Levetiracetam

ANDA 202095, held by Lotus Pharm Co Ltd. Levetiracetam.

As of Nov 15, 2026, ANDA 202095 (Levetiracetam), held by Lotus Pharm Co Ltd, was first approved by FDA on Jun 6, 2016, with 6 approved supplements and 0 published complete response letters.

First approved: Jun 6, 2016
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
Jun 6, 2016	Original application	Approved	None posted

Products

2 strengths and forms


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

All 7 submissions, including labeling and manufacturing supplements


Nov 10, 2021	Supplement 3Labeling · Standard review	Approved	None posted
Nov 10, 2021	Supplement 5Labeling · Standard review	Approved	None posted
Nov 10, 2021	Supplement 7Labeling · Standard review	Approved	None posted
Nov 10, 2021	Supplement 8Labeling · Standard review	Approved	None posted
Dec 15, 2016	Supplement 1Labeling · Standard review	Approved	None posted
Dec 15, 2016	Supplement 2Labeling · Standard review	Approved	None posted
Jun 6, 2016	Original application	Approved	None posted

Identifiers

Application: ANDA 202095
Drugs@FDA: Overview at FDA
Company: Lotus 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