Treats partial onset seizures. ANDA 78234, held by Invagen Pharms. Levetiracetam.
As of Nov 15, 2026, ANDA 78234 (Levetiracetam), held by Invagen Pharms, was first approved by FDA on Jan 15, 2009, with 1 approved supplement and 0 published complete response letters.
Levetiracetam tablets, USP are antiepileptic drug indicated for adjunctive therapy in the treatment of: Partial onset seizures in patients 4 years 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, USP are indicated as adjunctive therapy in the treatment of partial onset seizures in adults and children 4 years of age and older with epilepsy.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jan 15, 2009 | Original application | Approved | None posted |
| Levetiracetam250MG · tablet;oral | Levetiracetam | Discontinued |
| Levetiracetam500MG · tablet;oral | Levetiracetam | Discontinued |
| Levetiracetam750MG · tablet;oral | Levetiracetam | Discontinued |
| Jan 8, 2010 | 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
