Levetiracetam

ANDA 202533, held by Prinston. Levetiracetam.

As of Nov 15, 2026, ANDA 202533 (Levetiracetam), held by Prinston, was first approved by FDA on Jul 20, 2012, with 4 approved supplements and 0 published complete response letters.

First approved: Jul 20, 2012
Supplements approved: 4
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 5 submissions below

Date	Submission	Status	Documents
Jul 20, 2012	Original application	Approved	None posted

Products

2 strengths and forms


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

All 5 submissions, including labeling and manufacturing supplements


Feb 12, 2016	Supplement 3Labeling · Standard review	Approved	None posted
Feb 12, 2016	Supplement 4Labeling · Standard review	Approved	None posted
Feb 12, 2016	Supplement 7Labeling · Standard review	Approved	None posted
Feb 12, 2016	Supplement 9Labeling · Standard review	Approved	None posted
Jul 20, 2012	Original application	Approved	None posted

Identifiers

Application: ANDA 202533
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