Treats partial-onset seizures. ANDA 214757, held by Msn. Levetiracetam.
As of Nov 15, 2026, ANDA 214757 (Levetiracetam), held by Msn, was first approved by FDA on Jul 15, 2022, with 2 approved supplements and 0 published complete response letters.
Levetiracetam oral solution is indicated for the treatment of partial-onset seizures in patients 1 month of age and older Levetiracetam oral solution is indicated for adjunctive therapy for the treatment of: Myoclonic seizures in patients 12 years of age and older with juvenile myoclonic epilepsy Primary generalized tonic-clonic seizures in patients 6 years of age and older with idiopathic generalized epilepsy 1.1 Partial-Onset Seizures
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jul 15, 2022 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Levetiracetam100MG/ML · solution;oral | Levetiracetam | Rx |
| Mar 14, 2025 | Supplement 1Labeling · Standard review | Approved | None posted |
| Mar 14, 2025 | Supplement 3Labeling · Standard review | Approved | None posted |
| Jul 15, 2022 | 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
