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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: Amphotericin B lipid complex
Trade Name: Abelcet
Date Designated: 12/05/1991
Orphan Designation: Treatment of invasive fungal infections.
Orphan Designation Status: Designated/Approved
Liposome Company, Inc.
One Research Way
Princeton, New Jersey 08540
United States

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

Marketing approved:

1 Generic Name: Amphotericin B lipid complex
Trade Name: Abelcet
Marketing Approval Date: 10/18/1996
Approved Labeled Indication: Treatment of invasive fungal infections in patients who are refractory to or intolerant of conventional amphotericin B therapy.
Exclusivity End Date: 10/18/2003 
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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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