Levetiracetam

ANDA 90906, held by Lotus Pharm Co Ltd. Levetiracetam.

As of Nov 15, 2026, ANDA 90906 (Levetiracetam), held by Lotus Pharm Co Ltd, was first approved by FDA on Nov 5, 2010, with 4 approved supplements and 0 published complete response letters.

First approved: Nov 5, 2010
Supplements approved: 4
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 5 submissions below

Date	Submission	Status	Documents
Nov 5, 2010	Original application	Approved	None posted

Products

4 strengths and forms


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

All 5 submissions, including labeling and manufacturing supplements


Oct 31, 2016	Supplement 2Manufacturing	Approved	Letter
Dec 26, 2015	Supplement 7Labeling · Standard review	Approved	None posted
Nov 24, 2015	Supplement 6Labeling · Standard review	Approved	None posted
Jan 16, 2015	Supplement 5Labeling · Standard review	Approved	None posted
Nov 5, 2010	Original application	Approved	None posted

Identifiers

Application: ANDA 90906
Drugs@FDA: Overview at FDA
Company: Lotus Pharmaceutical

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