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As of Nov 15, 2026, ANDA 209474 (Levetiracetam), held by Prinston, was first approved by FDA on Mar 28, 2022, with 1 approved supplement and 0 published complete response letters.
First approved: Mar 28, 2022
Review: Standard
Supplements approved: 1
Complete response letters: 0
What It's For
From the FDA-approved label (Indications and Usage)
Levetiracetam injection is indicated for the treatment of partial-onset seizures in patients 1 month of age and older
Levetiracetam injection is indicated for adjunctive therapy for the treatment of: o Myoclonic seizures in patients 12 years of age and older with juvenile myoclonic epilepsy o Primary generalized tonic-clonic seizures in patients 6 years of age and older with idiopathic generalized epilepsy
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
