Treats partial-onset seizures. ANDA 79042, held by Ingenus Pharms LLC. Levetiracetam.
As of Nov 15, 2026, ANDA 79042 (Levetiracetam), held by Ingenus Pharms LLC, was first approved by FDA on Jan 15, 2009, with 4 approved supplements and 0 published complete response letters.
Levetiracetam tablets are indicated for the treatment of partial-onset seizures in patients 1 month of age and older Levetiracetam tablets are 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 | None posted |
| Levetiracetam250MG · tablet;oral | Levetiracetam | Rx |
| Levetiracetam500MG · tablet;oral | Levetiracetam | Rx |
| Levetiracetam750MG · tablet;oral | Levetiracetam | Rx |
| Levetiracetam1GM · tablet;oral | Levetiracetam | Rx |
| Dec 17, 2024 | Supplement 5Labeling · Standard review | Approved | None posted |
| Jan 24, 2024 | Supplement 4Labeling · Standard review | Approved | None posted |
| Jan 24, 2015 | Supplement 2Labeling · Standard review | Approved | None posted |
| Apr 7, 2010 | Supplement 1REMS | Approved | None posted |
| Jan 15, 2009 | 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
