 Aug 01, 2028

7579449*PED Feb 01, 2029

7713938 Apr 15, 2027

7713938*PED Oct 15, 2027

8551957 Oct 14, 2029

8551957*PED Apr 14, 2030

8673927 May 04, 2027

8673927*PED Nov 04, 2027

8883805 Nov 26, 2025

8883805*PED May 26, 2026

U-2290

DP

U-3191

U-3776

U-3777

DS DP

DS

DS DP

DP U-1651

U-1652

DP

Y

EMPAGLIFLOZIN; LINAGLIPTIN - GLYXAMBI

N 206073 002 10258637 Apr 03, 2034

10258637*PED Oct 03, 2034

11033552 May 04, 2027

11033552*PED Nov 04, 2027

U-2290

DP
A - 27

PATENT AND EXCLUSIVITY DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - December 2023

APPL/PROD PATENT PATENT EXCLUSIVITY

NO PATENT NO EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION

DATE CODES REQUESTED CODE(S) DATE

EMPAGLIFLOZIN; LINAGLIPTIN - GLYXAMBI

N 206073 002 11090323 Apr 03, 2034 U-3191

11090323*PED Oct 03, 2034

>A> 11833166 Apr 03, 2034 U-3776

>A> 11833166 Apr 03, 2034 U-3777

7407955 May 02, 2025 DS DP

7407955*PED Nov 02, 2025

7579449 Aug 01, 2028 DS

7579449*PED Feb 01, 2029

7713938 Apr 15, 2027 DS DP

7713938*PED Oct 15, 2027

8551957 Oct 14, 2029 DP U-1651

8551957*PED Apr 14, 2030

8673927 May 04, 2027 U-1652

8673927*PED Nov 04, 2027

8883805 Nov 26, 2025 DP

8883805*PED May 26, 2026

EMPAGLIFLOZIN; LINAGLIPTIN; METFORMIN HYDROCHLORIDE - TRIJARDY XR

N 212614 001 10258637 Apr 03, 2034 U-2731

10258637*PED Oct 03, 2034

11090323 Apr 03, 2034 U-3192

11090323*PED Oct 03, 2034

11564886 Mar 07, 2032 DP U-3531

>A> 11833166 Apr 03, 2034 U-3776

>A> 11833166 Apr 03, 2034 U-3777

7407955 May 02, 2025 DS DP

7407955*PED Nov 02, 2025

7579449 Aug 01, 2028 DS

7579449*PED Feb 01, 2029

7713938 Apr 15, 2027 DS DP

7713938*PED Oct 15, 2027

8551957 Oct 14, 2029 DP U-2730

8551957*PED Apr 14, 2030

8883805 Nov 26, 2025 DP

8883805*PED May 26, 2026

9949998 Jun 11, 2034 U-2731

9949998*PED Dec 11, 2034

EMPAGLIFLOZIN; LINAGLIPTIN; METFORMIN HYDROCHLORIDE - TRIJARDY XR

N 212614 002 10258637 Apr 03, 2034 U-2731

10258637*PED Oct 03, 2034

11090323 Apr 03, 2034 U-3192

11090323*PED Oct 03, 2034

11564886 Mar 07, 2032 DP U-3531

>A> 11833166 Apr 03, 2034 U-3776

>A> 11833166 Apr 03, 2034 U-3777

7407955 May 02, 2025 DS DP

7407955*PED Nov 02, 2025

7579449 Aug 01, 2028 DS

7579449*PED Feb 01, 2029

7713938 Apr 15, 2027 DS DP

7713938*PED Oct 15, 2027

8551957 Oct 14, 2029 DP U-2730

8551957*PED Apr 14, 2030

8883805 Nov 26, 2025 DP

8883805*PED May 26, 2026

9949998 Jun 11, 2034 U-2731

9949998*PED Dec 11, 2034

Y

EMPAGLIFLOZIN; LINAGLIPTIN; METFORMIN HYDROCHLORIDE - TRIJARDY XR

N 212614 003 10258637 Apr 03, 2034 U-2731

10258637*PED Oct 03, 2034

11090323 Apr 03, 2034 U-3192

11090323*PED Oct 03, 2034

11564886 Mar 07, 2032 DP U-3531

>A> 11833166 Apr 03, 2034 U-3776

>A> 11833166 Apr 03, 2034 U-3777
A - 28

PATENT AND EXCLUSIVITY DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - December 2023

APPL/PROD PATENT PATENT EXCLUSIVITY

NO PATENT NO EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION

DATE CODES REQUESTED CODE(S) DATE

EMPAGLIFLOZIN; LINAGLIPTIN; METFORMIN HYDROCHLORIDE - TRIJARDY XR

N 212614 003 7407955 May 02, 2025 DS DP

7407955*PED Nov 02, 2025

7579449 Aug 01, 2028 DS

7579449*PED Feb 01, 2029

7713938 Apr 15, 2027 DS DP

7713938*PED Oct 15, 2027

8551957 Oct 14, 2029 DP U-2730

8551957*PED Apr 14, 2030

8883805 Nov 26, 2025 DP

8883805*PED May 26, 2026

9949998 Jun 11, 2034 U-2731

9949998*PED Dec 11, 2034

EMPAGLIFLOZIN; LINAGLIPTIN; METFORMIN HYDROCHLORIDE - TRIJARDY XR

N 212614 004 10258637 Apr 03, 2034 U-2731

10258637*PED Oct 03, 2034

11090323 Apr 03, 2034 U-3192

11090323*PED Oct 03, 2034

>A> 11833166 Apr 03, 2034 U-3776

>A> 11833166 Apr 03, 2034 U-3777

7407955 May 02, 2025 DS DP

7407955*PED Nov 02, 2025

7579449 Aug 01, 2028 DS

7579449*PED Feb 01, 2029

7713938 Apr 15, 2027 DS DP

7713938*PED Oct 15, 2027

8551957 Oct 14, 2029 DP U-2730

8551957*PED Apr 14, 2030

8883805 Nov 26, 2025 DP

8883805*PED May 26, 2026

9949998 Jun 11, 2034 U-2731

9949998*PED Dec 11, 2034

EMPAGLIFLOZIN; METFORMIN HYDROCHLORIDE - SYNJARDY

N 206111 001 10258637 Apr 03, 2034 U-2290

10258637*PED Oct 03, 2034

10610489 Sep 30, 2030 DP

10610489*PED Mar 30, 2031

11090323 Apr 03, 2034 U-3193

11090323*PED Oct 03, 2034

>A> 11813275 Apr 03, 2034 U-3759

>A> 11833166 Apr 03, 2034 U-3776

>A> 11833166 Apr 03, 2034 U-3777

7579449 Aug 01, 2028 DS

7579449*PED Feb 01, 2029

7713938 Apr 15, 2027 DS DP

7713938*PED Oct 15, 2027

9949997 May 17, 2034 U-3532

9949997 May 17, 2034 U-3533

9949997*PED Nov 17, 2034

EMPAGLIFLOZIN; METFORMIN HYDROCHLORIDE - SYNJARDY

N 206111 002 10258637 Apr 03, 2034 U-2290

10258637*PED Oct 03, 2034

10610489 Sep 30, 2030 DP

10610489*PED Mar 30, 2031

11090323 Apr 03, 2034 U-3193

11090323*PED Oct 03, 2034

>A> 11813275 Apr 03, 2034 U-3759

>A> 11833166 Apr 03, 2034 U-3776

>A> 11833166 Apr 03, 2034 U-3777

7579449 Aug 01, 2028 DS

7579449*PED Feb 01, 2029

7713938 Apr 15, 2027 DS DP

7713938*PED Oct 15, 2027

9949997 May 17, 2034 U-3532

9949997 May 17, 2034 U-3533

NPP Jun 20, 2026

PED Dec 20, 2026

NPP Jun 20, 2026

PED Dec 20, 2026
A - 29

PATENT AND EXCLUSIVITY DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - December 2023

APPL/PROD PATENT PATENT EXCLUSIVITY

NO PATENT NO EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION

DATE CODES REQUESTED CODE(S) DATE

EMPAGLIFLOZIN; METFORMIN HYDROCHLORIDE - SYNJARDY

N 206111 002 9949997*PED Nov 17, 2034

EMPAGLIFLOZIN; METFORMIN HYDROCHLORIDE - SYNJARDY

N 206111 003 10258637 Apr 03, 2034

10258637*PED Oct 03, 2034

10610489 Sep 30, 2030

10610489*PED Mar 30, 2031

11090323 Apr 03, 2034

11090323*PED Oct 03, 2034

>A> 11833166 Apr 03, 2034

>A> 11833166 Apr 03, 2034

7579449 Aug 01, 2028 DS

7579449*PED Feb 01, 2029

7713938 Apr 15, 2027 DS

7713938*PED Oct 15, 2027

9949997 May 17, 2034

9949997 May 17, 2034

9949997*PED Nov 17, 2034

EMPAGLIFLOZIN; METFORMIN HYDROCHLORIDE - SYNJARDY

N 206111 004 10258637 Apr 03, 2034

10258637*PED Oct 03, 2034

10610489 Sep 30, 2030

10610489*PED Mar 30, 2031

11090323 Apr 03, 2034

11090323*PED Oct 03, 2034

>A> 11833166 Apr 03, 2034

>A> 11833166 Apr 03, 2034

7579449 Aug 01, 2028 DS

7579449*PED Feb 01, 2029

7713938 Apr 15, 2027 DS

7713938*PED Oct 15, 2027

9949997 May 17, 2034

9949997 May 17, 2034

9949997*PED Nov 17, 2034

EMPAGLIFLOZIN; METFORMIN HYDROCHLORIDE - SYNJARDY XR

N 208658 001 10258637 Apr 03, 2034

10258637*PED Oct 03, 2034

10596120 Mar 07, 2032

10596120 Mar 07, 2032

10596120*PED Sep 07, 2032

11090323 Apr 03, 2034

11090323*PED Oct 03, 2034

>A> 11813275 Apr 03, 2034

>A> 11833166 Apr 03, 2034

>A> 11833166 Apr 03, 2034

7579449 Aug 01, 2028 DS

7579449*PED Feb 01, 2029

7713938 Apr 15, 2027 DS

7713938*PED Oct 15, 2027

9949997 May 17, 2034

9949997 May 17, 2034

9949997*PED Nov 17, 2034

9949998 Jun 11, 2034

9949998*PED Dec 11, 2034

EMPAGLIFLOZIN; METFORMIN HYDROCHLORIDE - SYNJARDY XR

N 208658 002 10258637 Apr 03, 2034

10258637*PED Oct 03, 2034

10596120 Mar 07, 2032

10596120 Mar 07, 2032

10596120*PED Sep 07, 2032

11090323 Apr 03, 2034

11090323*PED Oct 03, 2034

>A> 11813275 Apr 03, 2034

>A> 11833166 Apr 03, 2034

U-2290 NPP Jun 20, 2026

PED Dec 20, 2026

DP

U-3193

U-3776

U-3777

DP

U-3532

U-3533

U-2290 NPP Jun 20, 2026

PED Dec 20, 2026

DP

U-3193

U-3776

U-3777

DP

U-3532

U-3533

U-2290 M-296 Jun 20, 2026

PED Dec 20, 2026

DP U-2775

DP U-2792

U-3193

U-3759

U-3776

U-3777

DP

U-3532

U-3533

U-2290

U-2290 M-296 Jun 20, 2026

PED Dec 20, 2026

DP U-2775

DP U-2792

U-3193

U-3759

U-3776
A - 30

PATENT AND EXCLUSIVITY DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - December 2023

APPL/PROD PATENT PATENT EXCLUSIVITY

NO PATENT NO EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION

DATE CODES REQUESTED CODE(S) DATE

EMPAGLIFLOZIN; METFORMIN HYDROCHLORIDE - SYNJARDY XR

N 208658 002 >A> 11833166 Apr 03, 2034 U-3777

7579449 Aug 01, 2028 DS

7579449*PED Feb 01, 2029

7713938 Apr 15, 2027 DS DP

7713938*PED Oct 15, 2027

9949997 May 17, 2034 U-3532

9949997 May 17, 2034 U-3533

9949997*PED Nov 17, 2034

9949998 Jun 11, 2034 U-2290

9949998*PED Dec 11, 2034

EMPAGLIFLOZIN; METFORMIN HYDROCHLORIDE - SYNJARDY XR

N 208658 003

>A>

>A>

10258637

10258637*PED

10596120

10596120

10596120*PED

11090323

11090323*PED

11833166

11833166

7579449

7579449*PED

7713938

7713938*PED

9949997

9949997

9949997*PED

9949998

9949998*PED

Apr 03, 2034

Oct 03, 2034

Mar 07, 2032

Mar 07, 2032

Sep 07, 2032

Apr 03, 2034

Oct 03, 2034

Apr 03, 2034

Apr 03, 2034

Aug 01, 2028

Feb 01, 2029

Apr 15, 2027

Oct 15, 2027

May 17, 2034

May 17, 2034

Nov 17, 2034

Jun 11, 2034

Dec 11, 2034

DS

DS

DP

DP

DP

U-2290

U-2775

U-2792

U-3193

U-3776

U-3777

U-3532

U-3533

U-2290

M-296

PED

Jun 20, 2026

Dec 20, 2026

EMPAGLIFLOZIN; METFORMIN HYDROCHLORIDE - SYNJARDY XR

N 208658 004 10258637 Apr 03, 2034

10258637*PED Oct 03, 2034

10596120 Mar 07, 2032

10596120 Mar 07, 2032

10596120*PED Sep 07, 2032

11090323 Apr 03, 2034

11090323*PED Oct 03, 2034

>A> 11833166 Apr 03, 2034

>A> 11833166 Apr 03, 2034

7579449 Aug 01, 2028

7579449*PED Feb 01, 2029

7713938 Apr 15, 2027

7713938*PED Oct 15, 2027

9949997 May 17, 2034

9949997 May 17, 2034

9949997*PED Nov 17, 2034

9949998 Jun 11, 2034

9949998*PED Dec 11, 2034

DS

DS

DP

DP

DP

U-2290

U-2775

U-2792

U-3193

U-3776

U-3777

U-3532

U-3533

U-2290

M-296

PED

Jun 20, 2026

Dec 20, 2026

ENCORAFENIB - BRAFTOVI

N 210496 001 >A> I-928

ODE-445

Oct 11, 2026

Oct 11, 2030

ENCORAFENIB - BRAFTOVI

N 210496 002 10005761

10005761

10005761

10005761

8501758

8541575

8541575

8541575

8541575

9314464

9314464

Aug 27, 2030

Aug 27, 2030

Aug 27, 2030

Aug 27, 2030

Aug 27, 2030

Feb 26, 2030

Feb 26, 2030

Feb 26, 2030

Feb 26, 2030

Jul 04, 2031

Jul 04, 2031

DS

DS

DS

DS

DS

DP

DP

DP

DP

DP

U-2335

U-2802

U-2803

U-3738

U-2335

U-2802

U-2803

U-3738

U-2336

U-2802

>A> I-928

ODE-445

Oct 11, 2026

Oct 11, 2030
A - 31

PATENT AND EXCLUSIVITY DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - December 2023

APPL/PROD PATENT PATENT EXCLUSIVITY

NO PATENT NO EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION

DATE CODES REQUESTED CODE(S) DATE

ENCORAFENIB - BRAFTOVI

N 210496 002 9314464 Jul 04, 2031 U-2803

9314464 Jul 04, 2031 U-3738

9850230 Aug 27, 2030 U-2334

9850230 Aug 27, 2030 U-2802

9850230 Aug 27, 2030 U-2803

9850230 Aug 27, 2030 U-3738

RE49556 Feb 27, 2030 DS DP

ENTRECTINIB - ROZLYTREK

N 212725 001 >A> NPP Oct 20, 2026

ODE-448 Oct 20, 2030

ENTRECTINIB - ROZLYTREK

N 212725 002 >A> NPP Oct 20, 2026

ODE-448 Oct 20, 2030

ENTRECTINIB - ROZLYTREK

N 218550 001 NCE Aug 15, 2024

NP Oct 20, 2026

ODE-448 Oct 20, 2030

ENZALUTAMIDE - XTANDI

N 203415 001 >A> 8183274 Aug 24, 2026 U-1281 >A> I-926 Nov 17, 2026

>A> 8183274 Aug 24, 2026 U-1588

>A> 8183274 Aug 24, 2026 U-2345

>A> 8183274 Aug 24, 2026 U-2708

>A> 8183274 Aug 24, 2026 U-3763

>A> 9126941 May 15, 2026 U-1588

>A> 9126941 May 15, 2026 U-2345

>A> 9126941 May 15, 2026 U-2708

>A> 9126941 May 15, 2026 U-3763

ENZALUTAMIDE - XTANDI

N 213674 001 >A> 11839689 Sep 11, 2033 DP >A> I-926 Nov 17, 2026

>A> 8183274 Aug 24, 2026 U-2345

>A> 8183274 Aug 24, 2026 U-2708

>A> 8183274 Aug 24, 2026 U-3763

>A> 9126941 May 15, 2026 U-2345

>A> 9126941 May 15, 2026 U-2708

>A> 9126941 May 15, 2026 U-3763

ENZALUTAMIDE - XTANDI

N 213674 002 >A> 11839689 Sep 11, 2033 DP >A> I-926 Nov 17, 2026

>A> 8183274 Aug 24, 2026 U-2345

>A> 8183274 Aug 24, 2026 U-2708

>A> 8183274 Aug 24, 2026 U-3763

>A> 9126941 May 15, 2026 U-2345

>A> 9126941 May 15, 2026 U-2708

>A> 9126941 May 15, 2026 U-3763

EPHEDRINE SULFATE - EMERPHED

N 213407 001 11571398 May 16, 2040 U-3183

EPHEDRINE SULFATE - EMERPHED

N 213407 002 11464752 May 16, 2040 DP

11571398 May 16, 2040 U-3183

EPINEPHRINE - AUVI-Q

N 201739 001 11590286 Dec 12, 2026 DP

EPINEPHRINE - AUVI-Q

N 201739 002 11590286 Dec 12, 2026 DP

>A> 11771830 Dec 21, 2037 DP U-2980
A - 32

PATENT AND EXCLUSIVITY DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - December 2023

APPL/PROD PATENT PATENT EXCLUSIVITY

NO PATENT NO EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION

DATE CODES REQUESTED CODE(S) DATE

EPINEPHRINE - AUVI-Q

N 201739 003 11590286

>A> 11771830

Dec 12, 2026

Dec 21, 2037

DP

DP U-2980

EPINEPHRINE - ADRENALIN

N 215875 001 10653646

11083698

11207280

Mar 21, 2039

Mar 21, 2039

Mar 21, 2039

DP

U-3567

DP

EPINEPHRINE - ADRENALIN

N 215875 002 10653646

11083698

11207280

Mar 21, 2039

Mar 21, 2039

Mar 21, 2039

DP

U-3567

DP

EPINEPHRINE - ADRENALIN

N 215875 003 10653646

11083698

11207280

Mar 21, 2039

Mar 21, 2039

Mar 21, 2039

DP

U-3567

DP

EPINEPHRINE - ADRENALIN

N 215875 004 10653646

11083698

11207280

Mar 21, 2039

Mar 21, 2039

Mar 21, 2039

DP

U-3567

DP

EPINEPHRINE - ADRENALIN

N 215875 005 10653646

11083698

11207280

Mar 21, 2039

Mar 21, 2039

Mar 21, 2039

DP

U-3567

DP

ERAVACYCLINE DIHYDROCHLORIDE - XERAVA

N 211109 001 11578044 Oct 19, 2037 DS

ERAVACYCLINE DIHYDROCHLORIDE - XERAVA

N 211109 002 11578044 Oct 19, 2037 DS

ERDAFITINIB - BALVERSA

N 212018 001 11684620

11684620

11684620

11684620

8895601

Feb 09, 2036

Feb 09, 2036

Feb 09, 2036

Feb 09, 2036

Apr 12, 2033

U-2518

U-3065

U-3066

U-3067

DS DP

ERDAFITINIB - BALVERSA

N 212018 002 11684620

11684620

11684620

11684620

8895601

Feb 09, 2036

Feb 09, 2036

Feb 09, 2036

Feb 09, 2036

Apr 12, 2033

U-2518

U-3065

U-3066

U-3067

DS DP

ERDAFITINIB - BALVERSA

N 212018 003 11684620

11684620

11684620

11684620

8895601

Feb 09, 2036

Feb 09, 2036

Feb 09, 2036

Feb 09, 2036

Apr 12, 2033

U-2518

U-3065

U-3066

U-3067

DS DP

ESCITALOPRAM OXALATE - LEXAPRO

N 021323 001 NPP May 12, 2026

ESCITALOPRAM OXALATE - LEXAPRO

N 021323 002 NPP May 12, 2026
A - 33

PATENT AND EXCLUSIVITY DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - December 2023

APPL/PROD

NO PATENT NO

PATENT

EXPIRATION PATENT

PATENT

DELIST EXCLUSIVITY

EXCLUSIVITY

EXPIRATION

DATE CODES REQUESTED CODE(S) DATE

ESCITALOPRAM OXALATE - LEXAPRO

N 021323 003 NPP May 12, 2026

ESCITALOPRAM OXALATE - LEXAPRO

N 021365 001 NPP May 12, 2026

ESKETAMINE HYDROCHLORIDE - SPRAVATO

N 211243 001 11173134

11173134

Sep 10, 2035

Sep 10, 2035

U-3257

U-3536

ESTRADIOL; NORETHINDRONE ACETATE; RELUGOLIX - MYFEMBREE

N 214846 001 11793812 May 03, 2038 U-2360

11795178 Sep 27, 2033 DS DP

>A> 7300935 Jan 28, 2025 DS

>A> 8058280 Jan 28, 2025 DS

M-289 Jan 27, 2026

ESTRADIOL; PROGESTERONE - BIJUVA

N 210132 001 11793819 Nov 21, 2032 U-2439

ESTRADIOL; PROGESTERONE - BIJUVA

N 210132 002 11793819 Nov 21, 2032 U-2439

ETRASIMOD ARGININE - VELSIPITY

N 216956 001 10301262

10676435

11007175

11091435

8580841

9126932

Jun 21, 2036

Jun 21, 2036

Jan 06, 2036

Jun 21, 2036

Mar 05, 2030

Jul 22, 2029

DS DP

U-3731

U-3730

DS DP

DS DP

U-3732

NCE Oct 12, 2028

FEDRATINIB HYDROCHLORIDE - INREBIC

N 212327 001 7528143 Nov 16, 2031 DS DP

FENFLURAMINE HYDROCHLORIDE - FINTEPLA

N 212102 001 >A>

>A>

>A>

>A>

11759440

11759440*PED

11786487

11786487*PED

Aug 02, 2037

Feb 02, 2038

Aug 02, 2037

Feb 02, 2038

U-3694

U-3733

ODE-393

PED

Mar 25, 2029

Sep 25, 2029

FERRIC CARBOXYMALTOSE - INJECTAFER

N 203565 001 11364260

11433091

11433091

11433091

11433091

11433091

11590097

11590097

7754702

7754702

7754702

7754702

7754702

7754702

7754702

7754702

8895612

8895612

8895612

8895612

8895612

8895612

8895612

8895612

Jan 08, 2027

Jan 08, 2027

Jan 08, 2027

Jan 08, 2027

Jan 08, 2027

Jan 08, 2027

Oct 20, 2023

Oct 20, 2023

Feb 15, 2028

Feb 15, 2028

Feb 15, 2028

Feb 15, 2028

Feb 15, 2028

Feb 15, 2028

Feb 15, 2028

Feb 15, 2028

Jan 08, 2027

Jan 08, 2027

Jan 08, 2027

Jan 08, 2027

Jan 08, 2027

Jan 08, 2027

Jan 08, 2027

Jan 08, 2027

U-3637

U-3435

U-3436

U-3437

U-3438

U-3634

DS DP U-3312

DS DP U-3313

U-1432

U-2555

U-2556

U-2557

U-3312

U-3313

U-3314

U-3636

U-1620

U-3050

U-3051

U-3115

U-3116

U-3315

U-3316

U-3635

I-915 May 31, 2026
A - 34

PATENT AND EXCLUSIVITY DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - December 2023

APPL/PROD PATENT PATENT EXCLUSIVITY

NO PATENT NO EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION

DATE CODES REQUESTED CODE(S) DATE

FERRIC CARBOXYMALTOSE - INJECTAFER

N 203565 002 11364260

11433091

11433091

11433091

11433091

11433091

11590097

11590097

7754702

7754702

7754702

7754702

7754702

7754702

7754702

8895612

8895612

8895612

8895612

8895612

8895612

8895612

8895612

FERRIC CARBOXYMALTOSE - INJECTAFER

N 203565 003 11364260

11433091

11433091

11433091

11433091

11433091

11590097

11590097

7754702

7754702

7754702

7754702

7754702

7754702

7754702

8895612

8895612

8895612

8895612

8895612

8895612

8895612

8895612

FERRIC CARBOXYMALTOSE - INJECTAFER

N 203565 004 11364260

11433091

11433091

11433091

11433091

11433091

11590097

11590097

7754702

7754702

7754702

7754702

8895612

8895612

8895612

8895612

8895612

Jan 08, 2027

Jan 08, 2027

Jan 08, 2027

Jan 08, 2027

Jan 08, 2027

Jan 08, 2027

Oct 20, 2023

Oct 20, 2023

Feb 15, 2028

Feb 15, 2028

Feb 15, 2028

Feb 15, 2028

Feb 15, 2028

Feb 15, 2028

Feb 15, 2028

Jan 08, 2027

Jan 08, 2027

Jan 08, 2027

Jan 08, 2027

Jan 08, 2027

Jan 08, 2027

Jan 08, 2027

Jan 08, 2027

Jan 08, 2027

Jan 08, 2027

Jan 08, 2027

Jan 08, 2027

Jan 08, 2027

Jan 08, 2027

Oct 20, 2023

Oct 20, 2023

Feb 15, 2028

Feb 15, 2028

Feb 15, 2028

Feb 15, 2028

Feb 15, 2028

Feb 15, 2028

Feb 15, 2028

Jan 08, 2027

Jan 08, 2027

Jan 08, 2027

Jan 08, 2027

Jan 08, 2027

Jan 08, 2027

Jan 08, 2027

Jan 08, 2027

Jan 08, 2027

Jan 08, 2027

Jan 08, 2027

Jan 08, 2027

Jan 08, 2027

Jan 08, 2027

Oct 20, 2023

Oct 20, 2023

Feb 15, 2028

Feb 15, 2028

Feb 15, 2028

Feb 15, 2028

Jan 08, 2027

Jan 08, 2027

Jan 08, 2027

Jan 08, 2027

Jan 08, 2027

U-3637

U-3435

U-3436

U-3437

U-3438

U-3634

DS DP U-3312

DS DP U-3313

U-2555

U-2556

U-2557

U-3312

U-3313

U-3314

U-3636

U-1620

U-3050

U-3051

U-3115

U-3116

U-3315

U-3316

U-3635

U-3637

U-3435

U-3436

U-3437

U-3438

U-3634

DS DP U-3312

DS DP U-3313

U-2555

U-2556

U-2557

U-3312

U-3313

U-3314

U-3636

U-1620

U-3050

U-3051

U-3115

U-3116

U-3315

U-3316

U-3635

U-3637

U-3435

U-3436

U-3437

U-3438

U-3634

DS DP U-3312

DS DP U-3313

U-3312

U-3313

U-3314

U-3636

U-3115

U-3116

U-3315

U-3316

U-3635

I-915 May 31, 2026

I-915 May 31, 2026

I-915 May 31, 2026
A - 35

PATENT AND EXCLUSIVITY DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - December 2023

