Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
  • Print
  • Share
  • E-mail
-
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
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.

Marketing approved:

1 Generic Name: benzoate/phenylacetate
Trade Name: Ammonul
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* :  
*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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
-
-