87 FR 176 pg. 56074 - Mikart, LLC, et al.; Withdrawal of Approval of 31 Abbreviated New Drug Applications; Correction
Type: NOTICEVolume: 87Number: 176Page: 56074
Page: 56074Docket number: [Docket No. FDA-2022-N-1349]
FR document: [FR Doc. 2022-19715 Filed 9-12-22; 8:45 am]
Agency: Health and Human Services Department
Sub Agency: Food and Drug Administration
Official PDF Version: PDF Version
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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.
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the approval of these ANDAs, USpharma Windlas, LLC, informed FDA that it did not want the approval of the ANDAs withdrawn. Because USpharma Windlas, LLC, timely requested that approval of ANDAs 204180 and 205790 not be withdrawn, the approvals are still in effect.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, Martha.Nguyen@fda.hhs.gov.
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]
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