APPL/PROD PATENT PATENT EXCLUSIVITY

NO PATENT NO EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION

DATE CODES REQUESTED CODE(S) DATE

FERRIC CARBOXYMALTOSE - INJECTAFER

N 203565 004 11364260

11433091

11433091

11433091

11433091

11433091

11590097

11590097

7754702

7754702

7754702

7754702

8895612

8895612

8895612

8895612

8895612

Jan 08, 2027

Jan 08, 2027

Jan 08, 2027

Jan 08, 2027

Jan 08, 2027

Jan 08, 2027

Oct 20, 2023

Oct 20, 2023

Feb 15, 2028

Feb 15, 2028

Feb 15, 2028

Feb 15, 2028

Jan 08, 2027

Jan 08, 2027

Jan 08, 2027

Jan 08, 2027

Jan 08, 2027

U-3637

U-3435

U-3436

U-3437

U-3438

U-3634

DS DP U-3312

DS DP U-3313

U-3312

U-3313

U-3314

U-3636

U-3115

U-3116

U-3315

U-3316

U-3635

I-915 May 31, 2026

FERRIC DERISOMALTOSE - MONOFERRIC

N 208171 001 11633489 Jun 22, 2036 U-3594

FERRIC DERISOMALTOSE - MONOFERRIC

N 208171 002 11633489 Jun 22, 2036 U-3594

FERRIC DERISOMALTOSE - MONOFERRIC

N 208171 003 11633489 Jun 22, 2036 U-3594

FEZOLINETANT - VEOZAH

N 216578 001 10836768

8871761

9422299

9987274

Mar 28, 2034

Apr 04, 2031

Mar 28, 2034

Mar 28, 2034

U-3621

DS

DS DP U-3622

U-3622

NCE May 12, 2028

FLORTAUCIPIR F-18 - TAUVID

N 212123 001 8932557 May 26, 2032 DS

FLORTAUCIPIR F-18 - TAUVID

N 212123 002 8932557 May 26, 2032 DS

FLORTAUCIPIR F-18 - TAUVID

N 212123 003 8932557 May 26, 2032 DS

FLORTAUCIPIR F-18 - TAUVID

N 212123 004 8932557 May 26, 2032 DS

FLOTUFOLASTAT F-18 GALLIUM - POSLUMA

N 216023 001 11413360 Nov 22, 2038

11413360 Nov 22, 2038

DS

DS

U-3614

U-3615

NCE May 25, 2028

FLUORESCEIN SODIUM - FLUORESCEIN SODIUM

A 215709 001 CGT Apr 21, 2024

FLUTICASONE FUROATE - ARNUITY ELLIPTA

N 205625 001 8746242 Oct 11, 2030

8746242*PED Apr 11, 2031

9333310 Oct 02, 2027

9333310*PED Apr 02, 2028

DP

DP

FLUTICASONE FUROATE - ARNUITY ELLIPTA

N 205625 002 8113199 Oct 23, 2027

8113199*PED Apr 23, 2028

8161968 Feb 05, 2028

8161968*PED Aug 05, 2028

8534281 Mar 08, 2030

DP

DP

DP
A - 36

PATENT AND EXCLUSIVITY DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - December 2023

APPL/PROD PATENT PATENT EXCLUSIVITY

NO PATENT NO EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION

DATE CODES REQUESTED CODE(S) DATE

FLUTICASONE FUROATE - ARNUITY ELLIPTA

N 205625 002 8534281*PED Sep 08, 2030

8746242 Oct 11, 2030 DP

8746242*PED Apr 11, 2031

9333310 Oct 02, 2027 DP

9333310*PED Apr 02, 2028

FLUTICASONE FUROATE - ARNUITY ELLIPTA

N 205625 003 8113199 Oct 23, 2027 DP M-290 Mar 01, 2026

8113199*PED Apr 23, 2028

8161968 Feb 05, 2028 DP

8161968*PED Aug 05, 2028

8534281 Mar 08, 2030 DP

8534281*PED Sep 08, 2030

8746242 Oct 11, 2030 DP

8746242*PED Apr 11, 2031

9333310 Oct 02, 2027 DP

9333310*PED Apr 02, 2028

FLUTICASONE FUROATE; UMECLIDINIUM BROMIDE; VILANTEROL TRIFENATATE - TRELEGY ELLIPTA

N 209482 001 7439393 May 21, 2025 DS DP U-2127

7439393 May 21, 2025 DS DP U-2957

7439393*PED Nov 21, 2025

8113199 Oct 23, 2027 DP

8113199*PED Apr 23, 2028

8161968 Feb 05, 2028 DP

8161968*PED Aug 05, 2028

8511304 Jun 14, 2027 DP U-2954

8511304*PED Dec 14, 2027

8534281 Mar 08, 2030 DP

8534281*PED Sep 08, 2030

8746242 Oct 11, 2030 DP

8746242*PED Apr 11, 2031

9333310 Oct 02, 2027 DP

9333310*PED Apr 02, 2028

FLUTICASONE FUROATE; UMECLIDINIUM BROMIDE; VILANTEROL TRIFENATATE - TRELEGY ELLIPTA

N 209482 002 7439393 May 21, 2025 DS DP U-2957

7439393*PED Nov 21, 2025

8113199 Oct 23, 2027 DP

8113199*PED Apr 23, 2028

8161968 Feb 05, 2028 DP

8161968*PED Aug 05, 2028

8511304 Jun 14, 2027 DP U-2954

8511304*PED Dec 14, 2027

8534281 Mar 08, 2030 DP

8534281*PED Sep 08, 2030

8746242 Oct 11, 2030 DP

8746242*PED Apr 11, 2031

9333310 Oct 02, 2027 DP

9333310*PED Apr 02, 2028

FLUTICASONE FUROATE; VILANTEROL TRIFENATATE - BREO ELLIPTA

N 204275 001 11116721 Feb 26, 2029 DP U-1401 NPP May 13, 2026

11116721 Feb 26, 2029 DP U-1691 PED Nov 13, 2026

11116721 Feb 26, 2029 DP U-3623

11116721*PED Aug 26, 2029

7439393 May 21, 2025 DS DP U-1401

7439393 May 21, 2025 DS DP U-1691

7439393 May 21, 2025 DS DP U-2099

7439393 May 21, 2025 DS DP U-2100

7439393 May 21, 2025 DS DP U-3623

7439393*PED Nov 21, 2025

8113199 Oct 23, 2027 DP

8113199*PED Apr 23, 2028

8161968 Feb 05, 2028 DP

8161968*PED Aug 05, 2028

8511304 Jun 14, 2027 DP U-1424
A - 37

PATENT AND EXCLUSIVITY DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - December 2023

APPL/PROD PATENT PATENT EXCLUSIVITY

NO PATENT NO EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION

DATE CODES REQUESTED CODE(S) DATE

FLUTICASONE FUROATE; VILANTEROL TRIFENATATE - BREO ELLIPTA

N 204275 001 8511304 Jun 14, 2027 DP

8511304 Jun 14, 2027 DP

8511304*PED Dec 14, 2027

8534281 Mar 08, 2030 DP

8534281*PED Sep 08, 2030

8746242 Oct 11, 2030 DP

8746242*PED Apr 11, 2031

9333310 Oct 02, 2027 DP

9333310*PED Apr 02, 2028

FLUTICASONE FUROATE; VILANTEROL TRIFENATATE - BREO ELLIPTA

N 204275 002 11116721 Feb 26, 2029 DP

11116721 Feb 26, 2029 DP

11116721*PED Aug 26, 2029

7439393 May 21, 2025 DS DP

7439393 May 21, 2025 DS DP

7439393 May 21, 2025 DS DP

7439393 May 21, 2025 DS DP

7439393*PED Nov 21, 2025

8113199 Oct 23, 2027 DP

8113199*PED Apr 23, 2028

8161968 Feb 05, 2028 DP

8161968*PED Aug 05, 2028

8511304 Jun 14, 2027 DP

8511304 Jun 14, 2027 DP

8511304*PED Dec 14, 2027

8534281 Mar 08, 2030 DP

8534281*PED Sep 08, 2030

8746242 Oct 11, 2030 DP

8746242*PED Apr 11, 2031

9333310 Oct 02, 2027 DP

9333310*PED Apr 02, 2028

FLUTICASONE FUROATE; VILANTEROL TRIFENATATE - BREO ELLIPTA

N 204275 003 11116721 Feb 26, 2029 DP

11116721*PED Aug 26, 2029

7439393 May 21, 2025 DS DP

7439393*PED Nov 21, 2025

8113199 Oct 23, 2027 DP

8113199*PED Apr 23, 2028

8161968 Feb 05, 2028 DP

8161968*PED Aug 05, 2028

8511304 Jun 14, 2027 DP

8511304*PED Dec 14, 2027

8534281 Mar 08, 2030 DP

8534281*PED Sep 08, 2030

8746242 Oct 11, 2030 DP

8746242*PED Apr 11, 2031

9333310 Oct 02, 2027 DP

9333310*PED Apr 02, 2028

FLUTICASONE PROPIONATE - ARMONAIR DIGIHALER

N 208798 004 11357935 Sep 24, 2038 DP

11357935*PED Mar 24, 2039

11439777 May 24, 2040 DP

11439777*PED Nov 24, 2040

11464923 Jun 19, 2040 DP

11464923*PED Dec 19, 2040

FLUTICASONE PROPIONATE - ARMONAIR DIGIHALER

N 208798 005 11357935 Sep 24, 2038 DP

11357935*PED Mar 24, 2039

11439777 May 24, 2040 DP

11439777*PED Nov 24, 2040

11464923 Jun 19, 2040 DP

11464923*PED Dec 19, 2040

U-1691

U-3623

U-1691

U-3623

U-1691

U-2099

U-2100

U-3623

U-1691

U-3623

U-3623

U-3623

NS

PED

May 13, 2026

Nov 13, 2026

U-3623
A - 38

PATENT AND EXCLUSIVITY DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - December 2023

APPL/PROD PATENT PATENT EXCLUSIVITY

NO PATENT NO EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION

DATE CODES REQUESTED CODE(S) DATE

FLUTICASONE PROPIONATE - ARMONAIR DIGIHALER

N 208798 006 11357935 Sep 24, 2038

11357935*PED Mar 24, 2039

11439777 May 24, 2040

11439777*PED Nov 24, 2040

11464923 Jun 19, 2040

11464923*PED Dec 19, 2040

DP

DP

DP

FLUTICASONE PROPIONATE - ARMONAIR DIGIHALER

N 208798 008 11357935 Sep 24, 2038

11357935*PED Mar 24, 2039

11439777 May 24, 2040

11439777*PED Nov 24, 2040

11464923 Jun 19, 2040

11464923*PED Dec 19, 2040

DP

DP

DP

FLUTICASONE PROPIONATE - XHANCE

N 209022 001 11554229

11602603

8327844

8522778

Feb 23, 2036

Oct 27, 2028

Oct 24, 2023

Apr 20, 2024

U-2133

DP U-2133

U-2133

DP

FOSAPREPITANT DIMEGLUMINE - FOCINVEZ

N 216686 001 11065265 Jan 11, 2039 DP

FOSDENOPTERIN HYDROBROMIDE - NULIBRY

N 214018 001 M-286 Oct 27, 2025

FOSNETUPITANT CHLORIDE HYDROCHLORIDE; PALONOSETRON HYDROCHLORIDE - AKYNZEO

N 210493 001 11529362 Jun 02, 2037 DP

FOSNETUPITANT CHLORIDE HYDROCHLORIDE; PALONOSETRON HYDROCHLORIDE - AKYNZEO

N 210493 002 11529362 Jun 02, 2037 DP

FOSTAMATINIB DISODIUM - TAVALISSE

N 209299 001 >A> 7449458 Sep 04, 2031 DS

FOSTAMATINIB DISODIUM - TAVALISSE

N 209299 002 >A> 7449458 Sep 04, 2031 DS

FRUQUINTINIB - FRUZAQLA

N 217564 001 10519142

11046674

7829574

8212033

Sep 07, 2035

Sep 07, 2035

May 09, 2028

May 09, 2028

DS DP U-3753

U-3753

DS DP

U-3753

FRUQUINTINIB - FRUZAQLA

N 217564 002 10519142

11046674

7829574

8212033

Sep 07, 2035

Sep 07, 2035

May 09, 2028

May 09, 2028

DS DP U-3753

U-3753

DS DP

U-3753

FUTIBATINIB - LYTGOBI

N 214801 001 >A> 11833151 Nov 05, 2039 DP ODE-410 Sep 30, 2029

GADOBUTROL - GADOBUTROL

A 216081 001 CGT Apr 29, 2024

GADOBUTROL - GADOBUTROL

A 216081 002 CGT Apr 29, 2024
A - 39

PATENT AND EXCLUSIVITY DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - December 2023

APPL/PROD

NO PATENT NO

PATENT

EXPIRATION

DATE

PATENT

CODES

PATENT

DELIST

REQUESTED

EXCLUSIVITY

CODE(S)

EXCLUSIVITY

EXPIRATION

DATE

GADOPICLENOL - ELUCIREM

N 216986 001 11590246 Jan 17, 2040 DP

GADOPICLENOL - ELUCIREM

N 216986 002 11590246 Jan 17, 2040 DP

GADOPICLENOL - ELUCIREM

N 216986 003 11590246 Jan 17, 2040 DP

GADOPICLENOL - ELUCIREM

N 216986 004 11590246 Jan 17, 2040 DP

GADOPICLENOL - ELUCIREM

N 216986 005 11590246 Jan 17, 2040 DP

GADOPICLENOL - ELUCIREM

N 216986 006 11590246 Jan 17, 2040 DP

GADOPICLENOL - ELUCIREM

N 216986 007 11590246 Jan 17, 2040 DP

GANAXOLONE - ZTALMY

N 215904 001 ODE-395 Jun 01, 2029

GEPIRONE HYDROCHLORIDE - EXXUA

N 021164 001 7538116 Sep 02, 2025 U-3699 NCE Sep 22, 2028

GEPIRONE HYDROCHLORIDE - EXXUA

N 021164 002 7538116 Sep 02, 2025 U-3699 NCE Sep 22, 2028

GEPIRONE HYDROCHLORIDE - EXXUA

N 021164 003 7538116 Sep 02, 2025 U-3699 NCE Sep 22, 2028

GEPIRONE HYDROCHLORIDE - EXXUA

N 021164 004 7538116 Sep 02, 2025 U-3699 NCE Sep 22, 2028

GIVOSIRAN SODIUM - GIVLAARI

N 212194 001 9133461 Nov 30, 2033 DS DP U-2672

GLIPIZIDE - GLIPIZIDE

A 214874 001 CGT Apr 15, 2024

GLUCAGON - GVOKE PFS

N 212097 001 11590205 Apr 22, 2036 DP U-2742

GLUCAGON - GVOKE PFS

N 212097 002 11590205 Apr 22, 2036 DP U-2742

GLUCAGON - GVOKE HYPOPEN

N 212097 003 11590205 Apr 22, 2036 DP U-2742

GLUCAGON - GVOKE HYPOPEN

N 212097 004 11590205 Apr 22, 2036 DP U-2742

GLUCAGON - GVOKE KIT

N 212097 005 11590205 Apr 22, 2036 DP U-2742

GLYCOPYRROLATE; NEOSTIGMINE METHYLSULFATE - PREVDUO

N 216903 001 10456354 Oct 25, 2038 DP

11110054 Oct 25, 2038 DP
A - 40

PATENT AND EXCLUSIVITY DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - December 2023

APPL/PROD PATENT PATENT EXCLUSIVITY

NO PATENT NO EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION

DATE CODES REQUESTED CODE(S) DATE

HALOBETASOL PROPIONATE - BRYHALI

N 209355 001 >A> 11839656 Nov 02, 2031 U-2625

HALOBETASOL PROPIONATE; TAZAROTENE - DUOBRII

N 209354 001 11648256 Jun 06, 2036

11679115 Jun 06, 2036

>A> 11839656 Nov 02, 2031

DP U-2625

DP U-2625

U-2625

HEPARIN SODIUM; TAUROLIDINE - DEFENCATH

N 214520 001 >A> 11738120 Apr 15, 2042

>A> 7696182 May 16, 2025

>A> 8541393 Nov 02, 2024

>A> 9339036 Nov 02, 2024

DS DP

DS DP U-3774

DS DP U-3774

DS DP

HEPARIN SODIUM; TAUROLIDINE - DEFENCATH

N 214520 002 >A> 11738120 Apr 15, 2042

>A> 7696182 May 16, 2025

>A> 8541393 Nov 02, 2024

>A> 9339036 Nov 02, 2024

DS DP

DS DP U-3774

DS DP U-3774

DS DP

HYDROCODONE BITARTRATE - HYSINGLA ER

N 206627 001 >A> 11844865 Feb 13, 2025 DP U-1556

HYDROCODONE BITARTRATE - HYSINGLA ER

N 206627 002 >A> 11844865 Feb 13, 2025 DP U-1556

HYDROCODONE BITARTRATE - HYSINGLA ER

N 206627 003 >A> 11844865 Feb 13, 2025 DP U-1556

HYDROCODONE BITARTRATE - HYSINGLA ER

N 206627 004 >A> 11844865 Feb 13, 2025 DP U-1556

HYDROCODONE BITARTRATE - HYSINGLA ER

N 206627 005 >A> 11844865 Feb 13, 2025 DP U-1556

HYDROCODONE BITARTRATE - HYSINGLA ER

N 206627 006 >A> 11844865 Feb 13, 2025 DP U-1556

HYDROCODONE BITARTRATE - HYSINGLA ER

N 206627 007 >A> 11844865 Feb 13, 2025 DP U-1556

HYDROMORPHONE HYDROCHLORIDE - DILAUDID

N 019034 006 9248229 Mar 12, 2034

9731082 Apr 23, 2032

DP

DP

HYDROMORPHONE HYDROCHLORIDE - DILAUDID

N 019034 007 >A> 9248229 Mar 12, 2034

>A> 9731082 Apr 23, 2032

DP

DP

IBREXAFUNGERP CITRATE - BREXAFEMME

N 214900 001 11534433

11534433

Jun 10, 2039

Jun 10, 2039

U-3159

U-3508

I-903 Nov 30, 2025

IBRUTINIB - IMBRUVICA

N 205552 001 10478439

10478439

10478439

10478439

10478439

10478439

10478439

10478439*PED

11672803

11672803

Jun 03, 2031

Jun 03, 2031

Jun 03, 2031

Jun 03, 2031

Jun 03, 2031

Jun 03, 2031

Jun 03, 2031

Dec 03, 2031

Jun 03, 2031

Jun 03, 2031

U-1650

U-1684

U-1946

U-2241

U-2242

U-2665

U-3422

U-1684

U-1946

ODE-109

ODE-117

ODE-152

ODE-405

PED

PED

Mar 04, 2023

May 06, 2023

Aug 02, 2024

Aug 24, 2029

Feb 02, 2025

Feb 24, 2030
A - 41

PATENT AND EXCLUSIVITY DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - December 2023

APPL/PROD PATENT PATENT EXCLUSIVITY

NO PATENT NO EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION

DATE CODES REQUESTED CODE(S) DATE

IBRUTINIB - IMBRUVICA

N 205552 001 11672803

11672803

8476284

8476284

8476284

8476284

8476284*PED

8497277

8497277

8497277

8497277

8497277

8497277

8497277

8497277

8497277*PED

8952015

8952015

8952015

8952015

8952015

8952015*PED

9540382

9540382

9540382

9540382

9540382

9540382*PED

IBRUTINIB - IMBRUVICA

N 205552 002 10478439

10478439

10478439

10478439

10478439

10478439

10478439

10478439*PED

11672803

11672803

11672803

11672803

8476284

8476284

8476284

8476284*PED

8497277

8497277

8497277

8497277

8497277

8497277

8497277

8497277*PED

8952015

8952015

8952015

8952015

8952015*PED

9540382

9540382

9540382

9540382

9540382*PED

Jun 03, 2031

Jun 03, 2031

Dec 28, 2026

Dec 28, 2026

Dec 28, 2026

Dec 28, 2026

Jun 28, 2027

Dec 28, 2026

Dec 28, 2026

Dec 28, 2026

Dec 28, 2026

Dec 28, 2026

Dec 28, 2026

Dec 28, 2026

Dec 28, 2026

Jun 28, 2027

Dec 28, 2026

Dec 28, 2026

Dec 28, 2026

Dec 28, 2026

Dec 28, 2026

Jun 28, 2027

Aug 18, 2033

Aug 18, 2033

Aug 18, 2033

Aug 18, 2033

Aug 18, 2033

Feb 18, 2034

Jun 03, 2031

Jun 03, 2031

Jun 03, 2031

Jun 03, 2031

Jun 03, 2031

Jun 03, 2031

Jun 03, 2031

Dec 03, 2031

Jun 03, 2031

Jun 03, 2031

Jun 03, 2031

Jun 03, 2031

Dec 28, 2026

Dec 28, 2026

Dec 28, 2026

Jun 28, 2027

Dec 28, 2026

Dec 28, 2026

Dec 28, 2026

Dec 28, 2026

Dec 28, 2026

Dec 28, 2026

Dec 28, 2026

Jun 28, 2027

Dec 28, 2026

Dec 28, 2026

Dec 28, 2026

Dec 28, 2026

Jun 28, 2027

Aug 18, 2033

Aug 18, 2033

Aug 18, 2033

Aug 18, 2033

Feb 18, 2034

U-2241

U-2242

U-1456

U-1650

U-1946

U-1947

U-1456

U-1491

U-1650

U-1946

U-1947

U-2241

U-2242

U-3422

U-1456

U-1491

U-1650

U-1946

U-1947

U-1456

U-1650

U-1684

U-1946

U-1947

U-1650 ODE* Mar 04, 2023

U-1684 ODE* May 06, 2023

U-1946 ODE* Aug 02, 2024

U-2241 ODE-405 Aug 24, 2029

U-2242 PED Feb 24, 2030

U-2665

U-3422

U-1684

U-1946

U-2241

U-2242

U-1456

U-1650

U-1946

U-1456

U-1491

U-1650

U-1946

U-2241

U-2242

U-3422

U-1456

U-1491

U-1650

U-1946

U-1456

U-1491

U-1650

U-1946
A - 42

PATENT AND EXCLUSIVITY DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - December 2023

APPL/PROD PATENT PATENT EXCLUSIVITY

NO PATENT NO EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION

DATE CODES REQUESTED CODE(S) DATE

IBRUTINIB - IMBRUVICA

N 210563 001 10478439

10478439

10478439

10478439

10478439

10478439

10478439

10478439*PED

11672803

11672803

11672803

11672803

8476284

8476284

8476284

8476284

8476284*PED

8497277

8497277

8497277

8497277

8497277

8497277

8497277

8497277*PED

8952015

8952015

8952015

8952015

8952015

8952015

8952015*PED

IBRUTINIB - IMBRUVICA

N 210563 002 10478439

10478439

10478439

10478439

10478439

10478439

10478439

10478439*PED

11672803

11672803

11672803

11672803

8476284

8476284

8476284

8476284

8476284*PED

8497277

8497277

8497277

8497277

8497277

8497277

8497277

8497277*PED

8952015

8952015

8952015

8952015

8952015

8952015

8952015*PED

Jun 03, 2031

Jun 03, 2031

Jun 03, 2031

Jun 03, 2031

Jun 03, 2031

Jun 03, 2031

Jun 03, 2031

Dec 03, 2031

Jun 03, 2031

Jun 03, 2031

Jun 03, 2031

Jun 03, 2031

Dec 28, 2026

Dec 28, 2026

Dec 28, 2026

Dec 28, 2026

Jun 28, 2027

Dec 28, 2026

Dec 28, 2026

Dec 28, 2026

Dec 28, 2026

Dec 28, 2026

Dec 28, 2026

Dec 28, 2026

Jun 28, 2027

Dec 28, 2026

Dec 28, 2026

Dec 28, 2026

Dec 28, 2026

Dec 28, 2026

Dec 28, 2026

Jun 28, 2027

Jun 03, 2031

Jun 03, 2031

Jun 03, 2031

Jun 03, 2031

Jun 03, 2031

Jun 03, 2031

Jun 03, 2031

Dec 03, 2031

Jun 03, 2031

Jun 03, 2031

Jun 03, 2031

Jun 03, 2031

Dec 28, 2026

Dec 28, 2026

Dec 28, 2026

Dec 28, 2026

Jun 28, 2027

Dec 28, 2026

Dec 28, 2026

Dec 28, 2026

Dec 28, 2026

Dec 28, 2026

Dec 28, 2026

Dec 28, 2026

Jun 28, 2027

Dec 28, 2026

Dec 28, 2026

Dec 28, 2026

Dec 28, 2026

Dec 28, 2026

Dec 28, 2026

Jun 28, 2027

U-1650

U-1684

U-1946

U-2241

U-2242

U-2665

U-3422

U-1684

U-1946

U-2241

U-2242

U-1456

U-1650

U-1946

U-2241

U-1456

U-1491

U-1650

U-1946

U-2241

U-2242

U-3422

U-1456

U-1491

U-1650

U-1946

U-2241

U-2242

U-1650

U-1684

U-1946

U-2241

U-2242

U-2665

U-3422

U-1684

U-1946

U-2241

U-2242

U-1456

U-1650

U-1946

U-2241

U-1456

U-1491

U-1650

U-1946

U-2241

U-2242

U-3422

U-1456

U-1491

U-1650

U-1946

U-2241

U-2242

ODE* Mar 04, 2023

ODE* May 06, 2023

ODE* Aug 02, 2024

ODE-405 Aug 24, 2029

PED Feb 24, 2030

ODE* Mar 04, 2023

ODE* May 06, 2023

ODE* Aug 02, 2024

ODE-405 Aug 24, 2029

PED Feb 24, 2030
A - 43

PATENT AND EXCLUSIVITY DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - December 2023

