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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals

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Generic Name: Sodium phenylacetate/sodium benzoate 10%/10% Injection
Date Designated: 06/03/2005
Orphan Designation: Treatment of grade III and IV hepatic encephalopathy
Orphan Designation Status: Designated
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
Ucyclyd Pharma, Inc.
7720 N. Dobson Road
Scottsdale, Alaska 85256
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.