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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: Trientine HCl
Trade Name: Syprine
Date Designated: 12/24/1984
Orphan Designation: Treatment of patients with Wilson's disease who are intolerant, or inadequately responsive to penicillamine.
Orphan Designation Status: Designated/Approved
Merck Sharp & Dohme Research
Division Of Merck And Company
West Point, Pennsylvania 19486
United States

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

Marketing approved:

1 Generic Name: Trientine HCl
Trade Name: Syprine
Marketing Approval Date: 11/08/1985
Approved Labeled Indication:
Exclusivity End Date: 11/08/1992 
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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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