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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: uridine triacetate
Trade Name:
Date Designated: 08/09/2013
Orphan Designation: Treatment of hereditary orotic aciduria
Orphan Designation Status: Designated/Approved
BTG International Inc.
300 Four Falls Corporate Center, 300 Conshohocken State Road
Suite 300
West Conshohocken, Pennsylvania 19428
United States

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

Marketing approved:

1 Generic Name: uridine triacetate
Trade Name:
Marketing Approval Date: 09/04/2015
Approved Labeled Indication: Treatment of hereditary orotic aciduria
Exclusivity End Date: 09/04/2022 
Exclusivity Protected Indication* :  Treatment of hereditary orotic aciduria
*Exclusivity Protected Indications are shown for approvals from 01/01/2013 to the present.
*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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