Levetiracetam

Treats partial-onset seizures. ANDA 90263, held by Chartwell Molecular. Levetiracetam.

As of Nov 15, 2026, ANDA 90263 (Levetiracetam), held by Chartwell Molecular, was first approved by FDA on Apr 3, 2009, with 12 approved supplements and 0 published complete response letters.

First approved: Apr 3, 2009
Supplements approved: 12
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 13 submissions below

Date	Submission	Status	Documents
Apr 3, 2009	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Levetiracetam100MG/ML · solution;oral	Levetiracetam	Rx

All 13 submissions, including labeling and manufacturing supplements


Apr 8, 2026	Supplement 17Labeling · Standard review	Approved	None posted
May 19, 2023	Supplement 15Labeling · Standard review	Approved	None posted
May 19, 2023	Supplement 14Labeling · Standard review	Approved	None posted
May 19, 2023	Supplement 13Labeling · Standard review	Approved	None posted
May 19, 2023	Supplement 12Labeling · Standard review	Approved	None posted
May 19, 2023	Supplement 11Labeling · Standard review	Approved	None posted
Aug 1, 2016	Supplement 10Labeling · Standard review	Approved	None posted
Aug 1, 2016	Supplement 9Labeling · Standard review	Approved	None posted
Jul 19, 2012	Supplement 7Labeling · Standard review	Approved	None posted
Oct 25, 2010	Supplement 3Labeling	Approved	None posted
Feb 19, 2010	Supplement 2Labeling	Approved	None posted
Aug 20, 2009	Supplement 1Labeling	Approved	None posted
Apr 3, 2009	Original application	Approved	None posted

Identifiers

Application: ANDA 90263
Drugs@FDA: Overview at FDA
Company: Chartwell Molecular

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