Treats partial-onset seizures. ANDA 215980, held by Msn. Levetiracetam.
As of Nov 15, 2026, ANDA 215980 (Levetiracetam), held by Msn, was first approved by FDA on Nov 15, 2022, with 0 approved supplements and 0 published complete response letters.
Levetiracetam injection is indicated for the treatment of partial-onset seizures in patients 1 month of age and older Levetiracetam injection 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 Levetiracetam injection is for intravenous use only as an alternative for patients when oral administration is temporarily not feasible 1.1 Partial-Onset Seizures
| Date | Submission | Status | Documents |
|---|---|---|---|
| Nov 15, 2022 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Levetiracetam500MG/5ML (100MG/ML) · injectable;intravenous | Levetiracetam | Rx |
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
