Levetiracetam

ANDA 202143, held by Am Regent. Levetiracetam.

As of Nov 15, 2026, ANDA 202143 (Levetiracetam), held by Am Regent, was first approved by FDA on Jan 31, 2012, with 3 approved supplements and 0 published complete response letters.

First approved: Jan 31, 2012
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
Jan 31, 2012	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Levetiracetam500MG/5ML (100MG/ML) · injectable;intravenous	Levetiracetam	Discontinued

All 4 submissions, including labeling and manufacturing supplements


Dec 28, 2015	Supplement 2Labeling · Standard review	Approved	None posted
Dec 28, 2015	Supplement 3Labeling · Standard review	Approved	None posted
Dec 28, 2015	Supplement 4Labeling · Standard review	Approved	None posted
Jan 31, 2012	Original application	Approved	None posted

Identifiers

Application: ANDA 202143
Drugs@FDA: Overview at FDA
Company: Am Regent

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