Federal Register - July 29, 2021
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Source: Federal Register
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Federal Register / Vol. 86, No. 143 / Thursday, July 29, 2021 / Notices
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration Docket No. FDA2021N0554
Actavis Elizabeth LLC, et al.;
Withdrawal of Approval of 85
Abbreviated New Drug Applications Food and Drug Administration, Health and Human Services HHS.
ACTION: Notice.
AGENCY:
The Food and Drug Administration FDA or Agency is
SUMMARY:
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 314.150c 21 CFR
314.150c. The applicants have also, by their requests, waived their opportunity for a hearing. Withdrawal of approval of an application or abbreviated application under 314.150c is without prejudice to refiling.
SUPPLEMENTARY INFORMATION:
Application No.
Drug
Applicant
ANDA 040113
Chlorzoxazone Tablets, 500 milligrams mg
ANDA 040152
Carisoprodol Tablets, 350 mg
ANDA
ANDA
ANDA
ANDA
Trihexyphenidyl Hydrochloride HCl Tablets, 2 mg and 5 mg Estradiol Tablets, 0.5 mg, 1 mg, 1.5 mg, and 2 mg
Phentermine HCl Tablets, 37.5 mg
Estropipate Tablets, 0.75 mg, 1.5 mg, and 3 mg
ANDA 060704
Tetracycline HCl Capsules, 250 mg and 500 mg
ANDA 062343
ANDA 062581
Tetracycline HCl Capsules, 250 mg and 500 mg
Doxycycline Hyclate Tablets, Equivalent to EQ 100 mg base.
Diazepam Tablets, 2 mg
Diazepam Tablets, 5 mg
Diazepam Tablets, 10 mg
Metoclopramide HCl Tablets, EQ 10 mg base
Propranolol HCl Tablets, 10 mg
Diazepam Tablets, 5 mg
Diazepam Tablets, 10 mg
Diazepam Tablets, 2 mg
Verapamil HCl Tablets, 120 mg
Oxazepam Capsules, 15 mg
Clonidine HCl Tablets, 0.2 mg
Clonidine HCI Tablets, 0.1 mg
Ibuprofen Tablets, 200 mg
ANDA 071019
ANDA 071050
Verapamil HCl Tablets, 80 mg
Morphine Sulfate Injection, 0.5 mg/milliliters mL
ANDA
ANDA
ANDA
ANDA
ANDA
ANDA
ANDA
ANDA
Lorazepam Tablets, 0.5 mg
Lorazepam Tablets, 1 mg
Lorazepam Tablets, 2 mg
Verapamil HCl Tablets, 80 mg
Verapamil HCl Tablets, 120 mg
Betamethasone Dipropionate Cream, EQ 0.05% base
Betamethasone Dipropionate Ointment, EQ 0.05% base
Carbamazepine Tablets, 200 mg
ANDA 071696
ANDA 071969
Carbamazepine Tablets, 200 mg
Triamterene and Hydrochlorothiazide Tablets, 50 mg and 75
mg.
Verapamil HCl Tablets, 80 mg
Verapamil HCl Tablets, 120 mg
Prazosin HCl Capsules, EQ 2 mg base
Prazosin HCl Capsules, EQ 1 mg base
Amoxapine Tablets, 25 mg
Amoxapine Tablets, 50 mg
Actavis Elizabeth LLC an indirect, wholly owned subsidiary of Teva Pharmaceuticals USA, Inc., 400 Interpace Pkwy., Building A, Parsippany, NJ 07054.
Watson Laboratories, Inc. an indirect, wholly owned subsidiary of Teva Pharmaceuticals USA, Inc., 400 Interpace Pkwy., Building A, Parsippany, NJ 07054.
Do.
Do.
Actavis Elizabeth LLC.
Barr Laboratories, Inc. an indirect, wholly owned subsidiary of Teva Pharmaceuticals USA, Inc., 400 Interpace Pkwy., Building A, Parsippany, NJ 07054.
Ivax Pharmaceuticals, Inc. an indirect, wholly owned subsidiary of Teva Pharmaceuticals USA, Inc., 400 Interpace Pkwy., Building A, Parsippany, NJ 07054.
Watson Laboratories, Inc.
Teva Pharmaceuticals USA, Inc., 400 Interpace Pkwy., Building A, Parsippany, NJ 07054.
Barr Laboratories, Inc.
Teva Pharmaceuticals USA, Inc.
Barr Laboratories, Inc.
Watson Laboratories, Inc.
Do.
Actavis Elizabeth LLC.
Do.
Do.
Watson Laboratories, Inc.
Ivax Pharmaceuticals, Inc.
Watson Laboratories, Inc.
Do.
Merro Pharmaceutical Co., Ltd., SciRegs International, Inc., Authorized U.S. Agent, 6333 Summercrest Dr., Columbia, MD 21045.
Actavis Elizabeth LLC.
Fresenius Kabi USA, LLC, Three Corporate Dr., Lake Zurich, IL 60047.
Watson Laboratories, Inc.
Do.
Do.
Do.
Do.
Teva Pharmaceuticals USA, Inc.
Do.
PLIVA Inc. an indirect, wholly owned subsidiary of Teva Pharmaceuticals USA, Inc., 400 Interpace Pkwy., Building A, Parsippany, NJ 07054.
Actavis Elizabeth LLC.
Watson Laboratories, Inc.
ANDA
ANDA
ANDA
ANDA
ANDA
ANDA
ANDA
ANDA
ANDA
ANDA
ANDA
ANDA
ANDA
jbell on DSKJLSW7X2PROD with NOTICES
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 209930002, 240
4026980, Martha.Nguyen@fda.hhs.gov.
ANDA
ANDA
ANDA
ANDA
ANDA
ANDA
040184
040212
040276
040296
070152
070153
070154
070511
070548
070706
070707
070781
070856
070944
070964
070965
070985
071086
071087
071088
071366
071367
071476
071477
071479
072124
072125
072333
072352
072418
072419
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PLIVA Inc.
Do.
Watson Laboratories, Inc.
Do.
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Do.
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