Lamotrigine

ANDA 90169, held by Glenmark Pharms Ltd. Lamotrigine.

As of Nov 14, 2026, ANDA 90169 (Lamotrigine), held by Glenmark Pharms Ltd, was first approved by FDA on May 4, 2012, with 10 approved supplements and 0 published complete response letters.

First approved: May 4, 2012
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
May 4, 2012	Original application	Approved	None posted

Products

4 strengths and forms


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

All 11 submissions, including labeling and manufacturing supplements


Apr 10, 2026	Supplement 10Labeling · Standard review	Approved	None posted
Aug 6, 2025	Supplement 9Labeling · Standard review	Approved	None posted
Jul 20, 2022	Supplement 8Labeling · Standard review	Approved	None posted
Mar 23, 2021	Supplement 2Labeling · Standard review	Approved	None posted
Mar 23, 2021	Supplement 3Labeling · Standard review	Approved	None posted
Mar 23, 2021	Supplement 4Labeling · Standard review	Approved	None posted
Mar 23, 2021	Supplement 5Labeling · Standard review	Approved	None posted
Mar 23, 2021	Supplement 6Labeling · Standard review	Approved	None posted
Mar 23, 2021	Supplement 7Labeling · Standard review	Approved	None posted
Feb 6, 2015	Supplement 1Labeling · Standard review	Approved	None posted
May 4, 2012	Original application	Approved	None posted

Identifiers

Application: ANDA 90169
Drugs@FDA: Overview at FDA
Company: Glenmark 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