Levetiracetam

Treats partial-onset seizures. ANDA 204312, held by Eugia Pharma. Levetiracetam.

As of Nov 15, 2026, ANDA 204312 (Levetiracetam), held by Eugia Pharma, was first approved by FDA on Feb 1, 2016, with 6 approved supplements and 0 published complete response letters.

First approved: Feb 1, 2016
Supplements approved: 6
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

Levetiracetam injection is indicated for the treatment of partial-onset seizures in patients 1 month of age and older
Levetiracetam injection is indicated for adjunctive therapy for the treatment of: o Myoclonic seizures in patients 12 years of age and older with juvenile myoclonic epilepsy o Primary generalized tonic-clonic seizures in patients 6 years of age and older with idiopathic generalized epilepsy

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 7 submissions below

Date	Submission	Status	Documents
Feb 1, 2016	Original application	Approved	Label Letter

Products

1 strengths and forms

Product	Active ingredient	Marketing
Levetiracetam500MG/5ML (100MG/ML) · injectable;intravenous	Levetiracetam	Rx

All 7 submissions, including labeling and manufacturing supplements


Feb 21, 2025	Supplement 13Labeling · Standard review	Approved	None posted
May 22, 2023	Supplement 9Labeling · Standard review	Approved	None posted
Apr 20, 2020	Supplement 2Labeling · Standard review	Approved	None posted
Apr 20, 2020	Supplement 4Labeling · Standard review	Approved	None posted
Apr 20, 2020	Supplement 6Labeling · Standard review	Approved	None posted
Apr 20, 2020	Supplement 8Labeling · Standard review	Approved	None posted
Feb 1, 2016	Original application	Approved	Label Letter

Identifiers

Application: ANDA 204312
Drugs@FDA: Overview at FDA
Company: Eugia 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