Search Orphan Drug Designations and Approvals
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Generic Name: | Phenobarbital Sodium |
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Date Designated: | 09/30/2020 |
Orphan Designation: | Treatment of neonatal seizures |
Orphan Designation Status: | Designated |
FDA Orphan Approval Status: | Not FDA Approved for Orphan Indication |
Sponsor: |
Hikma Pharmaceuticals USA, Inc. 2 Esterbrook Lane Cherry Hill, New Jersey 08003 United States The sponsor address listed is the last reported by the sponsor to OOPD. |
*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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