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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: Liposomal amphotericin B
Trade Name: AmBisome
Date Designated: 12/06/1996
Orphan Designation: Treatment of visceral leishmaniasis.
Orphan Designation Status: Designated/Approved
Fujisawa USA, Inc.
3 Parkway North Center
Deerfield, Illinois 60015
United States

The sponsor address listed is the last reported by the sponsor to OOPD.

Marketing approved:

1 Generic Name: Liposomal amphotericin B
Trade Name: AmBisome
Marketing Approval Date: 08/11/1997
Approved Labeled Indication: Treatment of visceral leishmaniasis.
Exclusivity End Date: 08/11/2004 
Exclusivity Protected Indication* :  
*Exclusivity Protected Indications are shown for approvals from 01/01/2013 to the present.
*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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