Diese Übersetzung wird noch vorbereitet. Bis dahin zeigen wir vorübergehend die englische Originalversion.
Geschäft · 10.4.20011 Min. Lesezeit
Parke-Davis Pharmaceutical Research et al.; Withdrawal of Approval of 14 New Drug Applications and 13 Abbreviated New Drug Applications; Correction
Lokale automatische Übersetzung · Originalsprache der Quelle
Zusammenfassung
The Food and Drug Administration (FDA) is correcting a notice that appeared in the Federal Register of September 25, 1998 (63 FR 51359). The document announced the withdrawal of approval of 14 new drug applications and 13 abbreviated new drug applications (ANDAs). The document inadvertently withdrew approval of ANDA 80-025 for Sulf-10 (sulfacetamide sodium ophthalmic solution, USP) 10% held by Ciba Vision, 11460 Johns Creek Pkwy., Duluth, GA 30097-1556. FDA confirms that approval of ANDA 80-025 is still in effect.
Originalsprache der Quelle: Federal Register — Food and Drug AdministrationOriginalquelle öffnen →