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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
Eton Pharmaceuticals, Inc
21925 W. Field Parkway, Suite 235
Deer Park, Illinois 60010
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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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