Federal Register / Vol. 82, No. 204 / Tuesday, October 24, 2017 / Notices 49211 

I. Background 

On December 17, 2014, FDA 

published a final guidance for industry 

entitled ‘‘Providing Regulatory 

Submissions in Electronic Format— 

Standardized Study Data’’ (eStudy Data 

Guidance), posted on FDA’s Study Data 

Standards Resources Web page at 

https://www.fda.gov/forindustry/ 

datastandards/studydatastandards/ 

default.htm. The eStudy Data Guidance 

implements the electronic submission 

requirements of section 745A(a) of the 

Federal Food, Drug, and Cosmetic Act 

for study data contained in NDAs, 

ANDAs, BLAs, and certain INDs to 

CBER or CDER by specifying the format 

for electronic submissions. The initial 

timetable for the implementation of 

electronic submission requirements for 

study data was December 17, 2016 (24 

months after issuance of final guidance 

for NDAs, BLAs, ANDAs, and 36 

months for INDs). The eStudy Data 

guidance states that a Federal Register 

notice will specify the transition date 

for all version updates (with the month 

and day for the transition date 

corresponding to March 15). 

FDA currently supports the use of 

WHODG for the coding of concomitant 

medications in studies submitted to 

CBER or CDER in NDAs, ANDAs, BLAs, 

and certain INDs in the electronic 

common technical document format. 

Generally, the studies included in a 

submission are conducted over many 

years and may have used different 

WHODG versions to code concomitant 

medications. The expectation is that 

sponsors and applicants will use the 

most current B3-format annual version 

of WHODG at the time of study start. 

However, there is no requirement to 

recode earlier studies. The transition 

date for support of the most current B3- 

format annual version of WHODG is 

March 15, 2018. Although the use of the 

current B3-format annual version of 

WHODG is supported as of this Federal 

Register notice and sponsors or 

applicants are encouraged to begin 

using it, the use of the most current B3- 

format annual version will only be 

required in submissions for studies that 

start after March 15, 2019. The Catalog 

will list March 15, 2019, as the ‘‘date 

requirement begins.’’ The Study Data 

Technical Conformance Guide provides 

addition information and 

recommendations on the coding of 

concomitant medications (https://

www.fda.gov/downloads/forindustry/ 

datastandards/studydatastandards/ 

ucm384744.pdf). 

FDA support for earlier versions of 

WHODG will end for studies that start 

after March 15, 2019. The Catalog will 

be updated to list March 15, 2019, as the 

‘‘date support ends.’’ Studies that start 

after March 15, 2019, will be required to 

use the most current B3-format annual 

version of WHODG. 

Dated: October 18, 2017. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2017–23029 Filed 10–23–17; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2011–N–0278] 

Trand Doan Nguyen; Denial of Hearing; 

Final Debarment Order 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is denying Trang 

Doan Nguyen’s (Nguyen’s) request for a 

hearing and is issuing an order under 

the Federal Food, Drug, and Cosmetic 

Act (the FD&C Act) debarring Nguyen 

for 5 years from providing services in 

any capacity to a person that has an 

approved or pending drug product 

application. FDA bases this order on a 

finding that Nguyen was convicted of a 

misdemeanor under Federal law for 

conduct relating to the development or 

approval of a drug product or otherwise 

relating the regulation of a drug product 

under the FD&C Act and that the type 

of conduct underlying the conviction 

undermines the process for the 

regulation of drugs. In determining the 

appropriateness and period of Nguyen’s 

debarment, FDA has considered the 

relevant factors listed in the FD&C Act. 

Nguyen has failed to file with the 

Agency information and analyses 

sufficient to create a basis for a hearing 

concerning this action. 

DATES: The order is effective October 24, 

2017. 

ADDRESSES: Any application by Nguyen 

for special termination of debarment 

under section 306(d) of the FD&C Act 

(application) may be submitted as 

follows: 

Electronic Submissions 

• Federal eRulemaking Portal: 

https://www.regulations.gov. Follow the 

instructions for submitting comments. 

