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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 acetate
Trade Name: Supprelin Injection
Date Designated: 08/10/1988
Orphan Designation: Treatment of central precocious puberty.
Orphan Designation Status: Designated/Approved
Roberts Pharmaceutical Corp.
Meridian Center III
6 Industrial Way West
Eatontown, New Jersey 07724
United States

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

Marketing approved:

1 Generic Name: Histrelin acetate
Trade Name: Supprelin Injection
Marketing Approval Date: 12/24/1991
Approved Labeled Indication: Treatment of central precocious puberty.
Exclusivity End Date: 12/24/1998 
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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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