Levetiracetam

Treats partial-onset seizures. ANDA 78858, held by Torrent Pharms. Levetiracetam.

As of Nov 15, 2026, ANDA 78858 (Levetiracetam), held by Torrent Pharms, was first approved by FDA on Jan 15, 2009, with 20 approved supplements and 0 published complete response letters.

First approved: Jan 15, 2009
Supplements approved: 20
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 21 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 21 submissions, including labeling and manufacturing supplements


Feb 5, 2025	Supplement 37Labeling · Standard review	Approved	None posted
Jan 24, 2024	Supplement 36Labeling · Standard review	Approved	None posted
Jan 24, 2024	Supplement 33Labeling · Standard review	Approved	None posted
Feb 5, 2020	Supplement 32Labeling · Standard review	Approved	None posted
Feb 5, 2020	Supplement 31Labeling · Standard review	Approved	None posted
Feb 5, 2020	Supplement 27Labeling · Standard review	Approved	None posted
Feb 5, 2020	Supplement 26Labeling · Standard review	Approved	None posted
Feb 5, 2020	Supplement 24Labeling · Standard review	Approved	None posted
Jan 14, 2016	Supplement 21Labeling · Standard review	Approved	None posted
Jan 14, 2016	Supplement 20Labeling	Approved	None posted
Sep 18, 2014	Supplement 19Labeling · Standard review	Approved	None posted
Sep 18, 2014	Supplement 18Labeling · Standard review	Approved	None posted
Sep 18, 2014	Supplement 16Labeling · Standard review	Approved	None posted
Sep 18, 2014	Supplement 13Labeling	Approved	None posted
Dec 29, 2011	Supplement 10Labeling	Approved	None posted
Jun 23, 2010	Supplement 8Labeling	Approved	None posted
Mar 31, 2010	Supplement 7REMS	Approved	None posted
Nov 13, 2009	Supplement 6Labeling	Approved	None posted
Nov 13, 2009	Supplement 5Labeling	Approved	None posted
Nov 5, 2009	Supplement 4Labeling	Approved	None posted
Jan 15, 2009	Original application	Approved	None posted

Identifiers

Application: ANDA 78858
Drugs@FDA: Overview at FDA
Company: Torrent Pharmaceuticals

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