Approved Drug Product List - Orange Book

Page 1 of 22

Reference Listed Drugs by ANDA Reference Standard List

December 2023

This list refers to drug products approved under an Abbreviated New Drug Application (ANDA) that

FDA has selected as reference standards and the associated reference listed drugs (RLDs). The

purpose of this list is to assist applicants submitting an ANDA to seek approval of a generic drug

in identifying an RLD when an ANDA RS has been selected. If the applicant has a question about

which listed drug it should refer to as the RLD, the applicant may consult with FDA (refer to

section 1.4 Reference Listed Drug and Reference Standard of the Orange Book Preface for more

information).

This list is updated monthly. Information in this list is sorted by Active Ingredient(s), Dosage

Form, Route, Trade Name, Applicant Name and Strength. Additional information included are

marketing status (RX, OTC, DISCN), Application Number, Product Number, and approval date of the

Reference Standard.

DESCRIPTION
Approved Drug Product List - Orange Book

Page 2 of 22

Reference Listed Drugs by ANDA Reference Standard List

December 2023

ABACAVIR SULFATE

TABLET;ORAL

ABACAVIR SULFATE

HETERO LABS LTD

III

RX EQ 300MG BASE A091560 001 Sep 13, 2013 RLD: N020977

ABACAVIR SULFATE; LAMIVUDINE; ZIDOVUDINE

TABLET;ORAL

ABACAVIR SULFATE, LAMIVUDINE AND ZIDOVUDINE

RX LUPIN LTD EQ 300MG BASE;150MG;300MG A202912 001 Dec 05, 2013 RLD: N021205

ACETAMINOPHEN

SOLUTION;INTRAVENOUS

ACETAMINOPHEN

RX SANDOZ 1GM/100ML (10MG/ML) A204052 001 Mar 22, 2016 RLD: N022450

ACETAMINOPHEN; BUTALBITAL

TABLET;ORAL

BUTAPAP

RX MIKART 325MG;50MG A089987 001 Oct 26, 1992 RLD: A087550

ACETAMINOPHEN; BUTALBITAL; CAFFEINE

CAPSULE;ORAL

BUTALBITAL, ACETAMINOPHEN AND CAFFEINE

RX DR REDDYS LABS SA 325MG;50MG;40MG A089007 001 Mar 17, 1986 RLD: A088825

TABLET;ORAL

BUTALBITAL, ACETAMINOPHEN AND CAFFEINE

RX STRIDES PHARMA 325MG;50MG;40MG A040511 001 Aug 27, 2003 RLD: A088616

ACETAMINOPHEN; CODEINE PHOSPHATE

TABLET;ORAL

ACETAMINOPHEN AND CODEINE PHOSPHATE

RX SPECGX LLC 300MG;15MG A040419 001 May 31, 2001 RLD: A085055

RX 300MG;30MG A040419 002 May 31, 2001 RLD: A085055

ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE

TABLET;ORAL

PERCOCET

RX VINTAGE PHARMS LLC 325MG;5MG A040330 002 Jun 25, 1999 RLD: A085106

ACETAZOLAMIDE

CAPSULE, EXTENDED RELEASE;ORAL

ACETAZOLAMIDE

RX CADILA 500MG A205301 001 Jan 16, 2019 RLD: N012945

ACYCLOVIR

CREAM;TOPICAL

ACYCLOVIR

RX PADAGIS ISRAEL 5% A208702 001 Feb 04, 2019 RLD: N021478

SUSPENSION;ORAL

ACYCLOVIR

RX NOVITIUM PHARMA 200MG/5ML A212252 001 Jul 10, 2020 RLD: N019909

ALBENDAZOLE

TABLET;ORAL

ALBENDAZOLE

RX DR REDDYS 200MG A211034 001 Jan 26, 2021 RLD: N020666

ALBUTEROL SULFATE

SOLUTION;INHALATION

ALBUTEROL SULFATE

RX RITEDOSE CORP EQ 0.021% BASE A214531 001 Dec 28, 2021 RLD: N020949
Approved Drug Product List - Orange Book

Page 3 of 22

Reference Listed Drugs by ANDA Reference Standard List

December 2023

ALBUTEROL SULFATE; IPRATROPIUM BROMIDE

SOLUTION;INHALATION

ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE

RX NEPHRON EQ 0.083% BASE;0.017% A076749 001 Dec 31, 2007 RLD: N020950

ALLOPURINOL

TABLET;ORAL

ALLOPURINOL

RX UNICHEM 300MG A211820 002 Mar 12, 2019 RLD: N016084

ALMOTRIPTAN MALATE

TABLET;ORAL

ALMOTRIPTAN MALATE

RX AJANTA PHARMA LTD EQ 12.5MG BASE A205523 002 Mar 03, 2016 RLD: N021001

ALVIMOPAN

CAPSULE;ORAL

ALVIMOPAN

RX WATSON LABS TEVA 12MG A208295 001 Dec 19, 2019 RLD: N021775

AMINOCAPROIC ACID

TABLET;ORAL

AMINOCAPROIC ACID

RX SUNNY 1GM A209060 002 Nov 27, 2018 RLD: N015197

AMLODIPINE BESYLATE; TELMISARTAN

TABLET;ORAL

TELMISARTAN AND AMLODIPINE

RX MYLAN EQ 10MG BASE;80MG A202516 004 Aug 26, 2014 RLD: N022401

AMMONIUM LACTATE

CREAM;TOPICAL

AMMONIUM LACTATE

RX PADAGIS ISRAEL EQ 12% BASE A075774 001 May 01, 2002 RLD: N020508

AMOXICILLIN

TABLET, CHEWABLE;ORAL

AMOXICILLIN

RX TEVA 250MG A064013 001 Dec 22, 1992 RLD: N050542

AMOXICILLIN; CLARITHROMYCIN; LANSOPRAZOLE

CAPSULE, TABLET, CAPSULE, DELAYED REL PELLETS;ORAL

LANSOPRAZOLE, AMOXICILLIN AND CLARITHROMYCIN (COPACKAGED)

RX RISING 500MG;500MG;30MG A206006 001 Oct 07, 2016 RLD: N050757

AMOXICILLIN; CLAVULANATE POTASSIUM

TABLET;ORAL

AMOXICILLIN AND CLAVULANATE POTASSIUM

RX SANDOZ 250MG;EQ 125MG BASE A065189 001 Aug 23, 2005 RLD: N050564

RX SANDOZ INC 500MG;EQ 125MG BASE A065117 001 Nov 27, 2002 RLD: N050564

AMPHETAMINE SULFATE

TABLET;ORAL

EVEKEO

RX ARBOR PHARMS LLC 10MG A200166 002 Aug 09, 2012 RLD: A083901

AMPICILLIN/AMPICILLIN TRIHYDRATE

CAPSULE;ORAL

AMPICILLIN TRIHYDRATE

RX SANDOZ EQ 500MG BASE A064082 002 Aug 29, 1995 RLD: N050056

ARGATROBAN

INJECTABLE;INJECTION

ARGATROBAN

RX HOSPIRA 250MG/2.5ML (100MG/ML) A204120 001 Sep 21, 2016 RLD: N020833
Approved Drug Product List - Orange Book

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Reference Listed Drugs by ANDA Reference Standard List

