Levetiracetam

ANDA 90461, held by Ajenat Pharms. Levetiracetam.

As of Nov 15, 2026, ANDA 90461 (Levetiracetam), held by Ajenat Pharms, was first approved by FDA on Sep 30, 2010, with 3 approved supplements and 0 published complete response letters.

First approved: Sep 30, 2010
Supplements approved: 3
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 4 submissions below

Date	Submission	Status	Documents
Sep 30, 2010	Original application	Approved	None posted

Products

1 strengths and forms

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

All 4 submissions, including labeling and manufacturing supplements


Sep 22, 2015	Supplement 1Labeling · Standard review	Approved	None posted
Sep 22, 2015	Supplement 2Labeling · Standard review	Approved	None posted
Sep 22, 2015	Supplement 3Labeling · Standard review	Approved	None posted
Sep 30, 2010	Original application	Approved	None posted

Identifiers

Application: ANDA 90461
Drugs@FDA: Overview at FDA
Company: Ajenat 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