Levetiracetam

ANDA 78797, held by Watson Labs Inc. Levetiracetam.

As of Nov 15, 2026, ANDA 78797 (Levetiracetam), held by Watson Labs Inc, was first approved by FDA on Jan 15, 2009, with 1 approved supplement and 0 published complete response letters.

First approved: Jan 15, 2009
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
Jan 15, 2009	Original application	Approved	None posted

Products

4 strengths and forms


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

All 2 submissions, including labeling and manufacturing supplements


Feb 10, 2016	Supplement 2Labeling	Approved	None posted
Jan 15, 2009	Original application	Approved	None posted

Identifiers

Application: ANDA 78797
Drugs@FDA: Overview at FDA
Company: Watson Laboratories

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