Levetiracetam

Treats partial-onset seizures. ANDA 79120, held by Bionpharma. Levetiracetam.

As of Nov 15, 2026, ANDA 79120 (Levetiracetam), held by Bionpharma, was first approved by FDA on Jan 16, 2009, with 13 approved supplements and 0 published complete response letters.

First approved: Jan 16, 2009
Supplements approved: 13
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 14 submissions below

Date	Submission	Status	Documents
Jan 16, 2009	Original application	Approved	Letter

Products

1 strengths and forms

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

All 14 submissions, including labeling and manufacturing supplements


Dec 20, 2024	Supplement 22Labeling · Standard review	Approved	None posted
Dec 20, 2024	Supplement 21Labeling · Standard review	Approved	None posted
Dec 20, 2024	Supplement 18Labeling · Standard review	Approved	None posted
Dec 20, 2024	Supplement 15Labeling · Standard review	Approved	None posted
Dec 20, 2024	Supplement 14Labeling · Standard review	Approved	None posted
Dec 20, 2024	Supplement 12Labeling · Standard review	Approved	None posted
Feb 18, 2015	Supplement 11Labeling · Standard review	Approved	None posted
Feb 18, 2015	Supplement 8Labeling · Standard review	Approved	None posted
Feb 18, 2015	Supplement 7Labeling · Standard review	Approved	None posted
Feb 18, 2015	Supplement 6Labeling	Approved	None posted
Feb 18, 2015	Supplement 5Labeling	Approved	None posted
Apr 26, 2010	Supplement 3Labeling	Approved	None posted
Feb 25, 2010	Supplement 2Labeling	Approved	None posted
Jan 16, 2009	Original application	Approved	Letter

Identifiers

Application: ANDA 79120
Drugs@FDA: Overview at FDA
Company: Bionpharma

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