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Geschäft · 4.12.20001 Min. Lesezeit
SangStat Medical Corp.; Withdrawal of Approval of an Abbreviated New Drug Application; Cyclosporine
Lokale automatische Übersetzung · Originalsprache der Quelle
Zusammenfassung
The Food and Drug Administration (FDA) is withdrawing approval of an abbreviated new drug application (ANDA) held by SangStat Medical Corp., 6300 Dumbarton Circle, Fremont, CA 94555 (Sangstat). The ANDA is for SangCya Oral Solution (Cyclosporine Oral Solution, USP) Modified, which was the subject of a class II recall announced on July 10, 2000. SangStat has agreed in writing to permit FDA to withdraw approval of the application and has waived its opportunity for a hearing.
Originalsprache der Quelle: Federal Register — Food and Drug AdministrationOriginalquelle öffnen →