Levetiracetam

ANDA 91557, held by Actavis Elizabeth. Levetiracetam.

As of Nov 15, 2026, ANDA 91557 (Levetiracetam), held by Actavis Elizabeth, was first approved by FDA on Sep 12, 2011, with 7 approved supplements and 0 published complete response letters.

First approved: Sep 12, 2011
Supplements approved: 7
Complete response letters: 0

Approvals and New Uses

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

Date	Submission	Status	Documents
Sep 12, 2011	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 8 submissions, including labeling and manufacturing supplements


Aug 27, 2024	Supplement 12Labeling · Standard review	Approved	None posted
Aug 27, 2024	Supplement 13Labeling · Standard review	Approved	None posted
Jun 10, 2021	Supplement 9Labeling · Standard review	Approved	None posted
Jun 10, 2021	Supplement 10Labeling · Standard review	Approved	None posted
Jun 10, 2021	Supplement 11Labeling · Standard review	Approved	None posted
Apr 7, 2016	Supplement 7Labeling · Standard review	Approved	None posted
Apr 7, 2016	Supplement 8Labeling · Standard review	Approved	None posted
Sep 12, 2011	Original application	Approved	None posted

Identifiers

Application: ANDA 91557
Drugs@FDA: Overview at FDA
Company: Actavis Elizabeth

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