Levetiracetam

ANDA 78042, held by Strides Pharma. Levetiracetam.

As of Nov 15, 2026, ANDA 78042 (Levetiracetam), held by Strides Pharma, was first approved by FDA on Jan 15, 2009, with 7 approved supplements and 0 published complete response letters.

First approved: Jan 15, 2009
Supplements approved: 7
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 8 submissions below

Date	Submission	Status	Documents
Jan 15, 2009	Original application	Approved	None posted

Products

4 strengths and forms


Levetiracetam250MG · tablet;oral	Levetiracetam	Discontinued
Levetiracetam500MG · tablet;oral	Levetiracetam	Discontinued
Levetiracetam750MG · tablet;oral	Levetiracetam	Discontinued
Levetiracetam1GM · tablet;oral	Levetiracetam	Discontinued

All 8 submissions, including labeling and manufacturing supplements


Feb 28, 2013	Supplement 9Labeling · Standard review	Approved	None posted
Nov 17, 2011	Supplement 8REMS	Approved	None posted
Nov 23, 2010	Supplement 6Labeling	Approved	None posted
Nov 22, 2010	Supplement 7Labeling	Approved	None posted
Apr 22, 2010	Supplement 5Labeling	Approved	None posted
Feb 26, 2010	Supplement 2Labeling	Approved	None posted
Feb 26, 2010	Supplement 4Labeling	Approved	None posted
Jan 15, 2009	Original application	Approved	None posted

Identifiers

Application: ANDA 78042
Drugs@FDA: Overview at FDA
Company: Strides Pharma Inc

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