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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
Trade Name: URSO 250
Date Designated: 06/20/1991
Orphan Designation: Treatment of patients with primary biliary cirrhosis
Orphan Designation Status: Designated/Approved
Aptalis Pharma US, Inc.
100 Somerset corporate Blvd
Bridgewater, New Jersey 08807
United States

The sponsor address listed is the last reported by the sponsor to OOPD.

Marketing approved:

1 Generic Name: Ursodiol
Trade Name: URSO 250
Marketing Approval Date: 12/10/1997
Approved Labeled Indication:
Exclusivity End Date: 12/10/2004 
Exclusivity Protected Indication* :  

*Exclusivity Protected Indications are shown for approvals from Jan. 1, 2013, to the present.