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Negócios · 24/04/20261 min de leitura
Egis Pharmaceuticals Limited, et al.; Withdrawal of Approval of Three Abbreviated New Drug Applications
Tradução automática local · Idioma original da fonte
Resumo
The Food and Drug Administration (FDA or Agency) is withdrawing approval of three abbreviated new drug applications (ANDAs) from the holders of those ANDAs. The basis for the withdrawal is that the ANDA holders have repeatedly failed to file required annual reports for those ANDAs.
Idioma original da fonte: Federal Register — Food and Drug AdministrationAbrir o comunicado original →