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Home » 2021 Issues » 86 FR (07/29/2021) » 2021-16178. Actavis Elizabeth LLC, et al.; Withdrawal of Approval of 85 Abbreviated New Drug Applications

  2021-16178. Actavis Elizabeth LLC, et al.; Withdrawal of Approval of 85 Abbreviated New Drug Applications  

  • Start Preamble Start Printed Page 40850

    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Agency in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn.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    Approval is withdrawn as of August 30, 2021.

    Start Further Info

    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.

    End Further Info End Preamble Start Supplemental Information

    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.DrugApplicant
    ANDA 040113Chlorzoxazone 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 040152Carisoprodol Tablets, 350 mgWatson Laboratories, Inc. (an indirect, wholly owned subsidiary of Teva Pharmaceuticals USA, Inc.), 400 Interpace Pkwy., Building A, Parsippany, NJ 07054.
    ANDA 040184Trihexyphenidyl Hydrochloride (HCl) Tablets, 2 mg and 5 mg  Do.
    ANDA 040212Estradiol Tablets, 0.5 mg, 1 mg, 1.5 mg, and 2 mg  Do.
    ANDA 040276Phentermine HCl Tablets, 37.5 mgActavis Elizabeth LLC.
    ANDA 040296Estropipate Tablets, 0.75 mg, 1.5 mg, and 3 mgBarr Laboratories, Inc. (an indirect, wholly owned subsidiary of Teva Pharmaceuticals USA, Inc.), 400 Interpace Pkwy., Building A, Parsippany, NJ 07054.
    ANDA 060704Tetracycline HCl Capsules, 250 mg and 500 mgIvax Pharmaceuticals, Inc. (an indirect, wholly owned subsidiary of Teva Pharmaceuticals USA, Inc.), 400 Interpace Pkwy., Building A, Parsippany, NJ 07054.
    ANDA 062343Tetracycline HCl Capsules, 250 mg and 500 mgWatson Laboratories, Inc.
    ANDA 062581Doxycycline Hyclate Tablets, Equivalent to (EQ) 100 mg baseTeva Pharmaceuticals USA, Inc., 400 Interpace Pkwy., Building A, Parsippany, NJ 07054.
    ANDA 070152Diazepam Tablets, 2 mgBarr Laboratories, Inc.
    ANDA 070153Diazepam Tablets, 5 mgTeva Pharmaceuticals USA, Inc.
    ANDA 070154Diazepam Tablets, 10 mgBarr Laboratories, Inc.
    ANDA 070511Metoclopramide HCl Tablets, EQ 10 mg baseWatson Laboratories, Inc.
    ANDA 070548Propranolol HCl Tablets, 10 mg  Do.
    ANDA 070706Diazepam Tablets, 5 mgActavis Elizabeth LLC.
    ANDA 070707Diazepam Tablets, 10 mg  Do.
    ANDA 070781Diazepam Tablets, 2 mg  Do.
    ANDA 070856Verapamil HCl Tablets, 120 mgWatson Laboratories, Inc.
    ANDA 070944Oxazepam Capsules, 15 mgIvax Pharmaceuticals, Inc.
    ANDA 070964Clonidine HCl Tablets, 0.2 mgWatson Laboratories, Inc.
    ANDA 070965Clonidine HCI Tablets, 0.1 mg  Do.
    ANDA 070985Ibuprofen Tablets, 200 mgMerro Pharmaceutical Co., Ltd., SciRegs International, Inc., Authorized U.S. Agent, 6333 Summercrest Dr., Columbia, MD 21045.
    ANDA 071019Verapamil HCl Tablets, 80 mgActavis Elizabeth LLC.
    ANDA 071050Morphine Sulfate Injection, 0.5 mg/milliliters (mL)Fresenius Kabi USA, LLC, Three Corporate Dr., Lake Zurich, IL 60047.
    ANDA 071086Lorazepam Tablets, 0.5 mgWatson Laboratories, Inc.
    ANDA 071087Lorazepam Tablets, 1 mg  Do.
    ANDA 071088Lorazepam Tablets, 2 mg  Do.
    ANDA 071366Verapamil HCl Tablets, 80 mg  Do.
    ANDA 071367Verapamil HCl Tablets, 120 mg  Do.
    ANDA 071476Betamethasone Dipropionate Cream, EQ 0.05% baseTeva Pharmaceuticals USA, Inc.
    ANDA 071477Betamethasone Dipropionate Ointment, EQ 0.05% base  Do.
    ANDA 071479Carbamazepine Tablets, 200 mgPLIVA Inc. (an indirect, wholly owned subsidiary of Teva Pharmaceuticals USA, Inc.), 400 Interpace Pkwy., Building A, Parsippany, NJ 07054.
    ANDA 071696Carbamazepine Tablets, 200 mgActavis Elizabeth LLC.
    ANDA 071969Triamterene and Hydrochlorothiazide Tablets, 50 mg and 75 mgWatson Laboratories, Inc.
    ANDA 072124Verapamil HCl Tablets, 80 mgPLIVA Inc.
    ANDA 072125Verapamil HCl Tablets, 120 mg  Do.
    ANDA 072333Prazosin HCl Capsules, EQ 2 mg baseWatson Laboratories, Inc.
    ANDA 072352Prazosin HCl Capsules, EQ 1 mg base  Do.
    ANDA 072418Amoxapine Tablets, 25 mg  Do.
