Treats partial-onset seizures. ANDA 206880, held by Gland. Levetiracetam.
As of Nov 15, 2026, ANDA 206880 (Levetiracetam In Sodium Chloride), held by Gland, was first approved by FDA on Oct 25, 2017, with 4 approved supplements and 0 published complete response letters.
Levetiracetam in Sodium Chloride Injection is an antiepileptic drug indicated for adult patients (16 years and older) when oral administration is temporarily not feasible. 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 |
|---|---|---|---|
| Oct 25, 2017 | 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 26, 2025 | Supplement 8Labeling · Standard review | Approved | None posted |
| May 23, 2023 | Supplement 7Labeling · Standard review | Approved | None posted |
| Apr 20, 2020 | Supplement 4Labeling · Standard review | Approved | None posted |
| Apr 20, 2020 | Supplement 5Labeling · Standard review | Approved | None posted |
| Oct 25, 2017 | 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