December 2023

ARIPIPRAZOLE

SOLUTION;ORAL

ARIPIPRAZOLE

RX AMNEAL PHARMS 1MG/ML A203906 001 Aug 14, 2015 RLD: N021713

ARSENIC TRIOXIDE

INJECTABLE;INJECTION

ARSENIC TRIOXIDE

RX FRESENIUS KABI USA 1MG/ML A208231 001 Aug 31, 2018 RLD: N021248

ASPIRIN; BUTALBITAL; CAFFEINE

TABLET;ORAL

BUTALBITAL, ASPIRIN AND CAFFEINE

RX STRIDES PHARMA 325MG;50MG;40MG A204195 001 Sep 22, 2016 RLD: A086162

ASPIRIN; DIPYRIDAMOLE

CAPSULE, EXTENDED RELEASE;ORAL

ASPIRIN AND DIPYRIDAMOLE

RX GLENMARK PHARMS SA 25MG;200MG A210318 001 May 24, 2019 RLD: N020884

ATORVASTATIN CALCIUM; EZETIMIBE

TABLET;ORAL

LYPQOZET

RX ALTHERA PHARMS EQ 80MG BASE;10MG A206084 004 Apr 26, 2017 RLD: N200153

ATROPINE SULFATE

SOLUTION/DROPS;OPHTHALMIC

ATROPINE SULFATE

RX AMNEAL 1% A214752 001 Jul 14, 2022 RLD: N206289

AZELASTINE HYDROCHLORIDE; FLUTICASONE PROPIONATE

SPRAY, METERED;NASAL

AZELASTINE HYDROCHLORIDE AND FLUTICASONE PROPIONATE

RX APOTEX 0.137MG/SPRAY;0.05MG/SPRAY A207712 001 Apr 28, 2017 RLD: N202236

BACLOFEN

TABLET;ORAL

BACLOFEN

RX RUBICON 5MG A209102 001 Nov 28, 2017 RLD: N017851

BENZONATATE

CAPSULE;ORAL

BENZONATATE

RX PURACAP PHARM LLC 100MG A206948 001 Dec 19, 2018 RLD: N011210

RX 200MG A206948 002 Dec 19, 2018 RLD: N011210

BENZOYL PEROXIDE; CLINDAMYCIN PHOSPHATE

GEL;TOPICAL

CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE

RX GLENMARK PHARMS 5%;EQ 1% BASE A209252 001 Mar 14, 2019 RLD: N050756

BETAMETHASONE VALERATE

AEROSOL, FOAM;TOPICAL

BETAMETHASONE VALERATE

RX TARO 0.12% A208204 001 May 24, 2017 RLD: N020934

BETHANECHOL CHLORIDE

TABLET;ORAL

BETHANECHOL CHLORIDE

RX AMNEAL PHARM 10MG A040855 002 Nov 21, 2007 RLD: A088440

RX 25MG A040855 003 Nov 21, 2007 RLD: A088441

BIMATOPROST

SOLUTION/DROPS;OPHTHALMIC

BIMATOPROST

RX ALEMBIC 0.03% A210263 001 Apr 12, 2019 RLD: N021275
Approved Drug Product List - Orange Book

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Reference Listed Drugs by ANDA Reference Standard List

December 2023

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,

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

RX A202584 001 Nov 30, 2018 RLD: N050719

BROMFENAC SODIUM

SOLUTION/DROPS;OPHTHALMIC

BROMFENAC SODIUM

RX ALEMBIC EQ 0.09% ACID A210560 001 Jun 21, 2019 RLD: N021664

BROMOCRIPTINE MESYLATE

CAPSULE;ORAL

BROMOCRIPTINE MESYLATE

RX MYLAN EQ 5MG BASE A077226 001 Apr 04, 2005 RLD: N017962

TABLET;ORAL

BROMOCRIPTINE MESYLATE

RX PADAGIS US EQ 2.5MG BASE A077646 001 Oct 01, 2008 RLD: N017962

BROMPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PSEUDOEPHEDRINE HYDROCHLORIDE

SYRUP;ORAL

BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE

RX PADAGIS US 2MG/5ML;10MG/5ML;30MG/5ML A205292 001 Jul 15, 2014 RLD: A088811

BUPRENORPHINE HYDROCHLORIDE

INJECTABLE;INJECTION

BUPRENORPHINE HYDROCHLORIDE

PAR STERILE

PRODUCTS

RX EQ 0.3MG BASE/ML A206586 001 Jul 28, 2015 RLD: N018401

BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE

TABLET;SUBLINGUAL

BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE

RX HIKMA EQ 8MG BASE;EQ 2MG BASE A203326 002 Jun 27, 2014 RLD: N020733

BUPROPION HYDROCHLORIDE

TABLET;ORAL

BUPROPION HYDROCHLORIDE

RX APOTEX INC 100MG A076143 002 Jan 17, 2006 RLD: N018644

CABERGOLINE

TABLET;ORAL

CABERGOLINE

RX INGENUS PHARMS LLC 0.5MG A204735 001 Aug 01, 2018 RLD: N020664

CAFFEINE; ERGOTAMINE TARTRATE

TABLET;ORAL

ERGOTAMINE TARTRATE AND CAFFEINE

RX MIKART 100MG;1MG A040590 001 Sep 16, 2005 RLD: A084294

CALCIPOTRIENE

OINTMENT;TOPICAL

CALCIPOTRIENE

GLENMARK PHARMS

INC

RX 0.005% A090633 001 Mar 24, 2010 RLD: N020273

CALCITONIN SALMON

SPRAY, METERED;NASAL

CALCITONIN-SALMON

RX APOTEX INC 200 IU/SPRAY A076396 001 Nov 17, 2008 RLD: N020313

CARBIDOPA; LEVODOPA

TABLET, EXTENDED RELEASE;ORAL

CARBIDOPA AND LEVODOPA

RX SCIEGEN PHARMS INC 50MG;200MG A214091 002 Oct 05, 2021 RLD: N019856
Approved Drug Product List - Orange Book

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Reference Listed Drugs by ANDA Reference Standard List

December 2023

CARBOPLATIN

INJECTABLE;INTRAVENOUS

CARBOPLATIN

RX ACCORD HLTHCARE 1GM/100ML (10MG/ML) A206775 005 Apr 06, 2020 RLD: N020452

CEFAZOLIN SODIUM

INJECTABLE;INJECTION

CEFAZOLIN SODIUM

RX QILU EQ 10GM BASE/VIAL A209217 001 Oct 17, 2018 RLD: N050461

CEFEPIME HYDROCHLORIDE

INJECTABLE;INJECTION

CEFEPIME HYDROCHLORIDE

RX QILU EQ 500MG BASE/VIAL A203704 001 Feb 01, 2016 RLD: N050679

RX EQ 1GM BASE/VIAL A203704 002 Feb 01, 2016 RLD: N050679

RX EQ 2GM BASE/VIAL A203704 003 Feb 01, 2016 RLD: N050679

CEFOTETAN DISODIUM

INJECTABLE;INJECTION

CEFOTETAN

RX FRESENIUS KABI USA EQ 1GM BASE/VIAL A065374 001 Aug 09, 2007 RLD: N050588

RX EQ 2GM BASE/VIAL A065374 002 Aug 09, 2007 RLD: N050588

CEFUROXIME SODIUM

INJECTABLE;INJECTION

CEFUROXIME SODIUM

RX HIKMA EQ 1.5GM BASE/VIAL A065048 002 Jan 09, 2004 RLD: N050558

INJECTABLE;INTRAMUSCULAR, INTRAVENOUS

CEFUROXIME SODIUM

RX HIKMA EQ 750MG BASE/VIAL A065048 001 Jan 09, 2004 RLD: N050558

CHLOROQUINE PHOSPHATE

TABLET;ORAL

CHLOROQUINE PHOSPHATE

RX NATCO PHARMA LTD 500MG A090612 001 Jan 21, 2011 RLD: N006002

CHLOROTHIAZIDE SODIUM

INJECTABLE;INJECTION

CHLOROTHIAZIDE SODIUM

RX SAGENT PHARMS INC EQ 500MG BASE/VIAL A202462 001 May 29, 2015 RLD: N011145

CHLORPROMAZINE HYDROCHLORIDE

CONCENTRATE;ORAL

CHLORPROMAZINE HYDROCHLORIDE

RX GENUS 30MG/ML A214542 001 Jun 02, 2021 RLD: N009149

RX 100MG/ML A214542 002 Jun 02, 2021 RLD: N009149

CHLORZOXAZONE

TABLET;ORAL

CHLORZOXAZONE

RX MIKART 250MG A207483 001 Jun 24, 2016 RLD: N011300

CIPROFLOXACIN

INJECTABLE;INJECTION

CIPROFLOXACIN

BAXTER HLTHCARE

CORP

RX 200MG/20ML (10MG/ML) A078062 001 Apr 29, 2008 RLD: N019847

RX 400MG/40ML (10MG/ML) A078062 002 Apr 29, 2008 RLD: N019847

CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER

RX HOSPIRA 200MG/100ML A077753 001 Mar 18, 2008 RLD: N019857

RX 400MG/200ML A077753 002 Mar 18, 2008 RLD: N019857
Approved Drug Product List - Orange Book

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Reference Listed Drugs by ANDA Reference Standard List

