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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: Histrelin
Trade Name: Supprelin LA
Date Designated: 11/18/2005
Orphan Designation: Treatment of central precocious puberty
Orphan Designation Status: Designated/Approved
Endo Pharmaceuticals Solutions, Inc.
100 Endo Blvd
Chadds Ford, Pennsylvania 19317
United States

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

Marketing approved:

1 Generic Name: Histrelin
Trade Name: Supprelin LA
Marketing Approval Date: 05/03/2007
Approved Labeled Indication: Treatment of central precocious puberty
Exclusivity End Date: 05/03/2014 
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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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