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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals

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Generic Name:  Ursodiol
Date Designated:  02/19/1991
Orphan Designation:  Management of the clinical signs and symptoms associated with primary biliary cirrhosis.
Orphan Designation Status:  Designated/Withdrawn
FDA Orphan Approval Status:  Not FDA Approved for Orphan Indication
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.
*Exclusivity Protected Indications are shown for approvals from Jan. 1, 2013, to the present.
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