An application submitted electronically, 

including attachments, to https://

www.regulations.gov will be posted to 

the docket unchanged. Because your 

application will be made public, you are 

solely responsible for ensuring that your 

application does not include any 

confidential information that you or a 

third party may not wish to be posted, 

such as medical information, your or 

anyone else’s Social Security number, or 

confidential business information, such 

as a manufacturing process. Please note 

that if you include your name, contact 

information, or other information that 

identifies you in the body of your 

application, that information will be 

posted on https://www.regulations.gov. 

• If you want to submit an 

application with confidential 

information that you do not wish to be 

made available to the public, submit the 

application as a written/paper 

submission and in the manner detailed 

(see ‘‘Written/Paper Submissions’’ and 

‘‘Instructions’’). 

Written/Paper Submissions 

Submit written/paper submissions as 

follows: 

• Mail/Hand delivery/Courier (for 

written/paper submissions): Dockets 

Management Staff (HFA–305), Food and 

Drug Administration, 5630 Fishers 

Lane, Rm. 1061, Rockville, MD 20852. 

• For a written/paper application 

submitted to the Dockets Management 

Staff, FDA will post your application, as 

well as any attachments, except for 

information submitted, marked and 

identified, as confidential, if submitted 

as detailed in ‘‘Instructions.’’ 

Instructions: Your application must 

include the Docket No. FDA–2011–N– 

0278. An application will be placed in 

the docket and, unless submitted as 

‘‘Confidential Submissions,’’ publicly 

viewable at https://www.regulations.gov 

or at the Dockets Management Staff 

between 9 a.m. and 4 p.m., Monday 

through Friday. 

• Confidential Submissions—To 

submit an application with confidential 

information that you do not wish to be 

made publicly available, submit your 

application only as a written/paper 

submission. You should submit two 

copies total. One copy will include the 

information you claim to be confidential 

with a heading or cover note that states 

‘‘THIS DOCUMENT CONTAINS 

CONFIDENTIAL INFORMATION.’’ The 

Agency will review this copy, including 

the claimed confidential information, in 

its consideration of your application. 

The second copy, which will have the 

claimed confidential information 

redacted/blacked out, will be available 

for public viewing and posted on 

https://www.regulations.gov. Submit 

both copies to the Dockets Management 

Staff. If you do not wish your name and 

contact information to be made publicly 

available, you can provide this 


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49212 Federal Register / Vol. 82, No. 204 / Tuesday, October 24, 2017 / Notices 

information on the cover sheet and not 

in the body of your application and you 

must identify this information as 

‘‘confidential.’’ Any information marked 

as ‘‘confidential’’ will not be disclosed 

except in accordance with 21 CFR 10.20 

and other applicable disclosure law. For 

more information about FDA’s posting 

of comments to public dockets, see 80 

FR 56469, September 18, 2015, or access 

the information at: https://www.gpo.gov/ 

fdsys/pkg/FR-2015-09-18/pdf/2015- 

23389.pdf. 

Docket: For access to the docket, go to 

https://www.regulations.gov and insert 

the docket number, found in brackets in 

the heading of this document, into the 

‘‘Search’’ box and follow the prompts 

and/or go to the Dockets Management 

Staff, 5630 Fishers Lane, Rm. 1061, 

Rockville, MD 20852. 

FOR FURTHER INFORMATION CONTACT: 

Nathan R. Sabel, Office of Scientific 

Integrity, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 1, Rm. 4218, Silver Spring, 

MD 20993, 301–796–8588. 

SUPPLEMENTARY INFORMATION: 

I. Background 

On December 12, 2008, in the U.S. 

District Court for the District of 

Missouri, Nguyen pled guilty to a 

misdemeanor for introducing a 

misbranded drug into interstate 

commerce in violation of sections 301(a) 

and 303(a)(1) of the FD&C Act (21 U.S.C. 

