40850 Federal Register / Vol. 86, No. 143 / Thursday, July 29, 2021 / Notices 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2021–N–0554] 

Actavis Elizabeth LLC, et al.; 

Withdrawal of Approval of 85 

Abbreviated New Drug Applications 

AGENCY: Food and Drug Administration, 

Health and Human Services (HHS). 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA or Agency) is 

withdrawing approval of 85 abbreviated 

new drug applications (ANDAs) from 

multiple applicants. The applicants 

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applications be withdrawn. 

DATES: Approval is withdrawn as of 

August 30, 2021. 

FOR FURTHER INFORMATION CONTACT: 

Martha Nguyen, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 75, Rm. 1676, 

Silver Spring, MD 20993–0002, 240– 

402–6980, Martha.Nguyen@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: The 

applicants listed in the table have 

informed FDA that these drug products 

are no longer marketed and have 

requested that FDA withdraw approval 

of the applications under the process 

described 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 application or 

abbreviated application under 

§ 314.150(c) is without prejudice to 

refiling. 

Application No. Drug Applicant 

ANDA 040113 .... Chlorzoxazone Tablets, 500 milligrams (mg) .......................... Actavis Elizabeth LLC (an indirect, wholly owned subsidiary 

of Teva Pharmaceuticals USA, Inc.), 400 Interpace Pkwy., 

Building A, Parsippany, NJ 07054. 

ANDA 040152 .... Carisoprodol Tablets, 350 mg .................................................. Watson Laboratories, Inc. (an indirect, wholly owned subsidiary of Teva Pharmaceuticals USA, Inc.), 400 Interpace 

Pkwy., Building A, Parsippany, NJ 07054. 

ANDA 040184 .... Trihexyphenidyl Hydrochloride (HCl) Tablets, 2 mg and 5 mg Do. 

ANDA 040212 .... Estradiol Tablets, 0.5 mg, 1 mg, 1.5 mg, and 2 mg ................ Do. 

ANDA 040276 .... Phentermine HCl Tablets, 37.5 mg ......................................... Actavis Elizabeth LLC. 

ANDA 040296 .... Estropipate Tablets, 0.75 mg, 1.5 mg, and 3 mg .................... Barr Laboratories, Inc. (an indirect, wholly owned subsidiary 

of Teva Pharmaceuticals USA, Inc.), 400 Interpace Pkwy., 

Building A, Parsippany, NJ 07054. 

ANDA 060704 .... Tetracycline HCl Capsules, 250 mg and 500 mg .................... Ivax Pharmaceuticals, Inc. (an indirect, wholly owned subsidiary of Teva Pharmaceuticals USA, Inc.), 400 Interpace 

Pkwy., Building A, Parsippany, NJ 07054. 

ANDA 062343 .... Tetracycline HCl Capsules, 250 mg and 500 mg .................... Watson Laboratories, Inc. 

ANDA 062581 .... Doxycycline Hyclate Tablets, Equivalent to (EQ) 100 mg 

base.

Teva Pharmaceuticals USA, Inc., 400 Interpace Pkwy., Building A, Parsippany, NJ 07054. 

ANDA 070152 .... Diazepam Tablets, 2 mg .......................................................... Barr Laboratories, Inc. 

ANDA 070153 .... Diazepam Tablets, 5 mg .......................................................... Teva Pharmaceuticals USA, Inc. 

ANDA 070154 .... Diazepam Tablets, 10 mg ........................................................ Barr Laboratories, Inc. 

ANDA 070511 .... Metoclopramide HCl Tablets, EQ 10 mg base ........................ Watson Laboratories, Inc. 

ANDA 070548 .... Propranolol HCl Tablets, 10 mg .............................................. Do. 

ANDA 070706 .... Diazepam Tablets, 5 mg .......................................................... Actavis Elizabeth LLC. 

ANDA 070707 .... Diazepam Tablets, 10 mg ........................................................ Do. 

ANDA 070781 .... Diazepam Tablets, 2 mg .......................................................... Do. 

ANDA 070856 .... Verapamil HCl Tablets, 120 mg ............................................... Watson Laboratories, Inc. 

ANDA 070944 .... Oxazepam Capsules, 15 mg ................................................... Ivax Pharmaceuticals, Inc. 

ANDA 070964 .... Clonidine HCl Tablets, 0.2 mg ................................................. Watson Laboratories, Inc. 

ANDA 070965 .... Clonidine HCI Tablets, 0.1 mg ................................................. Do. 

ANDA 070985 .... Ibuprofen Tablets, 200 mg ....................................................... Merro Pharmaceutical Co., Ltd., SciRegs International, Inc., 

Authorized U.S. Agent, 6333 Summercrest Dr., Columbia, 

MD 21045. 