December 2023

CITRIC ACID; MAGNESIUM OXIDE; SODIUM PICOSULFATE

FOR SOLUTION;ORAL

SODIUM PICOSULFATE, MAGNESIUM OXIDE AND ANHYDROUS CITRIC ACID

HETERO LABS LTD V 12GM/PACKET;3.5GM/PACKET;10MG/P

ACKET

RX A212789 001 Jul 18, 2022 RLD: N202535

CLINDAMYCIN PHOSPHATE

AEROSOL, FOAM;TOPICAL

CLINDAMYCIN PHOSPHATE

RX PADAGIS ISRAEL 1% A090785 001 Mar 31, 2010 RLD: N050801

INJECTABLE;INJECTION

CLINDAMYCIN PHOSPHATE IN 5% DEXTROSE IN PLASTIC CONTAINER

RX SANDOZ INC EQ 6MG BASE/ML A201692 001 May 31, 2012 RLD: N050639

RX EQ 12MG BASE/ML A201692 002 May 31, 2012 RLD: N050639

RX EQ 18MG BASE/ML A201692 003 May 31, 2012 RLD: N050639

CLOBETASOL PROPIONATE

AEROSOL, FOAM;TOPICAL

CLOBETASOL PROPIONATE

RX PADAGIS ISRAEL 0.05% A201402 001 Aug 14, 2012 RLD: N022013

RX TARO 0.05% A208779 001 Oct 04, 2018 RLD: N021142

CREAM;TOPICAL

CLOBETASOL PROPIONATE

RX ENCUBE 0.05% A212982 001 Aug 28, 2020 RLD: N019322

OINTMENT;TOPICAL

CLOBETASOL PROPIONATE

RX FOUGERA PHARMS 0.05% A074407 001 Feb 23, 1996 RLD: N019323

CLONIDINE HYDROCHLORIDE

TABLET, EXTENDED RELEASE;ORAL

CLONIDINE HYDROCHLORIDE

RX AJANTA PHARMA LTD 0.1MG A209686 001 Nov 20, 2017 RLD: N022331

CUPRIC SULFATE

INJECTABLE;INJECTION

CUPRIC SULFATE

RX AM REGENT EQ 0.4MG COPPER/ML A216324 001 Dec 16, 2022 RLD: N019350

CYCLOBENZAPRINE HYDROCHLORIDE

TABLET;ORAL

CYCLOBENZAPRINE HYDROCHLORIDE

RX RUBICON 10MG A208170 003 May 31, 2017 RLD: N017821

CYPROHEPTADINE HYDROCHLORIDE

TABLET;ORAL

CYPROHEPTADINE HYDROCHLORIDE

RX ZYDUS PHARMS 4MG A208938 001 May 19, 2017 RLD: N012649

CYTARABINE

INJECTABLE;INJECTION

CYTARABINE

RX FRESENIUS KABI USA 100MG/ML A076512 001 Jan 15, 2004 RLD: N016793

RX HOSPIRA 20MG/ML A071868 001 Jun 04, 1990 RLD: N016793

WEST-WARD PHARMS

INT

RX 2GM/VIAL A074245 002 Aug 31, 1994 RLD: N016793

DACARBAZINE

INJECTABLE;INJECTION

DACARBAZINE

RX FRESENIUS KABI USA 100MG/VIAL A075371 001 Aug 27, 1999 RLD: N017575

RX 200MG/VIAL A075371 002 Aug 27, 1999 RLD: N017575
Approved Drug Product List - Orange Book

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Reference Listed Drugs by ANDA Reference Standard List

December 2023

DAPSONE

TABLET;ORAL

DAPSONE

RX NOVITIUM PHARMA 100MG A206505 002 Dec 01, 2016 RLD: A086842

DAPTOMYCIN

POWDER;INTRAVENOUS

DAPTOMYCIN

RX QILU PHARM HAINAN 500MG/VIAL A215316 001 Aug 24, 2021 RLD: N021572

DARIFENACIN HYDROBROMIDE

TABLET, EXTENDED RELEASE;ORAL

DARIFENACIN

MACLEODS PHARMS

LTD

RX EQ 15MG BASE A207302 002 Jul 28, 2017 RLD: N021513

DECITABINE

INJECTABLE;INTRAVENOUS

DECITABINE

RX ACCORD HLTHCARE 50MG/VIAL A203475 001 Feb 27, 2017 RLD: N021790

DEFERIPRONE

TABLET;ORAL

DEFERIPRONE

RX HIKMA 1GM A213239 002 Feb 08, 2022 RLD: N021825

DESOGESTREL; ETHINYL ESTRADIOL

TABLET;ORAL-28

DESOGESTREL AND ETHINYL ESTRADIOL

DURAMED PHARMS

BARR

RX 0.15MG;0.03MG A075256 002 Aug 12, 1999 RLD: N020301

DESONIDE

GEL;TOPICAL

DESONIDE

RX CINTEX SVCS 0.05% A202470 001 May 11, 2020 RLD: N021844

DEXAMETHASONE SODIUM PHOSPHATE

INJECTABLE;INJECTION

DEXAMETHASONE SODIUM PHOSPHATE PRESERVATIVE FREE

RX FRESENIUS KABI USA EQ 10MG PHOSPHATE/ML A040491 001 Apr 11, 2003 RLD: N014694

DIAZEPAM

INJECTABLE;INJECTION

DIAZEPAM

RX BELOTECA 10MG/2ML (5MG/ML) A210363 001 Mar 18, 2019 RLD: N016087

DICLOFENAC POTASSIUM

TABLET;ORAL

DICLOFENAC POTASSIUM

RX RK PHARMA 50MG A075463 001 Jul 26, 1999 RLD: N020142

DICLOFENAC SODIUM

GEL;TOPICAL

DICLOFENAC SODIUM

RX TARO 3% A206298 001 Apr 28, 2016 RLD: N021005

TABLET, EXTENDED RELEASE;ORAL

DICLOFENAC SODIUM

RX DEXCEL LTD 100MG A076201 001 Nov 06, 2002 RLD: N020254

DICYCLOMINE HYDROCHLORIDE

SYRUP;ORAL

DICYCLOMINE HYDROCHLORIDE

RX GENERICS 10MG/5ML A040169 001 Mar 24, 2005 RLD: N007961
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Reference Listed Drugs by ANDA Reference Standard List

December 2023

DIHYDROERGOTAMINE MESYLATE

INJECTABLE;INJECTION

DIHYDROERGOTAMINE MESYLATE

RX HIKMA PHARMS 1MG/ML A206621 001 Sep 15, 2017 RLD: N005929

DIMENHYDRINATE

INJECTABLE;INJECTION

DIMENHYDRINATE

RX FRESENIUS KABI USA 50MG/ML A040519 001 Jun 23, 2004 RLD: A080615

DORZOLAMIDE HYDROCHLORIDE

SOLUTION/DROPS;OPHTHALMIC

DORZOLAMIDE HYDROCHLORIDE

RX MICRO LABS EQ 2% BASE A204778 001 Nov 08, 2019 RLD: N020408

DOXORUBICIN HYDROCHLORIDE

INJECTABLE, LIPOSOMAL;INJECTION

DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL)

RX SUN PHARM 20MG/10ML (2MG/ML) A203263 001 Feb 04, 2013 RLD: N050718

RX 50MG/25ML (2MG/ML) A203263 002 Feb 04, 2013 RLD: N050718

DOXYCYCLINE HYCLATE

INJECTABLE;INJECTION

DOXYCYCLINE

RX ZYDUS PHARMS EQ 100MG BASE/VIAL A207757 001 Sep 28, 2017 RLD: N050442

TABLET, DELAYED RELEASE;ORAL

DOXYCYCLINE HYCLATE

RX HERITAGE PHARMS EQ 200MG BASE A200856 004 Nov 13, 2018 RLD: N050795

DROPERIDOL

INJECTABLE;INJECTION

DROPERIDOL

RX AM REGENT 2.5MG/ML A072123 001 Oct 24, 1988 RLD: N016796

DYCLONINE HYDROCHLORIDE

SOLUTION;TOPICAL

DYCLOPRO

RX SEPTODONT 0.5% A200480 001 Nov 20, 2018 RLD: N009925

RX 1% A200480 002 Nov 20, 2018 RLD: N009925

EDETATE CALCIUM DISODIUM

INJECTABLE;INJECTION

EDETATE CALCIUM DISODIUM

RX CASPER PHARMA LLC 200MG/ML A216435 001 May 03, 2023 RLD: N008922

EFAVIRENZ

CAPSULE;ORAL

EFAVIRENZ

RX AUROBINDO PHARMA 200MG A078064 003 Dec 15, 2017 RLD: N020972

TABLET;ORAL

EFAVIRENZ

HETERO LABS LTD

III

RX 600MG A078886 001 Apr 27, 2018 RLD: N021360

EPOPROSTENOL SODIUM

INJECTABLE;INJECTION

EPOPROSTENOL SODIUM

RX SUN PHARM EQ 0.5MG BASE/VIAL A210473 001 Jan 15, 2021 RLD: N022260

EPTIFIBATIDE

INJECTABLE;INJECTION

EPTIFIBATIDE

RX MYLAN LABS LTD 2MG/ML A203258 001 Jul 20, 2018 RLD: N020718

RX 75MG/100ML A203258 002 Jul 20, 2018 RLD: N020718
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Reference Listed Drugs by ANDA Reference Standard List