331(a) and 333(a)(1)). The basis for 

Nguyen’s guilty plea was her admission 

that she repackaged unapproved 

versions of the drugs LIPITOR and 

CELEBREX, some of which were 

counterfeit, and relabeled them in a 

manner that did not disclose that they 

were unapproved or that they were 

counterfeit and then shipped them to 

other States. The drugs were 

misbranded under section 502(a) of the 

FD&C Act (21 U.S.C. 352(a)) in that their 

labeling was false and misleading. 

Nguyen is subject to debarment based 

on a finding, under section 

306(b)(2)(B)(i)(I) of the FD&C Act (21 

U.S.C. 335a(b)(2)(B)(i)(I)): (1) That she 

was convicted of a misdemeanor under 

Federal law for conduct relating to the 

development or approval of a drug 

product or otherwise relating to the 

regulation of a drug product under the 

FD&C Act and (2) that the type of 

conduct underlying the conviction 

undermines the process for the 

regulation of drugs. By letter dated July 

6, 2011, FDA served Nguyen a notice 

proposing to debar her for 5 years from 

providing services in any capacity to a 

person having an approved or pending 

drug product application and providing 

an opportunity for Nguyen to request a 

hearing. In a letter dated July 29, 2011, 

Nguyen requested a hearing on the 

proposal. In her request for a hearing, 

Nguyen acknowledges her conviction 

under Federal law, as stated by FDA in 

the proposal to debar. However, she 

argues that the proposal to debar her 

contains material inaccuracies with 

respect to certain facts related to her 

misdemeanor conviction. 

The Directors of the Office of 

Scientific Integrity (OSI) reviewed 

Nguyen’s request for a hearing, as well 

as the materials offered in support, and 

find that Nguyen has not created a basis 

for a hearing because hearings will be 

granted only if there is a genuine and 

substantial issue of fact for resolution at 

a hearing. Hearings will not be granted 

on issues of policy or law, on mere 

allegations, denials, or general 

descriptions of positions and 

contentions, or on data and information 

insufficient to justify the factual 

determination urged (see 21 CFR 

12.24(b)). 

The Director of OSI has considered 

Nguyen’s arguments and concludes that 

they are unpersuasive and fail to raise 

a genuine and substantial issue of fact 

requiring a hearing. 

II. Arguments 

Nguyen raises a number of arguments 

in support of her hearing request. She 

does not appear, however, to dispute 

that she is subject to debarment under 

section 306(b)(2)(B)(i)(I) of the FD&C 

Act. As noted above, to debar Nguyen 

under section 306(b)(2)(B)(i)(I), FDA 

must find both: (1) That Nguyen was 

convicted of a misdemeanor under 

Federal law for conduct relating to the 

development or approval of a drug 

product or otherwise relating the 

regulation of a drug product under the 

FD&C Act and (2) that the type of 

conduct underlying the conviction 

undermines the process for the 

regulation of drugs. As set forth in the 

proposal to debar Nguyen, her Federal 

misdemeanor conviction involved a 

violation of the FD&C Act’s 

requirements for drugs. As a result, the 

conduct underlying her conviction both 

related to the regulation of drug 

products under the FD&C Act and 

undermined the process for the 

regulation of drugs. Nguyen does not 

contradict the findings to that effect in 

the proposal to debar and has thus 

failed to create a material factual 

dispute with respect to whether she is 

subject to debarment under section 

306(b)(2)(B)(i)(I) of the FD&C Act. 

In her request for a hearing, Nguyen 

argues nonetheless that she is entitled to 

a hearing because, in the proposal to 

debar, FDA relied on findings that are 

not supported by the record in 

determining the appropriateness and 

period of debarment under section 

306(c)(3) of the FD&C Act. Under 

section 306(i) of the FD&C Act, FDA 

may not take any action under sections 

306(b) or section 306(c) with respect to 

any person ‘‘unless [FDA] has issued an 

order for such action made on the 

record after opportunity for agency 

hearing on disputed issues of material 

fact.’’ Section 306(c)(3) explicitly 

requires FDA to consider, ‘‘where 

applicable,’’ certain factors ‘‘[i]n 

determining the appropriateness and the 

period of debarment’’ for any permissive 

debarment. The proposal to debar 

Nguyen set forth four applicable 

considerations under section 306(c)(3): 

