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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: 02/06/1989
Orphan Designation: For use in combination with leucovorin for therapy of metastatic adenocarcinoma of the colon and rectum.
Orphan Designation Status: Designated/Designation Withdrawn or Revoked
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
Lederle Laboratories
Division of American Cyanamid Company
401 N. Middletown Road
Pearl River, New York 10965
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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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