Levetiracetam

Treats partial-onset seizures. ANDA 78154, held by Lupin. Levetiracetam.

As of Nov 15, 2026, ANDA 78154 (Levetiracetam), held by Lupin, 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 tablets USP are indicated for the treatment of partial-onset seizures in patients 1 month of age and older Levetiracetam tablets USP are indicated for adjunctive therapy for treatment of: Partial onset seizures in patients one month of age and older with epilepsy 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 Levetiracetam tablets USP are indicated for treatment of partial-onset seizures in patients 1 month of age and older. 1.

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

3 strengths and forms


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

All 17 submissions, including labeling and manufacturing supplements


Feb 14, 2025	Supplement 44Labeling · Standard review	Approved	None posted
Jan 24, 2024	Supplement 28Labeling · Standard review	Approved	None posted
Jan 24, 2024	Supplement 29Labeling · Standard review	Approved	None posted
Jan 24, 2024	Supplement 30Labeling · Standard review	Approved	None posted
Jan 24, 2024	Supplement 34Labeling · Standard review	Approved	None posted
Jan 24, 2024	Supplement 37Labeling · Standard review	Approved	None posted
Jan 24, 2024	Supplement 39Labeling · Standard review	Approved	None posted
Jan 24, 2024	Supplement 43Labeling · Standard review	Approved	None posted
Jan 14, 2016	Supplement 20Labeling · Standard review	Approved	None posted
Jan 14, 2016	Supplement 21Labeling · Standard review	Approved	None posted
Jan 14, 2016	Supplement 22Labeling · Standard review	Approved	None posted
Sep 26, 2014	Supplement 15Labeling · Standard review	Approved	None posted
Sep 26, 2014	Supplement 19Labeling · Standard review	Approved	None posted
Jul 20, 2012	Supplement 11REMS	Approved	None posted
Sep 15, 2011	Supplement 10Labeling	Approved	None posted
Nov 12, 2009	Supplement 5REMS	Approved	None posted
Jan 15, 2009	Original application	Approved	None posted

Identifiers

Application: ANDA 78154
Drugs@FDA: Overview at FDA
Company: Lupin

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