APPL/PROD PATENT PATENT EXCLUSIVITY

NO PATENT NO EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION

DATE CODES REQUESTED CODE(S) DATE

IBRUTINIB - IMBRUVICA

N 210563 003 10478439

10478439

10478439

10478439

10478439

10478439

10478439

10478439*PED

11672803

11672803

11672803

11672803

8476284

8476284

8476284

8476284

8476284*PED

8497277

8497277

8497277

8497277

8497277

8497277

8497277

8497277*PED

8952015

8952015

8952015

8952015

8952015

8952015

8952015*PED

Jun 03, 2031

Jun 03, 2031

Jun 03, 2031

Jun 03, 2031

Jun 03, 2031

Jun 03, 2031

Jun 03, 2031

Dec 03, 2031

Jun 03, 2031

Jun 03, 2031

Jun 03, 2031

Jun 03, 2031

Dec 28, 2026

Dec 28, 2026

Dec 28, 2026

Dec 28, 2026

Jun 28, 2027

Dec 28, 2026

Dec 28, 2026

Dec 28, 2026

Dec 28, 2026

Dec 28, 2026

Dec 28, 2026

Dec 28, 2026

Jun 28, 2027

Dec 28, 2026

Dec 28, 2026

Dec 28, 2026

Dec 28, 2026

Dec 28, 2026

Dec 28, 2026

Jun 28, 2027

U-1650

U-1684

U-1946

U-2241

U-2242

U-2665

U-3422

U-1684

U-1946

U-2241

U-2242

U-1456

U-1650

U-1946

U-2241

U-1456

U-1491

U-1650

U-1946

U-2241

U-2242

U-3422

U-1456

U-1491

U-1650

U-1946

U-2241

U-2242

ODE*

ODE*

ODE*

ODE-405

PED

Mar 04, 2023

May 06, 2023

Aug 02, 2024

Aug 24, 2029

Feb 24, 2030

IBRUTINIB - IMBRUVICA

N 210563 004 ODE*

ODE*

ODE*

ODE-405

PED

Mar 04, 2023

May 06, 2023

Aug 02, 2024

Aug 24, 2029

Feb 24, 2030

IBRUTINIB - IMBRUVICA

N 217003 001 10106548

10106548*PED

10125140

10125140*PED

10478439

10478439*PED

10961251

10961251*PED

7514444

7514444*PED

8008309

8008309*PED

8497277

8497277*PED

8697711

8697711*PED

8735403

8735403*PED

8754091

8754091*PED

8957079

8957079*PED

9181257

9181257*PED

9296753

9296753*PED

9725455

Jun 03, 2033

Dec 03, 2033

Jun 03, 2033

Dec 03, 2033

Jun 03, 2031

Dec 03, 2031

Jun 03, 2033

Dec 03, 2033

Dec 28, 2026

Jun 28, 2027

Nov 13, 2027

May 13, 2028

Dec 28, 2026

Jun 28, 2027

Dec 28, 2026

Jun 28, 2027

Dec 28, 2026

Jun 28, 2027

Dec 28, 2026

Jun 28, 2027

Dec 28, 2026

Jun 28, 2027

Dec 28, 2026

Jun 28, 2027

Oct 30, 2033

Apr 30, 2034

Jun 03, 2033

DS DP

DS DP

U-3422

DP

DS DP

DS DP

U-3422

DS DP

DS DP

DP

DS DP

DS

DS

DS

ODE-405

PED

Aug 24, 2029

Feb 24, 2030
A - 44

PATENT AND EXCLUSIVITY DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - December 2023

APPL/PROD PATENT PATENT EXCLUSIVITY

NO PATENT NO EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION

DATE CODES REQUESTED CODE(S) DATE

IBRUTINIB - IMBRUVICA

N 217003 001 9725455*PED Dec 03, 2033

9795604 Oct 24, 2034 U-3422

9795604*PED Apr 24, 2035

IBUPROFEN - CALDOLOR

N 022348 002 11806400 Mar 16, 2032 U-3746

IBUPROFEN - CALDOLOR

N 022348 003 11806400 Mar 16, 2032 U-3746

ICOSAPENT ETHYL - VASCEPA

N 202057 001 11717504 Apr 29, 2030 U-3669

ICOSAPENT ETHYL - VASCEPA

N 202057 002 11717504 Apr 29, 2030 U-3669

INCLISIRAN SODIUM - LEQVIO

N 214012 001 10125369 Aug 18, 2034 DS DP U-3652

10131907 Aug 24, 2028 DS DP U-3652

10266825 Nov 04, 2023 U-3652

10851377 Aug 25, 2036 U-3652

11078485 Nov 04, 2023 DS U-3652

8106022 Dec 12, 2029 DS DP U-3652

8222222 Dec 29, 2027 U-3652

8809292 May 10, 2027 DS DP U-3652

8828956 Dec 04, 2028 DS DP U-3652

9370582 Dec 04, 2028 DS DP U-3652

9708610 Jan 01, 2024 DS DP U-3652

INDIGOTINDISULFONATE SODIUM - BLUDIGO

N 216264 001 >A> 11845867 Nov 25, 2036 DS

INDOCYANINE GREEN - SPY AGENT GREEN KIT

N 211580 001 11712320 Jul 14, 2039 DP I-911 Jun 05, 2026

INDOMETHACIN - INDOMETHACIN

A 216184 001 CGT Jan 30, 2024

IPTACOPAN HYDROCHLORIDE - FABHALTA

N 218276 001 >A> 11603363 May 25, 2041 DS DP

>A> 9682968 Jul 14, 2034 DS DP

ISAVUCONAZONIUM SULFATE - CRESEMBA

N 207500 001 10206879 Sep 14, 2027 DP NCE Mar 06, 2020

10206879*PED Mar 14, 2028 ODE-305 Mar 06, 2022

10603280 Sep 14, 2027 DP ODE-90 Mar 06, 2022

10603280*PED Mar 14, 2028 PED Sep 06, 2020

6812238 Oct 31, 2025 DS PED Sep 06, 2022

6812238*PED May 01, 2026 PED Sep 06, 2022

GAIN Sep 06, 2025

GAIN Sep 06, 2027

GAIN Sep 06, 2027

ISAVUCONAZONIUM SULFATE - CRESEMBA

N 207500 002 10206879 Sep 14, 2027 DP NCE Mar 06, 2020

10206879*PED Mar 14, 2028 ODE* Mar 06, 2022

10603280 Sep 14, 2027 DP PED Sep 06, 2020

10603280*PED Mar 14, 2028 PED Sep 06, 2022

6812238 Oct 31, 2025 DS GAIN Sep 06, 2025

6812238*PED May 01, 2026 GAIN Sep 06, 2027
A - 45

PATENT AND EXCLUSIVITY DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - December 2023

APPL/PROD PATENT PATENT EXCLUSIVITY

NO PATENT NO EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION

DATE CODES REQUESTED CODE(S) DATE

ISAVUCONAZONIUM SULFATE - CRESEMBA

N 207501 001 6812238

6812238*PED

Oct 31, 2025

May 01, 2026

DS NCE

ODE-305

ODE-90

PED

PED

PED

GAIN

GAIN

GAIN

Mar 06, 2020

Mar 06, 2022

Mar 06, 2022

Sep 06, 2020

Sep 06, 2022

Sep 06, 2022

Sep 06, 2025

Sep 06, 2027

Sep 06, 2027

ISTRADEFYLLINE - NOURIANZ

N 022075 001 7727993 Jan 28, 2028 DP U-2623

ISTRADEFYLLINE - NOURIANZ

N 022075 002 7727993 Jan 28, 2028 DP U-2623

IVACAFTOR - KALYDECO

N 203188 001 11564916 Aug 13, 2029 U-3530

IVACAFTOR - KALYDECO

N 207925 001 11564916

11752106

Aug 13, 2029

Feb 27, 2033

U-3528

DP U-3697

ODE-435 May 03, 2030

IVACAFTOR - KALYDECO

N 207925 002 11564916

11752106

Aug 13, 2029

Feb 27, 2033

U-3528

DP U-3697

ODE-435 May 03, 2030

IVACAFTOR - KALYDECO

N 207925 003 11564916

11752106

Aug 13, 2029

Feb 27, 2033

U-3528

DP U-3697

ODE-435 May 03, 2030

IVACAFTOR - KALYDECO

N 207925 004 10272046

10646481

11147770

11564916

11752106

7495103

8324242

8354427

8410274

8629162

8754224

8883206

9670163

Feb 27, 2033

Aug 13, 2029

Feb 27, 2033

Aug 13, 2029

Feb 27, 2033

May 20, 2027

Aug 05, 2027

Jul 06, 2026

Dec 28, 2026

Jun 24, 2025

Dec 28, 2026

Feb 27, 2033

Dec 28, 2026

DP U-3605

DP

DP U-3604

U-3603

DP U-3697

DS DP

U-3609

U-3608

DP

U-3607

DS DP

DP

DP U-3606

NPP

ODE-435

May 03, 2026

May 03, 2030

IVACAFTOR - KALYDECO

N 207925 005 10272046

10646481

11147770

11564916

11752106

7495103

8324242

8354427

8410274

8629162

8754224

8883206

9670163

Feb 27, 2033

Aug 13, 2029

Feb 27, 2033

Aug 13, 2029

Feb 27, 2033

May 20, 2027

Aug 05, 2027

Jul 06, 2026

Dec 28, 2026

Jun 24, 2025

Dec 28, 2026

Feb 27, 2033

Dec 28, 2026

DP U-3605

DP

DP U-3604

U-3603

DP U-3697

DS DP

U-3609

U-3608

DP

U-3607

DS DP

DP

DP U-3606

NPP

ODE-435

May 03, 2026

May 03, 2030

IVACAFTOR; IVACAFTOR, TEZACAFTOR - SYMDEKO (COPACKAGED)

N 210491 001 11564916 Aug 13, 2029 U-3527

11578062 Mar 25, 2031 DP U-3545

11639347 Apr 09, 2027 DS DP U-2569
A - 46

PATENT AND EXCLUSIVITY DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - December 2023

APPL/PROD PATENT PATENT EXCLUSIVITY

NO PATENT NO EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION

DATE CODES REQUESTED CODE(S) DATE

IVACAFTOR; IVACAFTOR, TEZACAFTOR - SYMDEKO (COPACKAGED)

N 210491 001 11564916 Aug 13, 2029 U-3527

11578062 Mar 25, 2031 DP U-3545

11639347 Apr 09, 2027 DS DP U-2569

IVACAFTOR; IVACAFTOR, TEZACAFTOR - SYMDEKO (COPACKAGED)

N 210491 002 11564916 Aug 13, 2029 U-3527

11578062 Mar 25, 2031 DP U-3545

11639347 Apr 09, 2027 DS DP U-2569

IVACAFTOR; LUMACAFTOR - ORKAMBI

N 206038 001 11564916 Aug 13, 2029 U-3529

IVACAFTOR; LUMACAFTOR - ORKAMBI

N 206038 002 11564916 Aug 13, 2029 U-3529

IVACAFTOR; LUMACAFTOR - ORKAMBI

N 211358 001 11564916 Aug 13, 2029 U-3526 ODE-408 Sep 02, 2029

IVACAFTOR; LUMACAFTOR - ORKAMBI

N 211358 002 11564916 Aug 13, 2029 U-3526 ODE-408 Sep 02, 2029

IVACAFTOR; LUMACAFTOR - ORKAMBI

N 211358 003 11564916 Aug 13, 2029 U-3526 ODE-408 Sep 02, 2029

IVOSIDENIB - TIBSOVO

N 211192 001 10980788

10980788

10980788

10980788

10980788

11667673

9474779

9474779

9474779

9474779

9474779

9474779

9850277

9850277

9850277

9850277

9850277

9850277

Jun 07, 2039

Jun 07, 2039

Jun 07, 2039

Jun 07, 2039

Jun 07, 2039

Jan 18, 2033

Aug 19, 2033

Aug 19, 2033

Aug 19, 2033

Aug 19, 2033

Aug 19, 2033

Aug 19, 2033

Jan 18, 2033

Jan 18, 2033

Jan 18, 2033

Jan 18, 2033

Jan 18, 2033

Jan 18, 2033

U-3112

U-3113

U-3214

U-3383

U-3743

U-3742

DS DP U-2350

DS DP U-2533

DS DP U-2534

DS DP U-3213

DS DP U-3386

DS DP U-3742

DS DP U-2350

DS DP U-2533

DS DP U-2534

DS DP U-3213

DS DP U-3386

DS DP U-3742

I-924

ODE-447

Oct 24, 2026

Oct 24, 2030

LACOSAMIDE - VIMPAT

N 022253 001 D-188 Apr 28, 2026

LACOSAMIDE - VIMPAT

N 022253 002 D-188 Apr 28, 2026

LACOSAMIDE - VIMPAT

N 022253 003 D-188 Apr 28, 2026

LACOSAMIDE - VIMPAT

N 022253 004 D-188 Apr 28, 2026

LACOSAMIDE - VIMPAT

N 022254 001 D-188 Apr 28, 2026

LACOSAMIDE - VIMPAT

N 022255 001 D-188 Apr 28, 2026
A - 47

PATENT AND EXCLUSIVITY DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - December 2023

APPL/PROD

NO PATENT NO

PATENT

EXPIRATION

DATE

PATENT

CODES

PATENT

DELIST

REQUESTED

EXCLUSIVITY

CODE(S)

EXCLUSIVITY

EXPIRATION

DATE

LACOSAMIDE - MOTPOLY XR

N 216185 001 11337943 Jun 05, 2040 DP U-3660

LACOSAMIDE - MOTPOLY XR

N 216185 002 11337943 Jun 05, 2040 DP U-3660

LACOSAMIDE - MOTPOLY XR

N 216185 003 11337943 Jun 05, 2040 DP U-3660

LAROTRECTINIB SULFATE - VITRAKVI

N 211710 001 11191766

11484535

Apr 04, 2037

Apr 04, 2037

U-2471

U-2470

LASMIDITAN SUCCINATE - REYVOW

N 211280 001 7423050 Feb 17, 2028 DS DP U-1719

LASMIDITAN SUCCINATE - REYVOW

N 211280 002 7423050 Feb 17, 2028 DS DP U-1719

LASMIDITAN SUCCINATE - REYVOW

N 211280 003 7423050 Feb 17, 2028 DS DP U-1719

LATANOPROST; NETARSUDIL DIMESYLATE - ROCKLATAN

N 208259 001 11618748 Jan 27, 2030 U-1524

LEDIPASVIR; SOFOSBUVIR - HARVONI

N 205834 001 ODE* Aug 28, 2026

LEDIPASVIR; SOFOSBUVIR - HARVONI

N 205834 002 ODE*

ODE*

PED

Apr 07, 2024

Aug 28, 2026

Oct 07, 2024

LEMBOREXANT - DAYVIGO

N 212028 001 M-293 Apr 20, 2026

LEMBOREXANT - DAYVIGO

N 212028 002 M-293 Apr 20, 2026

LENACAPAVIR SODIUM - SUNLENCA

N 215973 001 10071985

10654827

11267799

9951043

Aug 17, 2037

Aug 17, 2037

Aug 16, 2038

Feb 28, 2034

DS DP

U-3507

DS

DS DP U-3507

NCE Dec 22, 2027

LENACAPAVIR SODIUM - SUNLENCA

N 215974 001 10071985

10654827

11267799

9951043

Aug 17, 2037

Aug 17, 2037

Aug 16, 2038

Feb 28, 2034

DS DP

U-3507

DS

DS DP U-3507

NCE Dec 22, 2027

LENIOLISIB PHOSPHATE - JOENJA

N 217759 001 8653092 Feb 19, 2032 DS DP NCE

ODE-430

Mar 24, 2028

Mar 24, 2030

LENVATINIB MESYLATE - LENVIMA

N 206947 001 11090386 Feb 23, 2036 U-3519

LENVATINIB MESYLATE - LENVIMA

N 206947 002 11090386 Feb 23, 2036 U-3519
A - 48

PATENT AND EXCLUSIVITY DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - December 2023

APPL/PROD PATENT PATENT EXCLUSIVITY

NO PATENT NO EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION

DATE CODES REQUESTED CODE(S) DATE

LETERMOVIR - PREVYMIS

N 209939 001 D-189

I-916

ODE-423

Aug 02, 2026

Jun 05, 2026

Jun 05, 2030

LETERMOVIR - PREVYMIS

N 209939 002 D-189

I-916

ODE-423

Aug 02, 2026

Jun 05, 2026

Jun 05, 2030

LETERMOVIR - PREVYMIS

N 209940 001 D-189

I-916

ODE-423

Aug 02, 2026

Jun 05, 2026

Jun 05, 2030

LETERMOVIR - PREVYMIS

N 209940 002 D-189

I-916

ODE-423

Aug 02, 2026

Jun 05, 2026

Jun 05, 2030

LEUPROLIDE ACETATE - LUPRON DEPOT-PED KIT

N 020263 009 8921326 Feb 05, 2031

9617303 Mar 22, 2028

DP

U-3611

NS Apr 14, 2026

LEUPROLIDE ACETATE - ELIGARD KIT

N 021343 001 11771841 Dec 22, 2041 DS DP

LEUPROLIDE ACETATE - ELIGARD KIT

N 021379 001 11771841 Dec 22, 2041 DS DP

LEUPROLIDE ACETATE - ELIGARD KIT

N 021488 001 11771841 Dec 22, 2041 DS DP

LEUPROLIDE ACETATE - ELIGARD KIT

N 021731 001 11771841 Dec 22, 2041 DS DP

LEUPROLIDE ACETATE - FENSOLVI KIT

N 213150 001 11771841 Dec 22, 2041 DS DP

LEUPROLIDE MESYLATE - CAMCEVI KIT

N 211488 001 11717555 Jan 01, 2039 DP

LEVOKETOCONAZOLE - RECORLEV

N 214133 001 ODE-385 Dec 30, 2028

LEVOLEUCOVORIN - KHAPZORY

N 211226 001 11541012 Mar 25, 2039 DP

LEVOLEUCOVORIN - KHAPZORY

N 211226 002 11541012 Mar 25, 2039 DP

LEVONORGESTREL - SKYLA

N 203159 001 11628088 Feb 07, 2027 DP

LEVONORGESTREL - LILETTA

N 206229 001 11571328 Sep 07, 2040 DP I-917 Jun 29, 2026

LEVONORGESTREL - KYLEENA

N 208224 001 11628088 Feb 07, 2027 DP
A - 49

PATENT AND EXCLUSIVITY DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - December 2023

APPL/PROD PATENT

NO PATENT NO EXPIRATION PATENT

DATE CODES

LEVOTHYROXINE SODIUM - TIROSINT-SOL

N 206977 001 >A> 11241382 Sep 17, 2039 U-3757

>A> 11241382 Sep 17, 2039 U-3758

LEVOTHYROXINE SODIUM - TIROSINT-SOL

N 206977 002 >A> 11241382 Sep 17, 2039 U-3757

>A> 11241382 Sep 17, 2039 U-3758

LEVOTHYROXINE SODIUM - TIROSINT-SOL

N 206977 003 >A> 11241382 Sep 17, 2039 U-3757

>A> 11241382 Sep 17, 2039 U-3758

LEVOTHYROXINE SODIUM - TIROSINT-SOL

N 206977 004 >A> 11241382 Sep 17, 2039 U-3757

>A> 11241382 Sep 17, 2039 U-3758

LEVOTHYROXINE SODIUM - TIROSINT-SOL

N 206977 005 >A> 11241382 Sep 17, 2039 U-3757

>A> 11241382 Sep 17, 2039 U-3758

LEVOTHYROXINE SODIUM - TIROSINT-SOL

N 206977 006 >A> 11241382 Sep 17, 2039 U-3757

>A> 11241382 Sep 17, 2039 U-3758

LEVOTHYROXINE SODIUM - TIROSINT-SOL

N 206977 007 >A> 11241382 Sep 17, 2039 U-3757

>A> 11241382 Sep 17, 2039 U-3758

LEVOTHYROXINE SODIUM - TIROSINT-SOL

N 206977 008 >A> 11241382 Sep 17, 2039 U-3757

>A> 11241382 Sep 17, 2039 U-3758

LEVOTHYROXINE SODIUM - TIROSINT-SOL

N 206977 009 >A> 11241382 Sep 17, 2039 U-3757

>A> 11241382 Sep 17, 2039 U-3758

LEVOTHYROXINE SODIUM - TIROSINT-SOL

N 206977 010 >A> 11241382 Sep 17, 2039 U-3757

>A> 11241382 Sep 17, 2039 U-3758

LEVOTHYROXINE SODIUM - TIROSINT-SOL

N 206977 011 >A> 11241382 Sep 17, 2039 U-3757

>A> 11241382 Sep 17, 2039 U-3758

LEVOTHYROXINE SODIUM - TIROSINT-SOL

N 206977 012 >A> 11241382 Sep 17, 2039 U-3757

>A> 11241382 Sep 17, 2039 U-3758

LEVOTHYROXINE SODIUM - TIROSINT-SOL

N 206977 013 >A> 11241382 Sep 17, 2039 U-3757

>A> 11241382 Sep 17, 2039 U-3758

LEVOTHYROXINE SODIUM - TIROSINT-SOL

N 206977 014 >A> 11241382 Sep 17, 2039 U-3757

>A> 11241382 Sep 17, 2039 U-3758

LEVOTHYROXINE SODIUM - TIROSINT-SOL

N 206977 015 >A> 11241382 Sep 17, 2039 U-3757

>A> 11241382 Sep 17, 2039 U-3758

LIDOCAINE - ZTLIDO

N 207962 001 11786455 May 10, 2031 DP U-2267

11793766 May 10, 2031 U-2267

PATENT EXCLUSIVITY

DELIST EXCLUSIVITY EXPIRATION

REQUESTED CODE(S) DATE
A - 50

PATENT AND EXCLUSIVITY DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - December 2023

PATENT

PATENT DELIST

CODES REQUESTED

DP U-2267

U-2267

U-1516

U-3644

DS DP U-1516

DS DP U-3644

U-1516

U-3644

DP U-1516

DP U-3644

DP U-1516

DP U-3644

U-2347

DP

DS DP

U-1503 Y

U-1503 Y

DP U-1642

DP

U-1915

U-2339

DP

DS DP

U-1503 Y

U-1503

DP

DP

DP

U-2339

DP

DS DP

U-1503 Y

U-1503

DP

EXCLUSIVITY

CODE(S)

I-921

I-921

M-295

PED

M-295

PED

M-295

PED

EXCLUSIVITY

EXPIRATION

DATE

Jun 12, 2026

Jun 12, 2026

Jun 20, 2026

Dec 20, 2026

Jun 20, 2026

Dec 20, 2026

Jun 20, 2026

Dec 20, 2026

APPL/PROD

NO PATENT NO

LIDOCAINE - ZTLIDO

N 207962 001 11786455

11793766

LINACLOTIDE - LINZESS

N 202811 001

LINACLOTIDE - LINZESS

N 202811 003 10702576

10702576

7304036

7304036

8110553

8110553

8933030

8933030

9708371

9708371

LINAGLIPTIN - TRADJENTA

N 201280 001 10034877

10034877*PED

11033552

11033552*PED

7407955

7407955*PED

8673927

8673927*PED

8846695

8846695*PED

8853156

8853156*PED

8883805

8883805*PED

9486526

9486526*PED

LINAGLIPTIN; METFORMIN HYDROCHLORIDE - JENTADUETO

N 201281 001 10022379

10022379*PED

10973827

10973827*PED

7407955

7407955*PED

8673927

8673927*PED

8846695

8846695*PED

8883805

8883805*PED

9155705

9155705*PED

9415016

9415016*PED

Apr 02, 2029

Oct 02, 2029

Apr 02, 2029

Oct 02, 2029

May 02, 2025

Nov 02, 2025

May 04, 2027

Nov 04, 2027

Jun 04, 2030

Dec 04, 2030

Nov 26, 2025

May 26, 2026

May 21, 2030

Nov 21, 2030

Apr 02, 2029

Oct 02, 2029

N 201281 002 10022379

10022379*PED

10973827

10973827*PED

7407955

7407955*PED

8673927

8673927*PED

8846695

8846695*PED

8883805

8883805*PED

PATENT

EXPIRATION

DATE

May 10, 2031

May 10, 2031

Aug 11, 2031

Aug 11, 2031

Aug 30, 2026

Aug 30, 2026

Jan 28, 2024

Jan 28, 2024

Feb 17, 2031

Feb 17, 2031

Aug 16, 2033

Aug 16, 2033

Aug 05, 2029

Feb 05, 2030

May 04, 2027

Nov 04, 2027

May 02, 2025

Nov 02, 2025

May 04, 2027

Nov 04, 2027

Jun 04, 2030

Dec 04, 2030

Mar 05, 2031

Sep 05, 2031

Nov 26, 2025

May 26, 2026

Aug 05, 2029

Feb 05, 2030

LINAGLIPTIN; METFORMIN HYDROCHLORIDE - JENTADUETO

Apr 02, 2029

Oct 02, 2029

Apr 02, 2029

Oct 02, 2029

May 02, 2025

Nov 02, 2025

May 04, 2027

Nov 04, 2027

Jun 04, 2030

Dec 04, 2030

Nov 26, 2025

May 26, 2026
A - 51

PATENT AND EXCLUSIVITY DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - December 2023

APPL/PROD PATENT PATENT EXCLUSIVITY

NO PATENT NO EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION

DATE CODES REQUESTED CODE(S) DATE

LINAGLIPTIN; METFORMIN HYDROCHLORIDE - JENTADUETO

N 201281 002 9155705 May 21, 2030

9155705*PED Nov 21, 2030

9415016 Apr 02, 2029

9415016*PED Oct 02, 2029

DP

DP

LINAGLIPTIN; METFORMIN HYDROCHLORIDE - JENTADUETO

N 201281 003 10022379 Apr 02, 2029

10022379*PED Oct 02, 2029

10973827 Apr 02, 2029

10973827*PED Oct 02, 2029

7407955 May 02, 2025

7407955*PED Nov 02, 2025

8673927 May 04, 2027

8673927*PED Nov 04, 2027

8846695 Jun 04, 2030

8846695*PED Dec 04, 2030

8883805 Nov 26, 2025

8883805*PED May 26, 2026

9155705 May 21, 2030

9155705*PED Nov 21, 2030

9415016 Apr 02, 2029

9415016*PED Oct 02, 2029

U-2339

DP

DS DP

U-1503

U-1503

DP

DP

DP

Y

Y

M-295

PED

Jun 20, 2026

Dec 20, 2026

LINAGLIPTIN; METFORMIN HYDROCHLORIDE - JENTADUETO XR

N 208026 001 10022379 Apr 02, 2029 U-2339

10022379*PED Oct 02, 2029

7407955 May 02, 2025 DS DP

7407955*PED Nov 02, 2025

8673927 May 04, 2027 U-1503

8673927*PED Nov 04, 2027

8883805 Nov 26, 2025 DP

8883805*PED May 26, 2026

9155705 May 21, 2030 DP

9155705*PED Nov 21, 2030

9173859 May 04, 2027 DP U-1503

9173859*PED Nov 04, 2027

9415016 Apr 02, 2029 DP

9415016*PED Oct 02, 2029

9555001 Mar 06, 2033 DP U-1967

9555001 Mar 06, 2033 DP U-1968

9555001*PED Sep 06, 2033

Y

Y

M-295

PED

Jun 20, 2026

Dec 20, 2026

LINAGLIPTIN; METFORMIN HYDROCHLORIDE - JENTADUETO XR

N 208026 002 10022379 Apr 02, 2029 U-2339

10022379*PED Oct 02, 2029

7407955 May 02, 2025 DS DP

7407955*PED Nov 02, 2025

8673927 May 04, 2027 U-1503

8673927*PED Nov 04, 2027

8883805 Nov 26, 2025 DP

8883805*PED May 26, 2026

9155705 May 21, 2030 DP

9155705*PED Nov 21, 2030

9173859 May 04, 2027 DP U-1503

9173859*PED Nov 04, 2027

9415016 Apr 02, 2029 DP

9415016*PED Oct 02, 2029

9555001 Mar 06, 2033 DP U-1967

9555001 Mar 06, 2033 DP U-1968

9555001*PED Sep 06, 2033

Y

Y

M-295

PED

Jun 20, 2026

Dec 20, 2026

LISINOPRIL - QBRELIS

N 208401 001 11771733 Nov 06, 2035 DP
A - 52

PATENT AND EXCLUSIVITY DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - December 2023