December 2023

ERGOCALCIFEROL

CAPSULE;ORAL

ERGOCALCIFEROL

RX STRIDES PHARMA 50,000 IU A090455 001 Aug 03, 2010 RLD: N003444

ERLOTINIB HYDROCHLORIDE

TABLET;ORAL

ERLOTINIB HYDROCHLORIDE

RX ZYDUS PHARMS EQ 150MG BASE A213065 003 Apr 16, 2020 RLD: N021743

ESOMEPRAZOLE MAGNESIUM; NAPROXEN

TABLET, DELAYED RELEASE;ORAL

NAPROXEN AND ESOMEPRAZOLE MAGNESIUM

RX DR REDDYS EQ 20MG BASE;500MG A204206 002 Feb 18, 2020 RLD: N022511

ESTRADIOL

TABLET;ORAL

ESTRADIOL

RX BARR LABS INC 2MG A040197 003 Oct 22, 1997 RLD: A084500

ETHINYL ESTRADIOL; NORETHINDRONE

TABLET;ORAL-28

BALZIVA-28

RX BARR 0.035MG;0.4MG A076238 001 Apr 22, 2004 RLD: N017716

ETHINYL ESTRADIOL; NORETHINDRONE ACETATE

TABLET;ORAL

HAILEY 24 FE

GLENMARK PHARMS

LTD

RX 0.02MG;1MG A204847 001 Nov 17, 2017 RLD: N021871

NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE

GLENMARK PHARMS

LTD

RX 0.02MG;1MG A210369 001 Dec 26, 2017 RLD: N203667

TABLET;ORAL-28

CHABELINA FE

NOVAST LABS 0.02MG,0.03MG,0.035MG;1MG,1MG,1

MG

RX A202962 001 Apr 15, 2020 RLD: N020130

ETHINYL ESTRADIOL; NORGESTIMATE

TABLET;ORAL-28

NORGESTIMATE AND ETHINYL ESTRADIOL

GLENMARK PHARMS 0.025MG,0.025MG,0.025MG;0.18MG,

0.215MG,0.25MG

RX A204057 001 Feb 23, 2016 RLD: N021241

FAMCICLOVIR

TABLET;ORAL

FAMCICLOVIR

RX TEVA PHARMS 500MG A077487 003 Aug 24, 2007 RLD: N020363

FAMOTIDINE

FOR SUSPENSION;ORAL

FAMOTIDINE

RX NOVITIUM PHARMA 40MG/5ML A215043 001 Apr 20, 2021 RLD: N019527

TABLET;ORAL

FAMOTIDINE

AUROBINDO PHARMA

LTD

RX 40MG A206530 002 Dec 22, 2015 RLD: N019462

FENOFIBRATE

CAPSULE;ORAL

FENOFIBRATE (MICRONIZED)

RX AJANTA PHARMA LTD 200MG A210705 003 Sep 10, 2018 RLD: N019304
Approved Drug Product List - Orange Book

Page 11 of 22

Reference Listed Drugs by ANDA Reference Standard List

December 2023

FLUCONAZOLE

INJECTABLE;INJECTION

FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER

RX INFORLIFE 200MG/100ML (2MG/ML) A079104 001 Jul 30, 2009 RLD: N019950

RX 400MG/200ML (2MG/ML) A079104 002 Jul 30, 2009 RLD: N019950

FLUNISOLIDE

SPRAY, METERED;NASAL

FLUNISOLIDE

RX BAUSCH 0.025MG/SPRAY A074805 001 Feb 20, 2002 RLD: N018148

FLUOCINONIDE

CREAM;TOPICAL

FLUOCINONIDE

RX AMNEAL 0.05% A210554 001 Aug 21, 2018 RLD: N019117

FLUOROURACIL

SOLUTION;TOPICAL

FLUOROURACIL

RX TARO 5% A076526 002 Nov 05, 2003 RLD: N016831

FLUOXETINE HYDROCHLORIDE

TABLET;ORAL

FLUOXETINE HYDROCHLORIDE

RX DR REDDYS EQ 20MG BASE A076006 002 Apr 23, 2018 RLD: N020974

RX TORRENT EQ 20MG BASE A206937 002 Oct 21, 2016 RLD: N021860

FLURANDRENOLIDE

LOTION;TOPICAL

FLURANDRENOLIDE

RX PADAGIS ISRAEL 0.05% A207133 001 Aug 30, 2016 RLD: N013790

OINTMENT;TOPICAL

FLURANDRENOLIDE

RX TELIGENT 0.05% A207851 001 Dec 30, 2016 RLD: N012806

FLURBIPROFEN

TABLET;ORAL

FLURBIPROFEN

RX TEVA 100MG A074431 001 May 31, 1995 RLD: N018766

FLUTICASONE PROPIONATE

SPRAY, METERED;NASAL

FLUTICASONE PROPIONATE

RX HIKMA 0.05MG/SPRAY A076504 001 Feb 22, 2006 RLD: N020121

OTC 0.05MG/SPRAY A207957 001 May 26, 2016 RLD: N205434

FOLIC ACID

TABLET;ORAL

FOLIC ACID

RX AMNEAL PHARM 1MG A040625 001 Jul 21, 2005 RLD: A080680

GALANTAMINE HYDROBROMIDE

CAPSULE, EXTENDED RELEASE;ORAL

GALANTAMINE HYDROBROMIDE

RX AUROBINDO PHARMA EQ 8MG BASE A204895 001 Aug 05, 2016 RLD: N021615

GANCICLOVIR SODIUM

INJECTABLE;INJECTION

GANCICLOVIR SODIUM

RX PHARMASCIENCE INC EQ 500MG BASE/VIAL A207645 001 Dec 08, 2017 RLD: N019661

GLUCAGON

INJECTABLE;INJECTION

GLUCAGON

AMPHASTAR PHARMS

INC

RX 1MG/VIAL A208086 001 Dec 28, 2020 RLD: N020928
Approved Drug Product List - Orange Book

