Levetiracetam

Treats partial-onset seizures. ANDA 79063, held by Aurobindo Pharma. Levetiracetam.

As of Nov 15, 2026, ANDA 79063 (Levetiracetam), held by Aurobindo Pharma, was first approved by FDA on Jan 15, 2009, with 16 approved supplements and 0 published complete response letters.

First approved: Jan 15, 2009
Supplements approved: 16
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

Levetiracetam oral solution is indicated for the treatment of partial-onset seizures in patients 1 month of age and older Levetiracetam oral solution 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 17 submissions below

Date	Submission	Status	Documents
Jan 15, 2009	Original application	Approved	Letter

Products

1 strengths and forms

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

All 17 submissions, including labeling and manufacturing supplements


Aug 28, 2024	Supplement 32Labeling · Standard review	Approved	None posted
Aug 28, 2024	Supplement 30Labeling · Standard review	Approved	None posted
Aug 28, 2024	Supplement 26Labeling · Standard review	Approved	None posted
Aug 28, 2024	Supplement 23Labeling · Standard review	Approved	None posted
Aug 28, 2024	Supplement 22Labeling · Standard review	Approved	None posted
Aug 28, 2024	Supplement 19Labeling · Standard review	Approved	None posted
Aug 28, 2024	Supplement 16Labeling · Standard review	Approved	None posted
Aug 28, 2024	Supplement 15Labeling · Standard review	Approved	None posted
Aug 14, 2017	Supplement 20Labeling · Standard review	Approved	None posted
Nov 3, 2014	Supplement 13Labeling · Standard review	Approved	None posted
Nov 3, 2014	Supplement 10Labeling · Standard review	Approved	None posted
Nov 3, 2014	Supplement 8Labeling · Standard review	Approved	None posted
Feb 27, 2013	Supplement 6Labeling · Standard review	Approved	None posted
Apr 26, 2012	Supplement 4Labeling	Approved	None posted
Dec 13, 2010	Supplement 2Labeling	Approved	None posted
Jun 30, 2009	Supplement 1Labeling	Approved	None posted
Jan 15, 2009	Original application	Approved	Letter

Identifiers

Application: ANDA 79063
Drugs@FDA: Overview at FDA
Company: Aurobindo Pharma

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