Levetiracetam

ANDA 201293, held by Chartwell Rx. Levetiracetam.

As of Nov 15, 2026, ANDA 201293 (Levetiracetam), held by Chartwell Rx, was first approved by FDA on Jun 14, 2011, with 2 approved supplements and 0 published complete response letters.

First approved: Jun 14, 2011
Supplements approved: 2
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 3 submissions below

Date	Submission	Status	Documents
Jun 14, 2011	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 3 submissions, including labeling and manufacturing supplements


Feb 19, 2016	Supplement 1Labeling · Standard review	Approved	None posted
Feb 19, 2016	Supplement 2Manufacturing	Approved	None posted
Jun 14, 2011	Original application	Approved	None posted

Identifiers

Application: ANDA 201293
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