Lamotrigine

ANDA 77783, held by Chartwell Molecular. Lamotrigine.

As of Nov 14, 2026, ANDA 77783 (Lamotrigine), held by Chartwell Molecular, was first approved by FDA on Nov 1, 2010, with 6 approved supplements and 0 published complete response letters.

First approved: Nov 1, 2010
Supplements approved: 6
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 7 submissions below

Date	Submission	Status	Documents
Nov 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 7 submissions, including labeling and manufacturing supplements


Oct 23, 2018	Supplement 14Labeling · Standard review	Approved	None posted
Oct 23, 2018	Supplement 13Labeling · Standard review	Approved	None posted
Sep 20, 2016	Supplement 9Labeling · Standard review	Approved	None posted
Sep 20, 2016	Supplement 7Labeling · Standard review	Approved	None posted
Sep 20, 2016	Supplement 6Labeling · Standard review	Approved	None posted
Sep 20, 2016	Supplement 3Labeling · Standard review	Approved	None posted
Nov 1, 2010	Original application	Approved	None posted

Identifiers

Application: ANDA 77783
Drugs@FDA: Overview at FDA
Company: Chartwell Molecular

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