Levetiracetam

ANDA 204754, held by Aiping Pharm Inc. Levetiracetam.

As of Nov 15, 2026, ANDA 204754 (Levetiracetam), held by Aiping Pharm Inc, was first approved by FDA on Aug 26, 2016, with 2 approved supplements and 0 published complete response letters.

First approved: Aug 26, 2016
Review: Standard
Supplements approved: 2
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 3 submissions below

Date	Submission	Status	Documents
Aug 26, 2016	Original application	Approved	None posted

Products

2 strengths and forms


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

All 3 submissions, including labeling and manufacturing supplements


Jun 8, 2026	Supplement 1Labeling · Standard review	Approved	None posted
Jun 8, 2026	Supplement 3Labeling · Standard review	Approved	None posted
Aug 26, 2016	Original application	Approved	None posted

Identifiers

Application: ANDA 204754
Drugs@FDA: Overview at FDA
Company: Aiping Pharmaceutical

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