Levetiracetam

Treats partial-onset seizures. ANDA 78993, held by Aurobindo Pharma. Levetiracetam.

As of Nov 15, 2026, ANDA 78993 (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 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 17 submissions below

Date	Submission	Status	Documents
Jan 15, 2009	Original application	Approved	None posted

Products

4 strengths and forms


Levetiracetam250MG · tablet;oral	Levetiracetam	Rx
Levetiracetam500MG · tablet;oral	Levetiracetam	Rx
Levetiracetam750MG · tablet;oral	Levetiracetam	Rx
Levetiracetam1GM · tablet;oral	Levetiracetam	Rx

All 17 submissions, including labeling and manufacturing supplements


Feb 5, 2025	Supplement 35Labeling · Standard review	Approved	None posted
Jan 24, 2024	Supplement 33Labeling · Standard review	Approved	None posted
Jan 24, 2024	Supplement 28Labeling · Standard review	Approved	None posted
Jan 24, 2024	Supplement 24Labeling · Standard review	Approved	None posted
Jan 24, 2024	Supplement 20Labeling · Standard review	Approved	None posted
Jan 24, 2024	Supplement 19Labeling · Standard review	Approved	None posted
Jan 24, 2024	Supplement 17Labeling · Standard review	Approved	None posted
Jan 24, 2024	Supplement 15Labeling · Standard review	Approved	None posted
Jan 24, 2024	Supplement 14Labeling · Standard review	Approved	None posted
Sep 26, 2014	Supplement 10Labeling · Standard review	Approved	None posted
Sep 26, 2014	Supplement 9Labeling · Standard review	Approved	None posted
Sep 26, 2014	Supplement 8Labeling · Standard review	Approved	None posted
Feb 28, 2013	Supplement 6Labeling · Standard review	Approved	None posted
Apr 25, 2012	Supplement 5Labeling	Approved	None posted
Dec 13, 2010	Supplement 2Labeling	Approved	None posted
Jun 29, 2009	Supplement 1Labeling	Approved	None posted
Jan 15, 2009	Original application	Approved	None posted

Identifiers

Application: ANDA 78993
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