Mikart, LLC, et al.; Withdrawal of Approval of 31 Abbreviated New Drug Applications; Correction
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Abstract
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the approval of these ANDAs, USpharma Windlas, LLC, informed FDA that it did not want the approval of the ANDAs withdrawn. Because USpharma Windlas, LLC, timely requested that approval of ANDAs 204180 and 205790 not be withdrawn, the approvals are still in effect.
Full Text
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<title>Federal Register, Volume 87 Issue 176 (Tuesday, September 13, 2022)</title>
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[Federal Register Volume 87, Number 176 (Tuesday, September 13, 2022)]
[Notices]
[Page 56074]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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, <a href="/cdn-cgi/l/email-protection#96dbf7e4e2fef7b8d8f1e3eff3f8d6f0f2f7b8fefee5b8f1f9e0"><span class="__cf_email__" data-cfemail="511c30232539307f1f362428343f113735307f3939227f363e27">[email protected]</span></a>.
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
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