Levetiracetam

ANDA 203059, held by Sun Pharm. Levetiracetam.

As of Nov 15, 2026, ANDA 203059 (Levetiracetam), held by Sun Pharm, was first approved by FDA on Sep 9, 2013, with 11 approved supplements and 0 published complete response letters.

First approved: Sep 9, 2013
Supplements approved: 11
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 12 submissions below

Date	Submission	Status	Documents
Sep 9, 2013	Original application	Approved	None posted

Products

2 strengths and forms


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

All 12 submissions, including labeling and manufacturing supplements


Nov 14, 2024	Supplement 29Labeling · Standard review	Approved	None posted
Nov 16, 2023	Supplement 27Labeling · Standard review	Approved	None posted
Nov 16, 2021	Supplement 22Labeling · Standard review	Approved	None posted
Aug 13, 2020	Supplement 20Labeling · Standard review	Approved	None posted
Aug 13, 2020	Supplement 13Labeling · Standard review	Approved	None posted
Aug 13, 2020	Supplement 12Labeling · Standard review	Approved	None posted
Jul 21, 2020	Supplement 11Labeling · Standard review	Approved	None posted
Jul 21, 2020	Supplement 10Labeling · Standard review	Approved	None posted
Jun 14, 2015	Supplement 8Labeling · Standard review	Approved	None posted
Jun 14, 2015	Supplement 7Labeling · Standard review	Approved	None posted
Jun 14, 2015	Supplement 4Labeling · Standard review	Approved	None posted
Sep 9, 2013	Original application	Approved	None posted

Identifiers

Application: ANDA 203059
Drugs@FDA: Overview at FDA
Company: Sun Pharma

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