Levetiracetam

Treats partial-onset seizures. ANDA 203308, held by Mylan Labs Ltd. Levetiracetam.

As of Nov 15, 2026, ANDA 203308 (Levetiracetam), held by Mylan Labs Ltd, was first approved by FDA on Sep 16, 2016, with 6 approved supplements and 0 published complete response letters.

First approved: Sep 16, 2016
Supplements approved: 6
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

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 7 submissions below

Date	Submission	Status	Documents
Sep 16, 2016	Original application	Approved	Letter

Products

1 strengths and forms

Product	Active ingredient	Marketing
Levetiracetam500MG/5ML (100MG/ML) · injectable;intravenous	Levetiracetam	Rx

All 7 submissions, including labeling and manufacturing supplements


Mar 17, 2025	Supplement 12Labeling · Standard review	Approved	None posted
Mar 17, 2025	Supplement 13Labeling · Standard review	Approved	None posted
Mar 8, 2022	Supplement 8Labeling · Standard review	Approved	None posted
Apr 20, 2020	Supplement 2Labeling · Standard review	Approved	None posted
Apr 20, 2020	Supplement 3Labeling · Standard review	Approved	None posted
Apr 20, 2020	Supplement 7Labeling · Standard review	Approved	None posted
Sep 16, 2016	Original application	Approved	Letter

Identifiers

Application: ANDA 203308
Drugs@FDA: Overview at FDA
Company: Mylan 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