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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 sodium
Trade Name: Sezaby
Date Designated: 10/02/2019
Orphan Designation: Treatment of neonatal seizures
Orphan Designation Status: Designated/Approved
Sun Pharmaceutical Industries, Inc.
2 Independence Way
Princeton, New Jersey 08540
United States

The sponsor address listed is the last reported by the sponsor to OOPD.

Marketing approved:

1 Generic Name: phenobarbital sodium
Trade Name: Sezaby
Marketing Approval Date: 11/17/2022
Approved Labeled Indication: treatment of neonatal seizures in term and preterm infants
Exclusivity End Date: 11/17/2029 
Exclusivity Protected Indication* :  treatment of neonatal seizures in term and preterm infants
*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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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