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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: 05/15/1995
Orphan Designation: Treatment and prevention of recurrent aphthous ulcers in severely, terminally immunocompromised patients.
Orphan Designation Status: Designated
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
Andrulis Research Corporation
11800 Baltimore Avenue, Suite 113
Beltsville, Maryland 20705
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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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