Page 12 of 22

Reference Listed Drugs by ANDA Reference Standard List

December 2023

GLYBURIDE; METFORMIN HYDROCHLORIDE

TABLET;ORAL

GLYBURIDE AND METFORMIN HYDROCHLORIDE

RX AUROBINDO PHARMA 2.5MG;500MG A077870 002 Nov 14, 2007 RLD: N021178

GLYCOPYRROLATE

INJECTABLE;INJECTION

GLYCOPYRROLATE

RX HIKMA FARMACEUTICA 0.2MG/ML A090963 001 Sep 21, 2011 RLD: N017558

GRANISETRON HYDROCHLORIDE

TABLET;ORAL

GRANISETRON HYDROCHLORIDE

RX ORBION PHARMS EQ 1MG BASE A078678 001 Feb 13, 2008 RLD: N020305

HOMATROPINE METHYLBROMIDE; HYDROCODONE BITARTRATE

TABLET;ORAL

HOMATROPINE METHYLBROMIDE AND HYDROCODONE BITARTRATE

RX AVANTHI INC 1.5MG;5MG A207176 001 Aug 07, 2017 RLD: N005213

HYDRALAZINE HYDROCHLORIDE; HYDROCHLOROTHIAZIDE

CAPSULE;ORAL

HYDRA-ZIDE

RX STRIDES PHARMA 50MG;50MG A088946 001 Oct 21, 1985 RLD: A084810

HYDROCHLOROTHIAZIDE; LISINOPRIL

TABLET;ORAL

LISINOPRIL AND HYDROCHLOROTHIAZIDE

RX INVAGEN PHARMS 12.5MG;20MG A204058 002 May 23, 2017 RLD: N019888

RX 25MG;20MG A204058 003 May 23, 2017 RLD: N019888

HYDROCODONE BITARTRATE

CAPSULE, EXTENDED RELEASE;ORAL

HYDROCODONE BITARTRATE

RX ALVOGEN 10MG A206986 001 Jan 21, 2020 RLD: N202880

HYDROCODONE BITARTRATE; IBUPROFEN

TABLET;ORAL

HYDROCODONE BITARTRATE AND IBUPROFEN

RX AMNEAL PHARMS NY 7.5MG;200MG A076642 001 Oct 12, 2004 RLD: N020716

HYDROCORTISONE

CREAM;TOPICAL

HYDROCORTISONE

RX FOUGERA PHARMS INC 2.5% A089414 001 Dec 16, 1986 RLD: A087457

HYDROMORPHONE HYDROCHLORIDE

TABLET, EXTENDED RELEASE;ORAL

HYDROMORPHONE HYDROCHLORIDE

RX OSMOTICA PHARM US 32MG A205629 004 Jul 07, 2016 RLD: N021217

HYDROXYCHLOROQUINE SULFATE

TABLET;ORAL

HYDROXYCHLOROQUINE SULFATE

RX ACCORD HLTHCARE 400MG A213342 004 Aug 18, 2021 RLD: N009768

IBANDRONATE SODIUM

TABLET;ORAL

IBANDRONATE SODIUM

RX DR REDDYS LABS LTD EQ 150MG BASE A078997 001 Apr 30, 2012 RLD: N021455

IMIPRAMINE PAMOATE

CAPSULE;ORAL

IMIPRAMINE PAMOATE

RX HIKMA EQ 75MG HYDROCHLORIDE A091099 001 Apr 16, 2010 RLD: N017090
Approved Drug Product List - Orange Book

Page 13 of 22

Reference Listed Drugs by ANDA Reference Standard List

December 2023

IMIQUIMOD

CREAM;TOPICAL

IMIQUIMOD

RX GLENMARK GENERICS 5% A201994 001 Mar 06, 2012 RLD: N020723

INDOMETHACIN SODIUM

INJECTABLE;INJECTION

INDOMETHACIN SODIUM

RX NAVINTA LLC EQ 1MG BASE/VIAL A206561 001 Jul 19, 2017 RLD: N018878

IPRATROPIUM BROMIDE

SPRAY, METERED;NASAL

IPRATROPIUM BROMIDE

RX HIKMA 0.021MG/SPRAY A076664 001 Nov 05, 2003 RLD: N020393

RX 0.042MG/SPRAY A076598 001 Nov 05, 2003 RLD: N020394

ISOPROTERENOL HYDROCHLORIDE

INJECTABLE;INJECTION

ISOPROTERENOL HYDROCHLORIDE

RX NEXUS 0.2MG/ML A206961 001 Aug 02, 2017 RLD: N010515

ISOSULFAN BLUE

INJECTABLE;INJECTION

ISOSULFAN BLUE

MYLAN

INSTITUTIONAL

RX 1% A090874 001 Jul 20, 2010 RLD: N018310

ISRADIPINE

CAPSULE;ORAL

ISRADIPINE

RX WATSON LABS TEVA 5MG A077317 002 Jan 05, 2006 RLD: N019546

KETOTIFEN FUMARATE

SOLUTION/DROPS;OPHTHALMIC

ZADITOR

OTC ALCON PHARMS LTD EQ 0.025% BASE A077200 001 Sep 02, 2008 RLD: N021066

LABETALOL HYDROCHLORIDE

INJECTABLE;INJECTION

LABETALOL HYDROCHLORIDE

RX HOSPIRA 5MG/ML A075239 001 Nov 29, 1999 RLD: N018686

TABLET;ORAL

LABETALOL HYDROCHLORIDE

RX SANDOZ 200MG A075113 002 Aug 04, 1998 RLD: N018687

LACTULOSE

SOLUTION;ORAL

LACTULOSE

RX HIKMA 10GM/15ML A074076 001 Jul 03, 1995 RLD: N017884

LEUCOVORIN CALCIUM

INJECTABLE;INJECTION

LEUCOVORIN CALCIUM

RX FRESENIUS KABI USA EQ 10MG BASE/ML A207226 001 Jul 27, 2018 RLD: N008107

RX EQ 10MG BASE/ML A207241 001 Mar 14, 2018 RLD: N008107

LEVOCETIRIZINE DIHYDROCHLORIDE

TABLET;ORAL

LEVOCETIRIZINE DIHYDROCHLORIDE

RX GLENMARK GENERICS 5MG A090385 001 Feb 24, 2011 RLD: N022064

LEVOFLOXACIN

INJECTABLE;INJECTION

LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER

RX INFORLIFE EQ 250MG/50ML (EQ 5MG/ML) A090343 001 Jul 07, 2011 RLD: N020635

RX EQ 500MG/100ML (EQ 5MG/ML) A090343 002 Jul 07, 2011 RLD: N020635

RX EQ 750MG/150ML (EQ 5MG/ML) A090343 003 Jul 07, 2011 RLD: N020635
Approved Drug Product List - Orange Book

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Reference Listed Drugs by ANDA Reference Standard List

December 2023

SOLUTION;ORAL

LEVOFLOXACIN

RX NOVITIUM PHARMA 250MG/10ML A091678 001 Jun 20, 2011 RLD: N021721

LEVOLEUCOVORIN CALCIUM

SOLUTION;INTRAVENOUS

LEVOLEUCOVORIN CALCIUM

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

BASE/ML)

RX A210892 002 Sep 14, 2018 RLD: N020140

MEITHEAL EQ 175MG BASE/17.5ML (EQ 10MG

BASE/ML)

RX A211002 001 Aug 16, 2019 RLD: N020140

LEVORPHANOL TARTRATE

TABLET;ORAL

LEVORPHANOL TARTRATE

RX NOVITIUM PHARMA 3MG A213479 002 Jan 12, 2021 RLD: N008720

LIDOCAINE HYDROCHLORIDE

SOLUTION;ORAL

LIDOCAINE HYDROCHLORIDE

RX RUBICON 2% A216780 001 Mar 28, 2023 RLD: N009470

SOLUTION;TOPICAL

LIDOCAINE HYDROCHLORIDE

RX HIKMA 4% A088803 001 Apr 03, 1985 RLD: N010417

LIDOCAINE; PRILOCAINE

CREAM;TOPICAL

LIDOCAINE AND PRILOCAINE

RX FOUGERA PHARMS 2.5%;2.5% A076453 001 Aug 18, 2003 RLD: N019941

LOPERAMIDE HYDROCHLORIDE

CAPSULE;ORAL

LOPERAMIDE HYDROCHLORIDE

RX MYLAN 2MG A072741 001 Sep 18, 1991 RLD: N017694

MEFLOQUINE HYDROCHLORIDE

TABLET;ORAL

MEFLOQUINE HYDROCHLORIDE

RX BARR 250MG A076392 001 Dec 29, 2003 RLD: N019591

MELOXICAM

CAPSULE;ORAL

MELOXICAM

RX LUPIN LTD 10MG A209487 002 Jun 01, 2020 RLD: N207233

MELPHALAN

TABLET;ORAL

MELPHALAN

RX ALVOGEN 2MG A207809 001 Mar 22, 2017 RLD: N014691

MEPERIDINE HYDROCHLORIDE

INJECTABLE;INJECTION

MEPERIDINE HYDROCHLORIDE PRESERVATIVE FREE

WEST-WARD PHARMS

INT

RX 10MG/ML A081002 001 Jul 30, 1993 RLD: A088432

MEPROBAMATE

TABLET;ORAL

MEPROBAMATE

RX ALEMBIC PHARMS LTD 200MG A090122 001 Feb 18, 2009 RLD: A083304

RX 400MG A090122 002 Feb 18, 2009 RLD: A083308

MESALAMINE

TABLET, DELAYED RELEASE;ORAL

MESALAMINE

RX ZYDUS PHARMS 800MG A203286 001 Jul 21, 2017 RLD: N021830
Approved Drug Product List - Orange Book

