Levetiracetam

ANDA 78918, held by Zydus Pharms USA Inc. Levetiracetam.

As of Nov 15, 2026, ANDA 78918 (Levetiracetam), held by Zydus Pharms USA Inc, was first approved by FDA on Apr 29, 2009, with 9 approved supplements and 0 published complete response letters.

First approved: Apr 29, 2009
Supplements approved: 9
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 10 submissions below

Date	Submission	Status	Documents
Apr 29, 2009	Original application	Approved	None posted

Products

2 strengths and forms


Levetiracetam250MG · tablet;oral	Levetiracetam	Rx
Levetiracetam1GM · tablet;oral	Levetiracetam	Rx

All 10 submissions, including labeling and manufacturing supplements


Jan 11, 2021	Supplement 8Labeling · Standard review	Approved	None posted
Jan 11, 2021	Supplement 9Labeling · Standard review	Approved	None posted
Jan 11, 2021	Supplement 10Labeling · Standard review	Approved	None posted
Feb 10, 2016	Supplement 7Labeling	Approved	None posted
Nov 29, 2011	Supplement 6REMS	Approved	None posted
Nov 17, 2010	Supplement 4Labeling	Approved	None posted
Sep 21, 2010	Supplement 3Labeling	Approved	None posted
Sep 15, 2009	Supplement 1Labeling	Approved	None posted
Sep 15, 2009	Supplement 2Labeling	Approved	None posted
Apr 29, 2009	Original application	Approved	None posted

Identifiers

Application: ANDA 78918
Drugs@FDA: Overview at FDA
Company: Zydus Pharmaceuticals (USA)

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