Levetiracetam

Treats partial-onset seizures. ANDA 203052, held by Hetero Labs Ltd Iii. Levetiracetam.

As of Nov 15, 2026, ANDA 203052 (Levetiracetam), held by Hetero Labs Ltd Iii, was first approved by FDA on Feb 28, 2013, with 8 approved supplements and 0 published complete response letters.

First approved: Feb 28, 2013
Supplements approved: 8
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 9 submissions below

Date	Submission	Status	Documents
Feb 28, 2013	Original application	Approved	None posted

Products

1 strengths and forms

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

All 9 submissions, including labeling and manufacturing supplements


Feb 25, 2025	Supplement 17Labeling · Standard review	Approved	None posted
Feb 25, 2025	Supplement 18Labeling · Standard review	Approved	None posted
Jul 28, 2020	Supplement 1Labeling · Standard review	Approved	None posted
Jul 28, 2020	Supplement 2Labeling · Standard review	Approved	None posted
Jul 28, 2020	Supplement 4Labeling · Standard review	Approved	None posted
Jul 28, 2020	Supplement 9Labeling · Standard review	Approved	None posted
Jul 28, 2020	Supplement 10Labeling · Standard review	Approved	None posted
Jul 28, 2020	Supplement 12Labeling · Standard review	Approved	None posted
Feb 28, 2013	Original application	Approved	None posted

Identifiers

Application: ANDA 203052
Drugs@FDA: Overview at FDA
Company: Hetero Labs Ltd Iii

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