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Negócios · 04/06/20191 min de leitura
Teva Pharmaceuticals USA, Inc., et al.; Withdrawal of Approval of Five Abbreviated New Drug Applications for Pemoline Products
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Resumo
The Food and Drug Administration (FDA) is withdrawing the approval of five abbreviated new drug applications (ANDAs) for products containing pemoline. The holders of the applications requested withdrawal of the applications and have waived their opportunity for a hearing.
Idioma original da fonte: Federal Register — Food and Drug AdministrationAbrir o comunicado original →