[Federal Register Volume 86, Number 143 (Thursday, July 29, 2021)]
[Notices]
[Pages 40850-40851]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-16178]



[[Page 40850]]

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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approval of the applications be withdrawn.

DATES: Approval is withdrawn as of August 30, 2021.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, <a href="/cdn-cgi/l/email-protection#55183427213d347b1b32202c303b153331347b3d3d267b323a23"><span class="__cf_email__" data-cfemail="4a072b383e222b64042d3f332f240a2c2e2b64222239642d253c">[email protected]</span></a>.

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 Sec.  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 Sec.  314.150(c) is without prejudice to refiling.

------------------------------------------------------------------------
    Application No.                Drug                  Applicant
------------------------------------------------------------------------
ANDA 040113............  Chlorzoxazone Tablets,   Actavis Elizabeth LLC
                          500 milligrams (mg).     (an indirect, wholly
                                                   owned subsidiary of
                                                   Teva Pharmaceuticals
                                                   USA, Inc.), 400
                                                   Interpace Pkwy.,
                                                   Building A,
                                                   Parsippany, NJ 07054.
ANDA 040152............  Carisoprodol Tablets,    Watson Laboratories,
                          350 mg.                  Inc. (an indirect,
                                                   wholly owned
                                                   subsidiary of Teva
                                                   Pharmaceuticals USA,
                                                   Inc.), 400 Interpace
                                                   Pkwy., Building A,
                                                   Parsippany, NJ 07054.
ANDA 040184............  Trihexyphenidyl           Do.
                          Hydrochloride (HCl)
                          Tablets, 2 mg and 5 mg.
ANDA 040212............  Estradiol Tablets, 0.5    Do.
                          mg, 1 mg, 1.5 mg, and
                          2 mg.
ANDA 040276............  Phentermine HCl          Actavis Elizabeth LLC.
                          Tablets, 37.5 mg.
ANDA 040296............  Estropipate Tablets,     Barr Laboratories,
                          0.75 mg, 1.5 mg, and 3   Inc. (an indirect,
                          mg.                      wholly owned
                                                   subsidiary of Teva
                                                   Pharmaceuticals USA,
                                                   Inc.), 400 Interpace
                                                   Pkwy., Building A,
                                                   Parsippany, NJ 07054.
ANDA 060704............  Tetracycline HCl         Ivax Pharmaceuticals,
                          Capsules, 250 mg and     Inc. (an indirect,
                          500 mg.                  wholly owned
                                                   subsidiary of Teva
                                                   Pharmaceuticals USA,
                                                   Inc.), 400 Interpace
                                                   Pkwy., Building A,
                                                   Parsippany, NJ 07054.
ANDA 062343............  Tetracycline HCl         Watson Laboratories,
                          Capsules, 250 mg and     Inc.
                          500 mg.
ANDA 062581............  Doxycycline Hyclate      Teva Pharmaceuticals