Page 15 of 22

Reference Listed Drugs by ANDA Reference Standard List

December 2023

METAXALONE

TABLET;ORAL

METAXALONE

RX AMNEAL PHARMS 800MG A203399 001 Jun 21, 2013 RLD: N013217

METFORMIN HYDROCHLORIDE

SOLUTION;ORAL

METFORMIN HYDROCHLORIDE

RX SAPTALIS PHARMS 500MG/5ML A211309 001 Mar 03, 2020 RLD: N021591

TABLET, EXTENDED RELEASE;ORAL

METFORMIN HYDROCHLORIDE

RX ALKEM LABS LTD 750MG A206145 002 Oct 22, 2018 RLD: N021202

METFORMIN HYDROCHLORIDE; SAXAGLIPTIN HYDROCHLORIDE

TABLET, EXTENDED RELEASE;ORAL

METFORMIN HYDROCHLORIDE; SAXAGLIPTIN HYDROCHLORIDE

RX DR REDDYS LABS SA 1GM;EQ 5MG BASE A207678 003 Aug 09, 2023 RLD: N200678

METHADONE HYDROCHLORIDE

TABLET;ORAL

METHADONE HYDROCHLORIDE

RX SPECGX LLC 5MG A040517 001 Apr 27, 2004 RLD: N006134

RX 10MG A040517 002 Apr 27, 2004 RLD: N006134

METHENAMINE HIPPURATE

TABLET;ORAL

METHENAMINE HIPPURATE

AUROBINDO PHARMA

LTD

RX 1GM A205661 001 Jul 05, 2016 RLD: N017681

METHOCARBAMOL

TABLET;ORAL

METHOCARBAMOL

RX AUSTARPHARMA LLC 1GM A200958 003 Dec 06, 2021 RLD: N011011

RX GRANULES 500MG A209312 001 May 07, 2018 RLD: N011011

RX 750MG A209312 002 May 07, 2018 RLD: N011011

METHOTREXATE SODIUM

INJECTABLE;INJECTION

METHOTREXATE SODIUM PRESERVATIVE FREE

ACCORD HLTHCARE EQ 250MG BASE/10ML (EQ 25MG

BASE/ML)

RX A040768 001 Apr 30, 2007 RLD: A088760

TABLET;ORAL

METHOTREXATE SODIUM

RX HIKMA EQ 2.5MG BASE A040054 001 Aug 01, 1994 RLD: N008085

METHYLERGONOVINE MALEATE

TABLET;ORAL

METHYLERGONOVINE MALEATE

RX CHARTWELL RX 0.2MG A091577 001 May 02, 2011 RLD: N006035

METHYLPHENIDATE HYDROCHLORIDE

CAPSULE, EXTENDED RELEASE;ORAL

METHYLPHENIDATE HYDROCHLORIDE

RX DR REDDYS LABS SA 60MG A078458 004 Jun 23, 2016 RLD: N021284

TABLET, CHEWABLE;ORAL

METHYLPHENIDATE HYDROCHLORIDE

RX ASCENT PHARMS INC 10MG A210354 003 Dec 29, 2017 RLD: N021475

TABLET, EXTENDED RELEASE;ORAL

METHYLPHENIDATE HYDROCHLORIDE

RX OSMOTICA PHARM US 72MG A205327 005 Jul 28, 2017 RLD: N021121
Approved Drug Product List - Orange Book

Page 16 of 22

Reference Listed Drugs by ANDA Reference Standard List

December 2023

METHYLPREDNISOLONE ACETATE

INJECTABLE;INJECTION

METHYLPREDNISOLONE ACETATE

RX AMNEAL 40MG/ML A210043 001 May 20, 2019 RLD: N011757

RX 80MG/ML A210043 002 May 20, 2019 RLD: N011757

RX SAGENT PHARMS INC 40MG/ML A201835 002 Jun 27, 2018 RLD: N011757

RX 80MG/ML A201835 003 Jun 27, 2018 RLD: N011757

METHYLTESTOSTERONE

CAPSULE;ORAL

METHYLTESTOSTERONE

RX IMPAX LABS INC 10MG A204851 001 Sep 21, 2015 RLD: A083976

METOPROLOL TARTRATE

TABLET;ORAL

METOPROLOL TARTRATE

RX MYLAN 100MG A076704 003 Jan 16, 2004 RLD: N017963

METRONIDAZOLE

TABLET;ORAL

METRONIDAZOLE

AUROBINDO PHARMA

LTD

RX 500MG A203974 002 May 29, 2015 RLD: N012623

MOMETASONE FUROATE

SPRAY, METERED;NASAL

MOMETASONE FUROATE

RX APOTEX 0.05MG/SPRAY A091161 001 Mar 22, 2016 RLD: N020762

MORPHINE SULFATE

CAPSULE, EXTENDED RELEASE;ORAL

MORPHINE SULFATE

RX UPSHER SMITH LABS 10MG A202104 001 Jun 03, 2013 RLD: N020616

RX 100MG A202104 007 Jun 03, 2013 RLD: N020616

MOXIFLOXACIN HYDROCHLORIDE

SOLUTION/DROPS;OPHTHALMIC

MOXIFLOXACIN HYDROCHLORIDE

RX LUPIN LTD EQ 0.5% BASE A204079 001 May 28, 2015 RLD: N022428

SOLUTION;INTRAVENOUS

MOXIFLOXACIN HYDROCHLORIDE IN SODIUM CHLORIDE 0.8% IN PLASTIC CONTAINER

RX MYLAN LABS LTD 400MG/250ML (1.6MG/ML) A205833 001 May 05, 2017 RLD: N021277

NAFTIFINE HYDROCHLORIDE

CREAM;TOPICAL

NAFTIFINE HYDROCHLORIDE

RX TARO 1% A205975 001 Sep 08, 2016 RLD: N019599

NALMEFENE HYDROCHLORIDE

SOLUTION;INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS

NALMEFENE HYDROCHLORIDE

PURDUE PHARMA LP EQ 2MG BASE/2ML (EQ 1MG

BASE/ML)

RX A212955 001 Feb 08, 2022 RLD: N020459

NALTREXONE HYDROCHLORIDE

TABLET;ORAL

NALTREXONE HYDROCHLORIDE

RX SPECGX LLC 50MG A076264 002 Mar 22, 2002 RLD: N018932

NARATRIPTAN HYDROCHLORIDE

TABLET;ORAL

NARATRIPTAN

RX HERITAGE PHARMS EQ 2.5MG BASE A200502 002 Feb 28, 2011 RLD: N020763
Approved Drug Product List - Orange Book

Page 17 of 22

Reference Listed Drugs by ANDA Reference Standard List

December 2023

NATEGLINIDE

TABLET;ORAL

NATEGLINIDE

RX ZYDUS PHARMS 120MG A205248 002 Jul 06, 2016 RLD: N021204

NEVIRAPINE

TABLET;ORAL

NEVIRAPINE

MACLEODS PHARMS

LTD

RX 200MG A090688 001 Jan 14, 2019 RLD: N020636

NIACIN

TABLET;ORAL

NIACOR

RX AVONDALE PHARMS 500MG A040378 001 May 03, 2000 RLD: A083823

NICARDIPINE HYDROCHLORIDE

CAPSULE;ORAL

NICARDIPINE HYDROCHLORIDE

RX EPIC PHARMA LLC 30MG A074928 002 Mar 19, 1998 RLD: N019488

NIFEDIPINE

TABLET, EXTENDED RELEASE;ORAL

NIFEDIPINE

RX NOVAST LABS 60MG A202987 002 Aug 25, 2016 RLD: N020198

RX 90MG A202987 003 Aug 25, 2016 RLD: N020198

NORTRIPTYLINE HYDROCHLORIDE

SOLUTION;ORAL

NORTRIPTYLINE HYDROCHLORIDE

RX PHARM ASSOC EQ 10MG BASE/5ML A075606 001 Aug 23, 2000 RLD: N014685

OFLOXACIN

SOLUTION/DROPS;OTIC

OFLOXACIN

RX BAUSCH AND LOMB 0.3% A076128 001 Mar 17, 2008 RLD: N020799

OLOPATADINE HYDROCHLORIDE

SPRAY, METERED;NASAL

OLOPATADINE HYDROCHLORIDE

RX AMNEAL 0.665MG/SPRAY A210901 001 Jan 28, 2020 RLD: N021861

OMEPRAZOLE

CAPSULE, DELAYED REL PELLETS;ORAL

OMEPRAZOLE

RX SANDOZ 20MG A075757 002 Jan 28, 2003 RLD: N019810

RX 40MG A076515 001 Jan 21, 2009 RLD: N019810

ONDANSETRON

TABLET, ORALLY DISINTEGRATING;ORAL

ONDANSETRON

CHARTWELL

MOLECULES

RX 16MG A077406 001 Dec 26, 2006 RLD: N020781

RX 24MG A077406 002 Dec 26, 2006 RLD: N020781

ONDANSETRON HYDROCHLORIDE

SOLUTION;ORAL

ONDANSETRON HYDROCHLORIDE

RX HIKMA EQ 4MG BASE/5ML A076960 001 Dec 26, 2006 RLD: N020605

OXALIPLATIN

INJECTABLE;INTRAVENOUS

OXALIPLATIN

RX QILU PHARM HAINAN 200MG/40ML (5MG/ML) A204368 003 Jun 07, 2016 RLD: N021759
Approved Drug Product List - Orange Book

