Treats partial-onset seizures. ANDA 209781, held by Hainan Poly Pharm. Levetiracetam.
As of Nov 15, 2026, ANDA 209781 (Levetiracetam), held by Hainan Poly Pharm, was first approved by FDA on Mar 20, 2018, with 2 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 |
|---|---|---|---|
| Mar 20, 2018 | Original application | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Levetiracetam500MG/5ML (100MG/ML) · injectable;intravenous | Levetiracetam | Rx |
| Aug 6, 2025 | Supplement 5Labeling · Standard review | Approved | None posted |
| Sep 26, 2023 | Supplement 2Labeling · Standard review | Approved | None posted |
| Mar 20, 2018 | Original application | Approved |
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
