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Negócios · 22/10/20211 min de leitura
Fresenius USA, Inc., et al.; Withdrawal of Approval of 216 Abbreviated New Drug Applications
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Resumo
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 da fonte: Federal Register — Food and Drug AdministrationAbrir o comunicado original →