[Federal Register Volume 86, Number 120 (Friday, June 25, 2021)]
[Notices]
[Pages 33718-33719]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-13593]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2021-N-0492]


Watson Laboratories, Inc. et al.; Withdrawal of Approval of 36 
Abbreviated New Drug Applications

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is 
withdrawing approval of 36 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approval of the applications be withdrawn.

DATES: Approval is withdrawn as of July 26, 2021.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#236e4251574b420d6d44565a464d634547420d4b4b500d444c55"><span class="__cf_email__" data-cfemail="d895b9aaacb0b9f696bfada1bdb698bebcb9f6b0b0abf6bfb7ae">[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 062142.................  Doxycycline Hyclate   Watson Laboratories,
                               Capsules,             Inc. (an indirect,
                               Equivalent to (EQ)    wholly owned
                               50 milligrams (mg)    subsidiary of Teva
                               base and EQ 200 mg    Pharmaceuticals
                               base.                 USA, Inc.), 400
                                                     Interpace Pkwy.,
                                                     Building A,
                                                     Parsippany, NJ
                                                     07054.
ANDA 062497.................  Doxycycline Hyclate   Teva Pharmaceuticals
                               Capsules, EQ 50 mg    USA, Inc. 400
                               base and EQ 100 mg    Interpace Pkwy.,
                               base.                 Building A,
                                                     Parsippany, NJ
                                                     07054.
ANDA 065152.................  Cephalexin Capsules,  Yung Shin
                               EQ 250 mg base and    Pharmaceutical Ind.
                               EQ 500 mg base.       Co. Ltd.,
                                                     authorized U.S.
                                                     agent, Carlsbad
                                                     Technology, Inc./
                                                     Simon Law, 5922
                                                     Farnsworth Ct.,
                                                     Suite 101,
                                                     Carlsbad, CA 92008.
ANDA 070550.................  Propranolol           Watson Laboratories,
                               Hydrochloride (HCl)   Inc.
                               Tablets, 40 mg.
ANDA 070551.................  Propranolol HCl       Do.
                               Tablets, 80 mg.
ANDA 070943.................  Oxazepam Capsules,    IVAX Pharmaceuticals
                               10 mg.                Inc. (an indirect
                                                     wholly owned
                                                     subsidiary of Teva
                                                     Pharmaceuticals
                                                     USA, Inc.), 400
                                                     Interpace Pkwy.,
                                                     Building A,
                                                     Parsippany, NJ
                                                     07054.
ANDA 070945.................  Oxazepam Capsules,    Do.
                               30 mg.
ANDA 071446.................  Temazepam Capsules,   Watson Laboratories,
                               15 mg.                Inc.
ANDA 071447.................  Temazepam Capsules,   Do.
                               30 mg.
ANDA 072952.................  Oxazepam Capsules,    Do.
                               10 mg.
ANDA 073092.................  Baclofen Tablets, 10  Do.
                               mg.

[[Page 33719]]

