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Negócios · 24/03/19991 min de leitura
Vale Chemical Co., Inc., et al.; Withdrawal of Approval of 13 New Drug Applications and 1 Abbreviated New Drug Application
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Resumo
The Food and Drug Administration (FDA) is withdrawing approval of 13 new drug applications (NDA's) and 1 abbreviated new drug application (ANDA). The basis for the withdrawals is that the holders of the applications have repeatedly failed to file required annual reports for these applications.
Idioma original da fonte: Federal Register — Food and Drug AdministrationAbrir o comunicado original →