Document ID: FDA-2022-N-2826-0002
Agency: fda
Document Type: Notice
Title: Allergan Sales LLC., et. al.; Withdrawal of Approval of 10 Abbreviated New Drug Applications; Correction
Posted Date: 2023-02-02T05:00Z

[Federal Register Volume 88, Number 22 (Thursday, February 2, 2023)]
[Notices]
[Page 7091]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-02155]

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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; Correction

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; correction.

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SUMMARY: The Food and Drug Administration (FDA) is correcting a notice 
that appeared in the Federal Register on November 21, 2022. The 
document announced the withdrawal of approval (as of December 21, 2022) 
of 10 abbreviated new drug applications (ANDAs) from multiple 
applicants. The document indicated that FDA was withdrawing approval of 
the following ANDAs after receiving withdrawal requests from Sunstar 
Americas, Inc., 301 East Central Rd., Schaumburg, IL 60195: ANDA 
076434, Chlorhexidine Gluconate Solution, 0.12%; Sofgen 
Pharmaceuticals, LLC, 21500 Biscayne Blvd., Suite 600, Aventura, FL 
33180: ANDA 201832, Nimodipine Capsules, 30 milligrams (mg); and 
Indicus Pharma, LLC, 2530 Meridian Parkway, Durham, NC 27713: ANDA 
203419, Donepezil HCl Tablets, 23 mg. Before FDA withdrew the approval 
of these ANDAs, Sunstar Americas, Inc., Sofgen Pharmaceuticals, LLC, 
and Indicus Pharma, LLC informed FDA that they did not want the 
approval of the ANDAs withdrawn. Because Sunstar Americas, Inc. timely 
requested that approval of ANDA 076434 not be withdrawn, Sofgen 
Pharmaceuticals, LLC timely requested that the approval of ANDA 201832 
not be withdrawn, and Indicus Pharma, LLC timely requested that the 
approval of ANDA 203419 not be withdrawn, the approvals are still in 
effect.

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: In the Federal Register of Monday, November 
21, 2022 (87 FR 223), in FR Doc. 2022-25315, the following correction 
is made:
    On page 70835, in the table, the entries for ANDAs 076434, 201832, 
and 203419 are removed.

    Dated: January 30, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-02155 Filed 2-1-23; 8:45 am]
BILLING CODE 4164-01-P