Lamotrigine

ANDA 79204, held by Taro. Lamotrigine.

As of Nov 14, 2026, ANDA 79204 (Lamotrigine), held by Taro, was first approved by FDA on Feb 4, 2009, with 10 approved supplements and 0 published complete response letters.

First approved: Feb 4, 2009
Supplements approved: 10
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 11 submissions below

Date	Submission	Status	Documents
Feb 4, 2009	Original application	Approved	None posted

Products

2 strengths and forms


Lamotrigine5MG · tablet, for suspension;oral	Lamotrigine	Discontinued
Lamotrigine25MG · tablet, for suspension;oral	Lamotrigine	Discontinued

All 11 submissions, including labeling and manufacturing supplements


May 6, 2026	Supplement 12Labeling · Standard review	Approved	None posted
May 6, 2026	Supplement 11Labeling · Standard review	Approved	None posted
May 6, 2026	Supplement 10Labeling · Standard review	Approved	None posted
Dec 12, 2014	Supplement 8Labeling · Standard review	Approved	None posted
Dec 12, 2014	Supplement 7Labeling · Standard review	Approved	None posted
Dec 12, 2014	Supplement 6Labeling · Standard review	Approved	None posted
May 16, 2012	Supplement 5Labeling	Approved	None posted
Mar 15, 2012	Supplement 4Labeling	Approved	None posted
Sep 29, 2011	Supplement 2Labeling	Approved	None posted
Feb 23, 2010	Supplement 1Labeling	Approved	None posted
Feb 4, 2009	Original application	Approved	None posted

Identifiers

Application: ANDA 79204
Drugs@FDA: Overview at FDA
Company: Taro Pharmaceuticals

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