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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 phenylbutyrate
Date Designated: 01/19/2010
Orphan Designation: Treatment of urea cycle disorder.
Orphan Designation Status: Designated
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
Navinta LLC
1499 Lower Ferry Road
Ewing, New Jersey 08618
United States

The sponsor address listed is the last reported by the sponsor to OOPD.
*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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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