APPL/PROD PATENT PATENT EXCLUSIVITY

NO PATENT NO EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION

DATE CODES REQUESTED CODE(S) DATE

LITHIUM CITRATE - LITHIUM CITRATE

A 218036 001 CGT Mar 18, 2024

LONAFARNIB - ZOKINVY

N 213969 001 8828356 Oct 17, 2024 U-3070

LONAFARNIB - ZOKINVY

N 213969 002 8828356 Oct 17, 2024 U-3070

LOTEPREDNOL ETABONATE - LOTEMAX SM

N 208219 001 11534395 Jan 26, 2036 DP U-2764

LOTEPREDNOL ETABONATE - INVELTYS

N 210565 001 11642317 May 03, 2033 DP

LOTEPREDNOL ETABONATE - EYSUVIS

N 210933 001 11596599

11642317

May 03, 2033

May 03, 2033

U-2985

DP

LOTILANER - XDEMVY

N 217603 001 10835517

11197847

11690826

11690827

11752137

8383659

Dec 14, 2038

Dec 14, 2038

Dec 14, 2038

Dec 14, 2038

Dec 14, 2038

Jan 17, 2030

U-3674

U-3674

U-3674

U-3674

DP

DS DP

NCE Jul 24, 2028

LUMASIRAN SODIUM - OXLUMO

N 214103 001 ODE-415 Oct 06, 2029

LUMATEPERONE TOSYLATE - CAPLYTA

N 209500 001 11690842

11690842

11753419

11806348

11806348

RE48839

RE48839

Aug 30, 2039

Aug 30, 2039

Dec 10, 2040

Aug 30, 2039

Aug 30, 2039

Aug 19, 2033

Aug 19, 2033

DP U-3362

DP U-3363

DP

DP U-3362

DP U-3363

U-3271

U-814

LUMATEPERONE TOSYLATE - CAPLYTA

N 209500 002 11690842

11690842

11753419

11806348

11806348

>A> 9168258

RE48839

RE48839

Aug 30, 2039

Aug 30, 2039

Dec 10, 2040

Aug 30, 2039

Aug 30, 2039

May 27, 2029

Aug 19, 2033

Aug 19, 2033

DP U-3362

DP U-3363

DP

DP U-3362

DP U-3363

DP

U-3271

U-814

LUMATEPERONE TOSYLATE - CAPLYTA

N 209500 003 11690842

11690842

11753419

11806348

11806348

RE48839

RE48839

Aug 30, 2039

Aug 30, 2039

Dec 10, 2040

Aug 30, 2039

Aug 30, 2039

Aug 19, 2033

Aug 19, 2033

DP U-3362

DP U-3363

DP

DP U-3362

DP U-3363

U-3271

U-814

LURASIDONE HYDROCHLORIDE - LATUDA

N 200603 001 9907794

9907794*PED

May 26, 2026

Nov 26, 2026

DP
A - 53

PATENT AND EXCLUSIVITY DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - December 2023

APPL/PROD PATENT PATENT EXCLUSIVITY

NO PATENT NO EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION

DATE CODES REQUESTED CODE(S) DATE

LURASIDONE HYDROCHLORIDE - LATUDA

N 200603 002 9907794 May 26, 2026 DP

9907794*PED Nov 26, 2026

LURASIDONE HYDROCHLORIDE - LATUDA

N 200603 003 9907794 May 26, 2026 DP

9907794*PED Nov 26, 2026

LURASIDONE HYDROCHLORIDE - LATUDA

N 200603 004 9907794 May 26, 2026 DP

9907794*PED Nov 26, 2026

LURASIDONE HYDROCHLORIDE - LATUDA

N 200603 005 9907794 May 26, 2026 DP

9907794*PED Nov 26, 2026

LURBINECTEDIN - ZEPZELCA

N 213702 001 7763615 Dec 13, 2029 DS DP U-2836

MAGNESIUM SULFATE; POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM SULFATE - SUFLAVE

N 215344 001 NP Jun 15, 2026

MAGNESIUM SULFATE; POTASSIUM CHLORIDE; SODIUM SULFATE - SUTAB

N 213135 001 11638697 Aug 04, 2037 DP

MARALIXIBAT CHLORIDE - LIVMARLI

N 214662 001 NPP Mar 13, 2026

ODE-429 Mar 13, 2030

MARIBAVIR - LIVTENCITY

N 215596 001 11684632 Jan 04, 2032 U-3650 ODE-388 Nov 23, 2028

MAVACAMTEN - CAMZYOS

N 214998 001 M-297 Jun 15, 2026

ODE-398 Apr 28, 2029

MAVACAMTEN - CAMZYOS

N 214998 002 M-297 Jun 15, 2026

ODE-398 Apr 28, 2029

MAVACAMTEN - CAMZYOS

N 214998 003 M-297 Jun 15, 2026

ODE-398 Apr 28, 2029

MAVACAMTEN - CAMZYOS

N 214998 004 M-297 Jun 15, 2026

ODE-398 Apr 28, 2029

MELPHALAN FLUFENAMIDE HYDROCHLORIDE - PEPAXTO

N 214383 001 6992207 Jun 25, 2024 DS DP U-3093

MELPHALAN HYDROCHLORIDE - HEPZATO

N 201848 001

>A>

10098997

10195334

10369264

10569004

10569004

11083831

11241522

11633528

11833286

9314561

9707331

Nov 07, 2032

Jan 16, 2033

Nov 07, 2032

Nov 07, 2032

Nov 07, 2032

Dec 30, 2032

Nov 07, 2032

Nov 07, 2032

Dec 30, 2032

Feb 07, 2034

Sep 17, 2034

DP

DP

DP

DP

DP

DP

DP

DP

U-3680

U-3683

U-3675

NP

ODE-438

Aug 14, 2026

Aug 14, 2030
A - 54

PATENT AND EXCLUSIVITY DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - December 2023

APPL/PROD PATENT PATENT EXCLUSIVITY

NO PATENT NO EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION

DATE CODES REQUESTED CODE(S) DATE

MELPHALAN HYDROCHLORIDE - MELPHALAN HYDROCHLORIDE

N 217110 001 10537520 Jun 29, 2036 DP

METHOTREXATE - OTREXUP

N 204824 001 11684723 Mar 10, 2029 DP

METHOTREXATE - OTREXUP

N 204824 002 11684723 Mar 10, 2029 DP

METHOTREXATE - OTREXUP

N 204824 003 11684723 Mar 10, 2029 DP

METHOTREXATE - OTREXUP

N 204824 004 11684723 Mar 10, 2029 DP

METHOTREXATE - OTREXUP

N 204824 005 11684723 Mar 10, 2029 DP

METHOTREXATE - OTREXUP

N 204824 006 11684723 Mar 10, 2029 DP

METHOTREXATE - OTREXUP

N 204824 007 11684723 Mar 10, 2029 DP

METHOTREXATE - OTREXUP

N 204824 008 11684723 Mar 10, 2029 DP

METHOTREXATE - JYLAMVO

N 212479 001 11129833

11771701

11771701

11771701

11771701

11771701

Oct 28, 2035

Oct 29, 2034

Oct 29, 2034

Oct 29, 2034

Oct 29, 2034

Oct 29, 2034

DP

DP U-3700

DP U-3701

DP U-3702

DP U-3703

DP U-3704

METHSUXIMIDE - METHSUXIMIDE

A 217213 001 CGT Oct 28, 2023

METHYLPHENIDATE HYDROCHLORIDE - QUILLICHEW ER

N 207960 001 11633389 Aug 14, 2033 DP

METHYLPHENIDATE HYDROCHLORIDE - QUILLICHEW ER

N 207960 002 11633389 Aug 14, 2033 DP

METHYLPHENIDATE HYDROCHLORIDE - QUILLICHEW ER

N 207960 003 11633389 Aug 14, 2033 DP

METOCLOPRAMIDE HYDROCHLORIDE - GIMOTI

N 209388 001 11628150 Dec 22, 2029

11813231 Dec 22, 2029

DP U-2843

DP U-2843

METRONIDAZOLE - LIKMEZ

N 216755 001 11541035 Oct 04, 2039 DP

MIDAZOLAM - MIDAZOLAM IN 0.9% SODIUM CHLORIDE

A 216159 001 PC Jan 02, 2024

MIDAZOLAM - MIDAZOLAM IN 0.9% SODIUM CHLORIDE

A 216159 002 PC Jan 02, 2024
A - 55

PATENT AND EXCLUSIVITY DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - December 2023

APPL/PROD PATENT PATENT EXCLUSIVITY

NO PATENT NO EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION

DATE CODES REQUESTED CODE(S) DATE

MIGALASTAT HYDROCHLORIDE - GALAFOLD

N 208623 001 11612593 May 30, 2038

11612594 May 30, 2038

11622962 Mar 17, 2039

11633387 May 30, 2038

11633388 Mar 25, 2039

11642334 Feb 20, 2039

11666564 May 30, 2038

11786516 May 30, 2038

>A> 11813255 May 30, 2038

>A> 11826360 Feb 16, 2039

>A> 11833164 Jan 11, 2042

DS

DS

DS

DS

DS

DS

U-2371

U-2371

U-2371

U-2371

U-2371

MIGLUSTAT - OPFOLDA

N 215211 001 10208299

10512677

10857212

10961522

11278599

11278601

11753632

Sep 30, 2035

Mar 07, 2033

Aug 12, 2037

Sep 30, 2035

Mar 07, 2033

Dec 29, 2036

Sep 30, 2035

DS DP U-3726

U-3726

U-3726

U-3726

U-3726

DP U-3726

U-3726

NP Sep 28, 2026

MIRABEGRON - MYRBETRIQ

N 202611 001 10842780

10842780

10842780*PED

11707451

11707451

11707451*PED

Sep 28, 2029

Sep 28, 2029

Mar 28, 2030

Sep 28, 2029

Sep 28, 2029

Mar 28, 2030

DP U-2996

DP U-3670

U-2996

U-3670

MIRABEGRON - MYRBETRIQ

N 202611 002 10842780

10842780

10842780*PED

11707451

11707451

11707451*PED

Sep 28, 2029

Sep 28, 2029

Mar 28, 2030

Sep 28, 2029

Sep 28, 2029

Mar 28, 2030

DP U-2996

DP U-3670

U-2996

U-3670

MITAPIVAT SULFATE - PYRUKYND

N 216196 001 11793806

RE49582

Apr 12, 2033

Feb 24, 2031

U-3320

DS DP

ODE-392 Feb 17, 2029

MITAPIVAT SULFATE - PYRUKYND

N 216196 002 11793806

RE49582

Apr 12, 2033

Feb 24, 2031

U-3320

DS DP

ODE-392 Feb 17, 2029

MITAPIVAT SULFATE - PYRUKYND

N 216196 003 11793806

RE49582

Apr 12, 2033

Feb 24, 2031

U-3320

DS DP

ODE-392 Feb 17, 2029

MOMELOTINIB DIHYDROCHLORIDE - OJJAARA

N 216873 001 8486941 Jan 03, 2030

9809559 Jun 11, 2035

RE48285 Jun 11, 2035

DS DP U-1201

U-1201

DS DP U-1201

NCE

ODE-441

Sep 15, 2028

Sep 15, 2030

MOMELOTINIB DIHYDROCHLORIDE - OJJAARA

N 216873 002 8486941 Jan 03, 2030

9809559 Jun 11, 2035

RE48285 Jun 11, 2035

DS DP U-1201

U-1201

DS DP U-1201

NCE

ODE-441

Sep 15, 2028

Sep 15, 2030

MOMELOTINIB DIHYDROCHLORIDE - OJJAARA

N 216873 003 8486941 Jan 03, 2030

9809559 Jun 11, 2035

RE48285 Jun 11, 2035

DS DP U-1201

U-1201

DS DP U-1201

NCE

ODE-441

Sep 15, 2028

Sep 15, 2030
A - 56

PATENT AND EXCLUSIVITY DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - December 2023

APPL/PROD PATENT PATENT EXCLUSIVITY

NO PATENT NO EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION

DATE CODES REQUESTED CODE(S) DATE

MOMETASONE FUROATE; OLOPATADINE HYDROCHLORIDE - RYALTRIS

N 211746 001 11679210 Sep 03, 2038 DP

MONOMETHYL FUMARATE - BAFIERTAM

N 210296 001 11590095 Mar 18, 2036 U-1384

MOTIXAFORTIDE ACETATE - APHEXDA

N 217159 001 NCE

ODE-442

Sep 08, 2028

Sep 08, 2030

NALMEFENE HYDROCHLORIDE - OPVEE

N 217470 001 11458091 Jul 10, 2038 DP U-3630 NP May 22, 2026

NALOXONE HYDROCHLORIDE - EVZIO

N 205787 001 11590286 Dec 12, 2026 DP

NALOXONE HYDROCHLORIDE - REXTOVY

N 208969 001 NP Mar 07, 2026

NALOXONE HYDROCHLORIDE - EVZIO (AUTOINJECTOR)

N 209862 001 11590286 Dec 12, 2026 DP

NALOXONE HYDROCHLORIDE - KLOXXADO

N 212045 001 11617713

11628139

Aug 26, 2034

Aug 26, 2034

DP U-3110

DP U-3110

NALOXONE HYDROCHLORIDE - ZIMHI

N 212854 001 11571518

11571518

11571518

Jun 14, 2041

Jun 14, 2041

Jun 14, 2041

DP U-3515

DP U-3516

DP U-3517

NALOXONE HYDROCHLORIDE - NALOXONE HYDROCHLORIDE (AUTOINJECTOR)

N 215457 001 11590286 Dec 12, 2026 DP

NALOXONE HYDROCHLORIDE - RIVIVE

N 217722 001 11020343 May 11, 2032 U-3671

NEDOSIRAN SODIUM - RIVFLOZA

N 215842 001 10351854

10738311

11053502

11286488

11359203

11661604

Oct 09, 2035

Oct 09, 2035

Oct 29, 2035

Oct 12, 2038

Oct 09, 2035

Oct 12, 2038

DS DP

DS DP U-3709

DS DP

DS DP U-3709

DS DP U-3709

DS DP U-3709

NCE

ODE-443

Sep 29, 2028

Sep 29, 2030

NEDOSIRAN SODIUM - RIVFLOZA

N 215842 002 10351854

10738311

11053502

11286488

11359203

11661604

Oct 09, 2035

Oct 09, 2035

Oct 29, 2035

Oct 12, 2038

Oct 09, 2035

Oct 12, 2038

DS DP

DS DP U-3709

DS DP

DS DP U-3709

DS DP U-3709

DS DP U-3709

NCE

ODE-443

Sep 29, 2028

Sep 29, 2030

NEDOSIRAN SODIUM - RIVFLOZA

N 215842 003 10351854

10738311

11053502

11286488

11359203

11661604

Oct 09, 2035

Oct 09, 2035

Oct 29, 2035

Oct 12, 2038

Oct 09, 2035

Oct 12, 2038

DS DP

DS DP U-3709

DS DP

DS DP U-3709

DS DP U-3709

DS DP U-3709

NCE

ODE-443

Sep 29, 2028

Sep 29, 2030
A - 57

PATENT AND EXCLUSIVITY DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - December 2023

APPL/PROD PATENT PATENT EXCLUSIVITY

NO PATENT NO EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION

DATE CODES REQUESTED CODE(S) DATE

NETARSUDIL MESYLATE - RHOPRESSA

N 208254 001 11618748 Jan 27, 2030 U-1524

NETUPITANT; PALONOSETRON HYDROCHLORIDE - AKYNZEO

N 205718 001 11559523 Nov 18, 2030 DP U-3522

NICARDIPINE HYDROCHLORIDE - NICARDIPINE HYDROCHLORIDE

A 215377 001 CGT Mar 20, 2024

NICARDIPINE HYDROCHLORIDE - NICARDIPINE HYDROCHLORIDE

A 215377 002 CGT Mar 20, 2024

NICARDIPINE HYDROCHLORIDE - CARDENE IN 4.8% DEXTROSE IN PLASTIC CONTAINER

N 019734 002 11547758 Apr 18, 2027 U-1029

NICARDIPINE HYDROCHLORIDE - CARDENE IN 0.86% SODIUM CHLORIDE IN PLASTIC CONTAINER

N 019734 003 11547758 Apr 18, 2027 U-1029

NICARDIPINE HYDROCHLORIDE - CARDENE IN 0.83% SODIUM CHLORIDE IN PLASTIC CONTAINER

N 019734 004 11547758 Apr 18, 2027 U-1029

NIMODIPINE - NYMALIZE

N 203340 002 11806338 Apr 16, 2038 DP

NINTEDANIB ESYLATE - OFEV

N 205832 001 10105323 Jun 04, 2029 DP ODE-261 Sep 06, 2026

10105323*PED Dec 04, 2029 PED Mar 06, 2027

10154990 Jan 08, 2026 U-2620

10154990*PED Jul 08, 2026

6762180 Oct 01, 2025 DS DP

6762180*PED Apr 01, 2026

9907756 Jun 07, 2029 DP

9907756*PED Dec 07, 2029

NINTEDANIB ESYLATE - OFEV

N 205832 002 10105323 Jun 04, 2029 DP ODE-261 Sep 06, 2026

10105323*PED Dec 04, 2029 PED Mar 06, 2027

10154990 Jan 08, 2026 U-2620

10154990*PED Jul 08, 2026

6762180 Oct 01, 2025 DS DP

6762180*PED Apr 01, 2026

9907756 Jun 07, 2029 DP

9907756*PED Dec 07, 2029

NIRAPARIB TOSYLATE - ZEJULA

N 208447 001 11673877 Mar 27, 2038 DP U-3646

11673877 Mar 27, 2038 DP U-3647

NIRAPARIB TOSYLATE - ZEJULA

N 214876 001 11091459 Mar 27, 2038 DP

11673877 Mar 27, 2038 DP U-3646

11673877 Mar 27, 2038 DP U-3647

11730725 Jan 04, 2039 DP

8071579 Aug 12, 2027 U-2655

8071623 Mar 27, 2031 DS DP

8143241 Aug 12, 2027 U-2655

8436185 Apr 24, 2029 DS

8859562 Aug 04, 2031 U-2655

NIRAPARIB TOSYLATE - ZEJULA

N 214876 002 11091459 Mar 27, 2038 DP

11673877 Mar 27, 2038 DP U-3646

11673877 Mar 27, 2038 DP U-3647

11730725 Jan 04, 2039 DP

8071579 Aug 12, 2027 U-2655
A - 58

PATENT AND EXCLUSIVITY DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - December 2023

APPL/PROD PATENT PATENT EXCLUSIVITY

NO PATENT NO EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION

DATE CODES REQUESTED CODE(S) DATE

NIRAPARIB TOSYLATE - ZEJULA

N 214876 002 8071623

8143241

8436185

8859562

Mar 27, 2031

Aug 12, 2027

Apr 24, 2029

Aug 04, 2031

DS DP

U-2655

DS

U-2655

NIRAPARIB TOSYLATE - ZEJULA

N 214876 003 11091459

11673877

11673877

11730725

8071579

8071623

8143241

8436185

8859562

Mar 27, 2038

Mar 27, 2038

Mar 27, 2038

Jan 04, 2039

Aug 12, 2027

Mar 27, 2031

Aug 12, 2027

Apr 24, 2029

Aug 04, 2031

DP

DP U-3646

DP U-3647

DP

U-2655

DS DP

U-2655

DS

U-2655

NIRMATRELVIR; RITONAVIR - PAXLOVID (COPACKAGED)

N 217188 001 11351149 Aug 05, 2041

11541034 Oct 31, 2041

DS DP U-3629

U-3629

NCE May 25, 2028

NIRMATRELVIR; RITONAVIR - PAXLOVID (COPACKAGED)

N 217188 002 NCE May 25, 2028

NIROGACESTAT HYDROBROMIDE - OGSIVEO

N 217677 001 10590087 Aug 09, 2039

10710966 Aug 09, 2039

10941118 Aug 09, 2039

11504354 Jul 08, 2042

11612588 Jul 08, 2042

11807611 Sep 08, 2042

11820748 Aug 09, 2039

>A> 11844780 Sep 08, 2042

>A> 11845732 Aug 09, 2039

7342118 Aug 18, 2025

7795447 Aug 18, 2025

7951958 Mar 11, 2025

DS

DS U-3754

DS U-3754

DP

DP U-3754

DP U-3754

DP

DP U-3754

DS U-3754

DS

DS

DS

NITRIC OXIDE - GENOSYL

N 202860 001 11511252

11554241

11672938

Sep 21, 2029

Aug 18, 2025

Jul 22, 2040

DP

U-3037

U-3037

NOREPINEPHRINE BITARTRATE - NOREPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDE

N 214628 001 11602508 Jan 30, 2038 DP

NOREPINEPHRINE BITARTRATE - NOREPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDE

N 214628 002 11602508 Jan 30, 2038 DP

NOREPINEPHRINE BITARTRATE - NOREPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDE

N 214628 003 11602508 Jan 30, 2038 DP

NORGESTREL - OPILL

N 017031 001 RTO Jul 13, 2026

ODEVIXIBAT - BYLVAY

N 215498 001 10011633

10011633

10011633

10011633

10093697

10093697

10093697

10093697

10487111

10487111

Nov 08, 2031

Nov 08, 2031

Nov 08, 2031

Nov 08, 2031

Nov 08, 2031

Nov 08, 2031

Nov 08, 2031

Nov 08, 2031

Nov 08, 2031

Nov 08, 2031

U-3186

U-3187

U-3648

U-3649

U-3186

U-3187

U-3648

U-3649

U-3186

U-3187

I-918

ODE-436

Jun 13, 2026

Jun 13, 2030
A - 59

PATENT AND EXCLUSIVITY DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - December 2023

APPL/PROD PATENT PATENT EXCLUSIVITY

NO PATENT NO EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION

DATE CODES REQUESTED CODE(S) DATE

ODEVIXIBAT - BYLVAY

N 215498 001 10487111

10487111

10981952

10981952

10981952

10981952

11365182

11365182

11365182

11365182

11583539

11732006

11732006

11732006

11732006

11801226

11802115

9694018

9694018

9694018

9694018

ODEVIXIBAT - BYLVAY

N 215498 002 10011633

10011633

10011633

10011633

10093697

10093697

10093697

10093697

10487111

10487111

10487111

10487111

10981952

10981952

10981952

10981952

11365182

11365182

11365182

11365182

11583539

11732006

11732006

11732006

11732006

11801226

11802115

9694018

9694018

9694018

9694018

ODEVIXIBAT - BYLVAY

N 215498 003 10011633

10011633

10011633

10011633

10093697

10093697

10093697

10093697

10487111

10487111

10487111

10487111

Nov 08, 2031

Nov 08, 2031

Nov 08, 2031

Nov 08, 2031

Nov 08, 2031

Nov 08, 2031

Jun 20, 2039

Jun 20, 2039

Jun 20, 2039

Jun 20, 2039

Nov 12, 2041

Nov 08, 2031

Nov 08, 2031

Nov 08, 2031

Nov 08, 2031

Jun 20, 2039

Jun 20, 2039

Nov 08, 2031

Nov 08, 2031

Nov 08, 2031

Nov 08, 2031

Nov 08, 2031

Nov 08, 2031

Nov 08, 2031

Nov 08, 2031

Nov 08, 2031

Nov 08, 2031

Nov 08, 2031

Nov 08, 2031

Nov 08, 2031

Nov 08, 2031

Nov 08, 2031

Nov 08, 2031

Nov 08, 2031

Nov 08, 2031

Nov 08, 2031

Nov 08, 2031

Jun 20, 2039

Jun 20, 2039

Jun 20, 2039

Jun 20, 2039

Nov 12, 2041

Nov 08, 2031

Nov 08, 2031

Nov 08, 2031

Nov 08, 2031

Jun 20, 2039

Jun 20, 2039

Nov 08, 2031

Nov 08, 2031

Nov 08, 2031

Nov 08, 2031

Nov 08, 2031

Nov 08, 2031

Nov 08, 2031

Nov 08, 2031

Nov 08, 2031

Nov 08, 2031

Nov 08, 2031

Nov 08, 2031

Nov 08, 2031

Nov 08, 2031

Nov 08, 2031

Nov 08, 2031

U-3648

U-3649

U-3186

U-3187

U-3648

U-3649

U-3186

U-3187

U-3648

U-3649

U-3186

U-3186

U-3187

U-3648

U-3649

DP

DP

U-3186

U-3187

U-3648

U-3649

U-3186

U-3187

U-3648

U-3649

U-3186

U-3187

U-3648

U-3649

U-3186

U-3187

U-3648

U-3649

U-3186

U-3187

U-3648

U-3649

U-3186

U-3187

U-3648

U-3649

U-3186

U-3186

U-3187

U-3648

U-3649

DP

DP

U-3186

U-3187

U-3648

U-3649

U-3186

U-3187

U-3648

U-3649

U-3186

U-3187

U-3648

U-3649

U-3186

U-3187

U-3648

U-3649

I-918 Jun 13, 2026

ODE-436 Jun 13, 2030

I-918 Jun 13, 2026

ODE-436 Jun 13, 2030
A - 60

PATENT AND EXCLUSIVITY DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - December 2023

