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Hoffman-LaRoche, Inc., et al.; Withdrawal of Approval of 11 New Drug Applications, 1 Abbreviated Antibiotic Application, and 20 Abbreviated New Drug Applications
Automatyczne tłumaczenie lokalne · Oryginalny język źródła
Streszczenie
The Food and Drug Administration (FDA) is withdrawing approval of 11 new drug applications (NDA's), 1 abbreviated antibiotic application (AADA), and 20 abbreviated new drug applications (ANDA's). The holders of the applications notified the agency in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn.