Levetiracetam

ANDA 90187, held by Apotex Inc. Levetiracetam.

As of Nov 15, 2026, ANDA 90187 (Levetiracetam), held by Apotex Inc, was first approved by FDA on Aug 5, 2011, with 9 approved supplements and 0 published complete response letters.

First approved: Aug 5, 2011
Supplements approved: 9
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 10 submissions below

Date	Submission	Status	Documents
Aug 5, 2011	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Levetiracetam100MG/ML · solution;oral	Levetiracetam	Discontinued

All 10 submissions, including labeling and manufacturing supplements


Dec 18, 2024	Supplement 9Labeling · Standard review	Approved	None posted
Oct 24, 2023	Supplement 7Labeling · Standard review	Approved	None posted
Oct 24, 2023	Supplement 8Labeling · Standard review	Approved	None posted
Jul 8, 2020	Supplement 3Labeling · Standard review	Approved	None posted
Jul 8, 2020	Supplement 4Labeling · Standard review	Approved	None posted
Jul 8, 2020	Supplement 5Labeling · Standard review	Approved	None posted
Jul 8, 2020	Supplement 6Labeling · Standard review	Approved	None posted
May 12, 2016	Supplement 1Labeling · Standard review	Approved	None posted
May 12, 2016	Supplement 2Labeling · Standard review	Approved	None posted
Aug 5, 2011	Original application	Approved	None posted

Identifiers

Application: ANDA 90187
Drugs@FDA: Overview at FDA
Company: Apotex

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