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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: Zinc acetate
Trade Name: Galzin
Date Designated: 11/06/1985
Orphan Designation: Treatment of Wilson's disease.
Orphan Designation Status: Designated/Approved
Lemmon Company
1510 Delp Drive
Kulpsville, Pennsylvania 19443
United States

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

Marketing approved:

1 Generic Name: Zinc acetate
Trade Name: Galzin
Marketing Approval Date: 01/28/1997
Approved Labeled Indication: For maintenance treatment of patients with Wilson's disease who have been initially treated with a chelating agent.
Exclusivity End Date: 01/28/2004 
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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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