Levetiracetam

ANDA 78960, held by Taro. Levetiracetam.

As of Nov 15, 2026, ANDA 78960 (Levetiracetam), held by Taro, was first approved by FDA on Feb 1, 2010, with 5 approved supplements and 0 published complete response letters.

First approved: Feb 1, 2010
Supplements approved: 5
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 6 submissions below

Date	Submission	Status	Documents
Feb 1, 2010	Original application	Approved	None posted

Products

4 strengths and forms


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

All 6 submissions, including labeling and manufacturing supplements


Dec 11, 2014	Supplement 2Labeling · Standard review	Approved	None posted
Dec 11, 2014	Supplement 3Labeling · Standard review	Approved	None posted
Dec 11, 2014	Supplement 4Labeling · Standard review	Approved	None posted
Dec 11, 2014	Supplement 5Labeling · Standard review	Approved	None posted
Dec 27, 2011	Supplement 1Labeling	Approved	None posted
Feb 1, 2010	Original application	Approved	None posted

Identifiers

Application: ANDA 78960
Drugs@FDA: Overview at FDA
Company: Taro Pharmaceuticals

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