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Entreprise · 04/12/20001 min de lecture
SangStat Medical Corp.; Withdrawal of Approval of an Abbreviated New Drug Application; Cyclosporine
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Résumé
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.
Langue originale de la source: Federal Register — Food and Drug AdministrationOuvrir le communiqué original →