[Federal Register Volume 87, Number 132 (Tuesday, July 12, 2022)]
[Notices]
[Pages 41322-41323]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-14798]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2022-N-1349]


Mikart, LLC, et al.; Withdrawal of Approval of 31 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 31 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approval of the applications be withdrawn.

DATES: Approval is withdrawn as of August 11, 2022.

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#84c9e5f6f0ece5aacae3f1fde1eac4e2e0e5aaececf7aae3ebf2"><span class="__cf_email__" data-cfemail="86cbe7f4f2eee7a8c8e1f3ffe3e8c6e0e2e7a8eeeef5a8e1e9f0">[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.

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            Application No.                               Drug                               Applicant
----------------------------------------------------------------------------------------------------------------
ANDA 040846...........................  Hydrocodone Bitartrate and Acetaminophen  Mikart, LLC, 1750
                                         Tablets, 325 milligrams (mg); 2.5 mg.     Chattahoochee Ave. NW,
                                                                                   Atlanta, GA 30318.
ANDA 040851...........................  Benzonatate Capsules, 100 mg, 150 mg,     Do.
                                         and 200 mg.
ANDA 072903...........................  Ibuprofen Tablets, 200 mg...............  ANI Pharmaceuticals, Inc., 210
                                                                                   Main St. West, Baudette, MN
                                                                                   56623.
ANDA 073519...........................  Tolmetin Sodium Capsules, Equivalent to   Do.
                                         (EQ) 400 mg base.
ANDA 074267...........................  Guanabenz Acetate Tablets, EQ 4 mg base   Do.
                                         and EQ 8 mg base.
ANDA 074498...........................  Indapamide Tablets, 1.25 mg and 2.5 mg..  Do.
ANDA 074840...........................  Etodolac Capsules, 200 mg and 300 mg....  Do.
ANDA 074844...........................  Etodolac Capsules, 200 mg and 300 mg....  Do.
ANDA 075212...........................  Ranitidine Hydrochloride (HCl) Tablets,   Do.
                                         EQ 75 mg base.
ANDA 076030...........................  Flecainide Acetate Tablets, 50 mg, 100    Do.
                                         mg, and 150 mg.
ANDA 076086...........................  Fluconazole Tablets, 50 mg, 100 mg, 150   Do.
                                         mg, and 200 mg.
ANDA 077426...........................  Ranitidine HCl Tablets, EQ 150 mg base    Do.
                                         and EQ 300 mg base.
ANDA 077641...........................  Zonisamide Capsules, 25 mg, 50 mg, and    Do.
                                         100 mg.
ANDA 077979...........................  Alprazolam Extended Release Tablets, 0.5  Do.
                                         mg, 1 mg, 2 mg, and 3 mg.
ANDA 085269...........................  Meclizine HCl Tablets, 12.5 mg..........  Do.
ANDA 085740...........................  Meclizine HCI Tablets, 25 mg............  Do.
ANDA 087296...........................  Chlorthalidone Tablets, 25 mg...........  Do.
ANDA 088164...........................  Chlorthalidone Tablets, 25 mg...........  Do.
ANDA 088641...........................  Glucamide Tablets, 250 mg...............  Do.
ANDA 088732...........................  Meclizine HCl Tablets, 12.5 mg..........  Do.
ANDA 088768...........................  Chlorpropamide Tablets, 100 mg..........  Do.
ANDA 088826...........................  Chlorpropamide Tablets, 250 mg..........  Do.
ANDA 090572...........................  Cetirizine HCl, Syrup 5 mg/5 milliliters  Tris Pharma, Inc., 2031 U.S.
                                         (mL).                                     Hwy. 130, Suite D, Monmouth
                                                                                   Junction, NJ 08852.
ANDA 090906...........................  Levetiracetam Tablets, 250 mg, 500 mg,    Alvogen PB Research and
                                         750 mg, and 1 gram (gm).                  Development, U.S. Agency for
                                                                                   Lotus Pharmaceutical Co.,
                                                                                   Ltd., Nantou Plant, 44
                                                                                   Whippany Rd., Suite 300,
                                                                                   Morristown, NJ 07960.
ANDA 201944...........................  Potassium Chloride Extended Release       Tris Pharma, Inc.
                                         Capsules, 8 milliequivalent (mEq) and
                                         10 mEq.
ANDA 202095...........................  Levetiracetam Extended Release Tablets,   Alvogen PB Research and
                                         500 mg and 750 mg.                        Development, U.S. Agency for
                                                                                   Lotus Pharmaceutical Co.,
                                                                                   Ltd.
ANDA 202246...........................  Levonorgestrel Tablets, 1.5 mg..........  Alvogen, Inc., 44 Whippany
                                                                                   Rd., Suite 300, Morristown,
                                                                                   NJ 07960.
ANDA 203298...........................  Calcium Acetate Capsules, 667 mg........  Alvogen PB Research and
                                                                                   Development, U.S. Agency for
                                                                                   Lotus Pharmaceutical Co.,
                                                                                   Ltd.
ANDA 204180...........................  Amiloride HCl Tablets, 5 mg.............  USpharma Windlas, LLC, 115
                                                                                   Blue Jay Dr., Suite 101,
                                                                                   Liberty, MO 64068.
ANDA 205442...........................  Linezolid Injection, 600 mg/300 mL (2 mg/ Hospira, Inc., 275 North Field
                                         mL).                                      Dr., Bldg. H1, Lake Forest,
                                                                                   IL 60045.
ANDA 205790...........................  Prasugrel Tablets, EQ 5 mg base and EQ    USpharma Windlas, LLC.
                                         10 mg base.
----------------------------------------------------------------------------------------------------------------

    Therefore, approval of the applications listed in the table, and 
all amendments and supplements thereto, is hereby withdrawn as of 
August 11, 2022. 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

[[Page 41323]]

(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 11, 2022 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 1, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-14798 Filed 7-11-22; 8:45 am]
BILLING CODE 4164-01-P


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