Levetiracetam

ANDA 90843, held by Accord Hlthcare. Levetiracetam.

As of Nov 15, 2026, ANDA 90843 (Levetiracetam), held by Accord Hlthcare, was first approved by FDA on Feb 14, 2011, with 10 approved supplements and 0 published complete response letters.

First approved: Feb 14, 2011
Supplements approved: 10
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 11 submissions below

Date	Submission	Status	Documents
Feb 14, 2011	Original application	Approved	None posted

Products

4 strengths and forms


Levetiracetam250MG · tablet;oral	Levetiracetam	Discontinued
Levetiracetam500MG · tablet;oral	Levetiracetam	Discontinued
Levetiracetam750MG · tablet;oral	Levetiracetam	Discontinued
Levetiracetam1GM · tablet;oral	Levetiracetam	Discontinued

All 11 submissions, including labeling and manufacturing supplements


Dec 19, 2024	Supplement 14Labeling · Standard review	Approved	None posted
Dec 19, 2024	Supplement 12Labeling · Standard review	Approved	None posted
Dec 19, 2024	Supplement 11Labeling · Standard review	Approved	None posted
Dec 19, 2024	Supplement 10Labeling · Standard review	Approved	None posted
Dec 19, 2024	Supplement 8Labeling · Standard review	Approved	None posted
Dec 19, 2024	Supplement 7Labeling · Standard review	Approved	None posted
Sep 6, 2016	Supplement 5Manufacturing	Approved	None posted
Sep 1, 2015	Supplement 6Labeling · Standard review	Approved	None posted
Sep 1, 2015	Supplement 4Labeling · Standard review	Approved	None posted
Sep 1, 2015	Supplement 3Labeling · Standard review	Approved	None posted
Feb 14, 2011	Original application	Approved	None posted

Identifiers

Application: ANDA 90843
Drugs@FDA: Overview at FDA
Company: Accord Healthcare

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