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* : | |
| Sponsor: |
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. |
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