Treats partial-onset seizures. ANDA 201157, held by Pharm Assoc. Levetiracetam.
As of Nov 15, 2026, ANDA 201157 (Levetiracetam), held by Pharm Assoc, was first approved by FDA on Jun 4, 2015, with 7 approved supplements and 0 published complete response letters.
Levetiracetam Oral Solution USP is indicated for the treatment of partial-onset seizures in patients 1 month of age and older Levetiracetam Oral Solution USP 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 4, 2015 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Levetiracetam100MG/ML · solution;oral | Levetiracetam | Rx |
| Nov 13, 2024 | Supplement 12Labeling · Standard review | Approved | None posted |
| Nov 21, 2023 | Supplement 11Labeling · Standard review | Approved | None posted |
| May 22, 2023 | Supplement 8Labeling · Standard review | Approved | None posted |
| Jul 8, 2020 | Supplement 1Labeling · Standard review | Approved | None posted |
| Jul 8, 2020 | Supplement 4Labeling · Standard review | Approved | None posted |
| Jul 8, 2020 | Supplement 5Labeling · Standard review | Approved | None posted |
| Jul 8, 2020 | Supplement 6Labeling · Standard review | Approved | None posted |
| Jun 4, 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
