Treats partial-onset seizures. ANDA 209705, held by B Braun Medical. Levetiracetam.
As of Nov 15, 2026, ANDA 209705 (Levetiracetam In Sodium Chloride), held by B Braun Medical, was first approved by FDA on Feb 27, 2024, with 1 approved supplement and 0 published complete response letters.
Levetiracetam in Sodium Chloride Injection is indicated for adjunct therapy in adults (greater than or equal to 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 27, 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 |
| Feb 27, 2025 | Supplement 1Labeling · Standard review | Approved | None posted |
| Feb 27, 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
