Treats partial-onset seizures. ANDA 217878, held by Granules. Levetiracetam.
As of Nov 15, 2026, ANDA 217878 (Levetiracetam), held by Granules, was first approved by FDA on Jun 13, 2023, with 2 approved supplements and 0 published complete response letters.
Levetiracetam is indicated for the treatment of partial-onset seizures in patients 1 month of age and older Levetiracetam 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 |
|---|---|---|---|
| Jun 13, 2023 | Original application | Approved | None posted |
| Levetiracetam250MG · tablet;oral | Levetiracetam | Discontinued |
| Levetiracetam500MG · tablet;oral | Levetiracetam | Discontinued |
| Levetiracetam750MG · tablet;oral | Levetiracetam | Discontinued |
| Levetiracetam1GM · tablet;oral | Levetiracetam | Discontinued |
| May 29, 2024 | Supplement 3Labeling · Standard review | Approved | None posted |
| Jan 12, 2024 | Supplement 2Labeling · Standard review | Approved | None posted |
| Jun 13, 2023 | 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
