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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: Thalidomide
Date Designated: 11/15/1988
Orphan Designation: Treatment and maintenance of reactional lepromatous leprosy.
Orphan Designation Status: Designated
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
Pediatric Pharmaceuticals, Inc.
718 Bradford Avenue
Westfield, New Jersey 07090
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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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