Treats neonatal seizures in term and preterm infants. NDA 215910, held by Sun Pharm Inds Inc. Phenobarbital Sodium.
As of Nov 13, 2026, NDA 215910 (Sezaby), held by Sun Pharm Inds Inc, was first approved by FDA on Nov 17, 2022, with 0 approved supplements and 0 published complete response letters.
SEZABY is indicated for the treatment of neonatal seizures in term and preterm infants.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Nov 17, 2022 | Original applicationNew dosage form · Priority review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Sezaby100MG/VIAL · powder;intravenous | Phenobarbital Sodium | RxReference drug |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
