Treats partial-onset seizures. ANDA 211954, held by Micro Labs. Levetiracetam.
As of Nov 15, 2026, ANDA 211954 (Levetiracetam), held by Micro Labs, was first approved by FDA on Aug 9, 2019, with 4 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 |
|---|---|---|---|
| Aug 9, 2019 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Levetiracetam500MG/5ML (100MG/ML) · injectable;intravenous | Levetiracetam | Rx |
| Jul 5, 2024 | Supplement 6Labeling · Standard review | Approved | None posted |
| Dec 12, 2023 | Supplement 5Labeling · Standard review | Approved | None posted |
| May 22, 2023 | Supplement 1Labeling · Standard review | Approved | None posted |
| May 22, 2023 | Supplement 2Labeling · Standard review | Approved | None posted |
| Aug 9, 2019 | 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
