Levetiracetam

Treats partial-onset seizures. ANDA 76919, held by Mylan. Levetiracetam.

As of Nov 15, 2026, ANDA 76919 (Levetiracetam), held by Mylan, was first approved by FDA on Nov 4, 2008, with 15 approved supplements and 0 published complete response letters.

First approved: Nov 4, 2008
Supplements approved: 15
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

Levetiracetam is indicated for the treatment of partial-onset seizures in patients 1 month of age and older Levetiracetam is 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 16 submissions below

Date	Submission	Status	Documents
Nov 4, 2008	Original application	Approved	None posted

Products

3 strengths and forms


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

All 16 submissions, including labeling and manufacturing supplements


Feb 10, 2025	Supplement 31Labeling · Standard review	Approved	None posted
Feb 10, 2025	Supplement 30Labeling · Standard review	Approved	None posted
Feb 10, 2025	Supplement 25Labeling · Standard review	Approved	None posted
Feb 10, 2025	Supplement 24Labeling · Standard review	Approved	None posted
Feb 10, 2025	Supplement 22Labeling · Standard review	Approved	None posted
Feb 10, 2025	Supplement 21Labeling · Standard review	Approved	None posted
Feb 10, 2025	Supplement 19Labeling · Standard review	Approved	None posted
Feb 10, 2025	Supplement 17Labeling · Standard review	Approved	None posted
Feb 10, 2025	Supplement 15Labeling · Standard review	Approved	None posted
Sep 24, 2014	Supplement 14Labeling · Standard review	Approved	None posted
Sep 24, 2014	Supplement 13Labeling · Standard review	Approved	None posted
Sep 24, 2014	Supplement 11Labeling · Standard review	Approved	None posted
Sep 24, 2014	Supplement 10Labeling · Standard review	Approved	None posted
Sep 24, 2014	Supplement 8Labeling	Approved	None posted
Nov 2, 2009	Supplement 4Labeling	Approved	None posted
Nov 4, 2008	Original application	Approved	None posted

Identifiers

Application: ANDA 76919
Drugs@FDA: Overview at FDA
Company: Mylan

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