 
ANDA 074400.................  Diflunisal Tablets,   Do.
                               250 mg and 500 mg.
ANDA 074432.................  Diclofenac Sodium     Pliva, Inc. (an
                               Delayed Release       indirect, wholly
                               Tablets, 50 mg and    owned subsidiary of
                               75 mg.                Teva
                                                     Pharmaceuticals
                                                     USA, Inc.), 400
                                                     Interpace Pkwy.,
                                                     Building A,
                                                     Parsippany, NJ
                                                     07054.
ANDA 074460.................  Piroxicam Capsules,   Watson Laboratories,
                               10 mg and 20 mg.      Inc.
ANDA 074585.................  Indapamide Tablets,   Do.
                               1.25 mg and 2.5 mg.
ANDA 074698.................  Baclofen Tablets, 10  Do.
                               mg and 20 mg.
ANDA 074711.................  Mexiletine HCl        Do.
                               Capsules, 150 mg,
                               200 mg and 250 mg.
ANDA 074723.................  Diclofenac Sodium     Teva Pharmaceuticals
                               Delayed Release       USA, Inc.
                               Tablets, 50 mg.
ANDA 074852.................  Diltiazem HCl         Actavis Laboratories
                               Extended Release      FL, Inc. (an
                               Capsules, 120 mg,     indirect, wholly
                               180 mg, and 240 mg.   owned subsidiary of
                                                     Teva
                                                     Pharmaceuticals
                                                     USA, Inc.), 400
                                                     Interpace Pkwy.,
                                                     Building A,
                                                     Parsippany, NJ
                                                     07054.
ANDA 074865.................  Mexiletine HCl        Watson Laboratories,
                               Capsules, 150 mg,     Inc.
                               200 mg, and 250 mg.
ANDA 074870.................  Acyclovir Tablets,    Actavis Elizabeth
                               400 mg and 800 mg.    LLC (an indirect,
                                                     wholly owned
                                                     subsidiary of Teva
                                                     Pharmaceuticals
                                                     USA, Inc.), 400
                                                     Interpace Pkwy.,
                                                     Building A,
                                                     Parsippany, NJ
                                                     07054.
ANDA 075101.................  Acyclovir Capsules,   Watson Laboratories,
                               200 mg.               Inc.
ANDA 076022.................  Fluoxetine HCl        Carlsbad Technology,
                               Capsules, EQ 10 mg    Inc., 5922
                               base and EQ 20 mg     Farnsworth Ct.,
                               base.                 Carlsbad, CA 92008.
ANDA 078345.................  Prednisolone Sodium   Amneal
                               Phosphate Solution,   Pharmaceuticals, 85
                               EQ 15 mg base/5       Adams Ave.,
                               milliliters (mL).     Hauppauge, NY
                                                     11788.
ANDA 080521.................  Isoniazid Tablets,    Watson Laboratories,
                               300 mg.               Inc.
ANDA 086537.................  Nitroglycerin         Lumara Health, Inc.,
                               Controlled-Release    1100 Winter St.,
                               Capsules, 6.5 mg.     Suite 3000,
                                                     Waltham, MA 02451.
ANDA 086889.................  Disulfiram Tablets,   Watson Laboratories,
                               250 mg.               Inc.
ANDA 086890.................  Disulfiram Tablets,   Watson Laboratories,
                               500 mg.               Inc.
ANDA 087975.................  Nitroglycerin         Sandoz Inc., 100
                               Controlled-Release    College Rd. West,
                               Capsules, 2.5 mg.     Princeton, NJ
                                                     08540.
ANDA 087976.................  Nitroglycerin         Do.
                               Controlled-Release
                               Capsules, 6.5 mg.
ANDA 088509.................  Nitroglycerin         Do.
                               Controlled-Release
                               Capsules, 9 mg.
ANDA 090833.................  Carbidopa/Levodopa    Morton Grove
                               and Entacapone        Pharmaceuticals
                               Tablets, 18.75 mg/    Inc./Wockhardt USA
                               200 mg/75 mg, 25 mg/  LLC., 6451 Main
                               200 mg/100 mg,        St., Morton Grove,
                               31.25 mg/200 mg/125   IL 60053.
                               mg, 37.5 mg/200 mg/
                               150 mg, and 50 mg/
                               200 mg/200 mg.
ANDA 200771.................  Irinotecan HCl        Heritage
                               Injection, 40 mg/2    Pharmaceuticals
                               mL (20 mg/mL) and     Inc. d/b/a/Avet
                               100 mg/5 mL (20 mg/   Pharmaceuticals
                               mL).                  Inc. U.S. Agent for
                                                     Emcure
                                                     Pharmaceuticals
                                                     Limited, One Tower
                                                     Center Blvd., East
                                                     Brunswick, NJ
                                                     08816.
ANDA 202063.................  Gemcitabine HCl for   Do.
                               Injection, EQ 200
                               mg base/vial; EQ 1
                               gram base/vial.
ANDA 204437.................  Sodium Fluoride 18    UCSF
                               Injection, 10-200     Radiopharmaceutical
                               millicurie (mCi)/mL.  Facility, 185 Berry
                                                     St., Suite 350, San
                                                     Francisco, CA
                                                     94107.
ANDA 208444.................  Choline C-11          Do.
                               Injection, 4-33.1
                               mCi/mL.
------------------------------------------------------------------------

    Therefore, approval of the applications listed in the table, and 
all amendments and supplements thereto, is hereby withdrawn as of July 
26, 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 July 26, 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: June 21, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-13593 Filed 6-24-21; 8:45 am]
BILLING CODE 4164-01-P


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