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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: Azathioprine
Date Designated: 09/14/1999
Orphan Designation: Treatment of oral manifestations of graft-versus-host disease.
Orphan Designation Status: Designated
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
Oral Solutions, Inc.
787 Seventh Ave., 48th Floor
New York, New York 10019
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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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