Lamotrigine

ANDA 76928, held by Watson Labs. Lamotrigine.

As of Nov 14, 2026, ANDA 76928 (Lamotrigine), held by Watson Labs, was first approved by FDA on Jan 22, 2009, with 7 approved supplements and 0 published complete response letters.

First approved: Jan 22, 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 22, 2009	Original application	Approved	None posted

Products

3 strengths and forms


Lamotrigine2MG · tablet, for suspension;oral	Lamotrigine	Rx
Lamotrigine5MG · tablet, for suspension;oral	Lamotrigine	Rx
Lamotrigine25MG · tablet, for suspension;oral	Lamotrigine	Rx

All 8 submissions, including labeling and manufacturing supplements


Jan 30, 2020	Supplement 15Labeling · Standard review	Approved	None posted
Jan 30, 2020	Supplement 16Labeling · Standard review	Approved	None posted
Sep 26, 2014	Supplement 14Labeling · Standard review	Approved	None posted
May 18, 2012	Supplement 9Labeling	Approved	None posted
Sep 29, 2011	Supplement 6Labeling	Approved	None posted
Sep 21, 2009	Supplement 1Labeling	Approved	None posted
Sep 21, 2009	Supplement 3Labeling	Approved	None posted
Jan 22, 2009	Original application	Approved	None posted

Identifiers

Application: ANDA 76928
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