    ANDA 072419Amoxapine Tablets, 50 mg  Do.
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    ANDA 072420Amoxapine Tablets, 100 mg  Do.
    ANDA 072421Amoxapine Tablets, 150 mg  Do.
    ANDA 072609Prazosin HCl Capsules, EQ 5 mg base  Do.
    ANDA 072751Verapamil HCl Tablets, 40 mgPLIVA Inc.
    ANDA 072923Verapamil HCl Tablets, 40 mgWatson Laboratories, Inc.
    ANDA 072953Oxazepam Capsules, 15 mg  Do.
    ANDA 072954Oxazepam Capsules, 30 mg  Do.
    ANDA 073093Baclofen Tablets, 20 mg  Do.
    ANDA 073122Loperamide HCl Capsules, 2 mgTeva Pharmaceuticals USA, Inc.
    ANDA 073334Amiloride HCl and Hydrochlorothiazide Tablets, EQ 5 mg anhydrous; 50 mgWatson Laboratories, Inc.
    ANDA 073352Atenolol Tablets, 50 mg  Do.
    ANDA 073353Atenolol Tablets, 100 mg  Do.
    ANDA 073637Piroxicam Capsules, 10 mgTeva Pharmaceuticals USA, Inc.
    ANDA 073638Piroxicam Capsules, 20 mg  Do.
    ANDA 074026Triamterene and Hydrochlorothiazide Tablets, 25 mg and 37.5 mgPLIVA Inc.
    ANDA 074359Butalbital, Aspirin, Caffeine, and Codeine Phosphate Capsules, 325 mg, 50 mg, 40 mg, and 30 mgWatson Laboratories, Inc.
    ANDA 074405Flurbiprofen Tablets, 50 mg and 100 mgTeva Pharmaceuticals USA, Inc.
    ANDA 074421Cyclobenzaprine HCl Tablets, 10 mgPLIVA Inc.
    ANDA 074436Cyclobenzaprine HCl Tablets, 10 mgWatson Laboratories, Inc.
    ANDA 074442Gemfibrozil Tablets, 600 mg  Do.
    ANDA 074479Alprazolam Tablets, 0.25 mg, 0.5 mg, and 1 mg  Do.
    ANDA 074647Flurbiprofen Tablets, 50 mg and 100 mgPLIVA Inc.
    ANDA 074762Guanfacine HCl Tablets, EQ 1 mg base and EQ 2 mg baseWatson Laboratories, Inc.
    ANDA 074836Acyclovir Tablets, 400 mg and 800 mgIVAX Pharmaceuticals, Inc.
    ANDA 074892Etodolac Tablets, 400 mg and 500 mgWatson Laboratories, Inc.
    ANDA 074955Ketorolac Tromethamine Tablets, 10 mg  Do.
    ANDA 074964Clonazepam Tablets, 0.5 mg, 1 mg, and 2 mg  Do.
    ANDA 075067Cromolyn Sodium Inhalation Solution, 10 mg/mLActavis Mid Atlantic LLC (an indirect, wholly owned subsidiary of Teva Pharmaceuticals USA, Inc.), 400 Interpace Pkwy., Building A, Parsippany, NJ 07054.
    ANDA 075069Etodolac Tablets, 400 mgWatson Laboratories, Inc.
    ANDA 075262Albuterol Sulfate Syrup, EQ 2 mg base/5 mLActavis Mid Atlantic LLC.
    ANDA 075284Ketorolac Tromethamine Tablets, 10 mgPLIVA Inc.
    ANDA 081165Hydroxyzine Pamoate Capsules, EQ 25 mg HClWatson Laboratories, Inc.
    ANDA 084503Hydralazine HCl Tablets, 50 mg  Do.
    ANDA 085054Hydrochlorothiazide Tablets, 25 mgActavis Mid Atlantic LLC.
    ANDA 085084Prednisone Tablets, 5 mgWatson Laboratories, Inc.
    ANDA 085085Prednisolone Tablets, 5 mg  Do.
    ANDA 085208Hydrochlorothiazide Tablets, 50 mgActavis Elizabeth LLC.
    ANDA 086710Aspirin, Butalbital, Caffeine Tablets, 325 mg, 50 mg, and 40 mg  Do.
    ANDA 086813Prednisone Tablets, 20 mgWatson Laboratories, Inc.
    ANDA 087773Prednisone Tablets, 10 mg  Do.
    ANDA 088348Hydroxyzine HCl Tablets, 10 mg  Do.
    ANDA 088349Hydroxyzine HCl Tablets, 25 mg  Do.
    ANDA 088350Hydroxyzine HCl Tablets, 50 mg  Do.
    ANDA 088497Methylprednisolone Tablets, 4 mgDuramed Pharmaceuticals Inc. (an indirect wholly owned subsidiary of Teva Pharmaceuticals USA, Inc.), 400 Interpace Pkwy., Building A, Parsippany, NJ 07054.
    ANDA 089536Acetaminophen, Butalbital, and Caffeine Tablets, 325 mg, 50 mg, and 40 mgWatson 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.

    Start Signature

    Dated: July 26, 2021.

    Lauren K. Roth,

    Acting Principal Associate Commissioner for Policy.

    End Signature End Supplemental Information

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

    BILLING CODE 4164-01-P

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Document Information

Published:
07/29/2021
Department:
Food and Drug Administration
Entry Type:
Notice
Action:
Notice.
Document Number:
2021-16178
Dates:
Approval is withdrawn as of August 30, 2021.
Pages:
40850-40851 (2 pages)
Docket Numbers:
Docket No. FDA-2021-N-0554
PDF File:
2021-16178.pdf
Supporting Documents:
» Actavis Elizabeth LLC, et al.; Withdrawal of Approval of 85 Abbreviated New Drug Applications