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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals

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Generic Name: phenobarbital
Date Designated: 10/25/2017
Orphan Designation: Treatment of neonatal seizures
Orphan Designation Status: Designated/Designation Withdrawn or Revoked
Date Designation Withdrawn or Revoked: 09/12/2019
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
Renaissance SSA, LLC
411 South State Street
Suite E100
Newtown, Pennsylvania 18940
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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.