Levetiracetam

ANDA 91291, held by Chartwell Rx. Levetiracetam.

As of Nov 15, 2026, ANDA 91291 (Levetiracetam), held by Chartwell Rx, was first approved by FDA on Sep 12, 2011, with 6 approved supplements and 0 published complete response letters.

First approved: Sep 12, 2011
Supplements approved: 6
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 7 submissions below

Date	Submission	Status	Documents
Sep 12, 2011	Original application	Approved	Letter

Products

2 strengths and forms


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

All 7 submissions, including labeling and manufacturing supplements


Apr 9, 2026	Supplement 8Labeling · Standard review	Approved	None posted
Apr 5, 2021	Supplement 5Labeling · Standard review	Approved	None posted
Apr 5, 2021	Supplement 6Labeling · Standard review	Approved	None posted
Apr 5, 2021	Supplement 7Labeling · Standard review	Approved	None posted
Jun 25, 2012	Supplement 2Labeling · Standard review	Approved	None posted
Apr 26, 2012	Supplement 1Labeling	Approved	None posted
Sep 12, 2011	Original application	Approved	Letter

Identifiers

Application: ANDA 91291
Drugs@FDA: Overview at FDA
Company: Chartwell RX

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