Treats partial onset seizures. ANDA 76920, held by Pharmazone. Levetiracetam.
As of Nov 15, 2026, ANDA 76920 (Levetiracetam), held by Pharmazone, was first approved by FDA on Jan 15, 2009, with 4 approved supplements and 0 published complete response letters.
Levetiracetam tablets are an antiepileptic drug indicated for adjunctive therapy in the treatment of: Partial onset seizures in patients one month of age and older with epilepsy 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 tablets are indicated as adjunctive therapy in the treatment of partial onset seizures in adults and children 1 month of age and older with epilepsy. 1.
| 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 |
| Apr 26, 2012 | Supplement 4Labeling | Approved | None posted |
| Sep 20, 2011 | Supplement 3REMS | Approved | None posted |
| Sep 21, 2010 | Supplement 2Labeling | Approved | None posted |
| Jul 31, 2009 | Supplement 1Labeling | 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
