Levetiracetam

ANDA 202167, held by Adaptis. Levetiracetam.

As of Nov 15, 2026, ANDA 202167 (Levetiracetam), held by Adaptis, was first approved by FDA on Sep 4, 2015, with 5 approved supplements and 0 published complete response letters.

First approved: Sep 4, 2015
Supplements approved: 5
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 6 submissions below

Date	Submission	Status	Documents
Sep 4, 2015	Original application	Approved	Letter

Products

2 strengths and forms


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

All 6 submissions, including labeling and manufacturing supplements


Nov 14, 2024	Supplement 10Labeling · Standard review	Approved	None posted
Nov 16, 2023	Supplement 9Labeling · Standard review	Approved	None posted
Dec 7, 2018	Supplement 4Labeling · Standard review	Approved	None posted
Dec 7, 2018	Supplement 5Labeling · Standard review	Approved	None posted
Dec 7, 2018	Supplement 6Labeling · Standard review	Approved	None posted
Sep 4, 2015	Original application	Approved	Letter

Identifiers

Application: ANDA 202167
Drugs@FDA: Overview at FDA
Company: Adaptis

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