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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
Marketing Approval Date:  12/10/1997 
Approved Labeled Indication:  
Exclusivity End Date:    12/10/2004 
Exclusivity Protected Indication* :  
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.
*Exclusivity Protected Indications are shown for approvals from Jan. 1, 2013, to the present.
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