Entreprise · 21/09/20051 min de lecture
High Chemical Co. et al.; Withdrawal of Approval of 13 New Drug Applications
Traduction automatique locale · Langue originale de la source
Résumé
The Food and Drug Administration (FDA) is withdrawing approval of 13 new drug applications (NDAs) from multiple holders of these applications. The basis for the withdrawals is that the holders of the applications have repeatedly failed to file required annual reports for the applications.