(1) The nature and seriousness of her 

offense under section 306(c)(3)(A); (2) 

the nature and extent of management 

participation in the offense under 

section 306(c)(3)(B); (3) the nature and 

extent of voluntary steps taken to 

mitigate the impact on the public under 

section 306(c)(3)(C); and (4) prior 

convictions involving matters within 

the jurisdiction of FDA under section 

306(c)(3)(F) of the FD&C Act. In the 

proposal, FDA found that the first three 

considerations weigh in favor of 

debarring Nguyen and noted that the 

fourth consideration would be treated as 

a favorable factor for her because the 

Agency was unaware of any prior 

convictions involving matters within 

the jurisdiction of FDA. 

Nguyen’s challenge to specific 

findings in the proposal to debar fails to 

create a genuine and substantial dispute 

of fact for resolution at a hearing with 

respect to any of the applicable 

considerations under section 306(c)(3) 

of the FD&C Act. In her request for a 

hearing, Nguyen argues that the records 

of her criminal proceedings do not 

support certain findings in the proposal 

to debar. Specifically, she contends that 

neither the plea agreement nor the 

criminal information to which she pled 

guilty support the following findings: 

(1) That she was ‘‘aware that the drugs 

[in question] needed to be relabeled for 

sale in the United States,’’ (2) that some 

of the drugs bore labeling in Portuguese 

before they were relabeled, or (3) that 

the conduct underlying her conviction 

continued for 13 months. Even after 

disregarding the findings in the 

proposal to debar to which Nguyen 

objects, we find that she should be 

debarred for the maximum period of 5 

years. 

Nguyen’s factual objections relate 

primarily to the consideration of the 

nature and seriousness of her offense 

under section 306(c)(3)(A) of the FD&C 


asabaliauskas on DSKBBXCHB2PROD with NOTICES
Federal Register / Vol. 82, No. 204 / Tuesday, October 24, 2017 / Notices 49213 

Act. As noted previously, Nguyen pled 

guilty to a misdemeanor under the 

FD&C Act by admitting that she 

acquired, repackaged, relabeled, and 

distributed unapproved prescription 

drugs in interstate commerce. In her 

criminal proceedings, Nguyen also 

admitted that some of these unapproved 

prescription drugs were counterfeit 

drugs. By definition, a counterfeit drug 

is a drug whose container or labeling 

falsely describes the manufacturer, 

processer, packer, or distributer of that 

drug (see 21 U.S.C. 331(g)(2)) and 

thereby can effectively conceal the 

actual manufacturer, processer, packer, 

or distributer from consumers and 

government regulators. An unapproved 

drug in this context is a drug requiring 

but lacking FDA approval that is not 

generally recognized as safe and 

effective for its intended use (see 21 

U.S.C. 331(g)(1)). As such, the products 

that Nguyen admitted to acquiring, 

repackaging, relabeling, and further 

distributing were not simply 

misbranded in some technical sense. 

With respect to Nguyen’s assertion 

that her offense was committed without 

knowledge, section 306(b)(2)(B)(i) of the 

FD&C Act specifically provides for the 

debarment of individuals convicted of 

Federal misdemeanors related to the 

regulation of drug products under the 

FD&C Act. Given that a misdemeanor 

violation of the FD&C Act itself is a 

strict liability offense, meaning an 

offense that does not require proof of 

knowledge as an element of the crime, 

it stands to reason that criminal intent 

is not required to subject an individual 

to debarment under section 

306(b)(2)(B)(i). As recognized by the 

U.S. Supreme Court, an individual who 

is responsible for the operation of an 

FDA-regulated business is also 

responsible for any violations of the 

FD&C Act that arise out of the conduct 

of the business, whether or not he or she 

intends to commit the violations or even 

knows that the violations have been 

committed. (United States v. Park, 421 

U.S. 658 (1975); United States v. 

