Lamotrigine

ANDA 78691, held by Lupin Ltd. Lamotrigine.

As of Nov 14, 2026, ANDA 78691 (Lamotrigine), held by Lupin Ltd, was first approved by FDA on Jun 1, 2010, with 10 approved supplements and 0 published complete response letters.

First approved: Jun 1, 2010
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
Jun 1, 2010	Original application	Approved	None posted

Products

4 strengths and forms


Lamotrigine25MG · tablet;oral	Lamotrigine	Discontinued
Lamotrigine100MG · tablet;oral	Lamotrigine	Discontinued
Lamotrigine150MG · tablet;oral	Lamotrigine	Discontinued
Lamotrigine200MG · tablet;oral	Lamotrigine	Discontinued

All 11 submissions, including labeling and manufacturing supplements


May 31, 2024	Supplement 9Labeling · Standard review	Approved	None posted
May 31, 2024	Supplement 10Labeling · Standard review	Approved	None posted
May 31, 2024	Supplement 11Labeling · Standard review	Approved	None posted
Jan 21, 2020	Supplement 5Labeling · Standard review	Approved	None posted
Jan 21, 2020	Supplement 6Labeling · Standard review	Approved	None posted
Jan 21, 2020	Supplement 7Labeling · Standard review	Approved	None posted
Jan 21, 2020	Supplement 8Labeling · Standard review	Approved	None posted
Aug 22, 2016	Supplement 4Labeling · Standard review	Approved	None posted
Apr 12, 2013	Supplement 3Labeling	Approved	None posted
Jun 17, 2011	Supplement 2Labeling	Approved	None posted
Jun 1, 2010	Original application	Approved	None posted

Identifiers

Application: ANDA 78691
Drugs@FDA: Overview at FDA
Company: Lupin

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