Levetiracetam

ANDA 78869, held by Novax. Levetiracetam.

As of Nov 15, 2026, ANDA 78869 (Levetiracetam), held by Novax, was first approved by FDA on Mar 13, 2009, with 6 approved supplements and 0 published complete response letters.

First approved: Mar 13, 2009
Supplements approved: 6
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 7 submissions below

Date	Submission	Status	Documents
Mar 13, 2009	Original application	Approved	None posted

Products

4 strengths and forms


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

All 7 submissions, including labeling and manufacturing supplements


Apr 5, 2024	Supplement 6Labeling · Standard review	Approved	None posted
Apr 5, 2024	Supplement 5Labeling · Standard review	Approved	None posted
Apr 5, 2024	Supplement 4Labeling · Standard review	Approved	None posted
Apr 5, 2024	Supplement 3Labeling · Standard review	Approved	None posted
Sep 21, 2014	Supplement 2Labeling · Standard review	Approved	None posted
Sep 21, 2014	Supplement 1Labeling · Standard review	Approved	None posted
Mar 13, 2009	Original application	Approved	None posted

Identifiers

Application: ANDA 78869
Drugs@FDA: Overview at FDA
Company: Novax

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