Dotterweich, 320 U.S. 277 (1943)). In 

keeping with the FD&C Act’s purpose of 

protecting the public from adulterated 

and misbranded products, Congress 

chose to place the burden of protecting 

the public on those who manufacture 

and distribute those products rather 

than on consumers, who cannot protect 

themselves. (Dotterweich, 320 U.S. at 

280–81.) Nguyen herself chose to run a 

business that acquired, repackaged, 

relabeled, and further distributed 

prescription drugs to consumers who 

were unable to protect themselves from 

the unapproved and counterfeit 

products that Nguyen admitted to 

providing them. 

Even though the law subjects Nguyen 

to permissive debarment as a 

responsible corporate officer regardless 

of her knowledge or intent to commit 

the violation, Nguyen has admitted that 

she personally engaged in the conduct 

underlying the violation as a hands-on 

participant. Nguyen admitted in her 

plea that she repackaged the drugs and 

affixed labeling to these prescription 

drugs that did not disclose that the 

drugs were counterfeit and not 

approved by FDA. Nguyen admitted that 

she repackaged and affixed this false 

and misleading labeling to these 

prescription drugs and then shipped 

these drugs in interstate commerce for 

eventual use by the unknowing public. 

In light of these undisputed and 

admitted facts, even crediting Nguyen’s 

objections related to her level of 

knowledge, the precise language of the 

product labeling on some of the drugs 

she received, and the precise length of 

time she committed this offense, these 

objections do not minimize the nature 

and seriousness the conduct Nguyen 

both committed and admitted. The 

proposal to debar alleges that Nguyen’s 

conduct ‘‘created a significant risk of 

injury to consumers who were exposed 

to misbranded drugs and seriously 

undermined the integrity of the 

Agency’s regulation of drug products.’’ 

Because of the uncontested and 

admitted facts already discussed, 

Nguyen’s objections, even if taken as 

true, would not undermine this 

conclusion. Therefore, we conclude that 

the nature and seriousness of her 

conduct weighs in favor of debarring 

Nguyen. 

Having found that the consideration 

in section 306(c)(3)(A) of the FD&C Act 

weighs in favor of debarring Nguyen, we 

turn to the remaining three applicable 

considerations. Nguyen does not 

dispute the unfavorable facts in the FDA 

proposal to debar that relate to the 

considerations in sections 306(c)(3)(B) 

and (C) of the FD&C Act. Specifically, 

Nguyen does not dispute the findings in 

the proposal that she used a company of 

which she was the owner and operator, 

AQ Pharmaceuticals, Inc., to distribute 

the unapproved and counterfeit drugs 

and that she served in a managerial role 

in this offense. Nor does Nguyen 

contradict the findings in the proposal 

to debar that she and her company did 

not discontinue their illegal conduct 

until it was discovered by authorities. In 

her hearing request, Nguyen does not 

point to any voluntary steps taken to 

mitigate the effect of her offenses on the 

public. Thus, the considerations in 

sections 306(c)(3)(B) and (C) of the 

FD&C Act regarding Nguyen’s 

management role and the voluntary 

steps taken by Nguyen to mitigate the 

impact of her offense on the public both 

weigh in favor of her debarment. 

Although Nguyen appears to have no 

previous criminal convictions related to 

matters within the jurisdiction of FDA 

(see section 306(c)(3)(F) of the FD&C 

Act), this consideration alone does not 

counter to a sufficient degree the nature 

and seriousness of the conduct 

underlying her misdemeanor 

conviction, her managerial role in the 

offense, and the lack of any voluntary 

steps taken to mitigate the impact of that 

offense of the public, to warrant 

decreasing the period of debarment from 

5 years. 

