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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/phenylacetate
Trade Name:  Ammonul
Date Designated:  11/22/1993
Orphan Designation:  Treatment of acute hyperammonemia and associated encephalopathy in patients with deficiencies in enzymes of the urea cycle.
Orphan Designation Status:  Designated/Approved
Marketing Approval Date:  02/17/2005 
Approved Labeled Indication:  Adjunctive therapy in the treatment of acute hyperammonemia and associated encephalopathy in patients with deficiencies in enzymes of the urea cycle.
Exclusivity End Date:    02/17/2012 
Exclusivity Protected Indication* :  
Medicis Pharmaceutical Corp.
8125 N. Hayden Road
Scottsdale, Alaska 85258
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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