Entreprise · 13/09/20221 min de lecture
Mikart, LLC, et al.; Withdrawal of Approval of 31 Abbreviated New Drug Applications; Correction
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Résumé
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the approval of these ANDAs, USpharma Windlas, LLC, informed FDA that it did not want the approval of the ANDAs withdrawn. Because USpharma Windlas, LLC, timely requested that approval of ANDAs 204180 and 205790 not be withdrawn, the approvals are still in effect.