                          Tablets, Equivalent to   USA, Inc., 400
                          (EQ) 100 mg base.        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       Watson Laboratories,
                          Tablets, EQ 10 mg base.  Inc.
ANDA 070548............  Propranolol HCl           Do.
                          Tablets, 10 mg.
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,   Watson Laboratories,
                          120 mg.                  Inc.
ANDA 070944............  Oxazepam Capsules, 15    Ivax Pharmaceuticals,
                          mg.                      Inc.
ANDA 070964............  Clonidine HCl Tablets,   Watson Laboratories,
                          0.2 mg.                  Inc.
ANDA 070965............  Clonidine HCI Tablets,    Do.
                          0.1 mg.
ANDA 070985............  Ibuprofen Tablets, 200   Merro Pharmaceutical
                          mg.                      Co., Ltd., SciRegs
                                                   International, Inc.,
                                                   Authorized U.S.
                                                   Agent, 6333
                                                   Summercrest Dr.,
                                                   Columbia, MD 21045.
ANDA 071019............  Verapamil HCl Tablets,   Actavis Elizabeth LLC.
                          80 mg.
ANDA 071050............  Morphine Sulfate         Fresenius Kabi USA,
                          Injection, 0.5 mg/       LLC, Three Corporate
                          milliliters (mL).        Dr., Lake Zurich, IL
                                                   60047.
ANDA 071086............  Lorazepam Tablets, 0.5   Watson Laboratories,
                          mg.                      Inc.
ANDA 071087............  Lorazepam Tablets, 1 mg   Do.
ANDA 071088............  Lorazepam Tablets, 2 mg   Do.
ANDA 071366............  Verapamil HCl Tablets,    Do.
                          80 mg.
ANDA 071367............  Verapamil HCl Tablets,    Do.
                          120 mg.
ANDA 071476............  Betamethasone            Teva Pharmaceuticals
                          Dipropionate Cream, EQ   USA, Inc.
                          0.05% base.
ANDA 071477............  Betamethasone             Do.
                          Dipropionate Ointment,
                          EQ 0.05% base.
ANDA 071479............  Carbamazepine Tablets,   PLIVA Inc. (an
                          200 mg.                  indirect, wholly
                                                   owned subsidiary of
                                                   Teva Pharmaceuticals
                                                   USA, Inc.), 400
                                                   Interpace Pkwy.,
                                                   Building A,
                                                   Parsippany, NJ 07054.
ANDA 071696............  Carbamazepine Tablets,   Actavis Elizabeth LLC.
                          200 mg.
ANDA 071969............  Triamterene and          Watson Laboratories,
                          Hydrochlorothiazide      Inc.
                          Tablets, 50 mg and 75
                          mg.
ANDA 072124............  Verapamil HCl Tablets,   PLIVA Inc.
                          80 mg.
ANDA 072125............  Verapamil HCl Tablets,    Do.
                          120 mg.
ANDA 072333............  Prazosin HCl Capsules,   Watson Laboratories,
                          EQ 2 mg base.            Inc.
ANDA 072352............  Prazosin HCl Capsules,    Do.
                          EQ 1 mg base.
ANDA 072418............  Amoxapine Tablets, 25     Do.
                          mg.
ANDA 072419............  Amoxapine Tablets, 50     Do.
                          mg.