III. Findings and Order 

Therefore, the Director of OSI, under 

section 306(b)(1)(B)(i)(I) of the FD&C 

Act and under authority delegated to 

him by the Commissioner of Food and 

Drugs, finds that Nguyen has been 

convicted of a misdemeanor under 

Federal law for conduct relating to the 

development or approval of a drug 

product or otherwise relating the 

regulation of a drug product under the 

FD&C Act and that the conduct 

underlying the conviction undermines 

the regulation of drugs. FDA has 

considered the relevant factors listed in 

section 306(c)(3) of the FD&C Act and 

determined that a debarment of 5 years 

is appropriate. 

As a result of the foregoing findings, 

Nguyen is debarred for 5 years from 

providing services in any capacity to a 

person with an approved or pending 

drug product application under section 

505, 512, or 802 of the FD&C Act (21 

U.S.C. 355, 360b, or 382), or under 

section 351 of the Public Health Service 

Act (42 U.S.C. 262), effective (see DATES) 

(21 U.S.C. 335a(c)(1)(B) and (c)(2)(A)(iii) 

and 21 U.S.C. 321(dd)). Any person 

with an approved or pending drug 

product application, who knowingly 

uses the services of Nguyen, in any 

capacity during her period of 

debarment, will be subject to civil 

money penalties. If Nguyen, during her 

period of debarment, provides services 

in any capacity to a person with an 

approved or pending drug product 

application, she will be subject to civil 

money penalties. In addition, FDA will 

not accept or review any abbreviated 

new drug applications submitted by or 

with the assistance of Nguyen during 

her period of debarment. 


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49214 Federal Register / Vol. 82, No. 204 / Tuesday, October 24, 2017 / Notices 

Dated: October 19, 2017. 

G. Matthew Warren, 

Director, Office of Scientific Integrity. 

[FR Doc. 2017–23019 Filed 10–23–17; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2017–N–5715] 

Watson Laboratories, Inc., and Barr 

Laboratories, Inc., Subsidiaries of Teva 

Pharmaceuticals USA, Inc.; Withdrawal 

of Approval of 54 Abbreviated New 

Drug Applications 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is withdrawing 

approval of 54 abbreviated new drug 

applications (ANDAs) from two 

applicants. The holders of the 

applications notified the Agency in 

writing that the drug products were no 

longer marketed and requested that the 

approval of the applications be 

withdrawn. 

DATES: Approval is withdrawn as of 

November 24, 2017. 

FOR FURTHER INFORMATION CONTACT: 

Trang Tran, Center for Drug Evaluation 

and Research, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 75, Rm. 1671, Silver Spring, 

MD 20993–0002, 240–402–7945. 

SUPPLEMENTARY INFORMATION: The 

holders of the applications listed in 

table 1 have informed FDA that these 

drug products are no longer marketed 

and have requested that FDA withdraw 

approval of the applications under the 

process in § 314.150(c) (21 CFR 

314.150(c)). The applicants have also, 

by their requests, waived their 

opportunity for a hearing. Withdrawal 

of approval of an abbreviated 

application under § 314.150(c) is 

without prejudice to refiling. 

TABLE 1 

Application No. Drug Applicant 

ANDA 061717 ........ Doxycycline Hyclate Capsules USP, Equivalent to (EQ) 50 milligrams 

(mg) base and EQ 100 mg base.

Watson Laboratories, Inc., Subsidiary of Teva 

Pharmaceuticals USA, Inc., 425 Privet Rd., 

Horsham, PA 19044. 

ANDA 062087 ........ Erythromycin Estolate Capsules USP, EQ 250 mg base ......................... Do. 

ANDA 062318 ........ Gentamicin Injection USP, EQ 10 mg base/milliliter (mL) and EQ 40 mg 

base/mL.

Do. 

ANDA 062816 ........ Ampicillin for Injection USP, EQ 125 mg base/vial, EQ 250 mg base/ 

vial, EQ 500 mg base/vial, EQ 1 gram (g) base/vial, and EQ 2 g 

base/vial.

Do. 

ANDA 062994 ........ Ampicillin for Injection USP, EQ 10 g base/vial ........................................ Do. 

ANDA 062999 ........ Erythromycin Delayed-Release Tablets USP, 500 mg ............................. Barr Laboratories, Inc., Subsidiary of Teva 

Pharmaceuticals USA, Inc., 425 Privet Rd., 

Horsham, PA 19044. 