Page 18 of 22

Reference Listed Drugs by ANDA Reference Standard List

December 2023

OXYBUTYNIN CHLORIDE

TABLET, EXTENDED RELEASE;ORAL

OXYBUTYNIN CHLORIDE

RX ACCORD HLTHCARE 15MG A207138 003 Feb 29, 2016 RLD: N020897

TABLET;ORAL

OXYBUTYNIN CHLORIDE

RX RISING 2.5MG A209025 002 Feb 07, 2023 RLD: N017577

PALONOSETRON HYDROCHLORIDE

INJECTABLE;INTRAVENOUS

PALONOSETRON HYDROCHLORIDE

AVET LIFESCIENCES EQ 0.075MG BASE/1.5ML (EQ

0.05MG BASE/ML)

RX A202951 001 Jun 29, 2021 RLD: N021372

DR REDDYS EQ 0.25MG BASE/5ML (EQ 0.05MG

BASE/ML)

RX A201533 002 Apr 21, 2016 RLD: N021372

PANCURONIUM BROMIDE

INJECTABLE;INJECTION

PANCURONIUM BROMIDE

RX DR REDDYS 1MG/ML A072759 001 Jul 31, 1990 RLD: N017015

RX 2MG/ML A072760 001 Jul 31, 1990 RLD: N017015

PARICALCITOL

CAPSULE;ORAL

PARICALCITOL

RX TEVA PHARMS USA 4MCG A090829 003 Sep 27, 2013 RLD: N021606

PEMETREXED DISODIUM

POWDER;INTRAVENOUS

PEMETREXED DISODIUM

RX FRESENIUS KABI USA EQ 750MG BASE/VIAL A090384 003 May 25, 2022 RLD: N021462

RX EQ 1GM BASE/VIAL A090384 004 May 25, 2022 RLD: N021462

PENTOXIFYLLINE

TABLET, EXTENDED RELEASE;ORAL

PENTOXIFYLLINE

RX APOTEX 400MG A075191 001 Jun 09, 1999 RLD: N018631

PHENOXYBENZAMINE HYDROCHLORIDE

CAPSULE;ORAL

PHENOXYBENZAMINE HYDROCHLORIDE

RX PAR PHARM INC 10MG A204522 001 Jan 24, 2017 RLD: N008708

PHENTERMINE HYDROCHLORIDE

TABLET;ORAL

LOMAIRA

RX AVANTHI INC 8MG A203495 001 Sep 12, 2016 RLD: N012737

PHENYLEPHRINE HYDROCHLORIDE

SOLUTION/DROPS;OPHTHALMIC

PHENYLEPHRINE HYDROCHLORIDE

RX MANKIND PHARMA 2.5% A216859 001 Sep 29, 2022 RLD: N207926

RX 10% A216496 001 Jan 11, 2023 RLD: N207926

PHENYLEPHRINE HYDROCHLORIDE; PROMETHAZINE HYDROCHLORIDE

SYRUP;ORAL

PHENYLEPHRINE HYDROCHLORIDE AND PROMETHAZINE HYDROCHLORIDE

RX PHARM ASSOC 5MG/5ML;6.25MG/5ML A040654 001 Dec 07, 2006 RLD: A088761

PHYTONADIONE

INJECTABLE;INJECTION

PHYTONADIONE

RX CIPLA 1MG/0.5ML A214596 001 Apr 22, 2022 RLD: N012223

RX 10MG/ML A214596 002 Apr 22, 2022 RLD: N012223
Approved Drug Product List - Orange Book

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Reference Listed Drugs by ANDA Reference Standard List

December 2023

TABLET;ORAL

PHYTONADIONE

RX ZYDUS 5MG A210189 001 Feb 20, 2019 RLD: N010104

PIPERACILLIN SODIUM; TAZOBACTAM SODIUM

INJECTABLE;INJECTION

PIPERACILLIN AND TAZOBACTAM

WOCKHARDT BIO AG EQ 2GM BASE/VIAL;EQ 250MG

BASE/VIAL

RX A206996 001 Mar 22, 2017 RLD: N050684

EQ 3GM BASE/VIAL;EQ 375MG

BASE/VIAL

RX A206996 002 Mar 22, 2017 RLD: N050684

EQ 4GM BASE/VIAL;EQ 500MG

BASE/VIAL

RX A206996 003 Mar 22, 2017 RLD: N050684

EQ 36GM BASE/VIAL;EQ 4.5GM

BASE/VIAL

RX A207146 001 Mar 17, 2017 RLD: N050684

POTASSIUM CHLORIDE

TABLET, EXTENDED RELEASE;ORAL

KLOR-CON M20

RX UPSHER SMITH LABS 20MEQ A074726 001 Nov 20, 1998 RLD: N019439

POTASSIUM CHLORIDE

RX TWI PHARMS 20MEQ A209688 002 Jan 12, 2018 RLD: N018279

PREDNISOLONE SODIUM PHOSPHATE

SOLUTION/DROPS;OPHTHALMIC

PREDNISOLONE SODIUM PHOSPHATE

RX BAUSCH AND LOMB EQ 0.9% PHOSPHATE A040070 001 Jul 29, 1994 RLD: A080751

SOLUTION;ORAL

PREDNISOLONE SODIUM PHOSPHATE

RX PHARM ASSOC EQ 15MG BASE/5ML A076913 001 Apr 25, 2005 RLD: N019157

PRILOCAINE HYDROCHLORIDE

INJECTABLE;INJECTION

PRILOCAINE HYDROCHLORIDE

RX SEPTODONT INC 4% A079235 001 Sep 29, 2010 RLD: N021382

PROGESTERONE

INJECTABLE;INJECTION

PROGESTERONE

RX EUGIA PHARMA 50MG/ML A210965 001 Dec 06, 2018 RLD: N017362

PROPAFENONE HYDROCHLORIDE

CAPSULE, EXTENDED RELEASE;ORAL

PROPAFENONE HYDROCHLORIDE

RX STRIDES PHARMA 425MG A078540 003 Oct 18, 2010 RLD: N021416

PROPARACAINE HYDROCHLORIDE

SOLUTION/DROPS;OPHTHALMIC

PROPARACAINE HYDROCHLORIDE

RX BAUSCH AND LOMB 0.5% A040074 001 Sep 29, 1995 RLD: N008883

PYRAZINAMIDE

TABLET;ORAL

PYRAZINAMIDE

RX HIKMA 500MG A081319 001 Jun 30, 1992 RLD: A080157

QUINAPRIL HYDROCHLORIDE

TABLET;ORAL

QUINAPRIL HYDROCHLORIDE

RX LUPIN EQ 40MG BASE A077690 004 Jun 20, 2006 RLD: N019885

RANOLAZINE

TABLET, EXTENDED RELEASE;ORAL

RANOLAZINE

RX SUN PHARM 1GM A211707 002 May 28, 2019 RLD: N021526
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SAXAGLIPTIN HYDROCHLORIDE