[[Page 40851]]

 
ANDA 072420............  Amoxapine Tablets, 100    Do.
                          mg.
ANDA 072421............  Amoxapine Tablets, 150    Do.
                          mg.
ANDA 072609............  Prazosin HCl Capsules,    Do.
                          EQ 5 mg base.
ANDA 072751............  Verapamil HCl Tablets,   PLIVA Inc.
                          40 mg.
ANDA 072923............  Verapamil HCl Tablets,   Watson Laboratories,
                          40 mg.                   Inc.
ANDA 072953............  Oxazepam Capsules, 15     Do.
                          mg.
ANDA 072954............  Oxazepam Capsules, 30     Do.
                          mg.
ANDA 073093............  Baclofen Tablets, 20 mg   Do.
ANDA 073122............  Loperamide HCl           Teva Pharmaceuticals
                          Capsules, 2 mg.          USA, Inc.
ANDA 073334............  Amiloride HCl and        Watson Laboratories,
                          Hydrochlorothiazide      Inc.
                          Tablets, EQ 5 mg
                          anhydrous; 50 mg.
ANDA 073352............  Atenolol Tablets, 50 mg   Do.
ANDA 073353............  Atenolol Tablets, 100     Do.
                          mg.
ANDA 073637............  Piroxicam Capsules, 10   Teva Pharmaceuticals
                          mg.                      USA, Inc.
ANDA 073638............  Piroxicam Capsules, 20    Do.
                          mg.
ANDA 074026............  Triamterene and          PLIVA Inc.
                          Hydrochlorothiazide
                          Tablets, 25 mg and
                          37.5 mg.
ANDA 074359............  Butalbital, Aspirin,     Watson Laboratories,
                          Caffeine, and Codeine    Inc.
                          Phosphate Capsules,
                          325 mg, 50 mg, 40 mg,
                          and 30 mg.
ANDA 074405............  Flurbiprofen Tablets,    Teva Pharmaceuticals
                          50 mg and 100 mg.        USA, Inc.
ANDA 074421............  Cyclobenzaprine HCl      PLIVA Inc.
                          Tablets, 10 mg.
ANDA 074436............  Cyclobenzaprine HCl      Watson Laboratories,
                          Tablets, 10 mg.          Inc.
ANDA 074442............  Gemfibrozil Tablets,      Do.
                          600 mg.
ANDA 074479............  Alprazolam Tablets,       Do.
                          0.25 mg, 0.5 mg, and 1
                          mg.
ANDA 074647............  Flurbiprofen Tablets,    PLIVA Inc.
                          50 mg and 100 mg.
ANDA 074762............  Guanfacine HCl Tablets,  Watson Laboratories,
                          EQ 1 mg base and EQ 2    Inc.
                          mg base.
ANDA 074836............  Acyclovir Tablets, 400   IVAX Pharmaceuticals,
                          mg and 800 mg.           Inc.
ANDA 074892............  Etodolac Tablets, 400    Watson Laboratories,
                          mg and 500 mg.           Inc.
ANDA 074955............  Ketorolac Tromethamine    Do.
                          Tablets, 10 mg.
ANDA 074964............  Clonazepam Tablets, 0.5   Do.
                          mg, 1 mg, and 2 mg.
ANDA 075067............  Cromolyn Sodium          Actavis Mid Atlantic
                          Inhalation Solution,     LLC (an indirect,
                          10 mg/mL.                wholly owned
                                                   subsidiary of Teva
                                                   Pharmaceuticals USA,
                                                   Inc.), 400 Interpace
                                                   Pkwy., Building A,
                                                   Parsippany, NJ 07054.
ANDA 075069............  Etodolac Tablets, 400    Watson Laboratories,
                          mg.                      Inc.
ANDA 075262............  Albuterol Sulfate        Actavis Mid Atlantic
                          Syrup, EQ 2 mg base/5    LLC.
                          mL.
ANDA 075284............  Ketorolac Tromethamine   PLIVA Inc.
                          Tablets, 10 mg.
ANDA 081165............  Hydroxyzine Pamoate      Watson Laboratories,
                          Capsules, EQ 25 mg HCl.  Inc.
ANDA 084503............  Hydralazine HCl           Do.
                          Tablets, 50 mg.
ANDA 085054............  Hydrochlorothiazide      Actavis Mid Atlantic
                          Tablets, 25 mg.          LLC.
ANDA 085084............  Prednisone Tablets, 5    Watson Laboratories,
                          mg.                      Inc.
ANDA 085085............  Prednisolone Tablets, 5   Do.
                          mg.
ANDA 085208............  Hydrochlorothiazide      Actavis Elizabeth LLC.
                          Tablets, 50 mg.
ANDA 086710............  Aspirin, Butalbital,      Do.
                          Caffeine Tablets, 325
                          mg, 50 mg, and 40 mg.
ANDA 086813............  Prednisone Tablets, 20   Watson Laboratories,
                          mg.                      Inc.
ANDA 087773............  Prednisone Tablets, 10    Do.
                          mg.
ANDA 088348............  Hydroxyzine HCl           Do.
                          Tablets, 10 mg.
ANDA 088349............  Hydroxyzine HCl           Do.
                          Tablets, 25 mg.
ANDA 088350............  Hydroxyzine HCl           Do.
                          Tablets, 50 mg.
ANDA 088497............  Methylprednisolone       Duramed
                          Tablets, 4 mg.           Pharmaceuticals Inc.
                                                   (an indirect wholly
                                                   owned subsidiary of
                                                   Teva Pharmaceuticals
                                                   USA, Inc.), 400
                                                   Interpace Pkwy.,
                                                   Building A,
                                                   Parsippany, NJ 07054.
ANDA 089536............  Acetaminophen,           Watson Laboratories,
                          Butalbital, and          Inc.
                          Caffeine Tablets, 325
                          mg, 50 mg, and 40 mg.
------------------------------------------------------------------------

    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


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