Levetiracetam

ANDA 206838, held by Jubilant Generics. Levetiracetam.

As of Nov 15, 2026, ANDA 206838 (Levetiracetam), held by Jubilant Generics, was first approved by FDA on Jun 2, 2016, with 1 approved supplement and 0 published complete response letters.

First approved: Jun 2, 2016
Review: Standard
Supplements approved: 1
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 2 submissions below

Date	Submission	Status	Documents
Jun 2, 2016	Original application	Approved	None posted

Products

1 strengths and forms

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

All 2 submissions, including labeling and manufacturing supplements


Jun 2, 2016	Original application	Approved	None posted
Jun 2, 2016	Supplement 1Labeling	Approved	None posted

Identifiers

Application: ANDA 206838
Drugs@FDA: Overview at FDA
Company: Jubilant Generics

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