Document ID: FDA-2022-N-1349-0002
Agency: fda
Document Type: Notice
Title: Mikart, LLC, et al.; Withdrawal of Approval of 31 Abbreviated New Drug Applications; Correction
Posted Date: 2022-09-13T04:00Z

[Federal Register Volume 87, Number 176 (Tuesday, September 13, 2022)]
[Notices]
[Page 56074]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-19715]

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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; 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 July 12, 2022. The document 
announced the withdrawal of approval (as of August 11, 2022) of 31 
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 USpharma Windlas, LLC, 
115 Blue Jay Dr., Suite 101, Liberty, MO 64068: ANDA 204180, Amiloride 
Hydrochloride Tablets, 5 milligrams (mg); and ANDA 205790, Prasugrel 
Tablets, Equivalent to (EQ) 5 mg base and EQ 10 mg base. Before FDA 
withdrew the approval of these ANDAs, USpharma Windlas, LLC, informed 
FDA that it did not want the approval of the ANDAs withdrawn. Because 
USpharma Windlas, LLC, timely requested that approval of ANDAs 204180 
and 205790 not be withdrawn, the approvals are still in effect.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 Tuesday, July 12, 
2022 (87 FR 41322), in FR Doc. 2022-14798, the following correction is 
made:
    On page 41322, in the table, the entries for ANDAs 204180 and 
205790 are removed.

    Dated: September 7, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-19715 Filed 9-12-22; 8:45 am]
BILLING CODE 4164-01-P