ANDA 064036 ........ Cefuroxime for Injection USP, EQ 7.5 g base/vial ................................... Watson Laboratories, Inc., Subsidiary of Teva 

Pharmaceuticals USA, Inc. 

ANDA 070296 ........ Diazepam Injection USP, 5 mg/mL ........................................................... Do. 

ANDA 070412 ........ Furosemide Tablets USP, 20 mg .............................................................. Do. 

ANDA 070435 ........ Ibuprofen Tablets USP, 200 mg ............................................................... Do. 

ANDA 070436 ........ Ibuprofen Tablets USP, 400 mg ............................................................... Do. 

ANDA 070437 ........ Ibuprofen Tablets USP, 600 mg ............................................................... Do. 

ANDA 070449 ........ Furosemide Tablets USP, 20 mg .............................................................. Do. 

ANDA 070450 ........ Furosemide Tablets USP, 40 mg .............................................................. Do. 

ANDA 070515 ........ Tolazamide Tablets USP, 500 mg ............................................................ Do. 

ANDA 070528 ........ Furosemide Tablets USP, 80 mg .............................................................. Do. 

ANDA 071238 ........ Doxepin Hydrochloride (HCl) Capsules USP, EQ 50 mg base ................ Do. 

ANDA 071547 ........ Ibuprofen Tablets USP, 800 mg ............................................................... Do. 

ANDA 072397 ........ Diazepam Injection USP, 5 mg/mL ........................................................... Do. 

ANDA 072407 ........ Fenoprofen Calcium Tablets USP, EQ 600 mg base ............................... Do. 

ANDA 072602 ........ Fenoprofen Calcium Tablets USP, EQ 600 mg base ............................... Do. 

ANDA 072630 ........ Albuterol Tablets USP, EQ 4 mg base ..................................................... Do. 

ANDA 072825 ........ Baclofen Tablets USP, 20 mg ................................................................... Do. 

ANDA 073013 ........ Metaproterenol Sulfate Tablets USP, 10 mg ............................................ Do. 

ANDA 073445 ........ Meperidine HCl Injection USP, 100 mg/mL .............................................. Do. 

ANDA 074025 ........ Guanabenz Acetate Tablets USP, EQ 4 mg base and EQ 8 mg base ... Do. 

ANDA 074114 ........ Dobutamine Injection USP, EQ 12.5 mg base/mL ................................... Do. 

ANDA 074163 ........ Naproxen Tablets USP, 250 mg, 375 mg, and 500 mg ........................... Do. 

ANDA 074287 ........ Piroxicam Capsules USP, 10 mg and 20 mg ........................................... Do. 

ANDA 074303 ........ Pentamidine Isethionate for Injection, 300 mg/vial ................................... Do. 

ANDA 074437 ........ Pindolol Tablets USP, 5 mg and 10 mg ................................................... Do. 

ANDA 074456 ........ Alprazolam Tablets USP, 0.25 mg, 0.5 mg, and 1 mg ............................. Do. 

ANDA 077643 ........ Topiramate Tablets USP, 25 mg, 50 mg, 100 mg, and 200 mg .............. Do. 

ANDA 080728 ........ Diphenhydramine HCl Capsules USP, 25 mg .......................................... Do. 

ANDA 080968 ........ Dexamethasone Tablets USP, 0.75 mg ................................................... Do. 

ANDA 081040 ........ Chlorzoxazone Tablets USP, 500 mg ....................................................... Do. 

ANDA 081149 ........ Hydroxyzine HCl Tablets USP, 10 mg ...................................................... Do. 

ANDA 081189 ........ Hydrochlorothiazide Tablets USP, 25 mg ................................................. Do. 

ANDA 081216 ........ Estropipate Tablets USP, 6 mg ................................................................ Do. 

ANDA 083232 ........ Hydrochlorothiazide Tablets USP, 50 mg ................................................. Do. 


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