Levetiracetam

ANDA 79107, held by Tolmar. Levetiracetam.

As of Nov 15, 2026, ANDA 79107 (Levetiracetam), held by Tolmar, was first approved by FDA on Jan 15, 2009, with 7 approved supplements and 0 published complete response letters.

First approved: Jan 15, 2009
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
Jan 15, 2009	Original application	Approved	Letter

Products

1 strengths and forms

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

All 8 submissions, including labeling and manufacturing supplements


Nov 3, 2014	Supplement 18Labeling · Standard review	Approved	None posted
Nov 3, 2014	Supplement 15Labeling · Standard review	Approved	None posted
Nov 3, 2014	Supplement 12Labeling · Standard review	Approved	None posted
Nov 3, 2014	Supplement 10Labeling	Approved	None posted
Oct 26, 2012	Supplement 11Labeling · Standard review	Approved	None posted
Dec 29, 2010	Supplement 7Labeling	Approved	None posted
Aug 20, 2009	Supplement 3Labeling	Approved	None posted
Jan 15, 2009	Original application	Approved	Letter

Identifiers

Application: ANDA 79107
Drugs@FDA: Overview at FDA
Company: Tolmar, Inc.

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