APPL/PROD PATENT PATENT EXCLUSIVITY

NO PATENT NO EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION

DATE CODES REQUESTED CODE(S) DATE

ODEVIXIBAT - BYLVAY

N 215498 003 10981952 Nov 08, 2031

10981952 Nov 08, 2031

10981952 Nov 08, 2031

10981952 Nov 08, 2031

11365182 Jun 20, 2039

11365182 Jun 20, 2039

11365182 Jun 20, 2039

11365182 Jun 20, 2039

11583539 Nov 12, 2041

11732006 Nov 08, 2031

11732006 Nov 08, 2031

11732006 Nov 08, 2031

11732006 Nov 08, 2031

11801226 Jun 20, 2039

11802115 Jun 20, 2039

9694018 Nov 08, 2031

9694018 Nov 08, 2031

9694018 Nov 08, 2031

9694018 Nov 08, 2031

ODEVIXIBAT - BYLVAY

N 215498 004 10011633 Nov 08, 2031

10011633 Nov 08, 2031

10011633 Nov 08, 2031

10011633 Nov 08, 2031

10093697 Nov 08, 2031

10093697 Nov 08, 2031

10093697 Nov 08, 2031

10093697 Nov 08, 2031

10487111 Nov 08, 2031

10487111 Nov 08, 2031

10487111 Nov 08, 2031

10487111 Nov 08, 2031

10981952 Nov 08, 2031

10981952 Nov 08, 2031

10981952 Nov 08, 2031

10981952 Nov 08, 2031

11365182 Jun 20, 2039

11365182 Jun 20, 2039

11365182 Jun 20, 2039

11365182 Jun 20, 2039

11583539 Nov 12, 2041

11732006 Nov 08, 2031

11732006 Nov 08, 2031

11732006 Nov 08, 2031

11732006 Nov 08, 2031

11801226 Jun 20, 2039

11802115 Jun 20, 2039

9694018 Nov 08, 2031

9694018 Nov 08, 2031

9694018 Nov 08, 2031

9694018 Nov 08, 2031

OLANZAPINE; SAMIDORPHAN L-MALATE - LYBALVI

N 213378 001 11707466 Nov 12, 2041

11793805 Aug 23, 2031

OLANZAPINE; SAMIDORPHAN L-MALATE - LYBALVI

N 213378 002 11707466 Nov 12, 2041

11793805 Aug 23, 2031

OLANZAPINE; SAMIDORPHAN L-MALATE - LYBALVI

N 213378 003 11707466 Nov 12, 2041

11793805 Aug 23, 2031

U-3186

U-3187

U-3648

U-3649

U-3186

U-3187

U-3648

U-3649

U-3186

U-3186

U-3187

U-3648

U-3649

DP

DP

U-3186

U-3187

U-3648

U-3649

U-3186 I-918 Jun 13, 2026

U-3187 ODE-436 Jun 13, 2030

U-3648

U-3649

U-3186

U-3187

U-3648

U-3649

U-3186

U-3187

U-3648

U-3649

U-3186

U-3187

U-3648

U-3649

U-3186

U-3187

U-3648

U-3649

U-3186

U-3186

U-3187

U-3648

U-3649

DP

DP

U-3186

U-3187

U-3648

U-3649

DP

U-3734

DP

U-3734

DP

U-3734
A - 61

PATENT AND EXCLUSIVITY DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - December 2023

APPL/PROD PATENT PATENT EXCLUSIVITY

NO PATENT NO EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION

DATE CODES REQUESTED CODE(S) DATE

OLANZAPINE; SAMIDORPHAN L-MALATE - LYBALVI

N 213378 004 11707466 Nov 12, 2041 DP

11793805 Aug 23, 2031 U-3734

OLAPARIB - LYNPARZA

N 208558 001 11633396 Oct 07, 2029 DP I-914 May 31, 2026

8071579 Aug 12, 2027 U-2480

8071579 Aug 12, 2027 U-2482

8071579 Aug 12, 2027 U-2483

8071579 Aug 12, 2027 U-2716

8071579 Aug 12, 2027 U-2819

8071579 Aug 12, 2027 U-2820

8071579 Aug 12, 2027 U-2821

8071579 Aug 12, 2027 U-2822

8071579 Aug 12, 2027 U-2823

8071579 Aug 12, 2027 U-2824

8071579 Aug 12, 2027 U-2832

8071579 Aug 12, 2027 U-2833

8071579 Aug 12, 2027 U-3333

8071579 Aug 12, 2027 U-3631

8071579 Aug 12, 2027 U-3695

8143241 Aug 12, 2027 U-2480

8143241 Aug 12, 2027 U-2482

8143241 Aug 12, 2027 U-2483

8143241 Aug 12, 2027 U-2716

8143241 Aug 12, 2027 U-2819

8143241 Aug 12, 2027 U-2820

8143241 Aug 12, 2027 U-2821

8143241 Aug 12, 2027 U-2822

8143241 Aug 12, 2027 U-2823

8143241 Aug 12, 2027 U-2824

8143241 Aug 12, 2027 U-2832

8143241 Aug 12, 2027 U-2833

8143241 Aug 12, 2027 U-3333

8143241 Aug 12, 2027 U-3631

8143241 Aug 12, 2027 U-3695

8859562 Aug 04, 2031 U-2101

8859562 Aug 04, 2031 U-2103

8859562 Aug 04, 2031 U-2480

8859562 Aug 04, 2031 U-2482

8859562 Aug 04, 2031 U-2483

8859562 Aug 04, 2031 U-2716

8859562 Aug 04, 2031 U-2819

8859562 Aug 04, 2031 U-2820

8859562 Aug 04, 2031 U-2821

8859562 Aug 04, 2031 U-2822

8859562 Aug 04, 2031 U-2823

8859562 Aug 04, 2031 U-2824

8859562 Aug 04, 2031 U-2832

8859562 Aug 04, 2031 U-2833

8859562 Aug 04, 2031 U-3333

8859562 Aug 04, 2031 U-3631

8859562 Aug 04, 2031 U-3695

8912187 Mar 12, 2024 U-2480

8912187 Mar 12, 2024 U-2482

8912187 Mar 12, 2024 U-2483

8912187 Mar 12, 2024 U-2819

8912187 Mar 12, 2024 U-2820

8912187 Mar 12, 2024 U-2821

8912187 Mar 12, 2024 U-2822

8912187 Mar 12, 2024 U-2823

8912187 Mar 12, 2024 U-2824

8912187 Mar 12, 2024 U-3333

8912187 Mar 12, 2024 U-3695

9169235 Mar 12, 2024 U-2832

9169235 Mar 12, 2024 U-2833

9169235 Mar 12, 2024 U-3631
A - 62

PATENT AND EXCLUSIVITY DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - December 2023

APPL/PROD PATENT PATENT EXCLUSIVITY

NO PATENT NO EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION

DATE CODES REQUESTED CODE(S) DATE

OLAPARIB - LYNPARZA

N 208558 002 11633396

8071579

8071579

8071579

8071579

8071579

8071579

8071579

8071579

8071579

8071579

8071579

8071579

8071579

8071579

8071579

8143241

8143241

8143241

8143241

8143241

8143241

8143241

8143241

8143241

8143241

8143241

8143241

8143241

8143241

8143241

8859562

8859562

8859562

8859562

8859562

8859562

8859562

8859562

8859562

8859562

8859562

8859562

8859562

8859562

8859562

8859562

8859562

8912187

8912187

8912187

8912187

8912187

8912187

8912187

8912187

8912187

8912187

8912187

9169235

9169235

9169235

Oct 07, 2029 DP I-914 May 31, 2026

Aug 12, 2027 U-2480

Aug 12, 2027 U-2482

Aug 12, 2027 U-2483

Aug 12, 2027 U-2716

Aug 12, 2027 U-2819

Aug 12, 2027 U-2820

Aug 12, 2027 U-2821

Aug 12, 2027 U-2822

Aug 12, 2027 U-2823

Aug 12, 2027 U-2824

Aug 12, 2027 U-2832

Aug 12, 2027 U-2833

Aug 12, 2027 U-3333

Aug 12, 2027 U-3631

Aug 12, 2027 U-3695

Aug 12, 2027 U-2480

Aug 12, 2027 U-2482

Aug 12, 2027 U-2483

Aug 12, 2027 U-2716

Aug 12, 2027 U-2819

Aug 12, 2027 U-2820

Aug 12, 2027 U-2821

Aug 12, 2027 U-2822

Aug 12, 2027 U-2823

Aug 12, 2027 U-2824

Aug 12, 2027 U-2832

Aug 12, 2027 U-2833

Aug 12, 2027 U-3333

Aug 12, 2027 U-3631

Aug 12, 2027 U-3695

Aug 04, 2031 U-2101

Aug 04, 2031 U-2103

Aug 04, 2031 U-2480

Aug 04, 2031 U-2482

Aug 04, 2031 U-2483

Aug 04, 2031 U-2716

Aug 04, 2031 U-2819

Aug 04, 2031 U-2820

Aug 04, 2031 U-2821

Aug 04, 2031 U-2822

Aug 04, 2031 U-2823

Aug 04, 2031 U-2824

Aug 04, 2031 U-2832

Aug 04, 2031 U-2833

Aug 04, 2031 U-3333

Aug 04, 2031 U-3631

Aug 04, 2031 U-3695

Mar 12, 2024 U-2480

Mar 12, 2024 U-2482

Mar 12, 2024 U-2483

Mar 12, 2024 U-2819

Mar 12, 2024 U-2820

Mar 12, 2024 U-2821

Mar 12, 2024 U-2822

Mar 12, 2024 U-2823

Mar 12, 2024 U-2824

Mar 12, 2024 U-3333

Mar 12, 2024 U-3695

Mar 12, 2024 U-2832

Mar 12, 2024 U-2833

Mar 12, 2024 U-3631

OLUTASIDENIB - REZLIDHIA

N 215814 001 11723905 Nov 12, 2039 DP NCE Dec 01, 2027

11738018 Jul 17, 2039 U-3684 ODE-413 Dec 01, 2029
A - 63

PATENT AND EXCLUSIVITY DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - December 2023

APPL/PROD

NO PATENT NO

PATENT

EXPIRATION

DATE

PATENT

CODES

PATENT

DELIST

REQUESTED

EXCLUSIVITY

CODE(S)

EXCLUSIVITY

EXPIRATION

DATE

OMADACYCLINE TOSYLATE - NUZYRA

N 209816 001 7553828 Jun 02, 2024 DS

OMADACYCLINE TOSYLATE - NUZYRA

N 209817 001 7553828 Jun 02, 2024 DS

OMAVELOXOLONE - SKYCLARYS

N 216718 001 11091430

8124799

8440854

8993640

9670147

9701709

Apr 20, 2029

Dec 03, 2029

Apr 20, 2029

Apr 24, 2033

Apr 20, 2029

Apr 24, 2033

U-3552

DS

DP

DS DP

DS

DS DP

NCE

ODE-427

Feb 28, 2028

Feb 28, 2030

OMEPRAZOLE; SODIUM BICARBONATE - KONVOMEP

N 213593 001 11633478 Jul 16, 2039

11771686 Mar 01, 2040

DP

U-623

OMIDENEPAG ISOPROPYL - OMLONTI

N 215092 001 11666563

11793798

Jul 16, 2039

Jan 08, 2035

U-3454

DP U-3454

OXYMETAZOLINE HYDROCHLORIDE - UPNEEQ

N 212520 001 11701343 Dec 16, 2039 U-2849

OZANIMOD HYDROCHLORIDE - ZEPOSIA

N 209899 001 11680050

11680050

Sep 30, 2038

Sep 30, 2038

DS DP U-2774

DS DP U-3740

OZANIMOD HYDROCHLORIDE - ZEPOSIA

N 209899 002 11680050

11680050

Sep 30, 2038

Sep 30, 2038

DS DP U-2774

DS DP U-3740

OZANIMOD HYDROCHLORIDE - ZEPOSIA

N 209899 003 11680050

11680050

Sep 30, 2038

Sep 30, 2038

DS DP U-2774

DS DP U-3740

PACRITINIB CITRATE - VONJO

N 208712 001 ODE-397 Feb 28, 2029

PAFOLACIANINE SODIUM - CYTALUX

N 214907 001 I-905

ODE-390

Dec 16, 2025

Nov 29, 2028

PALBOCICLIB - IBRANCE

N 212436 001 11065250 Aug 19, 2036 DP

PALBOCICLIB - IBRANCE

N 212436 002 11065250 Aug 19, 2036 DP

PALBOCICLIB - IBRANCE

N 212436 003 11065250 Aug 19, 2036 DP

PALIPERIDONE PALMITATE - INVEGA HAFYERA

N 207946 005 11666697 Nov 24, 2041 U-3626

PALIPERIDONE PALMITATE - INVEGA HAFYERA

N 207946 006 11666697 Nov 24, 2041 U-3626

PALOVAROTENE - SOHONOS

N 215559 001 10292954

10864194

11622959

Aug 31, 2031

Jun 08, 2037

Jun 08, 2037

U-3676

U-3676

U-3676

NCE

ODE-439

Aug 16, 2028

Aug 16, 2030
A - 64

PATENT AND EXCLUSIVITY DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - December 2023

APPL/PROD PATENT PATENT EXCLUSIVITY

NO PATENT NO EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION

DATE CODES REQUESTED CODE(S) DATE

PALOVAROTENE - SOHONOS

N 215559 001 9314439 Aug 31, 2031 U-3676

9789074 Aug 31, 2031 U-3676

PALOVAROTENE - SOHONOS

N 215559 002 10292954 Aug 31, 2031 U-3676 NCE Aug 16, 2028

10864194 Jun 08, 2037 U-3676 ODE-439 Aug 16, 2030

11622959 Jun 08, 2037 U-3676

9314439 Aug 31, 2031 U-3676

9789074 Aug 31, 2031 U-3676

PALOVAROTENE - SOHONOS

N 215559 003 10292954 Aug 31, 2031 U-3676 NCE Aug 16, 2028

10864194 Jun 08, 2037 U-3676 ODE-439 Aug 16, 2030

11622959 Jun 08, 2037 U-3676

9314439 Aug 31, 2031 U-3676

9789074 Aug 31, 2031 U-3676

PALOVAROTENE - SOHONOS

N 215559 004 10292954 Aug 31, 2031 U-3676 NCE Aug 16, 2028

10864194 Jun 08, 2037 U-3676 ODE-439 Aug 16, 2030

11622959 Jun 08, 2037 U-3676

9314439 Aug 31, 2031 U-3676

9789074 Aug 31, 2031 U-3676

PALOVAROTENE - SOHONOS

N 215559 005 10292954 Aug 31, 2031 U-3676 NCE Aug 16, 2028

10864194 Jun 08, 2037 U-3676 ODE-439 Aug 16, 2030

11622959 Jun 08, 2037 U-3676

9314439 Aug 31, 2031 U-3676

9789074 Aug 31, 2031 U-3676

PATIROMER SORBITEX CALCIUM - VELTASSA

N 205739 001 NPP Oct 02, 2026

PATIROMER SORBITEX CALCIUM - VELTASSA

N 205739 002 NPP Oct 02, 2026

PATIROMER SORBITEX CALCIUM - VELTASSA

N 205739 003 NPP Oct 02, 2026

PATIROMER SORBITEX CALCIUM - VELTASSA

N 205739 004 10485821 Mar 30, 2024 U-1766 NS Oct 02, 2026

11123363 Oct 08, 2033 U-1766

7556799 Feb 27, 2025 U-1766

8147873 Jun 20, 2028 DP

8216560 Mar 14, 2027 U-1766

8282913 May 29, 2027 DP

8287847 Mar 30, 2024 U-1766

8337824 May 29, 2030 DS U-1766

8475780 Mar 30, 2024 U-1766

8778324 Mar 30, 2024 U-1766

8889115 Mar 30, 2024 U-1766

9492476 Oct 08, 2033 U-1766

9925212 Oct 08, 2033 U-1766

PEGCETACOPLAN - EMPAVELI

N 215014 001 11661441 Jan 13, 2033 DS U-3124 M-288 Feb 08, 2026

PEGCETACOPLAN - SYFOVRE

N 217171 001 10035822 Nov 15, 2033 DS NCE May 14, 2026

10125171 Aug 02, 2033 DS NP Feb 22, 2026

10875893 Nov 15, 2033 DS U-3540

11292815 Nov 15, 2033 DS DP U-3540

11661441 Jan 13, 2033 DS U-3540

7888323 Dec 04, 2027 DS
A - 65

PATENT AND EXCLUSIVITY DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - December 2023

APPL/PROD PATENT PATENT EXCLUSIVITY

NO PATENT NO EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION

DATE CODES REQUESTED CODE(S) DATE

PEGCETACOPLAN - SYFOVRE

N 217171 001 7989589 Dec 04, 2027 DS

8168584 Apr 07, 2027 U-3540

8168584 Apr 07, 2027 U-3542

9056076 Oct 25, 2026 U-3540

9169307 Nov 18, 2027 DS U-3541

PEMETREXED - PEMFEXY

N 209472 001 11793813 Feb 19, 2036 DP

PEMETREXED DISODIUM - PEMETREXED

N 215179 001 11147817 Mar 26, 2035 DP

PEMETREXED DISODIUM - PEMETREXED

N 215179 002 11147817 Mar 26, 2035 DP

PEMETREXED DISODIUM - PEMETREXED

N 215179 003 11147817 Mar 26, 2035 DP

PEMIGATINIB - PEMAZYRE

N 213736 001 11628162 Aug 30, 2040 U-3568 ODE-404 Aug 26, 2029

11628162 Aug 30, 2040 U-3569

11628162 Aug 30, 2040 U-3570

11628162 Aug 30, 2040 U-3571

PEMIGATINIB - PEMAZYRE

N 213736 002 11628162 Aug 30, 2040 U-3568 ODE-404 Aug 26, 2029

11628162 Aug 30, 2040 U-3569

11628162 Aug 30, 2040 U-3570

11628162 Aug 30, 2040 U-3571

PEMIGATINIB - PEMAZYRE

N 213736 003 11628162 Aug 30, 2040 U-3568 ODE-404 Aug 26, 2029

11628162 Aug 30, 2040 U-3569

11628162 Aug 30, 2040 U-3570

11628162 Aug 30, 2040 U-3571

PENCICLOVIR - PENCICLOVIR

A 216981 001 CGT Feb 28, 2024

PERAMPANEL - FYCOMPA

N 202834 001 6949571 Jun 08, 2024 DS DP U-106

6949571 Jun 08, 2024 DS DP U-2088

6949571 Jun 08, 2024 DS DP U-2089

6949571 Jun 08, 2024 DS DP U-2428

6949571 Jun 08, 2024 DS DP U-2429

PERAMPANEL - FYCOMPA

N 202834 002 6949571 Jun 08, 2024 DS DP U-106

6949571 Jun 08, 2024 DS DP U-2088

6949571 Jun 08, 2024 DS DP U-2089

6949571 Jun 08, 2024 DS DP U-2428

6949571 Jun 08, 2024 DS DP U-2429

PERAMPANEL - FYCOMPA

N 202834 003 6949571 Jun 08, 2024 DS DP U-106

6949571 Jun 08, 2024 DS DP U-2088

6949571 Jun 08, 2024 DS DP U-2089

6949571 Jun 08, 2024 DS DP U-2428

6949571 Jun 08, 2024 DS DP U-2429

PERAMPANEL - FYCOMPA

N 202834 004 6949571

6949571

6949571

Jun 08, 2024

Jun 08, 2024

Jun 08, 2024

DS DP U-106

DS DP U-2088

DS DP U-2089
A - 66

PATENT AND EXCLUSIVITY DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - December 2023

APPL/PROD PATENT PATENT EXCLUSIVITY

NO PATENT NO EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION

DATE CODES REQUESTED CODE(S) DATE

PERAMPANEL - FYCOMPA

N 202834 004 6949571

6949571

Jun 08, 2024

Jun 08, 2024

DS DP U-2428

DS DP U-2429

PERAMPANEL - FYCOMPA

N 202834 005 6949571

6949571

6949571

6949571

6949571

Jun 08, 2024

Jun 08, 2024

Jun 08, 2024

Jun 08, 2024

Jun 08, 2024

DS DP U-106

DS DP U-2088

DS DP U-2089

DS DP U-2428

DS DP U-2429

PERAMPANEL - FYCOMPA

N 202834 006 6949571

6949571

6949571

6949571

6949571

Jun 08, 2024

Jun 08, 2024

Jun 08, 2024

Jun 08, 2024

Jun 08, 2024

DS DP U-106

DS DP U-2088

DS DP U-2089

DS DP U-2428

DS DP U-2429

PERAMPANEL - FYCOMPA

N 208277 001 6949571

6949571

6949571

6949571

6949571

Jun 08, 2024

Jun 08, 2024

Jun 08, 2024

Jun 08, 2024

Jun 08, 2024

DS DP U-106

DS DP U-2088

DS DP U-2089

DS DP U-2428

DS DP U-2429

PERFLUOROHEXYLOCTANE - MIEBO

N 216675 001 10058615

10369117

10449164

10507132

10576154

11357738

Sep 12, 2033

Sep 12, 2033

Sep 12, 2033

Jun 21, 2037

Sep 12, 2033

Sep 29, 2036

U-1900

U-1900

U-1900

U-1900

U-1900

DP

NCE May 18, 2028

PHENOBARBITAL SODIUM - SEZABY

N 215910 001 >A> 11857683 Apr 07, 2042 DP U-3779 ODE-414 Nov 17, 2029

PHENTOLAMINE MESYLATE - ORAVERSE

N 022159 001 7229630

7575757

Jul 31, 2023

Jul 31, 2023

DP

DP

PHENTOLAMINE MESYLATE - RYZUMVI

N 217064 001 NP Sep 25, 2026

PHENYLEPHRINE HYDROCHLORIDE - PHENYLEPHRINE HYDROCHLORIDE

A 216496 001 CGT Jul 17, 2023

PHENYLEPHRINE HYDROCHLORIDE - IMMPHENTIV

N 203826 004 11213480 Sep 26, 2036

11471400 Aug 05, 2036

DP

DP

PHENYLEPHRINE HYDROCHLORIDE - IMMPHENTIV

N 203826 005 11213480 Sep 26, 2036

11471400 Aug 05, 2036

DP

DP

PHENYLEPHRINE HYDROCHLORIDE; TROPICAMIDE - MYDCOMBI

N 215352 001 10839960 Jul 15, 2031

11398306 Jul 15, 2031

U-3685

U-3685

NP May 05, 2026

PILOCARPINE HYDROCHLORIDE - VUITY

N 214028 001 10610518 Apr 24, 2039 U-3252 D-187 Mar 28, 2026

10610518 Apr 24, 2039 U-3561

10610518 Apr 24, 2039 U-3562

11285134 Apr 24, 2039 U-3252

11285134 Apr 24, 2039 U-3561

11285134 Apr 24, 2039 U-3562
A - 67

PATENT AND EXCLUSIVITY DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - December 2023

APPL/PROD PATENT PATENT EXCLUSIVITY

NO PATENT NO EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION

DATE CODES REQUESTED CODE(S) DATE

PILOCARPINE HYDROCHLORIDE - VUITY

N 214028 001 10610518 Apr 24, 2039 U-3252 D-187 Mar 28, 2026

10610518 Apr 24, 2039 U-3561

10610518 Apr 24, 2039 U-3562

11285134 Apr 24, 2039 U-3252

11285134 Apr 24, 2039 U-3561

11285134 Apr 24, 2039 U-3562

PILOCARPINE HYDROCHLORIDE - QLOSI

N 217836 001 10639297 Aug 18, 2037 DP U-3741 NP Oct 17, 2026

11129812 Aug 18, 2037 U-3741

9867810 Aug 18, 2037 DP U-3741

PIRTOBRUTINIB - JAYPIRCA

N 216059 001 10342780 Dec 16, 2036 DS DP NCE Jan 27, 2028

>A> 10464905 Dec 16, 2036 U-3518 ODE-424 Jan 27, 2030

>A> 10464905 Dec 16, 2036 U-3761

>A> 10695323 Dec 16, 2036 DS DP U-3518

>A> 10695323 Dec 16, 2036 DS DP U-3761

>A> 10918622 Dec 16, 2036 U-3518

>A> 10918622 Dec 16, 2036 U-3761

PIRTOBRUTINIB - JAYPIRCA

N 216059 002 10342780 Dec 16, 2036 DS DP NCE Jan 27, 2028

>A> 10464905 Dec 16, 2036 U-3518 ODE-424 Jan 27, 2030

>A> 10464905 Dec 16, 2036 U-3761

>A> 10695323 Dec 16, 2036 DS DP U-3518

>A> 10695323 Dec 16, 2036 DS DP U-3761

>A> 10918622 Dec 16, 2036 U-3518

>A> 10918622 Dec 16, 2036 U-3761

PITAVASTATIN CALCIUM - PITAVASTATIN CALCIUM

A 206015 001 PC Feb 19, 2024

PITAVASTATIN CALCIUM - PITAVASTATIN CALCIUM

A 206015 002 PC Feb 19, 2024

PITAVASTATIN CALCIUM - PITAVASTATIN CALCIUM

A 206015 003 PC Feb 19, 2024

PLECANATIDE - TRULANCE

N 208745 001 >A> 11834521 Jun 05, 2034 DP

PODOFILOX - PODOFILOX

A 211871 001 >A> CGT Jun 10, 2024

POSACONAZOLE - POSACONAZOLE

A 208768 001 PC Dec 26, 2023

POTASSIUM CHLORIDE - POTASSIUM CHLORIDE

A 217704 001 CGT Mar 11, 2024

POTASSIUM PHOSPHATE, DIBASIC; POTASSIUM PHOSPHATE, MONOBASIC - POTASSIUM PHOSPHATES

A 216274 001 CGT Apr 13, 2024

POTASSIUM PHOSPHATE, DIBASIC; POTASSIUM PHOSPHATE, MONOBASIC - POTASSIUM PHOSPHATES

A 216274 002 CGT Apr 10, 2024

POTASSIUM PHOSPHATE, DIBASIC; POTASSIUM PHOSPHATE, MONOBASIC - POTASSIUM PHOSPHATES

A 216274 003 CGT Apr 10, 2024
A - 68

PATENT AND EXCLUSIVITY DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - December 2023

APPL/PROD

NO PATENT NO

PATENT

EXPIRATION

DATE

PATENT

CODES

PATENT

DELIST

REQUESTED

EXCLUSIVITY

CODE(S)

