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Negócios · 10/07/20191 min de leitura
Apotex, Inc.; Withdrawal of Approval of 31 Abbreviated New Drug Applications
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Resumo
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 da fonte: Federal Register — Food and Drug AdministrationAbrir o comunicado original →