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Negocios · 22/10/20211 min de lectura
Fresenius USA, Inc., et al.; Withdrawal of Approval of 216 Abbreviated New Drug Applications
Traducción automática local · Idioma original de la fuente
Resumen
The Food and Drug Administration (FDA or Agency) is withdrawing approval of 216 abbreviated new drug applications (ANDAs) from multiple holders of those ANDAs. The basis for the withdrawal is that these ANDA holders have repeatedly failed to submit required annual reports for those ANDAs.
Idioma original de la fuente: Federal Register — Food and Drug AdministrationAbrir el comunicado original →