EXCLUSIVITY

EXPIRATION

DATE

PRALSETINIB - GAVRETO

N 213721 001 10030005

10030005

Nov 01, 2036

Nov 01, 2036

DS DP U-2952

DS DP U-3002

PREDNISOLONE - PREDNISOLONE

A 215673 001 CGT Nov 18, 2023

QUIZARTINIB DIHYDROCHLORIDE - VANFLYTA

N 216993 001 7820657 Sep 26, 2028

7968543 Aug 15, 2029

8129374 Mar 16, 2027

8357690 Feb 26, 2031

8557810 Mar 16, 2027

8836218 Mar 23, 2030

8865710 Aug 15, 2029

8883783 Mar 16, 2027

9555040 May 14, 2030

9585892 Mar 16, 2027

9675549 Sep 30, 2033

DS

DP U-3661

U-3661

U-3661

DP

U-3661

DP

DS

U-3661

U-3661

DP

NCE

ODE-437

Jul 20, 2028

Jul 20, 2030

QUIZARTINIB DIHYDROCHLORIDE - VANFLYTA

N 216993 002 7820657 Sep 26, 2028

7968543 Aug 15, 2029

8129374 Mar 16, 2027

8357690 Feb 26, 2031

8557810 Mar 16, 2027

8836218 Mar 23, 2030

8865710 Aug 15, 2029

8883783 Mar 16, 2027

9555040 May 14, 2030

9585892 Mar 16, 2027

9675549 Sep 30, 2033

DS

DP U-3661

U-3661

U-3661

DP

U-3661

DP

DS

U-3661

U-3661

DP

NCE

ODE-437

Jul 20, 2028

Jul 20, 2030

RALTEGRAVIR POTASSIUM - ISENTRESS

N 022145 001 8771733

8852632

Jun 02, 2030

Jan 28, 2028

DS DP U-257

DS DP U-257

RALTEGRAVIR POTASSIUM - ISENTRESS HD

N 022145 002 8771733 Jun 02, 2030 DS DP U-257

RALTEGRAVIR POTASSIUM - ISENTRESS

N 203045 002 8771733 Jun 02, 2030 DS DP U-257

RELUGOLIX - ORGOVYX

N 214621 001 11583526

11795178

>A> 7300935

>A> 8058280

Sep 29, 2037

Sep 27, 2033

Jan 28, 2025

Jan 28, 2025

U-3020

DS DP

DS

DS DP

REMDESIVIR - VEKLURY

N 214787 001 M-301 Jul 13, 2026

REMDESIVIR - VEKLURY

N 214787 002 M-301 Jul 13, 2026

REPOTRECTINIB - AUGTYRO

N 218213 001 >A> 10294242

>A> 11452725

>A> 9714258

Jul 05, 2036

Jul 24, 2036

Jan 23, 2035

DS

U-3755

DS DP

REVEFENACIN - YUPELRI

N 210598 001 11691948

>A> 11858898

Jul 14, 2030

Jul 14, 2030

DP

DS DP U-2440
A - 69

PATENT AND EXCLUSIVITY DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - December 2023

APPL/PROD PATENT PATENT EXCLUSIVITY

NO PATENT NO EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION

DATE CODES REQUESTED CODE(S) DATE

REZAFUNGIN ACETATE - REZZAYO

N 217417 001 10702573 Mar 14, 2033 DS DP U-3566 NCE Mar 22, 2028

11197909 Jul 14, 2038 DS DP U-3566 ODE-426 Mar 22, 2030

11654196 Mar 02, 2032 DS DP U-3566 GAIN Mar 22, 2033

11712459 Mar 15, 2037 DP U-3566 GAIN Mar 22, 2035

>A> 11819533 Jul 11, 2038 DS DP U-3566

8722619 Mar 02, 2032 DS DP U-3566

9526835 Mar 14, 2033 DS DP U-3566

RIFAXIMIN - XIFAXAN

N 021361 002 11564912 Feb 26, 2029 U-3511

11564912 Feb 26, 2029 U-3512

11779571 Feb 26, 2029 U-3706

RIMEGEPANT SULFATE - NURTEC ODT

N 212728 001 8314117 Mar 09, 2030 DS DP U-2718

8314117 Mar 09, 2030 DS DP U-3142

RIPRETINIB - QINLOCK

N 213973 001 11529336 Aug 12, 2040 U-3382

11534432 Aug 12, 2040 U-3442

11576903 Dec 30, 2040 DP

11576904 Aug 12, 2040 U-3537

11612591 Dec 30, 2040 DP

11779572 Oct 06, 2042 U-3714

11793795 Dec 30, 2040 DP

11801237 Dec 30, 2040 DP U-3219

11813251 Aug 12, 2040 U-3750

>A> 11844788 Dec 30, 2040 DP

>A> 11850240 Dec 30, 2040 DP

>A> 11850241 Dec 30, 2040 DP

8461179 May 15, 2034 DS DP

RISDIPLAM - EVRYSDI

N 213535 001 11534444 Oct 04, 2038 U-1943 M-270 Oct 03, 2026

>A> 11827646 Jan 25, 2036 U-1943 ODE-400 May 27, 2029

RISPERIDONE - PERSERIS KIT

N 210655 001 11712475 Feb 13, 2028 U-3135

RISPERIDONE - PERSERIS KIT

N 210655 002 11712475 Feb 13, 2028 U-3135

RISPERIDONE - RYKINDO

N 212849 001 10098882 Apr 10, 2032 DP U-3513

10406161 Apr 10, 2032 DP U-3513

11110094 Apr 10, 2032 DP

9446135 Apr 10, 2032 DP U-3513

9532991 Apr 10, 2032 DP U-3513

RISPERIDONE - RYKINDO

N 212849 002 10098882 Apr 10, 2032 DP U-3513

10406161 Apr 10, 2032 DP U-3513

11110094 Apr 10, 2032 DP

9446135 Apr 10, 2032 DP U-3513

9532991 Apr 10, 2032 DP U-3513

RISPERIDONE - RYKINDO

N 212849 003 10098882 Apr 10, 2032 DP U-3513

10406161 Apr 10, 2032 DP U-3513

11110094 Apr 10, 2032 DP

9446135 Apr 10, 2032 DP U-3513

9532991 Apr 10, 2032 DP U-3513
A - 70

PATENT AND EXCLUSIVITY DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - December 2023

APPL/PROD PATENT PATENT EXCLUSIVITY

NO PATENT NO EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION

DATE CODES REQUESTED CODE(S) DATE

RISPERIDONE - RYKINDO

N 212849 004 10098882

10406161

11110094

9446135

9532991

Apr 10, 2032

Apr 10, 2032

Apr 10, 2032

Apr 10, 2032

Apr 10, 2032

DP U-3513

DP U-3513

DP

DP U-3513

DP U-3513

RISPERIDONE - UZEDY

N 213586 001 10736965

8221778

8741327

8802127

9023897

9439905

9717799

9895447

9925268

Jan 12, 2025

Nov 12, 2027

Nov 12, 2027

Jan 12, 2025

Apr 05, 2033

Jan 12, 2025

Jan 12, 2025

Jan 12, 2025

Jan 12, 2025

DP

DP U-543

DP U-543

DP

DP

DP U-543

DP

DP

DP

NP Apr 28, 2026

RISPERIDONE - UZEDY

N 213586 002 10736965

8221778

8741327

8802127

9023897

9439905

9717799

9895447

9925268

Jan 12, 2025

Nov 12, 2027

Nov 12, 2027

Jan 12, 2025

Apr 05, 2033

Jan 12, 2025

Jan 12, 2025

Jan 12, 2025

Jan 12, 2025

DP

DP U-543

DP U-543

DP

DP

DP U-543

DP

DP

DP

NP Apr 28, 2026

RISPERIDONE - UZEDY

N 213586 003 10736965

8221778

8741327

8802127

9023897

9439905

9717799

9895447

9925268

Jan 12, 2025

Nov 12, 2027

Nov 12, 2027

Jan 12, 2025

Apr 05, 2033

Jan 12, 2025

Jan 12, 2025

Jan 12, 2025

Jan 12, 2025

DP

DP U-543

DP U-543

DP

DP

DP U-543

DP

DP

DP

NP Apr 28, 2026

RISPERIDONE - UZEDY

N 213586 004 10736965

8221778

8741327

8802127

9023897

9439905

9717799

9895447

9925268

Jan 12, 2025

Nov 12, 2027

Nov 12, 2027

Jan 12, 2025

Apr 05, 2033

Jan 12, 2025

Jan 12, 2025

Jan 12, 2025

Jan 12, 2025

DP

DP U-543

DP U-543

DP

DP

DP U-543

DP

DP

DP

NP Apr 28, 2026

RISPERIDONE - UZEDY

N 213586 005 10736965

8221778

8741327

8802127

9023897

9439905

9717799

9895447

9925268

Jan 12, 2025

Nov 12, 2027

Nov 12, 2027

Jan 12, 2025

Apr 05, 2033

Jan 12, 2025

Jan 12, 2025

Jan 12, 2025

Jan 12, 2025

DP

DP U-543

DP U-543

DP

DP

DP U-543

DP

DP

DP

NP Apr 28, 2026

RISPERIDONE - UZEDY

N 213586 006 10736965

8221778

8741327

8802127

Jan 12, 2025

Nov 12, 2027

Nov 12, 2027

Jan 12, 2025

DP

DP U-543

DP U-543

DP

NP Apr 28, 2026
A - 71

PATENT AND EXCLUSIVITY DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - December 2023

APPL/PROD

NO PATENT NO

PATENT

EXPIRATION

DATE

PATENT

CODES

PATENT

DELIST

REQUESTED

EXCLUSIVITY

CODE(S)

EXCLUSIVITY

EXPIRATION

DATE

RISPERIDONE - UZEDY

N 213586 006 9023897

9439905

9717799

9895447

9925268

Apr 05, 2033

Jan 12, 2025

Jan 12, 2025

Jan 12, 2025

Jan 12, 2025

DP

DP U-543

DP

DP

DP

RISPERIDONE - UZEDY

N 213586 007 10736965

8221778

8741327

8802127

9023897

9439905

9717799

9895447

9925268

Jan 12, 2025

Nov 12, 2027

Nov 12, 2027

Jan 12, 2025

Apr 05, 2033

Jan 12, 2025

Jan 12, 2025

Jan 12, 2025

Jan 12, 2025

DP

DP U-543

DP U-543

DP

DP

DP U-543

DP

DP

DP

NP Apr 28, 2026

RITLECITINIB TOSYLATE - LITFULO

N 215830 001 9617258 Dec 03, 2034 DS DP NCE Jun 23, 2028

RIZATRIPTAN BENZOATE - RIZAFILM

N 205394 001 9301948 Jul 30, 2034 DS DP

ROFLUMILAST - ZORYVE

N 215985 001 11129818

11129818

11793796

11819496

9907788

9907788

Aug 25, 2037

Aug 25, 2037

Jun 07, 2037

Jun 07, 2037

Jun 07, 2037

Jun 07, 2037

U-3408

U-3712

DP

U-3748

U-3408

U-3712

NPP Oct 05, 2026

ROFLUMILAST - ZORYVE

N 217242 001 >A> 10940142

>A> 11129818

>A> 11707454

>A> 11793796

>A> 11819496

>A> 9884050

>A> 9907788

Jun 07, 2037

Aug 25, 2037

Dec 03, 2041

Jun 07, 2037

Jun 07, 2037

Jun 07, 2037

Jun 07, 2037

DP

U-3773

U-3773

DP

U-3773

DP

U-3773

RUXOLITINIB PHOSPHATE - JAKAFI

N 202192 001 M-285

PED

Dec 19, 2025

Jun 19, 2026

RUXOLITINIB PHOSPHATE - JAKAFI

N 202192 002 M-285

PED

Dec 19, 2025

Jun 19, 2026

RUXOLITINIB PHOSPHATE - JAKAFI

N 202192 003 M-285

PED

Dec 19, 2025

Jun 19, 2026

RUXOLITINIB PHOSPHATE - JAKAFI

N 202192 004 M-285

PED

Dec 19, 2025

Jun 19, 2026

RUXOLITINIB PHOSPHATE - JAKAFI

N 202192 005 M-285

PED

Dec 19, 2025

Jun 19, 2026

RUXOLITINIB PHOSPHATE - OPZELURA

N 215309 001 11510923

11571425

11590136

Sep 04, 2040

May 20, 2031

May 20, 2031

U-3505

DP

U-3229
A - 72

PATENT AND EXCLUSIVITY DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - December 2023

APPL/PROD PATENT PATENT EXCLUSIVITY

NO PATENT NO EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION

DATE CODES REQUESTED CODE(S) DATE

RUXOLITINIB PHOSPHATE - OPZELURA

N 215309 001 11590136

11590137

11590138

11602536

May 20, 2031

Sep 04, 2040

Jun 10, 2040

May 05, 2041

U-3404

U-3505

U-3551

U-3550

SAXAGLIPTIN HYDROCHLORIDE - SAXAGLIPTIN

A 205941 001 PC Jan 27, 2024

SAXAGLIPTIN HYDROCHLORIDE - SAXAGLIPTIN

A 205941 002 PC Jan 27, 2024

SAXAGLIPTIN HYDROCHLORIDE - SAXAGLIPTIN

A 205972 001 PC Jan 27, 2024

SAXAGLIPTIN HYDROCHLORIDE - SAXAGLIPTIN

A 205972 002 PC Jan 27, 2024

SECNIDAZOLE - SOLOSEC

N 209363 001 11602522

11602522

11684607

11684607

11684607

11684607

Sep 04, 2035

Sep 04, 2035

Sep 16, 2035

Sep 16, 2035

Sep 16, 2035

Sep 16, 2035

DP U-3169

DP U-3302

DP U-2583

DP U-3169

DP U-3270

DP U-3302

SELINEXOR - XPOVIO

N 212306 001 11746102

11746102

11746102

11753401

11753401

11753401

11787771

11787771

11787771

11807629

8999996

Aug 14, 2035

Aug 14, 2035

Aug 14, 2035

Aug 14, 2035

Aug 14, 2035

Aug 14, 2035

Jul 26, 2032

Jul 26, 2032

Jul 26, 2032

Aug 14, 2035

Jul 03, 2033

U-2584

U-2855

U-3018

DP U-2584

DP U-2855

DP U-3018

U-2584

U-2855

U-3018

DS DP

DS DP

SELINEXOR - XPOVIO

N 212306 002 11746102

11746102

11746102

11753401

11753401

11753401

11787771

11787771

11787771

11807629

8999996

Aug 14, 2035

Aug 14, 2035

Aug 14, 2035

Aug 14, 2035

Aug 14, 2035

Aug 14, 2035

Jul 26, 2032

Jul 26, 2032

Jul 26, 2032

Aug 14, 2035

Jul 03, 2033

U-2584

U-2855

U-3018

DP U-2584

DP U-2855

DP U-3018

U-2584

U-2855

U-3018

DS DP

DS DP

SELINEXOR - XPOVIO

N 212306 003 11746102

11746102

11746102

11753401

11753401

11753401

11787771

11787771

11787771

11807629

8999996

Aug 14, 2035

Aug 14, 2035

Aug 14, 2035

Aug 14, 2035

Aug 14, 2035

Aug 14, 2035

Jul 26, 2032

Jul 26, 2032

Jul 26, 2032

Aug 14, 2035

Jul 03, 2033

U-2584

U-2855

U-3018

DP U-2584

DP U-2855

DP U-3018

U-2584

U-2855

U-3018

DS DP

DS DP
A - 73

PATENT AND EXCLUSIVITY DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - December 2023

APPL/PROD PATENT PATENT EXCLUSIVITY

NO PATENT NO EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION

DATE CODES REQUESTED CODE(S) DATE

SELINEXOR - XPOVIO

N 212306 004 11746102

11746102

11746102

11753401

11753401

11753401

11787771

11787771

11787771

11807629

8999996

Aug 14, 2035

Aug 14, 2035

Aug 14, 2035

Aug 14, 2035

Aug 14, 2035

Aug 14, 2035

Jul 26, 2032

Jul 26, 2032

Jul 26, 2032

Aug 14, 2035

Jul 03, 2033

U-2584

U-2855

U-3018

DP U-2584

DP U-2855

DP U-3018

U-2584

U-2855

U-3018

DS DP

DS DP

SELPERCATINIB - RETEVMO

N 213246 001 ODE-409

ODE-412

Sep 21, 2029

Sep 21, 2029

SELPERCATINIB - RETEVMO

N 213246 002 ODE-409

ODE-412

Sep 21, 2029

Sep 21, 2029

SELUMETINIB SULFATE - KOSELUGO

N 213756 001 >A> 11813246

7425637

Mar 26, 2029

Mar 13, 2024

DP

DS

SELUMETINIB SULFATE - KOSELUGO

N 213756 002 >A> 11813246

7425637

Mar 26, 2029

Mar 13, 2024

DP

DS

SEMAGLUTIDE - RYBELSUS

N 213051 001 11759501

11759502

11759503

Mar 15, 2033

Mar 15, 2033

Mar 15, 2033

DP

DP

DP

SEMAGLUTIDE - RYBELSUS

N 213051 002 11759501

11759502

11759503

Mar 15, 2033

Mar 15, 2033

Mar 15, 2033

DP

DP

DP

SEMAGLUTIDE - RYBELSUS

N 213051 003 11759501

11759502

11759503

Mar 15, 2033

Mar 15, 2033

Mar 15, 2033

DP

DP

DP

SEMAGLUTIDE - WEGOVY

N 215256 001 11752198 Aug 24, 2038 DP U-3162 NPP Dec 23, 2025

SEMAGLUTIDE - WEGOVY

N 215256 002 11752198 Aug 24, 2038 DP U-3162 NPP Dec 23, 2025

SEMAGLUTIDE - WEGOVY

N 215256 003 11752198 Aug 24, 2038 DP U-3162 NPP Dec 23, 2025

SEMAGLUTIDE - WEGOVY

N 215256 004 11752198 Aug 24, 2038 DP U-3162 D-190

NPP

Jul 21, 2026

Dec 23, 2025

SEMAGLUTIDE - WEGOVY

N 215256 005 11752198 Aug 24, 2038 DP U-3162 NPP Dec 23, 2025

SETMELANOTIDE ACETATE - IMCIVREE

N 213793 001 ODE-402 Jun 16, 2029
A - 74

PATENT AND EXCLUSIVITY DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - December 2023

APPL/PROD PATENT PATENT EXCLUSIVITY

NO PATENT NO EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION

DATE CODES REQUESTED CODE(S) DATE

SILDENAFIL CITRATE - REVATIO

N 021845 001 M-287 Jan 31, 2026

SILDENAFIL CITRATE - REVATIO

N 022473 001 M-287 Jan 31, 2026

SILDENAFIL CITRATE - REVATIO

N 203109 001 M-287 Jan 31, 2026

SILDENAFIL CITRATE - LIQREV

N 214952 001 11337979

11464778

11759468

Dec 24, 2038

Dec 24, 2038

Dec 24, 2038

DP U-3582

DP U-3582

DP U-3582

SINCALIDE - SINCALIDE

N 210850 001 11737983

11737983

Apr 20, 2038

Apr 20, 2038

DP U-3482

DP U-3689

SIROLIMUS - FYARRO

N 213312 001 ODE-386 Nov 22, 2028

SIROLIMUS - HYFTOR

N 213478 001 ODE-391 Mar 22, 2029

SITAGLIPTIN - ZITUVIO

N 211566 001 >A> 10925871 Feb 25, 2035 DP

SITAGLIPTIN - ZITUVIO

N 211566 002 >A> 10925871 Feb 25, 2035 DP

SITAGLIPTIN - ZITUVIO

N 211566 003 >A> 10925871 Feb 25, 2035 DP

SODIUM BENZOATE; SODIUM PHENYLACETATE - SODIUM PHENYLACETATE AND SODIUM BENZOATE

A 217526 001 CGT Mar 17, 2024

SODIUM CHLORIDE - SODIUM CHLORIDE 23.4%

A 217796 001 CGT Jan 23, 2024

SODIUM NITRITE; SODIUM THIOSULFATE - NITHIODOTE

N 201444 001 11753301 Feb 10, 2030 DS DP U-3681

SODIUM OXYBATE - LUMRYZ

N 214755 001 10272062

10736866

10925844

10952986

10973795

11000498

11052061

11065224

11400065

11504347

11583510

11602512

11602513

11766418

11779557

>A> 11839597

Jul 21, 2037

Jul 21, 2037

Feb 28, 2040

Jul 21, 2037

Jul 21, 2037

Jul 21, 2037

Jul 21, 2037

Jul 21, 2037

Jul 21, 2037

Jul 21, 2037

Feb 07, 2042

Jul 21, 2037

Jul 21, 2037

Jul 21, 2037

Mar 16, 2042

Jul 21, 2037

DP

DP

DP

U-3601

DP

DP U-3580

DP

DP

U-3579

DP

U-3578

U-3577

U-3576

DP

U-3705

DP

NP

ODE-431

May 01, 2026

May 01, 2030

SODIUM OXYBATE - LUMRYZ

N 214755 002 10272062 Jul 21, 2037 DP NP May 01, 2026

10736866 Jul 21, 2037 DP ODE-431 May 01, 2030

10925844 Feb 28, 2040 DP
A - 75

PATENT AND EXCLUSIVITY DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - December 2023

APPL/PROD PATENT PATENT EXCLUSIVITY

NO PATENT NO EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION

DATE CODES REQUESTED CODE(S) DATE

SODIUM OXYBATE - LUMRYZ

N 214755 002

>A>

10952986

10973795

11000498

11052061

11065224

11400065

11504347

11583510

11602512

11602513

11766418

11779557

11826335

11839597

Jul 21, 2037

Jul 21, 2037

Jul 21, 2037

Jul 21, 2037

Jul 21, 2037

Jul 21, 2037

Jul 21, 2037

Feb 07, 2042

Jul 21, 2037

Jul 21, 2037

Jul 21, 2037

Mar 16, 2042

Jul 21, 2037

Jul 21, 2037

U-3601

DP

DP U-3580

DP

DP

U-3579

DP

U-3578

U-3577

U-3576

DP

U-3705

U-3751

DP

SODIUM OXYBATE - LUMRYZ

N 214755 003

>A>

10272062

10736866

10925844

10952986

10973795

11000498

11052061

11065224

11400065

11504347

11583510

11602512

11602513

11766418

11779557

11839597

Jul 21, 2037

Jul 21, 2037

Feb 28, 2040

Jul 21, 2037

Jul 21, 2037

Jul 21, 2037

Jul 21, 2037

Jul 21, 2037

Jul 21, 2037

Jul 21, 2037

Feb 07, 2042

Jul 21, 2037

Jul 21, 2037

Jul 21, 2037

Mar 16, 2042

Jul 21, 2037

DP

DP

DP

U-3601

DP

DP U-3580

DP

DP

U-3579

DP

U-3578

U-3577

U-3576

DP

U-3705

DP

NP

ODE-431

May 01, 2026

May 01, 2030

SODIUM OXYBATE - LUMRYZ

N 214755 004

>A>

10272062

10736866

10925844

10952986

10973795

11000498

11052061

11065224

11400065

11504347

11583510

11602512

11602513

11766418

11779557

11839597

Jul 21, 2037

Jul 21, 2037

Feb 28, 2040

Jul 21, 2037

Jul 21, 2037

Jul 21, 2037

Jul 21, 2037

Jul 21, 2037

Jul 21, 2037

Jul 21, 2037

Feb 07, 2042

Jul 21, 2037

Jul 21, 2037

Jul 21, 2037

Mar 16, 2042

Jul 21, 2037

DP

DP

DP

U-3601

DP

DP U-3580

DP

DP

U-3579

DP

U-3578

U-3577

U-3576

DP

U-3705

DP

NP

ODE-431

May 01, 2026

May 01, 2030

SODIUM PHENYLBUTYRATE - OLPRUVA

N 214860 001 11154521

11202767

11433041

Oct 17, 2036

Oct 17, 2036

Oct 17, 2036

DP

U-3502

DP

SODIUM PHENYLBUTYRATE - OLPRUVA

N 214860 002 11154521

11202767

11433041

Oct 17, 2036

Oct 17, 2036

Oct 17, 2036

DP

U-3502

DP

SODIUM PHENYLBUTYRATE - OLPRUVA

N 214860 003 11154521

11202767

11433041

Oct 17, 2036

Oct 17, 2036

Oct 17, 2036

DP

U-3502

DP
A - 76

PATENT AND EXCLUSIVITY DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - December 2023

APPL/PROD PATENT PATENT EXCLUSIVITY

NO PATENT NO EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION

DATE CODES REQUESTED CODE(S) DATE

SODIUM PHENYLBUTYRATE - OLPRUVA

N 214860 004 11154521

11202767

11433041

Oct 17, 2036

Oct 17, 2036

Oct 17, 2036

DP

U-3502

DP

SODIUM PHENYLBUTYRATE - OLPRUVA

N 214860 005 11154521

11202767

11433041

Oct 17, 2036

Oct 17, 2036

Oct 17, 2036

DP

U-3502

DP

SODIUM PHENYLBUTYRATE - OLPRUVA

N 214860 006 11154521

11202767

11433041

Oct 17, 2036

Oct 17, 2036

Oct 17, 2036

DP

U-3502

DP

SODIUM PHENYLBUTYRATE; TAURURSODIOL - RELYVRIO

N 216660 001 11583542 Jul 27, 2040 DP ODE-411 Sep 29, 2029

SODIUM THIOSULFATE - SODIUM THIOSULFATE

N 203923 001 11753301 Feb 10, 2030 DS DP U-3682

SODIUM THIOSULFATE - PEDMARK

N 212937 001 10596190

11617793

Jan 05, 2038

Jul 01, 2039

U-3443

DP

Y ODE-384 Sep 20, 2029

SODIUM ZIRCONIUM CYCLOSILICATE - LOKELMA

N 207078 001 11738044 Oct 14, 2035 U-2312

SODIUM ZIRCONIUM CYCLOSILICATE - LOKELMA

N 207078 002 11738044 Oct 14, 2035 U-2312

SOFOSBUVIR; VELPATASVIR - EPCLUSA

N 214187 001 11707479

11707479*PED

Jan 30, 2034

Jul 30, 2034

DP U-1470

SOFOSBUVIR; VELPATASVIR - EPCLUSA

N 214187 002 11707479

11707479*PED

Jan 30, 2034

Jul 30, 2034

DP U-1470

SOLIFENACIN SUCCINATE - VESICARE LS

N 209529 001 NP

W

May 26, 2023

Nov 26, 2023

SOLRIAMFETOL HYDROCHLORIDE - SUNOSI

N 211230 001 11160779 Mar 19, 2040

11439597 Sep 05, 2037

11560354 Mar 06, 2039

11648232 Jun 01, 2038

11753368 Jun 07, 2026

11771666 Dec 30, 2042

11771667 Dec 30, 2042

11779554 Dec 30, 2042

11793776 Dec 30, 2042

>A> 11839598 Mar 19, 2040

>A> 11839599 Mar 19, 2040

>A> 11850226 Mar 19, 2040

>A> 11850227 Mar 19, 2040

>A> 11850228 Mar 19, 2040

8440715 Jun 11, 2031

U-3521

DP

DP U-3520

U-3602

U-2548

U-3693

U-3693

U-3693

U-3693

U-3765

U-3764

U-3775

U-3775

U-3775

U-2548

SOLRIAMFETOL HYDROCHLORIDE - SUNOSI

N 211230 002 11160779 Mar 19, 2040

11439597 Sep 05, 2037

11560354 Mar 06, 2039

11648232 Jun 01, 2038

U-3521

DP

DP U-3520

U-3602
A - 77

PATENT AND EXCLUSIVITY DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - December 2023

