Levetiracetam

ANDA 200475, held by Aurobindo Pharma USA. Levetiracetam.

As of Nov 15, 2026, ANDA 200475 (Levetiracetam), held by Aurobindo Pharma USA, was first approved by FDA on Dec 19, 2011, with 7 approved supplements and 0 published complete response letters.

First approved: Dec 19, 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
Dec 19, 2011	Original application	Approved	None posted

Products

3 strengths and forms


Levetiracetam500MG · tablet, extended release;oral	Levetiracetam	Discontinued
Levetiracetam750MG · tablet, extended release;oral	Levetiracetam	Discontinued
Levetiracetam1GM · tablet, extended release;oral	Levetiracetam	Discontinued

All 8 submissions, including labeling and manufacturing supplements


Aug 27, 2024	Supplement 12Labeling · Standard review	Approved	None posted
Nov 16, 2023	Supplement 11Labeling · Standard review	Approved	None posted
Jan 29, 2021	Supplement 6Labeling · Standard review	Approved	None posted
Jan 29, 2021	Supplement 7Labeling · Standard review	Approved	None posted
Jan 29, 2021	Supplement 8Labeling · Standard review	Approved	None posted
Jan 29, 2021	Supplement 9Labeling · Standard review	Approved	None posted
Mar 18, 2014	Supplement 4Labeling · Standard review	Approved	None posted
Dec 19, 2011	Original application	Approved	None posted

Identifiers

Application: ANDA 200475
Drugs@FDA: Overview at FDA
Company: Aurobindo Pharma USA

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