Treats partial-onset seizures. ANDA 90079, held by Quagen. Levetiracetam.
As of Nov 15, 2026, ANDA 90079 (Levetiracetam), held by Quagen, was first approved by FDA on Apr 11, 2012, with 5 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 Levetiracetam oral solution is indicated for the treatment of partial-onset-seizures in patients 1 month of age and older. 1.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Apr 11, 2012 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Levetiracetam100MG/ML · solution;oral | Levetiracetam | Rx |
| Feb 2, 2016 | Supplement 8Labeling · Standard review | Approved | None posted |
| Feb 2, 2016 | Supplement 7Labeling · Standard review | Approved | None posted |
| Feb 2, 2016 | Supplement 6Labeling · Standard review | Approved | None posted |
| Feb 2, 2016 | Supplement 5Labeling · Standard review | Approved | None posted |
| Feb 27, 2013 | Supplement 4Labeling · Standard review | Approved | None posted |
| Apr 11, 2012 | 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
