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Geschäft · 29.8.20051 Min. Lesezeit
Able Laboratories, Inc.; Withdrawal of Approval of Ten Abbreviated New Drug Applications
Lokale automatische Übersetzung · Originalsprache der Quelle
Zusammenfassung
The Food and Drug Administration (FDA) is withdrawing approval of ten abbreviated new drug applications (ANDAs) held by Able Laboratories, Inc. (Able Labs), One Able Dr., Cranbury, NJ 08512. Able Labs has initiated a class II recall of the products covered by these ANDAs. The company has requested that the applications be withdrawn and has waived its opportunity for a hearing.
Originalsprache der Quelle: Federal Register — Food and Drug AdministrationOriginalquelle öffnen →