APPL/PROD PATENT PATENT EXCLUSIVITY

NO PATENT NO EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION

DATE CODES REQUESTED CODE(S) DATE

SOLRIAMFETOL HYDROCHLORIDE - SUNOSI

N 211230 002 11753368 Jun 07, 2026

11771666 Dec 30, 2042

11771667 Dec 30, 2042

11779554 Dec 30, 2042

11793776 Dec 30, 2042

>A> 11839598 Mar 19, 2040

>A> 11839599 Mar 19, 2040

>A> 11850226 Mar 19, 2040

>A> 11850227 Mar 19, 2040

>A> 11850228 Mar 19, 2040

8440715 Jun 11, 2031

U-2548

U-3693

U-3693

U-3693

U-3693

U-3765

U-3764

U-3775

U-3775

U-3775

U-2548

SOTAGLIFLOZIN - INPEFA

N 216203 001 7781577

8217156

8476413

May 04, 2028

Oct 07, 2030

May 29, 2028

DS DP U-3628

DS DP

DS DP U-3628

NCE May 26, 2028

SOTAGLIFLOZIN - INPEFA

N 216203 002 7781577

8217156

8476413

May 04, 2028

Oct 07, 2030

May 29, 2028

DS DP U-3628

DS DP

DS DP U-3628

NCE May 26, 2028

SOTALOL HYDROCHLORIDE - SOTALOL HYDROCHLORIDE

N 022306 001 10512620 Aug 14, 2038

10512620 Aug 14, 2038

10799138 Apr 05, 2039

10799138 Apr 05, 2039

11583216 Aug 21, 2039

11696902 Aug 14, 2038

U-2769

U-3547

U-3125

U-3549

U-3549

U-2769

SOTALOL HYDROCHLORIDE - SOTYLIZE

N 205108 001 >A> 11850222

>A> 11850222

Nov 19, 2034

Nov 19, 2034

U-2096

U-2494

SOTORASIB - LUMAKRAS

N 214665 001 11426404

>A> 11827635

Sep 15, 2040

May 20, 2040

U-3306

DS DP U-3306

SOTORASIB - LUMAKRAS

N 214665 002 10519146

11236091

11426404

>A> 11827635

May 21, 2038

May 20, 2040

Sep 15, 2040

May 20, 2040

DS DP

DS DP U-3306

U-3306

DS DP U-3306

NCE

ODE-352

May 28, 2026

May 28, 2028

SPARSENTAN - FILSPARI

N 216403 001 9993461 Mar 29, 2030 U-3269 NCE

ODE-389

Feb 17, 2028

Feb 17, 2030

SPARSENTAN - FILSPARI

N 216403 002 9993461 Mar 29, 2030 U-3269 NCE

ODE-389

Feb 17, 2028

Feb 17, 2030

STIRIPENTOL - DIACOMIT

N 206709 001 ODE-403 Jul 14, 2029

STIRIPENTOL - DIACOMIT

N 206709 002 ODE-403 Jul 14, 2029

STIRIPENTOL - DIACOMIT

N 207223 001 ODE-403 Jul 14, 2029
A - 78

PATENT AND EXCLUSIVITY DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - December 2023

APPL/PROD PATENT PATENT EXCLUSIVITY

NO PATENT NO EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION

DATE CODES REQUESTED CODE(S) DATE

STIRIPENTOL - DIACOMIT

N 207223 002 ODE-403 Jul 14, 2029

SUFENTANIL CITRATE - DSUVIA

N 209128 001 11672738

11676691

Feb 02, 2038

Mar 16, 2030

DP

DP

SUGAMMADEX SODIUM - BRIDION

N 022225 001 M-291 Jan 22, 2024

SUGAMMADEX SODIUM - BRIDION

N 022225 002 M-291 Jan 22, 2024

SULFUR HEXAFLUORIDE LIPID-TYPE A MICROSPHERES - LUMASON

N 203684 001 11723869 May 15, 2039 DP U-3666

11723869 May 15, 2039 DP U-3667

11723869 May 15, 2039 DP U-3668

SUMATRIPTAN SUCCINATE - ONZETRA XSAIL

N 206099 001 11571531 Feb 23, 2026 U-1809

TADALAFIL - TADLIQ

N 214522 001 11666576 Dec 24, 2038 DP U-3397

TAFAMIDIS - VYNDAMAX

N 212161 001 7214695

7214696

Dec 19, 2024

Dec 19, 2024

DS DP

U-2524

TAFAMIDIS MEGLUMINE - VYNDAQEL

N 211996 001 7214695

7214696

8653119

Dec 19, 2024

Dec 19, 2024

Dec 19, 2023

DS DP

U-2524

U-2524

TAFENOQUINE SUCCINATE - ARAKODA

N 210607 001 11744828 Dec 02, 2035 U-2582

TALAZOPARIB TOSYLATE - TALZENNA

N 211651 001 10780088 Jul 27, 2029 U-3651 I-920 Jun 20, 2026

TALAZOPARIB TOSYLATE - TALZENNA

N 211651 003 10780088 Jul 27, 2029 U-3651 I-920 Jun 20, 2026

TALAZOPARIB TOSYLATE - TALZENNA

N 211651 005 10189837

10780088

8012976

8420650

8735392

9820985

Oct 20, 2031

Jul 27, 2029

Oct 19, 2029

Jul 27, 2029

Oct 20, 2031

Jul 27, 2029

DS DP

U-3651

DS DP

DS DP

DS DP

U-2437

I-920

NCE

Jun 20, 2026

Oct 16, 2023

TALAZOPARIB TOSYLATE - TALZENNA

N 211651 006 10189837

10780088

8012976

8420650

8735392

9820985

Oct 20, 2031

Jul 27, 2029

Oct 19, 2029

Jul 27, 2029

Oct 20, 2031

Jul 27, 2029

DS DP

U-3651

DS DP

DS DP

DS DP

U-2437

NCE Oct 16, 2023

TAPENTADOL HYDROCHLORIDE - NUCYNTA

N 022304 001 NPP Jul 03, 2026
A - 79

PATENT AND EXCLUSIVITY DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - December 2023

APPL/PROD

NO PATENT NO

PATENT

EXPIRATION

DATE

PATENT

CODES

PATENT

DELIST

REQUESTED

EXCLUSIVITY

CODE(S)

EXCLUSIVITY

EXPIRATION

DATE

TAPENTADOL HYDROCHLORIDE - NUCYNTA

N 022304 002 NPP Jul 03, 2026

TAPENTADOL HYDROCHLORIDE - NUCYNTA

N 022304 003 NPP Jul 03, 2026

TAPENTADOL HYDROCHLORIDE - NUCYNTA

N 203794 001 NPP Jul 03, 2026

TAPINAROF - VTAMA

N 215272 001 11590088

11597692

11612573

11617724

11622945

Nov 13, 2039

Nov 13, 2038

May 19, 2036

May 19, 2036

May 19, 2036

U-2625

DS DP

U-2625

DP

DP

TASIMELTEON - HETLIOZ

N 205677 001 11566011

11633377

11633377

11759446

11760740

11786502

11786502

>A> 11833130

>A> 11833130

>A> 11850229

>A> 11850229

Feb 12, 2035

Jan 25, 2033

Jan 25, 2033

Feb 21, 2041

Feb 12, 2035

Oct 10, 2034

Oct 10, 2034

Jan 25, 2033

Jan 25, 2033

Jan 25, 2033

Jan 25, 2033

DS DP

U-2149

U-3003

U-3003

DS DP

U-3007

U-3739

U-2149

U-3003

U-3342

U-3343

TASIMELTEON - HETLIOZ LQ

N 214517 001 11566011

11633377

11759446

11760740

11786502

>A> 11833130

>A> 11850229

Feb 12, 2035

Jan 25, 2033

Feb 21, 2041

Feb 12, 2035

Oct 10, 2034

Jan 25, 2033

Jan 25, 2033

DS DP

U-3003

U-3003

DS DP

U-3007

U-3003

U-3342

TAZAROTENE - ARAZLO

N 211882 001 11679116 Jun 06, 2036 DP

TAZEMETOSTAT HYDROBROMIDE - TAZVERIK

N 211723 001 8410088 Jan 23, 2034 DS DP

TECHNETIUM TC-99M LABELED CARBON - TECHNEGAS KIT

N 022335 001 NP Sep 29, 2026

TECHNETIUM TC-99M SULFUR COLLOID KIT - TECHNETIUM TC-99M SULFUR COLLOID KIT

A 213516 001 >A> CGT Jun 01, 2024

TENAPANOR HYDROCHLORIDE - XPHOZAH

N 213931 001 10272079

10272079

10940146

10940146

8541448

8969377

Apr 10, 2034

Apr 10, 2034

Apr 10, 2034

Apr 10, 2034

Aug 01, 2033

Dec 30, 2029

U-3736

U-381

U-3736

U-381

DS DP

DS DP

NCE

NP

Sep 12, 2024

Oct 17, 2026

TENAPANOR HYDROCHLORIDE - XPHOZAH

N 213931 002 10272079

10272079

10940146

10940146

8541448

8969377

Apr 10, 2034

Apr 10, 2034

Apr 10, 2034

Apr 10, 2034

Aug 01, 2033

Dec 30, 2029

U-3736

U-381

U-3736

U-381

DS DP

DS DP

NCE

NP

Sep 12, 2024

Oct 17, 2026
A - 80

PATENT AND EXCLUSIVITY DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - December 2023

APPL/PROD PATENT PATENT EXCLUSIVITY

NO PATENT NO EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION

DATE CODES REQUESTED CODE(S) DATE

TENAPANOR HYDROCHLORIDE - XPHOZAH

N 213931 002 10272079

10272079

10940146

10940146

8541448

8969377

Apr 10, 2034

Apr 10, 2034

Apr 10, 2034

Apr 10, 2034

Aug 01, 2033

Dec 30, 2029

U-3736

U-381

U-3736

U-381

DS DP

DS DP

NCE

NP

Sep 12, 2024

Oct 17, 2026

TENAPANOR HYDROCHLORIDE - XPHOZAH

N 213931 003 10272079

10272079

10940146

10940146

8541448

8969377

Apr 10, 2034

Apr 10, 2034

Apr 10, 2034

Apr 10, 2034

Aug 01, 2033

Dec 30, 2029

U-3736

U-381

U-3736

U-381

DS DP

DS DP

NCE

NP

Sep 12, 2024

Oct 17, 2026

TERIFLUNOMIDE - TERIFLUNOMIDE

A 209549 001 PC Sep 08, 2023

TERIFLUNOMIDE - TERIFLUNOMIDE

A 209549 002 PC Sep 08, 2023

TERIFLUNOMIDE - TERIFLUNOMIDE

A 209601 001 PC Sep 08, 2023

TERIFLUNOMIDE - TERIFLUNOMIDE

A 209601 002 PC Sep 08, 2023

TERIFLUNOMIDE - TERIFLUNOMIDE

A 209613 001 PC Sep 08, 2023

TERIFLUNOMIDE - TERIFLUNOMIDE

A 209613 002 PC Sep 08, 2023

TERIFLUNOMIDE - TERIFLUNOMIDE

A 209638 001 PC Sep 08, 2023

TERIFLUNOMIDE - TERIFLUNOMIDE

A 209638 002 PC Sep 08, 2023

TERIFLUNOMIDE - TERIFLUNOMIDE

A 209663 001 PC Sep 08, 2023

TERIFLUNOMIDE - TERIFLUNOMIDE

A 209663 002 PC Sep 08, 2023

TERIFLUNOMIDE - TERIFLUNOMIDE

A 209668 001 PC Sep 08, 2023

TERIFLUNOMIDE - TERIFLUNOMIDE

A 209668 002 PC Sep 08, 2023

TERIFLUNOMIDE - TERIFLUNOMIDE

A 209690 001 PC Sep 08, 2023

TERIFLUNOMIDE - TERIFLUNOMIDE

A 209690 002 PC Sep 08, 2023

TERIFLUNOMIDE - TERIFLUNOMIDE

A 209700 001 PC Sep 08, 2023
A - 81

PATENT AND EXCLUSIVITY DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - December 2023

APPL/PROD PATENT PATENT EXCLUSIVITY

NO PATENT NO EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION

DATE CODES REQUESTED CODE(S) DATE

TERIFLUNOMIDE - TERIFLUNOMIDE

A 209700 002 PC Sep 08, 2023

TERIFLUNOMIDE - TERIFLUNOMIDE

A 209710 001 PC Sep 08, 2023

TERIFLUNOMIDE - TERIFLUNOMIDE

A 209710 002 PC Sep 08, 2023

TERIPARATIDE - FORTEO

N 021318 001 M-302 Nov 16, 2023

TERIPARATIDE - FORTEO

N 021318 002 M-302 Nov 16, 2023

TERLIPRESSIN ACETATE - TERLIVAZ

N 022231 001 10335452 Apr 05, 2037 U-3711 ODE-406 Sep 14, 2029

TESTOSTERONE CYPIONATE - TESTOSTERONE CYPIONATE

N 216318 001 11642355 Mar 25, 2039 DP

TESTOSTERONE ENANTHATE - XYOSTED (AUTOINJECTOR)

N 209863 001 11771646 Apr 10, 2034

11813435 Feb 25, 2035

DP

DP

TESTOSTERONE ENANTHATE - XYOSTED (AUTOINJECTOR)

N 209863 002 11771646 Apr 10, 2034

11813435 Feb 25, 2035

DP

DP

TESTOSTERONE ENANTHATE - XYOSTED (AUTOINJECTOR)

N 209863 003 11771646 Apr 10, 2034

11813435 Feb 25, 2035

DP

DP

TESTOSTERONE UNDECANOATE - JATENZO

N 206089 001 11564933 Apr 12, 2039 U-1103

TESTOSTERONE UNDECANOATE - JATENZO

N 206089 002 11564933 Apr 12, 2039 U-1103

TESTOSTERONE UNDECANOATE - JATENZO

N 206089 003 11564933 Apr 12, 2039 U-1103

TESTOSTERONE UNDECANOATE - TLANDO

N 208088 001 11559530 Nov 28, 2037 U-1500

TESTOSTERONE UNDECANOATE - KYZATREX

N 213953 001 11590146 Dec 31, 2030

11617758 Mar 15, 2033

DP

DP U-2506

TESTOSTERONE UNDECANOATE - KYZATREX

N 213953 002 11590146 Dec 31, 2030

11617758 Mar 15, 2033

DP

DP U-2506

TESTOSTERONE UNDECANOATE - KYZATREX

N 213953 003 11590146 Dec 31, 2030

11617758 Mar 15, 2033

DP

DP U-2506

TIPIRACIL HYDROCHLORIDE; TRIFLURIDINE - LONSURF

N 207981 001 10456399 Feb 03, 2037

10456399 Feb 03, 2037

10960004 Feb 03, 2037

10960004 Feb 03, 2037

9943537 Sep 05, 2034

U-3657

U-3658

U-3657

U-3658

U-3659
A - 82

PATENT AND EXCLUSIVITY DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - December 2023

APPL/PROD PATENT PATENT EXCLUSIVITY

NO PATENT NO EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION

DATE CODES REQUESTED CODE(S) DATE

TIPIRACIL HYDROCHLORIDE; TRIFLURIDINE - LONSURF

N 207981 001 RE46284 Sep 22, 2029

RE46284 Sep 22, 2029

RE46284 Sep 22, 2029

U-1751

U-2503

U-3656

TIPIRACIL HYDROCHLORIDE; TRIFLURIDINE - LONSURF

N 207981 002 10456399 Feb 03, 2037

10456399 Feb 03, 2037

10960004 Feb 03, 2037

10960004 Feb 03, 2037

9943537 Sep 05, 2034

RE46284 Sep 22, 2029

RE46284 Sep 22, 2029

RE46284 Sep 22, 2029

U-3657

U-3658

U-3657

U-3658

U-3659

U-1751

U-2503

U-3656

TIRZEPATIDE - ZEPBOUND

N 217806 001 11357820

8734394

9402957

9474780

Jun 14, 2039

Feb 24, 2031

Jun 29, 2031

Jan 05, 2036

DP

DP

DP

DS DP

NCE

NP

May 13, 2027

Nov 08, 2026

TIRZEPATIDE - ZEPBOUND

N 217806 002 11357820

8734394

9402957

9474780

Jun 14, 2039

Feb 24, 2031

Jun 29, 2031

Jan 05, 2036

DP

DP

DP

DS DP

NCE

NP

May 13, 2027

Nov 08, 2026

TIRZEPATIDE - ZEPBOUND

N 217806 003 11357820

8734394

9402957

9474780

Jun 14, 2039

Feb 24, 2031

Jun 29, 2031

Jan 05, 2036

DP

DP

DP

DS DP

NCE

NP

May 13, 2027

Nov 08, 2026

TIRZEPATIDE - ZEPBOUND

N 217806 004 11357820

8734394

9402957

9474780

Jun 14, 2039

Feb 24, 2031

Jun 29, 2031

Jan 05, 2036

DP

DP

DP

DS DP

NCE

NP

May 13, 2027

Nov 08, 2026

TIRZEPATIDE - ZEPBOUND

N 217806 005 11357820

8734394

9402957

9474780

Jun 14, 2039

Feb 24, 2031

Jun 29, 2031

Jan 05, 2036

DP

DP

DP

DS DP

NCE

NP

May 13, 2027

Nov 08, 2026

TIRZEPATIDE - ZEPBOUND

N 217806 006 11357820

8734394

9402957

9474780

Jun 14, 2039

Feb 24, 2031

Jun 29, 2031

Jan 05, 2036

DP

DP

DP

DS DP

NCE

NP

May 13, 2027

Nov 08, 2026

TIVOZANIB HYDROCHLORIDE - FOTIVDA

N 212904 001 6821987 Apr 26, 2024 DS DP U-3100

TIVOZANIB HYDROCHLORIDE - FOTIVDA

N 212904 002 6821987 Apr 26, 2024 DS DP U-3100

TOFERSEN - QALSODY

N 215887 001 10385341

10669546

10968453

Apr 01, 2035

Apr 01, 2035

Apr 01, 2035

DS DP

U-3575

U-3575

NCE

ODE-432

Apr 25, 2028

Apr 25, 2030

TOPIRAMATE - EPRONTIA

N 214679 001 11633374

>A> 11826343

Aug 21, 2040

Aug 21, 2040

DP

DP
A - 83

PATENT AND EXCLUSIVITY DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - December 2023

APPL/PROD PATENT PATENT EXCLUSIVITY

NO PATENT NO EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION

DATE CODES REQUESTED CODE(S) DATE

TOPIRAMATE - EPRONTIA

N 214679 001 11633374 Aug 21, 2040 DP

>A> 11826343 Aug 21, 2040 DP

TRAMADOL HYDROCHLORIDE - QDOLO

N 214044 001 11752103 Sep 01, 2040 DP U-3197

TRAMETINIB DIMETHYL SULFOXIDE - MEKINIST

N 204114 001 10869869 Aug 30, 2033 U-3184 I-895 Jun 22, 2025

10869869*PED Mar 02, 2034 I-908 Mar 16, 2026

7378423 May 29, 2027 DS DP ODE-148 Jun 22, 2024

7378423*PED Nov 29, 2027 ODE-182 Apr 30, 2025

8580304 Jan 28, 2032 DP ODE-183 May 04, 2025

8580304*PED Jul 28, 2032 ODE-428 Mar 16, 2030

8703781 Oct 15, 2030 DS DP U-1712 PED Dec 22, 2024

8703781 Oct 15, 2030 DS DP U-2020 PED Oct 30, 2025

8703781 Oct 15, 2030 DS DP U-2037 PED Nov 04, 2025

8703781 Oct 15, 2030 DS DP U-2302 PED Dec 22, 2025

8703781 Oct 15, 2030 DS DP U-2305

8703781*PED Apr 15, 2031

8835443 Jun 10, 2025 U-1581

8835443 Jun 10, 2025 U-1582

8835443 Jun 10, 2025 U-2020

8835443 Jun 10, 2025 U-2037

8835443 Jun 10, 2025 U-2302

8835443 Jun 10, 2025 U-2305

8835443*PED Dec 10, 2025

8952018 Oct 15, 2030 U-2020

8952018*PED Apr 15, 2031

9155706 Jan 28, 2032 DP

9155706*PED Jul 28, 2032

9271941 Jan 28, 2032 DP

9271941*PED Jul 28, 2032

9399021 Jan 28, 2032 DP

9399021*PED Jul 28, 2032

TRAMETINIB DIMETHYL SULFOXIDE - MEKINIST

N 204114 002 10869869 Aug 30, 2033 U-3184 I-895 Jun 22, 2025

10869869*PED Mar 02, 2034 I-908 Mar 16, 2026

7378423 May 29, 2027 DS DP ODE-148 Jun 22, 2024

7378423*PED Nov 29, 2027 ODE-182 Apr 30, 2025

8580304 Jan 28, 2032 DP ODE-183 May 04, 2025

8580304*PED Jul 28, 2032 ODE-428 Mar 16, 2030

8703781 Oct 15, 2030 DS DP U-1712 PED Dec 22, 2024

8703781 Oct 15, 2030 DS DP U-2020 PED Oct 30, 2025

8703781 Oct 15, 2030 DS DP U-2037 PED Nov 04, 2025

8703781 Oct 15, 2030 DS DP U-2302 PED Dec 22, 2025

8703781 Oct 15, 2030 DS DP U-2305

8703781*PED Apr 15, 2031

8835443 Jun 10, 2025 U-1581

8835443 Jun 10, 2025 U-1582

8835443 Jun 10, 2025 U-2020

8835443 Jun 10, 2025 U-2037

8835443 Jun 10, 2025 U-2302

8835443 Jun 10, 2025 U-2305

8835443*PED Dec 10, 2025

8952018 Oct 15, 2030 U-2020

8952018*PED Apr 15, 2031

9155706 Jan 28, 2032 DP

9155706*PED Jul 28, 2032

9271941 Jan 28, 2032 DP

9271941*PED Jul 28, 2032

9399021 Jan 28, 2032 DP

9399021*PED Jul 28, 2032
A - 84

PATENT AND EXCLUSIVITY DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - December 2023

APPL/PROD PATENT PATENT EXCLUSIVITY

NO PATENT NO EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION

DATE CODES REQUESTED CODE(S) DATE

TRAMETINIB DIMETHYL SULFOXIDE - MEKINIST

N 204114 003 10869869 Aug 30, 2033

10869869*PED Mar 02, 2034

7378423 May 29, 2027

7378423*PED Nov 29, 2027

8580304 Jan 28, 2032

8580304*PED Jul 28, 2032

8703781 Oct 15, 2030

8703781 Oct 15, 2030

8703781 Oct 15, 2030

8703781 Oct 15, 2030

8703781 Oct 15, 2030

8703781*PED Apr 15, 2031

8835443 Jun 10, 2025

8835443 Jun 10, 2025

8835443 Jun 10, 2025

8835443 Jun 10, 2025

8835443 Jun 10, 2025

8835443 Jun 10, 2025

8835443*PED Dec 10, 2025

8952018 Oct 15, 2030

8952018*PED Apr 15, 2031

9155706 Jan 28, 2032

9155706*PED Jul 28, 2032

9271941 Jan 28, 2032

9271941*PED Jul 28, 2032

9399021 Jan 28, 2032

9399021*PED Jul 28, 2032

U-3184

DS DP

DP

DS DP U-1712

DS DP U-2020

DS DP U-2037

DS DP U-2302

DS DP U-2305

U-1581

U-1582

U-2020

U-2037

U-2302

U-2305

U-2020

DP

DP

DP

I-895

I-908

ODE-148

ODE-182

ODE-183

ODE-428

PED

PED

PED

PED

Jun 22, 2025

Mar 16, 2026

Jun 22, 2024

Apr 30, 2025

May 04, 2025

Mar 16, 2030

Dec 22, 2024

Oct 30, 2025

Nov 04, 2025

Dec 22, 2025

TRAMETINIB DIMETHYL SULFOXIDE - MEKINIST

N 217513 001 7378423 May 29, 2027

8703781 Oct 15, 2030

8835443 Jun 10, 2025

DS DP

DS DP U-3564

U-3564

NP

ODE-428

Mar 16, 2026

Mar 16, 2030

TRANEXAMIC ACID - TRANEXAMIC ACID

A 217155 001 CGT Apr 16, 2024

TRAVOPROST - IDOSE TR

N 218010 001 >A> 10206813

>A> 11426306

Oct 17, 2030

Oct 17, 2030

DP

DP

TREPROSTINIL - REMODULIN

N 021272 001 11723887 Dec 15, 2028 DS

TREPROSTINIL - REMODULIN

N 021272 002 11723887 Dec 15, 2028 DS

TREPROSTINIL - REMODULIN

N 021272 003 11723887 Dec 15, 2028 DS

TREPROSTINIL - REMODULIN

N 021272 004 11723887 Dec 15, 2028 DS

TREPROSTINIL - REMODULIN

N 021272 005 11723887 Dec 15, 2028 DS

TREPROSTINIL - REMODULIN

N 021272 006 11723887

7999007

8653137

8658694

9199908

9593066

9604901

Dec 15, 2028

Mar 29, 2029

Sep 05, 2028

Sep 05, 2028

May 24, 2024

Dec 15, 2028

Dec 15, 2028

DS

DP U-1437

U-1437

U-1437

U-1771

DS

DS
A - 85

PATENT AND EXCLUSIVITY DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - December 2023

APPL/PROD

NO PATENT NO

PATENT

EXPIRATION

DATE

PATENT

CODES

PATENT

DELIST

REQUESTED

EXCLUSIVITY

CODE(S)

EXCLUSIVITY

EXPIRATION

DATE

TREPROSTINIL - REMODULIN

N 021272 007 11723887

7999007

8653137

8658694

9199908

9593066

9604901

Dec 15, 2028

Mar 29, 2029

Sep 05, 2028

Sep 05, 2028

May 24, 2024

Dec 15, 2028

Dec 15, 2028

DS

DP U-1437

U-1437

U-1437

U-1771

DS

DS

TREPROSTINIL - REMODULIN

N 021272 008 11723887

7999007

8653137

8658694

9199908

9593066

9604901

Dec 15, 2028

Mar 29, 2029

Sep 05, 2028

Sep 05, 2028

May 24, 2024

Dec 15, 2028

Dec 15, 2028

DS

DP U-1437

U-1437

U-1437

U-1771

DS

DS

TREPROSTINIL - TYVASO

N 022387 001 11723887

11826327

Dec 15, 2028

Jan 04, 2042

DS

U-3749

TREPROSTINIL - TYVASO DPI

N 214324 001 11723887

11826327

Dec 15, 2028

Jan 04, 2042

DS

U-3749

TREPROSTINIL - TYVASO DPI

N 214324 002 11723887

11826327

Dec 15, 2028

Jan 04, 2042

DS

U-3749

TREPROSTINIL - TYVASO DPI

N 214324 003 11723887

11826327

Dec 15, 2028

Jan 04, 2042

DS

U-3749

TREPROSTINIL - TYVASO DPI

N 214324 004 11723887

11826327

Dec 15, 2028

Jan 04, 2042

DS

U-3749

TREPROSTINIL DIOLAMINE - ORENITRAM

N 203496 001 11723887 Dec 15, 2028 DS

TREPROSTINIL DIOLAMINE - ORENITRAM

N 203496 002 11723887 Dec 15, 2028 DS

TREPROSTINIL DIOLAMINE - ORENITRAM

N 203496 003 11723887 Dec 15, 2028 DS

TREPROSTINIL DIOLAMINE - ORENITRAM

N 203496 004 11723887 Dec 15, 2028 DS

TREPROSTINIL DIOLAMINE - ORENITRAM

N 203496 005 11723887 Dec 15, 2028 DS

TRETINOIN - TRETINOIN MICROSPHERE

A 215609 001 CGT Mar 06, 2024

TRIENTINE TETRAHYDROCHLORIDE - CUVRIOR

N 215760 001 ODE-401 Apr 28, 2029

TRIFAROTENE - AKLIEF

N 211527 001 7807708 Jul 19, 2031 DS DP
A - 86

PATENT AND EXCLUSIVITY DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - December 2023

APPL/PROD PATENT PATENT EXCLUSIVITY

NO PATENT NO EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION

DATE CODES REQUESTED CODE(S) DATE

TRIHEPTANOIN - DOJOLVI

N 213687 001 8697748 Apr 28, 2029 DP

TRILACICLIB DIHYDROCHLORIDE - COSELA

N 214200 001 11529352 Jul 23, 2039

11717523 Mar 14, 2034

11717523 Mar 14, 2034

U-3504

U-3678

U-3679

TROFINETIDE - DAYBUE

N 217026 001 11370755

9212204

Aug 03, 2040

Jan 27, 2032

DS DP

U-3556

NCE

ODE-425

Mar 10, 2028

Mar 10, 2030

TUCATINIB - TUKYSA

N 213411 001 11207324 Apr 27, 2038 U-3510 I-906

ODE-422

Jan 19, 2026

Jan 19, 2030

TUCATINIB - TUKYSA

N 213411 002 11207324 Apr 27, 2038 U-3510 I-906

ODE-422

Jan 19, 2026

Jan 19, 2030

UBROGEPANT - UBRELVY

N 211765 001 11717515

8912210

Dec 22, 2041

Dec 23, 2033

U-3677

DS DP

UBROGEPANT - UBRELVY

N 211765 002 8912210 Dec 23, 2033 DS DP

UMECLIDINIUM BROMIDE; VILANTEROL TRIFENATATE - ANORO ELLIPTA

N 203975 001 7439393 May 21, 2025 DS DP U-1476

7439393*PED Nov 21, 2025

8113199 Oct 23, 2027 DP

8113199*PED Apr 23, 2028

8161968 Feb 05, 2028 DP

8161968*PED Aug 05, 2028

8511304 Jun 14, 2027 DP U-1476

8511304*PED Dec 14, 2027

8534281 Mar 08, 2030 DP

8534281*PED Sep 08, 2030

8746242 Oct 11, 2030 DP

8746242*PED Apr 11, 2031

9333310 Oct 02, 2027 DP

9333310*PED Apr 02, 2028

UPADACITINIB - RINVOQ

N 211675 001 11524964

11535624

11535625

11564922

11607411

11661425

11680069

11718627

11767326

11773105

11773106

11773106

11773106

11780847

11780848

11787815

11795175

8962629

8962629

8962629

8962629

8962629

Oct 17, 2036

Oct 17, 2036

Oct 17, 2036

Mar 09, 2038

Mar 09, 2038

Oct 17, 2036

Oct 17, 2036

Oct 17, 2036

Oct 17, 2036

Oct 17, 2036

Oct 17, 2036

Oct 17, 2036

Oct 17, 2036

Oct 17, 2036

Oct 17, 2036

Oct 17, 2036

Oct 17, 2036

Jan 15, 2031

Jan 15, 2031

Jan 15, 2031

Jan 15, 2031

Jan 15, 2031

U-3371

U-3255

U-3298

U-3624

U-3341

DS DP

DS DP

DS DP

U-3298

DS DP

U-3275

U-3371

U-3487

DP

U-3371

DP

U-3255

DS U-3255

DS U-3275

DS U-3341

DS U-3371

DS U-3624

I-919 May 18, 2026
A - 87

PATENT AND EXCLUSIVITY DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - December 2023

APPL/PROD PATENT PATENT EXCLUSIVITY

NO PATENT NO EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION

DATE CODES REQUESTED CODE(S) DATE

UPADACITINIB - RINVOQ

N 211675 001 11524964 Oct 17, 2036 U-3371 I-919 May 18, 2026

11535624 Oct 17, 2036 U-3255

11535625 Oct 17, 2036 U-3298

11564922 Mar 09, 2038 U-3624

11607411 Mar 09, 2038 U-3341

11661425 Oct 17, 2036 DS DP

11680069 Oct 17, 2036 DS DP

11718627 Oct 17, 2036 DS DP

11767326 Oct 17, 2036 U-3298

11773105 Oct 17, 2036 DS DP

11773106 Oct 17, 2036 U-3275

11773106 Oct 17, 2036 U-3371

11773106 Oct 17, 2036 U-3487

11780847 Oct 17, 2036 DP

11780848 Oct 17, 2036 U-3371

11787815 Oct 17, 2036 DP

11795175 Oct 17, 2036 U-3255

8962629 Jan 15, 2031 DS U-3255

8962629 Jan 15, 2031 DS U-3275

8962629 Jan 15, 2031 DS U-3341

8962629 Jan 15, 2031 DS U-3371

8962629 Jan 15, 2031 DS U-3624

UPADACITINIB - RINVOQ

N 211675 002 11535626 Oct 17, 2036 U-3298 I-919 May 18, 2026

11564922 Mar 09, 2038 U-3624

11607411 Mar 09, 2038 U-3341

11661425 Oct 17, 2036 DS DP

11680069 Oct 17, 2036 DS DP

11718627 Oct 17, 2036 DS DP

11767326 Oct 17, 2036 U-3298

11773105 Oct 17, 2036 DS DP

8962629 Jan 15, 2031 DS U-3341

8962629 Jan 15, 2031 DS U-3624

UPADACITINIB - RINVOQ

N 211675 003 11564922 Mar 09, 2038 U-3624 I-919 May 18, 2026

11607411 Mar 09, 2038 U-3341

11661425 Oct 17, 2036 DS DP

11680069 Oct 17, 2036 DS DP

11718627 Oct 17, 2036 DS DP

11773105 Oct 17, 2036 DS DP

8962629 Jan 15, 2031 DS U-3341

8962629 Jan 15, 2031 DS U-3624

VALBENAZINE TOSYLATE - INGREZZA

N 209241 001 10065952 Oct 28, 2036 DS DP U-1995 I-925 Aug 18, 2026

10065952 Oct 28, 2036 DS DP U-3055 ODE-440 Aug 18, 2030

10844058 Oct 28, 2036 DS DP U-1995

10844058 Oct 28, 2036 DS DP U-3055

10851103 Oct 28, 2036 DS DP U-1995

10851103 Oct 28, 2036 DS DP U-3055

10851104 Oct 28, 2036 DS U-1995

10851104 Oct 28, 2036 DS U-3055

10874648 Oct 10, 2037 U-1995

10874648 Oct 10, 2037 U-3046

10874648 Oct 10, 2037 U-3055

10912771 Oct 10, 2037 U-1995

10912771 Oct 10, 2037 U-3055

10912771 Oct 10, 2037 U-3076

11026939 Sep 18, 2038 DP U-1995

11026939 Sep 18, 2038 DP U-3055

11311532 Sep 18, 2038 DP U-1995

11311532 Sep 18, 2038 DP U-3055

11439629 Oct 10, 2037 U-3055

11654142 Nov 14, 2038 U-3055

8357697 Nov 08, 2027 U-1995
A - 88

PATENT AND EXCLUSIVITY DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - December 2023

APPL/PROD PATENT PATENT EXCLUSIVITY

NO PATENT NO EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION

DATE CODES REQUESTED CODE(S) DATE

VALBENAZINE TOSYLATE - INGREZZA

N 209241 001 8357697 Nov 08, 2027 U-3055

VALBENAZINE TOSYLATE - INGREZZA

N 209241 002 10065952 Oct 28, 2036 DS DP U-1995 I-925 Aug 18, 2026

10065952 Oct 28, 2036 DS DP U-3055 ODE-440 Aug 18, 2030

10844058 Oct 28, 2036 DS DP U-1995

10844058 Oct 28, 2036 DS DP U-3055

10851103 Oct 28, 2036 DS DP U-1995

10851103 Oct 28, 2036 DS DP U-3055

10851104 Oct 28, 2036 DS U-1995

10851104 Oct 28, 2036 DS U-3055

10874648 Oct 10, 2037 U-1995

10874648 Oct 10, 2037 U-3046

10874648 Oct 10, 2037 U-3055

10912771 Oct 10, 2037 U-1995

10912771 Oct 10, 2037 U-3055

10912771 Oct 10, 2037 U-3076

11026939 Sep 18, 2038 DP U-1995

11026939 Sep 18, 2038 DP U-3055

11311532 Sep 18, 2038 DP U-1995

11311532 Sep 18, 2038 DP U-3055

11439629 Oct 10, 2037 U-3055

11654142 Nov 14, 2038 U-3055

8357697 Nov 08, 2027 U-1995

8357697 Nov 08, 2027 U-3055

VALBENAZINE TOSYLATE - INGREZZA

N 209241 003 10065952 Oct 28, 2036 DS DP U-1995 I-925 Aug 18, 2026

10065952 Oct 28, 2036 DS DP U-3055 ODE-440 Aug 18, 2030

10844058 Oct 28, 2036 DS DP U-1995

10844058 Oct 28, 2036 DS DP U-3055

10851103 Oct 28, 2036 DS DP U-1995

10851103 Oct 28, 2036 DS DP U-3055

10851104 Oct 28, 2036 DS U-1995

10851104 Oct 28, 2036 DS U-3055

10874648 Oct 10, 2037 U-1995

10874648 Oct 10, 2037 U-3046

10874648 Oct 10, 2037 U-3055

10912771 Oct 10, 2037 U-1995

10912771 Oct 10, 2037 U-3055

10912771 Oct 10, 2037 U-3076

11026939 Sep 18, 2038 DP U-1995

11026939 Sep 18, 2038 DP U-3055

11311532 Sep 18, 2038 DP U-1995

11311532 Sep 18, 2038 DP U-3055

11439629 Oct 10, 2037 U-3055

11654142 Nov 14, 2038 U-3055

8357697 Nov 08, 2027 U-1995

8357697 Nov 08, 2027 U-3055

VAMOROLONE - AGAMREE

N 215239 001 10857161 May 28, 2029 DP U-3747 NCE Oct 26, 2028

11382922 Jul 16, 2040 DS DP ODE-450 Oct 26, 2030

11471471 Mar 17, 2040 U-3747

11690853 Jun 29, 2036 U-3747

>A> 11833159 May 28, 2029 DP

8334279 May 28, 2029 U-3747

VANCOMYCIN - VANCOMYCIN

N 213895 001 11517609 Nov 06, 2035 U-282

VANCOMYCIN HYDROCHLORIDE - VANCOMYCIN HYDROCHLORIDE

A 214913 001 PC Feb 25, 2024
A - 89

PATENT AND EXCLUSIVITY DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - December 2023

APPL/PROD PATENT

NO PATENT NO EXPIRATION PATENT

DATE CODES

VANCOMYCIN HYDROCHLORIDE - VANCOMYCIN HYDROCHLORIDE

A 214913 002

VANCOMYCIN HYDROCHLORIDE - VANCOMYCIN HYDROCHLORIDE

A 215338 001

VANCOMYCIN HYDROCHLORIDE - VANCOMYCIN HYDROCHLORIDE

A 217489 001

VANCOMYCIN HYDROCHLORIDE - VANCOMYCIN HYDROCHLORIDE

A 217489 002

VANCOMYCIN HYDROCHLORIDE - FIRVANQ KIT

N 208910 001 11638692 Mar 13, 2035 DP

VANCOMYCIN HYDROCHLORIDE - FIRVANQ KIT

N 208910 002 11638692 Mar 13, 2035 DP

VANCOMYCIN HYDROCHLORIDE - VANCOMYCIN HYDROCHLORIDE

N 211962 001 11628200 Nov 06, 2035 DP

VANCOMYCIN HYDROCHLORIDE - VANCOMYCIN HYDROCHLORIDE

N 211962 002 11628200 Nov 06, 2035 DP

VANCOMYCIN HYDROCHLORIDE - VANCOMYCIN HYDROCHLORIDE

N 211962 003 11628200 Nov 06, 2035 DP

VANCOMYCIN HYDROCHLORIDE - VANCOMYCIN HYDROCHLORIDE

N 211962 004 11628200 Nov 06, 2035 DP

VANCOMYCIN HYDROCHLORIDE - VANCOMYCIN HYDROCHLORIDE

N 211962 005 11628200 Nov 06, 2035 DP

VANCOMYCIN HYDROCHLORIDE - VANCOMYCIN HYDROCHLORIDE

N 211962 006 11628200 Nov 06, 2035 DP

VANCOMYCIN HYDROCHLORIDE - VANCOMYCIN HYDROCHLORIDE

N 211962 007 11628200 Nov 06, 2035 DP

VASOPRESSIN - VASOSTRICT

N 204485 006 10010575

9919026

9925233

9925234

9962422

9968649

9974827

9981006

Jan 30, 2035

Jan 30, 2035

Jan 30, 2035

Jan 30, 2035

Jan 30, 2035

Jan 30, 2035

Jan 30, 2035

Jan 30, 2035

DP

U-1857

U-1857

U-1857

U-1857

U-1857

U-1857

U-1857

VENETOCLAX - VENCLEXTA

N 208573 001 11590128 Sep 06, 2033 U-3548

VENETOCLAX - VENCLEXTA

N 208573 002 11590128 Sep 06, 2033 U-3548

VENETOCLAX - VENCLEXTA

N 208573 003 11590128 Sep 06, 2033 U-3548

VOCLOSPORIN - LUPKYNIS

N 213716 001 11622991

7332472

Dec 07, 2037

Oct 17, 2024 DS DP

U-3056

U-3056

PATENT

DELIST

REQUESTED

EXCLUSIVITY

CODE(S)

EXCLUSIVITY

EXPIRATION

DATE

PC Feb 25, 2024

CGT Dec 20, 2023

CGT Feb 12, 2024

CGT Feb 12, 2024
A - 90

PATENT AND EXCLUSIVITY DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - December 2023

APPL/PROD PATENT PATENT EXCLUSIVITY

NO PATENT NO EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION

DATE CODES REQUESTED CODE(S) DATE

VONOPRAZAN FUMARATE - VOQUEZNA

N 215151 001 7977488

9186411

Aug 11, 2028

Aug 11, 2030

DS

DP

>A> NCE

>A> NP

May 03, 2027

Nov 01, 2026

VONOPRAZAN FUMARATE - VOQUEZNA

N 215151 002 7977488

9186411

Aug 11, 2028

Aug 11, 2030

DS

DP

>A> NCE

>A> NP

May 03, 2027

Nov 01, 2026

VORTIOXETINE HYDROBROMIDE - TRINTELLIX

N 204447 001 11458134 Jun 15, 2027

11458134*PED Dec 15, 2027

7144884 Jun 17, 2026

7144884*PED Dec 17, 2026

8722684 Jun 30, 2031

8722684*PED Dec 30, 2031

8969355 Jun 15, 2027

8969355*PED Dec 15, 2027

9125908 Jun 15, 2027

9125908*PED Dec 15, 2027

9125909 Jun 15, 2027

9125909*PED Dec 15, 2027

9125910 Jun 15, 2027

9125910*PED Dec 15, 2027

9227946 Jun 15, 2027

9227946*PED Dec 15, 2027

9278096 Mar 21, 2032

9278096*PED Sep 21, 2032

9861630 Jun 15, 2027

9861630*PED Dec 15, 2027

VORTIOXETINE HYDROBROMIDE - TRINTELLIX

N 204447 002 11458134 Jun 15, 2027

11458134*PED Dec 15, 2027

7144884 Jun 17, 2026

7144884*PED Dec 17, 2026

8722684 Jun 30, 2031

8722684*PED Dec 30, 2031

8969355 Jun 15, 2027

8969355*PED Dec 15, 2027

9125908 Jun 15, 2027

9125908*PED Dec 15, 2027

9125909 Jun 15, 2027

9125909*PED Dec 15, 2027

9125910 Jun 15, 2027

9125910*PED Dec 15, 2027

9227946 Jun 15, 2027

9227946*PED Dec 15, 2027

9278096 Mar 21, 2032

9278096*PED Sep 21, 2032

9861630 Jun 15, 2027

9861630*PED Dec 15, 2027

VORTIOXETINE HYDROBROMIDE - TRINTELLIX

N 204447 003 11458134 Jun 15, 2027

11458134*PED Dec 15, 2027

7144884 Jun 17, 2026

7144884*PED Dec 17, 2026

8722684 Jun 30, 2031

8722684*PED Dec 30, 2031

8969355 Jun 15, 2027

8969355*PED Dec 15, 2027

9125908 Jun 15, 2027

9125908*PED Dec 15, 2027

9125909 Jun 15, 2027

9125909*PED Dec 15, 2027

9125910 Jun 15, 2027

9125910*PED Dec 15, 2027

9227946 Jun 15, 2027

DP U-3463 M-232 Aug 23, 2026

PED Feb 23, 2027

DS DP U-1439

DS DP

U-1668

U-2309

U-2309

U-2309

U-1668

U-2436

U-1668

DP U-3463 M-232 Aug 23, 2026

PED Feb 23, 2027

DS DP U-1439

DS DP

U-1668

U-2309

U-2309

U-2309

U-1668

U-2436

U-1668

DP U-3463 M-232 Aug 23, 2026

PED Feb 23, 2027

DS DP U-1439

DS DP

U-1668

U-2309

U-2309

U-2309

U-1668
A - 91

PATENT AND EXCLUSIVITY DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - December 2023

APPL/PROD

NO PATENT NO

PATENT

EXPIRATION

DATE

PATENT

CODES

PATENT

DELIST

REQUESTED

EXCLUSIVITY

CODE(S)

EXCLUSIVITY

EXPIRATION

DATE

VORTIOXETINE HYDROBROMIDE - TRINTELLIX

N 204447 003 9227946*PED Dec 15, 2027

9278096 Mar 21, 2032

9278096*PED Sep 21, 2032

9861630 Jun 15, 2027

9861630*PED Dec 15, 2027

U-2436

U-1668

VORTIOXETINE HYDROBROMIDE - TRINTELLIX

N 204447 004 11458134 Jun 15, 2027

11458134*PED Dec 15, 2027

7144884 Jun 17, 2026

7144884*PED Dec 17, 2026

8722684 Jun 30, 2031

8722684*PED Dec 30, 2031

8969355 Jun 15, 2027

8969355*PED Dec 15, 2027

9125908 Jun 15, 2027

9125908*PED Dec 15, 2027

9125909 Jun 15, 2027

9125909*PED Dec 15, 2027

9125910 Jun 15, 2027

9125910*PED Dec 15, 2027

9227946 Jun 15, 2027

9227946*PED Dec 15, 2027

9278096 Mar 21, 2032

9278096*PED Sep 21, 2032

9861630 Jun 15, 2027

9861630*PED Dec 15, 2027

DP U-3463

DS DP U-1439

DS DP

U-1668

U-2309

U-2309

U-2309

U-1668

U-2436

U-1668

M-232

PED

Aug 23, 2026

Feb 23, 2027

VOSORITIDE - VOXZOGO

N 214938 001 NPP

ODE-387

ODE-449

Oct 20, 2026

Nov 19, 2028

Oct 20, 2030

VOSORITIDE - VOXZOGO

N 214938 002 NPP

ODE-387

ODE-449

Oct 20, 2026

Nov 19, 2028

Oct 20, 2030

VOSORITIDE - VOXZOGO

N 214938 003 NPP

ODE-387

ODE-449

Oct 20, 2026

Nov 19, 2028

Oct 20, 2030

VOXELOTOR - OXBRYTA

N 213137 001 ODE-394 Dec 17, 2028

VOXELOTOR - OXBRYTA

N 213137 002 NCE

ODE-394

Nov 25, 2024

Dec 17, 2028

VOXELOTOR - OXBRYTA

N 216157 001 ODE-394 Dec 17, 2028

VUTRISIRAN SODIUM - AMVUTTRA

N 215515 001 ODE-212 Jun 13, 2029

XENON XE-129 HYPERPOLARIZED - XENOVIEW

N 214375 001 10583205 Feb 20, 2035

11052161 Dec 29, 2035

DP

DP

NCE Dec 23, 2027

ZANUBRUTINIB - BRUKINSA

N 213217 001 10570139

10570139

10570139

10570139

Apr 22, 2034

Apr 22, 2034

Apr 22, 2034

Apr 22, 2034

U-1745

U-2145

U-2537

U-2666

I-817

ODE-274

Jan 19, 2026

Jan 19, 2030
A - 92

PATENT AND EXCLUSIVITY DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - December 2023

APPL/PROD PATENT PATENT EXCLUSIVITY

NO PATENT NO EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION

DATE CODES REQUESTED CODE(S) DATE

ZANUBRUTINIB - BRUKINSA

N 213217 001 10570139 Apr 22, 2034 U-3063

10570139 Apr 22, 2034 U-3486

11142528 Apr 22, 2034 DP U-1745

11142528 Apr 22, 2034 DP U-2145

11142528 Apr 22, 2034 DP U-2537

11142528 Apr 22, 2034 DP U-2666

11142528 Apr 22, 2034 DP U-3063

11142528 Apr 22, 2034 DP U-3486

11591340 Aug 15, 2037 U-1745

11591340 Aug 15, 2037 U-2145

11591340 Aug 15, 2037 U-2537

11591340 Aug 15, 2037 U-2666

11591340 Aug 15, 2037 U-3063

11591340 Aug 15, 2037 U-3486

11786531 Jan 19, 2043 U-3715

11786531 Jan 19, 2043 U-3716

11786531 Jan 19, 2043 U-3717

11786531 Jan 19, 2043 U-3718

11786531 Jan 19, 2043 U-3719

11786531 Jan 19, 2043 U-3720

9447106 Apr 22, 2034 DS DP U-1745

9447106 Apr 22, 2034 DS DP U-2145

9447106 Apr 22, 2034 DS DP U-2537

9447106 Apr 22, 2034 DS DP U-2666

9447106 Apr 22, 2034 DS DP U-3063

9447106 Apr 22, 2034 DS DP U-3486

ZAVEGEPANT HYDROCHLORIDE - ZAVZPRET

N 216386 001 7220862 Jan 21, 2024 DS DP NCE Mar 09, 2028

7314883 Dec 05, 2023 U-3555

8481546 Oct 07, 2031 DS DP U-3555

ZILUCOPLAN SODIUM - ZILBRYSQ

N 216834 001 10106579 Jun 12, 2035 DS DP U-3735 NCE Oct 17, 2028

10208089 Jun 12, 2035 DS U-3735 ODE-446 Oct 17, 2030

10435438 Jun 12, 2035 DS U-3735

10562934 Jun 12, 2035 DS

10835574 Jun 12, 2035 DP

11014965 Jun 12, 2035 DS U-3735

11535650 Jun 12, 2035 DP

11752190 Jun 12, 2035 DP U-3735

ZILUCOPLAN SODIUM - ZILBRYSQ

N 216834 002 10106579 Jun 12, 2035 DS DP U-3735 NCE Oct 17, 2028

10208089 Jun 12, 2035 DS U-3735 ODE-446 Oct 17, 2030

10435438 Jun 12, 2035 DS U-3735

10562934 Jun 12, 2035 DS

10835574 Jun 12, 2035 DP

11014965 Jun 12, 2035 DS U-3735

11535650 Jun 12, 2035 DP

11752190 Jun 12, 2035 DP U-3735

ZILUCOPLAN SODIUM - ZILBRYSQ

N 216834 003 10106579 Jun 12, 2035 DS DP U-3735 NCE Oct 17, 2028

10208089 Jun 12, 2035 DS U-3735 ODE-446 Oct 17, 2030

10435438 Jun 12, 2035 DS U-3735

10562934 Jun 12, 2035 DS

10835574 Jun 12, 2035 DP

11014965 Jun 12, 2035 DS U-3735

11535650 Jun 12, 2035 DP

11752190 Jun 12, 2035 DP U-3735

ZINC SULFATE - ZINC SULFATE

A 216145 001 CGT Aug 14, 2023
A - 93

PATENT AND EXCLUSIVITY DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 12 - December 2023

APPL/PROD PATENT PATENT EXCLUSIVITY

NO PATENT NO EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION

DATE CODES REQUESTED CODE(S) DATE

ZURANOLONE - ZURZUVAE

N 217369 001 10172871

10342810

11236121

9512165

Apr 17, 2034

Apr 17, 2034

Aug 23, 2037

Apr 17, 2034

U-2552

U-2552

DS

DS DP

NCE Oct 31, 2028

ZURANOLONE - ZURZUVAE

N 217369 002 10172871

10342810

11236121

9512165

Apr 17, 2034

Apr 17, 2034

Aug 23, 2037

Apr 17, 2034

U-2552

U-2552

DS

DS DP

NCE Oct 31, 2028

ZURANOLONE - ZURZUVAE

N 217369 003 10172871

10342810

11236121

9512165

Apr 17, 2034

Apr 17, 2034

Aug 23, 2037

Apr 17, 2034

U-2552

U-2552

DS

DS DP

NCE Oct 31, 2028
B-1 

PATENT AND EXCLUSIVITY TERMS 

Due to space limitations in the patent and exclusivity columns, 

abbreviations and references have been developed. Refer to the APPROVED DRUG 

PRODUCTS WITH THERAPEUTIC EQUIVALENCE EVALUATIONS, 43rd Edition for a full listing of 

patent and exclusivity terms (Abbreviations, Dosing Schedule, Indications, 

and Patent Use Codes). 

The current complete list of patent terms is available at 

http://www.accessdata.fda.gov/scripts/cder/ob/results_patent.cfm 

The current complete list of exclusivity terms is available at 

http://www.accessdata.fda.gov/scripts/cder/ob/results_exclusivity.cfm