Search Orphan Drug Designations and Approvals
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Generic Name: | Ursodiol |
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Date Designated: | 02/19/1991 |
Orphan Designation: | Management of the clinical signs and symptoms associated with primary biliary cirrhosis. |
Orphan Designation Status: | Designated/Designation Withdrawn or Revoked |
FDA Orphan Approval Status: | Not FDA Approved for Orphan Indication |
Sponsor: |
Novartis Pharmaceuticals Corporation 59 Route 10 East Hanover, New Jersey 07936 United States The sponsor address listed is the last reported by the sponsor to OOPD. |
*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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