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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals

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Generic Name:  Benzoate and phenylacetate
Trade Name:  Ucephan
Date Designated:  01/21/1986
Orphan Designation:  For adjunctive therapy in the prevention and treatment of hyperammonemia in patients with urea cycle enzymopathy due to carbamylphosphate synthetase, ornithine, transcarbamylase, or argininosuccinate synthetase deficiency.
Orphan Designation Status:  Designated/Approved
Marketing Approval Date:  12/23/1987 
Approved Labeled Indication:  
Exclusivity End Date:    12/23/1994 
Exclusivity Protected Indication* :  
2525 McGaw Avenue
P.O. Box 19791
Irvine, California 92623
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.