Treats partial-onset seizures. ANDA 207160, held by Eugia Pharma. Levetiracetam.
As of Nov 15, 2026, ANDA 207160 (Levetiracetam In Sodium Chloride), held by Eugia Pharma, was first approved by FDA on Jan 4, 2017, with 5 approved supplements 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 |
|---|---|---|---|
| Jan 4, 2017 | Original application | Approved |
| 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 10, 2025 | Supplement 9Labeling · Standard review | Approved | None posted |
| May 23, 2023 | Supplement 5Labeling · Standard review | Approved | None posted |
| Jul 11, 2020 | Supplement 2Labeling · Standard review | Approved | None posted |
| Jul 11, 2020 | Supplement 3Labeling · Standard review | Approved | None posted |
| Jul 11, 2020 | Supplement 4Labeling · Standard review | Approved | None posted |
| Jan 4, 2017 | Original application | Approved |
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
