Treats partial-onset seizures. ANDA 211356, held by Hikma. Levetiracetam.
As of Nov 15, 2026, ANDA 211356 (Levetiracetam In Sodium Chloride), held by Hikma, was first approved by FDA on Feb 12, 2024, with 1 approved supplement and 0 published complete response letters.
Levetiracetam in Sodium Chloride Injection is indicated for adjunct therapy in adults (≥16 years of age) with the following seizure types when oral administration is temporarily not feasible: Partial-onset seizures Myoclonic seizures in patients with juvenile myoclonic epilepsy Primary generalized tonic-clonic seizures 1.1 Partial-Onset Seizures Levetiracetam in Sodium Chloride Injection is indicated as adjunctive therapy in the treatment of partial-onset seizures in adults with epilepsy. 1.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Feb 12, 2024 | Original application | Approved | None posted |
| Levetiracetam In Sodium Chloride500MG/100ML (5MG/ML) · injectable;intravenous | Levetiracetam | Rx |
| Levetiracetam In Sodium Chloride1GM/100ML (10MG/ML) · injectable;intravenous | Levetiracetam | Rx |
| Levetiracetam In Sodium Chloride1.5GM/100ML (15MG/ML) · injectable;intravenous | Levetiracetam | Rx |
| Mar 5, 2025 | Supplement 2Labeling · Standard review | Approved | None posted |
| Feb 12, 2024 | Original application | Approved | None posted |
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