TABLET;ORAL

SAXAGLIPTIN

RX MYLAN EQ 5MG BASE A205980 002 Jul 31, 2023 RLD: N022350

SELEGILINE HYDROCHLORIDE

CAPSULE;ORAL

SELEGILINE HYDROCHLORIDE

RX APOTEX 5MG A075321 001 Dec 04, 1998 RLD: N020647

SODIUM BICARBONATE

INJECTABLE;INJECTION

SODIUM BICARBONATE

RX EXELA PHARMA 0.5MEQ/ML A211091 001 Jun 20, 2019 RLD: N019443

RX 0.9MEQ/ML A211091 002 Jun 20, 2019 RLD: N019443

RX 1MEQ/ML A211091 003 Jun 20, 2019 RLD: N019443

SODIUM CHLORIDE

SOLUTION;INJECTION

SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER

RX TARO 45MG/5ML (9MG/ML) A077407 001 Aug 11, 2006 RLD: N019217

RX 90MG/10ML (9MG/ML) A077407 002 Aug 11, 2006 RLD: N019217

SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE; SODIUM PHOSPHATE, MONOBASIC, ANHYDROUS

INJECTABLE;INJECTION

SODIUM PHOSPHATES

RX FRESENIUS KABI USA 142MG/ML;276MG/ML A209997 001 Mar 30, 2022 RLD: N018892

SODIUM POLYSTYRENE SULFONATE

POWDER;ORAL, RECTAL

KALEXATE

RX KVK TECH 454GM/BOT A040905 001 Mar 30, 2009 RLD: N011287

STERILE WATER FOR INJECTION

LIQUID;N/A

STERILE WATER FOR INJECTION

RX MEDEFIL INC 100% (2.5ML) A211188 002 Dec 02, 2019 RLD: N018801

RX 100% (3ML) A211188 003 Dec 02, 2019 RLD: N018801

RX 100% (5ML) A211188 004 Dec 02, 2019 RLD: N018801

SUCCINYLCHOLINE CHLORIDE

INJECTABLE;INJECTION

SUCCINYLCHOLINE CHLORIDE

RX ZYDUS PHARMS 20MG/ML A209467 001 May 04, 2018 RLD: N008845

SULFADIAZINE

TABLET;ORAL

SULFADIAZINE

RX EPIC PHARMA LLC 500MG A040091 001 Jul 29, 1994 RLD: N004122

SULFAMETHOXAZOLE; TRIMETHOPRIM

INJECTABLE;INJECTION

SULFAMETHOXAZOLE AND TRIMETHOPRIM

RX MYLAN LABS LTD 80MG/ML;16MG/ML A206607 001 Aug 30, 2017 RLD: N018374

TEMOZOLOMIDE

CAPSULE;ORAL

TEMOZOLOMIDE

RX ACCORD HLTHCARE 250MG A201528 006 Feb 27, 2017 RLD: N021029

TERBUTALINE SULFATE

TABLET;ORAL

TERBUTALINE SULFATE

RX LANNETT CO INC 5MG A077152 002 Mar 25, 2005 RLD: N017849
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TERCONAZOLE

CREAM;VAGINAL

TERCONAZOLE

RX TARO 0.8% A075953 001 Apr 06, 2004 RLD: N019964

TESTOSTERONE

GEL, METERED;TRANSDERMAL

TESTOSTERONE

ACTAVIS LABS UT

INC

RX 12.5MG/1.25GM ACTUATION A076737 003 Mar 09, 2015 RLD: N021015

GEL;TRANSDERMAL

TESTOSTERONE

RX PADAGIS ISRAEL 1.62% (40.5MG/2.5GM PACKET) A205781 002 Jul 12, 2017 RLD: N022309

SOLUTION, METERED;TRANSDERMAL

TESTOSTERONE

RX PADAGIS ISRAEL 30MG/1.5ML ACTUATION A204255 001 Feb 28, 2017 RLD: N022504

TETRACYCLINE HYDROCHLORIDE

CAPSULE;ORAL

TETRACYCLINE HYDROCHLORIDE

RX AMNEAL PHARMS NY 500MG A210674 002 Sep 18, 2018 RLD: N050278

THEOPHYLLINE

SOLUTION;ORAL

THEOPHYLLINE

CHARTWELL

MOLECULAR

RX 80MG/15ML A091156 001 Apr 13, 2011 RLD: A087449

TABLET, EXTENDED RELEASE;ORAL

THEOPHYLLINE

RX ALEMBIC 450MG A090430 002 Oct 27, 2010 RLD: A085328

THIOTHIXENE

CAPSULE;ORAL

THIOTHIXENE

RX NOVITIUM PHARMA 5MG A211642 003 Apr 05, 2019 RLD: N016584

TIMOLOL MALEATE

SOLUTION, GEL FORMING/DROPS;OPHTHALMIC

TIMOLOL MALEATE

RX ALEMBIC EQ 0.25% BASE A212942 001 Oct 22, 2020 RLD: N020330

RX EQ 0.5% BASE A212942 002 Oct 22, 2020 RLD: N020330

SOLUTION/DROPS;OPHTHALMIC

TIMOLOL MALEATE

RX SANDOZ EQ 0.25% BASE A074261 001 Apr 28, 1995 RLD: N018086

RX EQ 0.5% BASE A074262 001 Apr 28, 1995 RLD: N018086

TABLET;ORAL

TIMOLOL MALEATE

RX MYLAN 20MG A072668 001 Jun 08, 1990 RLD: N018017

TRAVOPROST

SOLUTION/DROPS;OPHTHALMIC

TRAVOPROST

RX CHARTWELL RX 0.004% A091340 001 Mar 01, 2013 RLD: N021257

TRIAMCINOLONE ACETONIDE

OINTMENT;TOPICAL

TRIAMCINOLONE ACETONIDE

RX ENCUBE 0.05% A212384 001 Nov 29, 2019 RLD: N011600

SPRAY;TOPICAL

TRIAMCINOLONE ACETONIDE

RX PADAGIS ISRAEL 0.147MG/GM A205782 001 Apr 13, 2015 RLD: N012104
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TRIMIPRAMINE MALEATE

CAPSULE;ORAL

TRIMIPRAMINE MALEATE

RX CROSSMEDIKA SA EQ 50MG BASE A208127 002 Apr 15, 2016 RLD: N016792

URSODIOL

CAPSULE;ORAL

URSODIOL

RX LGM PHARMA 400MG A205789 002 May 08, 2020 RLD: N019594

VALSARTAN

SOLUTION;ORAL

VALSARTAN

RX NOVITIUM PHARMA 20MG/5ML A214102 001 Nov 02, 2021 RLD: N209139

VARDENAFIL HYDROCHLORIDE

TABLET, ORALLY DISINTEGRATING;ORAL

VARDENAFIL HYDROCHLORIDE

RX ALEMBIC 10MG A208324 001 Nov 16, 2018 RLD: N200179

TABLET;ORAL

VARDENAFIL HYDROCHLORIDE

RX ZYDUS PHARMS EQ 20MG BASE A208960 004 Oct 31, 2018 RLD: N021400

VARENICLINE TARTRATE

TABLET;ORAL

VARENICLINE TARTRATE

RX PAR PHARM INC EQ 1MG BASE A201785 002 Aug 11, 2021 RLD: N021928

VERAPAMIL HYDROCHLORIDE

INJECTABLE;INJECTION

VERAPAMIL HYDROCHLORIDE

RX EUGIA PHARMA 2.5MG/ML A212965 001 Jul 06, 2020 RLD: N018485

TABLET, EXTENDED RELEASE;ORAL

VERAPAMIL HYDROCHLORIDE

RX GLENMARK GENERICS 180MG A090700 002 Aug 03, 2011 RLD: N019152

TABLET;ORAL

VERAPAMIL HYDROCHLORIDE

RX HERITAGE PHARMS 120MG A071881 001 Apr 05, 1988 RLD: N018593

VINBLASTINE SULFATE

INJECTABLE;INJECTION

VINBLASTINE SULFATE

RX HIKMA 10MG/VIAL A089395 001 Apr 09, 1987 RLD: N012665

ZILEUTON

TABLET, EXTENDED RELEASE;ORAL

ZILEUTON

RX RISING 600MG A204929 001 Mar 17, 2017 RLD: N022052

ZOLEDRONIC ACID

INJECTABLE;INTRAVENOUS

ZOLEDRONIC

RX GLAND PHARMA LTD EQ 4MG BASE/100ML A205749 001 Jun 29, 2018 RLD: N021223

ZOLMITRIPTAN

TABLET, ORALLY DISINTEGRATING;ORAL

ZOLMITRIPTAN

ZYDUS PHARMS USA

INC

RX 5MG A202890 002 May 15, 2013 RLD: N021231

TABLET;ORAL

ZOLMITRIPTAN

RX AJANTA PHARMA LTD 5MG A204041 002 May 20, 2016 RLD: N020768