Levetiracetam

Treats partial-onset seizures. ANDA 78106, held by Prinston Inc. Levetiracetam.

As of Nov 15, 2026, ANDA 78106 (Levetiracetam), held by Prinston Inc, was first approved by FDA on Feb 10, 2009, with 11 approved supplements and 0 published complete response letters.

First approved: Feb 10, 2009
Supplements approved: 11
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

Levetiracetam is indicated for the treatment of partial-onset seizures in patients 1 month of age and older Levetiracetam 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
Feb 10, 2009	Original application	Approved	None posted

Products

4 strengths and forms


Levetiracetam250MG · tablet;oral	Levetiracetam	Rx
Levetiracetam500MG · tablet;oral	Levetiracetam	Rx
Levetiracetam750MG · tablet;oral	Levetiracetam	Rx
Levetiracetam1GM · tablet;oral	Levetiracetam	Rx

All 12 submissions, including labeling and manufacturing supplements


Feb 21, 2025	Supplement 19Labeling · Standard review	Approved	None posted
Jan 5, 2023	Supplement 17Labeling · Standard review	Approved	None posted
Jan 5, 2023	Supplement 16Labeling · Standard review	Approved	None posted
Jan 5, 2023	Supplement 15Labeling · Standard review	Approved	None posted
Jan 5, 2023	Supplement 14Labeling · Standard review	Approved	None posted
Oct 19, 2015	Supplement 12Labeling · Standard review	Approved	None posted
Oct 19, 2015	Supplement 11Labeling · Standard review	Approved	None posted
Sep 18, 2014	Supplement 10Labeling · Standard review	Approved	None posted
Sep 18, 2014	Supplement 9Labeling · Standard review	Approved	None posted
Sep 18, 2014	Supplement 6Labeling · Standard review	Approved	None posted
Oct 28, 2010	Supplement 2Labeling	Approved	None posted
Feb 10, 2009	Original application	Approved	None posted

Identifiers

Application: ANDA 78106
Drugs@FDA: Overview at FDA
Company: Prinston Pharmaceutical

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