Levetiracetam

ANDA 78101, held by Teva Pharms. Levetiracetam.

As of Nov 15, 2026, ANDA 78101 (Levetiracetam), held by Teva Pharms, 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	None posted

Products

4 strengths and forms


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

All 8 submissions, including labeling and manufacturing supplements


Sep 18, 2014	Supplement 8Labeling · Standard review	Approved	None posted
Sep 18, 2014	Supplement 10Labeling · Standard review	Approved	None posted
Sep 18, 2014	Supplement 11Labeling · Standard review	Approved	None posted
Aug 22, 2012	Supplement 7Labeling · Standard review	Approved	None posted
Oct 27, 2010	Supplement 4Labeling	Approved	None posted
Oct 27, 2010	Supplement 5Labeling	Approved	None posted
Oct 27, 2010	Supplement 6Labeling	Approved	None posted
Jan 15, 2009	Original application	Approved	None posted

Identifiers

Application: ANDA 78101
Drugs@FDA: Overview at FDA
Company: Teva 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