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Negocios · 4/6/20191 min de lectura

Teva Pharmaceuticals USA, Inc., et al.; Withdrawal of Approval of Five Abbreviated New Drug Applications for Pemoline Products

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Resumen

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 de la fuente: Federal Register — Food and Drug AdministrationAbrir el comunicado original →