ANDA 071019 .... Verapamil HCl Tablets, 80 mg ................................................. Actavis Elizabeth LLC. 

ANDA 071050 .... Morphine Sulfate Injection, 0.5 mg/milliliters (mL) ................... Fresenius Kabi USA, LLC, Three Corporate Dr., Lake Zurich, 

IL 60047. 

ANDA 071086 .... Lorazepam Tablets, 0.5 mg ..................................................... Watson Laboratories, Inc. 

ANDA 071087 .... Lorazepam Tablets, 1 mg ........................................................ Do. 

ANDA 071088 .... Lorazepam Tablets, 2 mg ........................................................ Do. 

ANDA 071366 .... Verapamil HCl Tablets, 80 mg ................................................. Do. 

ANDA 071367 .... Verapamil HCl Tablets, 120 mg ............................................... Do. 

ANDA 071476 .... Betamethasone Dipropionate Cream, EQ 0.05% base ........... Teva Pharmaceuticals USA, Inc. 

ANDA 071477 .... Betamethasone Dipropionate Ointment, EQ 0.05% base ....... Do. 

ANDA 071479 .... Carbamazepine Tablets, 200 mg ............................................. PLIVA Inc. (an indirect, wholly owned subsidiary of Teva 

Pharmaceuticals USA, Inc.), 400 Interpace Pkwy., Building 

A, Parsippany, NJ 07054. 

ANDA 071696 .... Carbamazepine Tablets, 200 mg ............................................. Actavis Elizabeth LLC. 

ANDA 071969 .... Triamterene and Hydrochlorothiazide Tablets, 50 mg and 75 

mg.

Watson Laboratories, Inc. 

ANDA 072124 .... Verapamil HCl Tablets, 80 mg ................................................. PLIVA Inc. 

ANDA 072125 .... Verapamil HCl Tablets, 120 mg ............................................... Do. 

ANDA 072333 .... Prazosin HCl Capsules, EQ 2 mg base .................................. Watson Laboratories, Inc. 

ANDA 072352 .... Prazosin HCl Capsules, EQ 1 mg base .................................. Do. 

ANDA 072418 .... Amoxapine Tablets, 25 mg ...................................................... Do. 

ANDA 072419 .... Amoxapine Tablets, 50 mg ...................................................... Do. 


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Federal Register / Vol. 86, No. 143 / Thursday, July 29, 2021 / Notices 40851 

Application No. Drug Applicant 

ANDA 072420 .... Amoxapine Tablets, 100 mg .................................................... Do. 

ANDA 072421 .... Amoxapine Tablets, 150 mg .................................................... Do. 

ANDA 072609 .... Prazosin HCl Capsules, EQ 5 mg base .................................. Do. 

ANDA 072751 .... Verapamil HCl Tablets, 40 mg ................................................. PLIVA Inc. 

ANDA 072923 .... Verapamil HCl Tablets, 40 mg ................................................. Watson Laboratories, Inc. 

ANDA 072953 .... Oxazepam Capsules, 15 mg ................................................... Do. 

ANDA 072954 .... Oxazepam Capsules, 30 mg ................................................... Do. 

ANDA 073093 .... Baclofen Tablets, 20 mg .......................................................... Do. 

ANDA 073122 .... Loperamide HCl Capsules, 2 mg ............................................. Teva Pharmaceuticals USA, Inc. 

ANDA 073334 .... Amiloride HCl and Hydrochlorothiazide Tablets, EQ 5 mg anhydrous; 50 mg.Watson Laboratories, Inc. 

ANDA 073352 .... Atenolol Tablets, 50 mg ........................................................... Do. 

ANDA 073353 .... Atenolol Tablets, 100 mg ......................................................... Do. 

ANDA 073637 .... Piroxicam Capsules, 10 mg ..................................................... Teva Pharmaceuticals USA, Inc. 

ANDA 073638 .... Piroxicam Capsules, 20 mg ..................................................... Do. 

ANDA 074026 .... Triamterene and Hydrochlorothiazide Tablets, 25 mg and 

37.5 mg.

PLIVA Inc. 

ANDA 074359 .... Butalbital, Aspirin, Caffeine, and Codeine Phosphate Capsules, 325 mg, 50 mg, 40 mg, and 30 mg.Watson Laboratories, Inc. 

ANDA 074405 .... Flurbiprofen Tablets, 50 mg and 100 mg ................................ Teva Pharmaceuticals USA, Inc. 

ANDA 074421 .... Cyclobenzaprine HCl Tablets, 10 mg ...................................... PLIVA Inc. 

ANDA 074436 .... Cyclobenzaprine HCl Tablets, 10 mg ...................................... Watson Laboratories, Inc. 

