Treats partial-onset seizures. ANDA 78976, held by Actavis Mid Atlantic. Levetiracetam.
As of Nov 15, 2026, ANDA 78976 (Levetiracetam), held by Actavis Mid Atlantic, was first approved by FDA on Jan 15, 2009, with 10 approved supplements and 0 published complete response letters.
Levetiracetam Oral Solution is indicated for the treatment of partial-onset seizures in patients 1 month of age and older Levetiracetam Oral Solution 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 |
|---|---|---|---|
| Jan 15, 2009 | Original application | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Levetiracetam100MG/ML · solution;oral | Levetiracetam | Rx |
| Mar 4, 2025 | Supplement 22Labeling · Standard review | Approved | None posted |
| Apr 6, 2023 | Supplement 15Labeling · Standard review | Approved | None posted |
| Apr 6, 2023 | Supplement 16Labeling · Standard review | Approved | None posted |
| Apr 6, 2023 | Supplement 17Labeling · Standard review | Approved | None posted |
| Sep 26, 2014 | Supplement 6Labeling · Standard review | Approved | None posted |
| Sep 26, 2014 | Supplement 9Labeling · Standard review | Approved | None posted |
| Sep 26, 2014 | Supplement 11Labeling · Standard review | Approved | None posted |
| Sep 26, 2014 | Supplement 13Labeling · Standard review | Approved | None posted |
| Nov 17, 2010 | Supplement 4Labeling | Approved | None posted |
| Feb 16, 2010 | Supplement 3REMS | Approved | None posted |
| Jan 15, 2009 | 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
