Levetiracetam

ANDA 201464, held by Alicora. Levetiracetam.

As of Nov 15, 2026, ANDA 201464 (Levetiracetam), held by Alicora, was first approved by FDA on May 25, 2012, with 3 approved supplements and 0 published complete response letters.

First approved: May 25, 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
May 25, 2012	Original application	Approved	None posted

Products

2 strengths and forms


Levetiracetam500MG · tablet, extended release;oral	Levetiracetam	Discontinued
Levetiracetam750MG · tablet, extended release;oral	Levetiracetam	Discontinued

All 4 submissions, including labeling and manufacturing supplements


Nov 14, 2024	Supplement 12Labeling · Standard review	Approved	None posted
Jan 25, 2024	Supplement 11Labeling · Standard review	Approved	None posted
Oct 1, 2021	Supplement 3Labeling · Standard review	Approved	None posted
May 25, 2012	Original application	Approved	None posted

Identifiers

Application: ANDA 201464
Drugs@FDA: Overview at FDA
Company: Alicora

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