Levetiracetam

Treats partial-onset seizures. ANDA 214815, held by Msn. Levetiracetam.

As of Nov 15, 2026, ANDA 214815 (Levetiracetam), held by Msn, was first approved by FDA on Oct 7, 2022, with 1 approved supplement and 0 published complete response letters.

First approved: Oct 7, 2022
Review: Standard
Supplements approved: 1
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

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

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 2 submissions below

Date	Submission	Status	Documents
Oct 7, 2022	Original application	Approved	None posted

Products

4 strengths and forms


Levetiracetam250MG · tablet;oral	Levetiracetam	Rx
Levetiracetam500MG · tablet;oral	Levetiracetam	Rx
Levetiracetam750MG · tablet;oral	Levetiracetam	Rx
Levetiracetam1GM · tablet;oral	Levetiracetam	Rx

All 2 submissions, including labeling and manufacturing supplements


Nov 14, 2024	Supplement 4Labeling · Standard review	Approved	None posted
Oct 7, 2022	Original application	Approved	None posted

Identifiers

Application: ANDA 214815
Drugs@FDA: Overview at FDA
Company: MSN Laboratories

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