Treats partial-onset seizures. ANDA 90876, held by Fresenius Kabi USA. Levetiracetam.
As of Nov 15, 2026, ANDA 90876 (Levetiracetam), held by Fresenius Kabi USA, was first approved by FDA on Aug 13, 2015, 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 13, 2015 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Levetiracetam500MG/5ML (100MG/ML) · injectable;intravenous | Levetiracetam | Rx |
| Apr 4, 2025 | Supplement 9Labeling · Standard review | Approved | None posted |
| Nov 16, 2023 | Supplement 8Labeling · Standard review | Approved | None posted |
| May 17, 2023 | Supplement 3Labeling · Standard review | Approved | None posted |
| May 17, 2023 | Supplement 4Labeling · Standard review | Approved | None posted |
| Aug 13, 2015 | 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
