Levetiracetam

Treats partial- onset seizures. ANDA 78582, held by Strides Pharma. Levetiracetam.

As of Nov 15, 2026, ANDA 78582 (Levetiracetam), held by Strides Pharma, was first approved by FDA on Jan 15, 2009, with 11 approved supplements and 0 published complete response letters.

First approved: Jan 15, 2009
Supplements approved: 11
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

Levetiracetam oral solution, USP is indicated for the treatment of partial- onset seizures in patients 1 month of age and older Levetiracetam oral solution, USP 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 Levetiracetam oral solution, USP is indicated for the 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 12 submissions below

Date	Submission	Status	Documents
Jan 15, 2009	Original application	Approved	Letter

Products

1 strengths and forms

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

All 12 submissions, including labeling and manufacturing supplements


Apr 21, 2026	Supplement 15Labeling · Standard review	Approved	None posted
Apr 21, 2026	Supplement 13Labeling · Standard review	Approved	None posted
Apr 21, 2026	Supplement 12Labeling · Standard review	Approved	None posted
May 18, 2015	Supplement 10Labeling · Standard review	Approved	None posted
Dec 9, 2014	Supplement 9Labeling · Standard review	Approved	None posted
Dec 9, 2014	Supplement 7Labeling · Standard review	Approved	None posted
Dec 9, 2014	Supplement 5Labeling	Approved	None posted
Feb 27, 2013	Supplement 6Labeling · Standard review	Approved	None posted
Nov 17, 2011	Supplement 4REMS	Approved	None posted
Sep 21, 2010	Supplement 3Labeling	Approved	None posted
Sep 15, 2009	Supplement 2Labeling	Approved	None posted
Jan 15, 2009	Original application	Approved	Letter

Identifiers

Application: ANDA 78582
Drugs@FDA: Overview at FDA
Company: Strides Pharma Inc

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