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Imprese · 15/06/20211 min di lettura
Lederle Laboratories et al.; Withdrawal of Approval of 12 Abbreviated New Drug Applications; Correction
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Riepilogo
The Food and Drug Administration (FDA) is correcting a notice that appeared in the Federal Register on May 12, 2021. The document announced the withdrawal of approval of 12 abbreviated new drug applications (ANDAs) from multiple applicants, withdrawn as of June 11, 2021. The document indicated that FDA was withdrawing the approval of ANDA 060164, Nystatin Ointment, held by Lederle Laboratories. However, the document published with an incorrect application number for this product. This document corrects that error.
Lingua originale della fonte: Federal Register — Food and Drug AdministrationApri il comunicato originale →