Levetiracetam

Treats partial-onset. ANDA 203468, held by Prinston. Levetiracetam.

As of Nov 15, 2026, ANDA 203468 (Levetiracetam), held by Prinston, was first approved by FDA on May 21, 2015, with 7 approved supplements and 0 published complete response letters.

First approved: May 21, 2015
Supplements approved: 7
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

Levetiracetam extended-release tablets are indicated for the treatment of partial-onset in patients 12 years of age and older.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 8 submissions below

Date	Submission	Status	Documents
May 21, 2015	Original application	Approved	None posted

Products

2 strengths and forms


Levetiracetam500MG · tablet, extended release;oral	Levetiracetam	Rx
Levetiracetam750MG · tablet, extended release;oral	Levetiracetam	Rx

All 8 submissions, including labeling and manufacturing supplements


Aug 29, 2024	Supplement 10Labeling · Standard review	Approved	None posted
Nov 17, 2021	Supplement 7Manufacturing	Approved	None posted
Nov 16, 2021	Supplement 1Labeling · Standard review	Approved	None posted
Nov 16, 2021	Supplement 3Labeling · Standard review	Approved	None posted
Nov 16, 2021	Supplement 5Labeling · Standard review	Approved	None posted
Nov 16, 2021	Supplement 6Labeling · Standard review	Approved	None posted
Nov 16, 2021	Supplement 8Labeling · Standard review	Approved	None posted
May 21, 2015	Original application	Approved	None posted

Identifiers

Application: ANDA 203468
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