Levetiracetam

Treats partial-onset seizures. ANDA 90261, held by Mylan. Levetiracetam.

As of Nov 15, 2026, ANDA 90261 (Levetiracetam), held by Mylan, was first approved by FDA on Dec 8, 2009, with 14 approved supplements and 0 published complete response letters.

First approved: Dec 8, 2009
Supplements approved: 14
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 15 submissions below

Date	Submission	Status	Documents
Dec 8, 2009	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Levetiracetam1GM · tablet;oral	Levetiracetam	Rx

All 15 submissions, including labeling and manufacturing supplements


Feb 10, 2025	Supplement 14Labeling · Standard review	Approved	None posted
Feb 10, 2025	Supplement 16Labeling · Standard review	Approved	None posted
Feb 10, 2025	Supplement 18Labeling · Standard review	Approved	None posted
Feb 10, 2025	Supplement 20Labeling · Standard review	Approved	None posted
Feb 10, 2025	Supplement 21Labeling · Standard review	Approved	None posted
Feb 10, 2025	Supplement 23Labeling · Standard review	Approved	None posted
Feb 10, 2025	Supplement 24Labeling · Standard review	Approved	None posted
Feb 10, 2025	Supplement 29Labeling · Standard review	Approved	None posted
Feb 10, 2025	Supplement 30Labeling · Standard review	Approved	None posted
Sep 24, 2014	Supplement 6Labeling	Approved	None posted
Sep 24, 2014	Supplement 8Labeling · Standard review	Approved	None posted
Sep 24, 2014	Supplement 9Labeling · Standard review	Approved	None posted
Sep 24, 2014	Supplement 11Labeling · Standard review	Approved	None posted
Sep 24, 2014	Supplement 12Labeling · Standard review	Approved	None posted
Dec 8, 2009	Original application	Approved	None posted

Identifiers

Application: ANDA 90261
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