Document ID: FDA-2022-N-2826-0001
Agency: fda
Document Type: Notice
Title: Allergan Sales, LLC, et al.; Withdrawal of Approval of 10 Abbreviated New Drug Applications
Posted Date: 2022-11-21T05:00Z

[Federal Register Volume 87, Number 223 (Monday, November 21, 2022)]
[Notices]
[Pages 70835-70836]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-25315]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2022-N-2826]

Allergan Sales, LLC, et al.; Withdrawal of Approval of 10 
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 10 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approval of the applications be withdrawn.

DATES: Approval is withdrawn as of December 21, 2022.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, [email protected].

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 040099.................  Norco (hydrocodone bitartrate and         Allergan Sales, LLC, U.S. Agent for
                               acetaminophen) Tablets, 5 milligrams      Allergan Pharmaceuticals International
                               (mg)/325 mg.                              Limited, 5 Giralda Farms, Madison, NJ
                                                                         07940.
ANDA 040148.................  Norco (hydrocodone bitartrate and          Do.
                               acetaminophen) Tablets, 2.5 mg/325 mg,
                               5 mg/325 mg, 7.5 mg/325 mg, 10 mg/325
                               mg, and 10 mg/500 mg.
ANDA 076434.................  Chlorhexidine Gluconate Solution, 0.12%.  Sunstar Americas, Inc., 301 East Central
                                                                         Rd., Schaumburg, IL 60195.
ANDA 079076.................  Ranitidine Hydrochloride (HCl)            Mylan Pharmaceuticals Inc., a Viatris
                               Injection, Equivalent to (EQ) 25 mg       Company, U.S. Agent for Mylan
                               base/milliliters (mL).                    Laboratories Limited, 3711 Collins
                                                                         Ferry Rd., Morgantown, WV 26505.
ANDA 090054.................  Ranitidine HCl Syrup, EQ 15 mg base/mL..  Tolmar Inc., 701 Centre Ave., Fort
                                                                         Collins, CO 80526.
ANDA 201804.................  Letrozole Tablets, 2.5 mg...............  Indicus Pharma, LLC, 2530 Meridian
                                                                         Parkway, Durham, NC 27713.
ANDA 201832.................  Nimodipine Capsules, 30 mg..............  Sofgen Pharmaceuticals, LLC, 21500
                                                                         Biscayne Blvd., Suite 600, Aventura, FL
                                                                         33180.
ANDA 203419.................  Donepezil HCl Tablets, 23 mg............  Indicus Pharma, LLC.
ANDA 203519.................  Morphine Sulfate Solution, 20 mg/5 mL...  Tris Pharma, Inc., 2033 Route 130, Suite
                                                                         D, Monmouth Junction, NJ 08852.
ANDA 206151.................  Abacavir Sulfate and Lamivudine Tablets,  Aurobindo Pharma USA, Inc., U.S. Agent
                               EQ 600 mg base; 300 mg.                   for Aurobindo Pharma Limited, 279
                                                                         Princeton-Hightstown Rd., East Windsor,
                                                                         NJ 08520.
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[[Page 70836]]

    Therefore, approval of the applications listed in the table, and 
all amendments and supplements thereto, is hereby withdrawn as of 
December 21, 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 (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 December 21, 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: November 16, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-25315 Filed 11-18-22; 8:45 am]
BILLING CODE 4164-01-P