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Negocios · 10/7/20191 min de lectura
Apotex, Inc.; Withdrawal of Approval of 31 Abbreviated New Drug Applications
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Resumen
The Food and Drug Administration (FDA or Agency) is withdrawing the approval of 31 abbreviated new drug applications (ANDAs) held by Apotex, Inc. (Apotex). Apotex, through its U.S. agent, has requested withdrawal of these applications and has waived its opportunity for a hearing.
Idioma original de la fuente: Federal Register — Food and Drug AdministrationAbrir el comunicado original →