Levetiracetam

Treats partial-onset seizures. ANDA 90992, held by Amneal Pharms. Levetiracetam.

As of Nov 15, 2026, ANDA 90992 (Levetiracetam), held by Amneal Pharms, was first approved by FDA on Oct 27, 2009, with 11 approved supplements and 0 published complete response letters.

First approved: Oct 27, 2009
Supplements approved: 11
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 12 submissions below

Date	Submission	Status	Documents
Oct 27, 2009	Original application	Approved	None posted

Products

1 strengths and forms

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

All 12 submissions, including labeling and manufacturing supplements


Sep 16, 2024	Supplement 11Labeling · Standard review	Approved	None posted
Oct 24, 2023	Supplement 10Labeling · Standard review	Approved	None posted
May 19, 2023	Supplement 5Labeling · Standard review	Approved	None posted
May 19, 2023	Supplement 6Labeling · Standard review	Approved	None posted
May 19, 2023	Supplement 7Labeling · Standard review	Approved	None posted
May 19, 2023	Supplement 8Labeling · Standard review	Approved	None posted
May 19, 2023	Supplement 9Labeling · Standard review	Approved	None posted
Aug 10, 2015	Supplement 1Labeling	Approved	None posted
Aug 10, 2015	Supplement 3Labeling · Standard review	Approved	None posted
Aug 10, 2015	Supplement 4Labeling · Standard review	Approved	None posted
Oct 26, 2012	Supplement 2Labeling · Standard review	Approved	None posted
Oct 27, 2009	Original application	Approved	None posted

Identifiers

Application: ANDA 90992
Drugs@FDA: Overview at FDA
Company: Amneal 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