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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: Sucralfate suspension
Date Designated: 03/04/1991
Orphan Designation: Treatment of oral ulcerations and dysphagia in patients with epidermolysis bullosa.
Orphan Designation Status: Designated
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
Darby Pharmaceuticals, Inc.
100 Banks Avenue
Rockville Centre, New York 11570
United States

The sponsor address listed is the last reported by the sponsor to OOPD.
*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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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