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 Department of Health and Human Services Food and Drug Administration [Docket No. FDA-2021-N-0554]
 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Agency in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn.
 DATES: Approval is withdrawn as of August 30, 2021.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
ApplicantANDA 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.( print page 40851)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