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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: Fluorouracil
Date Designated: 10/27/1989
Orphan Designation: For use in combination with interferon alpha-2a, recombinant, for the treatment of esophageal carcinoma.
Orphan Designation Status: Designated/Designation Withdrawn or Revoked
Date Designation Withdrawn or Revoked: 09/12/2024
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
Hoffmann-La Roche, Inc.
340 Kingsland Street
Nutley, New Jersey 07110
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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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