Levetiracetam

ANDA 90893, held by Lupin Ltd. Levetiracetam.

As of Nov 15, 2026, ANDA 90893 (Levetiracetam), held by Lupin Ltd, was first approved by FDA on Oct 17, 2011, with 12 approved supplements and 0 published complete response letters.

First approved: Oct 17, 2011
Supplements approved: 12
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 13 submissions below

Date	Submission	Status	Documents
Oct 17, 2011	Original application	Approved	None posted

Products

1 strengths and forms

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

All 13 submissions, including labeling and manufacturing supplements


Nov 22, 2024	Supplement 23Labeling · Standard review	Approved	None posted
Oct 24, 2023	Supplement 22Labeling · Standard review	Approved	None posted
Mar 16, 2023	Supplement 20Labeling · Standard review	Approved	None posted
Mar 16, 2023	Supplement 18Labeling · Standard review	Approved	None posted
Mar 16, 2023	Supplement 15Labeling · Standard review	Approved	None posted
Mar 16, 2023	Supplement 14Labeling · Standard review	Approved	None posted
Mar 16, 2023	Supplement 13Labeling · Standard review	Approved	None posted
Dec 24, 2015	Supplement 10Labeling · Standard review	Approved	None posted
Dec 24, 2015	Supplement 9Labeling · Standard review	Approved	None posted
Nov 3, 2014	Supplement 6Labeling · Standard review	Approved	None posted
Nov 3, 2014	Supplement 1Labeling · Standard review	Approved	None posted
Apr 12, 2013	Supplement 3Labeling	Approved	None posted
Oct 17, 2011	Original application	Approved	None posted

Identifiers

Application: ANDA 90893
Drugs@FDA: Overview at FDA
Company: Lupin

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