ANDA 074442 .... Gemfibrozil Tablets, 600 mg .................................................... Do. 

ANDA 074479 .... Alprazolam Tablets, 0.25 mg, 0.5 mg, and 1 mg .................... Do. 

ANDA 074647 .... Flurbiprofen Tablets, 50 mg and 100 mg ................................ PLIVA Inc. 

ANDA 074762 .... Guanfacine HCl Tablets, EQ 1 mg base and EQ 2 mg base Watson Laboratories, Inc. 

ANDA 074836 .... Acyclovir Tablets, 400 mg and 800 mg ................................... IVAX Pharmaceuticals, Inc. 

ANDA 074892 .... Etodolac Tablets, 400 mg and 500 mg ................................... Watson Laboratories, Inc. 

ANDA 074955 .... Ketorolac Tromethamine Tablets, 10 mg ................................ Do. 

ANDA 074964 .... Clonazepam Tablets, 0.5 mg, 1 mg, and 2 mg ....................... Do. 

ANDA 075067 .... Cromolyn Sodium Inhalation Solution, 10 mg/mL ................... Actavis Mid Atlantic LLC (an indirect, wholly owned subsidiary of Teva Pharmaceuticals USA, Inc.), 400 Interpace 

Pkwy., Building A, Parsippany, NJ 07054. 

ANDA 075069 .... Etodolac Tablets, 400 mg ........................................................ Watson Laboratories, Inc. 

ANDA 075262 .... Albuterol Sulfate Syrup, EQ 2 mg base/5 mL ......................... Actavis Mid Atlantic LLC. 

ANDA 075284 .... Ketorolac Tromethamine Tablets, 10 mg ................................ PLIVA Inc. 

ANDA 081165 .... Hydroxyzine Pamoate Capsules, EQ 25 mg HCl .................... Watson Laboratories, Inc. 

ANDA 084503 .... Hydralazine HCl Tablets, 50 mg .............................................. Do. 

ANDA 085054 .... Hydrochlorothiazide Tablets, 25 mg ........................................ Actavis Mid Atlantic LLC. 

ANDA 085084 .... Prednisone Tablets, 5 mg ........................................................ Watson Laboratories, Inc. 

ANDA 085085 .... Prednisolone Tablets, 5 mg ..................................................... Do. 

ANDA 085208 .... Hydrochlorothiazide Tablets, 50 mg ........................................ Actavis Elizabeth LLC. 

ANDA 086710 .... Aspirin, Butalbital, Caffeine Tablets, 325 mg, 50 mg, and 40 

mg.

Do. 

ANDA 086813 .... Prednisone Tablets, 20 mg ...................................................... Watson Laboratories, Inc. 

ANDA 087773 .... Prednisone Tablets, 10 mg ...................................................... Do. 

ANDA 088348 .... Hydroxyzine HCl Tablets, 10 mg ............................................. Do. 

ANDA 088349 .... Hydroxyzine HCl Tablets, 25 mg ............................................. Do. 

ANDA 088350 .... Hydroxyzine HCl Tablets, 50 mg ............................................. Do. 

ANDA 088497 .... Methylprednisolone Tablets, 4 mg ........................................... Duramed Pharmaceuticals Inc. (an indirect wholly owned 

subsidiary of Teva Pharmaceuticals USA, Inc.), 400 

Interpace Pkwy., Building A, Parsippany, NJ 07054. 

ANDA 089536 .... Acetaminophen, Butalbital, and Caffeine Tablets, 325 mg, 50 

mg, and 40 mg.

Watson Laboratories, Inc. 

Therefore, approval of the 

applications listed in the table, and all 

amendments and supplements thereto, 

is hereby withdrawn as of August 30, 

2021. Approval of each entire 

application is withdrawn, including any 

strengths and dosage forms 

inadvertently missing from the table. 

Introduction or delivery for introduction 

into interstate commerce of products 

without approved new drug 

applications violates section 301(a) and 

(d) of the Federal Food, Drug, and 

Cosmetic Act (21 U.S.C. 331(a) and (d)). 

Drug products that are listed in the table 

that are in inventory on August 30, 2021 

may continue to be dispensed until the 

inventories have been depleted or the 

drug products have reached their 

expiration dates or otherwise become 

violative, whichever occurs first. 

Dated: July 26, 2021. 

Lauren K. Roth, 

Acting Principal Associate Commissioner for 

Policy. 

[FR Doc. 2021–16178 Filed 7–28–21; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2021–D–0519] 

Rabies: Developing Monoclonal 

Antibody Cocktails for the Passive 

Immunization Component of PostExposure Prophylaxis; Draft Guidance 

for Industry; Availability 

AGENCY: Food and Drug Administration, 

Health and Human Services (HHS). 

ACTION: Notice of availability. 


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