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Geschäft · 14.6.20121 Min. Lesezeit
Notice of Withdrawal of Certain Unapproved Abbreviated New Drug Applications
Lokale automatische Übersetzung · Originalsprache der Quelle
Zusammenfassung
The Food and Drug Administration (FDA or the Agency) is announcing its intention to deem to be withdrawn any abbreviated new drug applications (ANDAs) that have been determined to be incomplete and as to which the ANDA applicant has not communicated with FDA since July 8, 1991. Each of these applications will be deemed to have been withdrawn voluntarily by the applicant unless the applicant informs the Agency in writing that it intends to actively pursue approval of the application(s) (see DATES).
Originalsprache der Quelle: Federal Register — Food and Drug AdministrationOriginalquelle öffnen →