Lamotrigine

ANDA 78409, held by Chartwell Rx. Lamotrigine.

As of Nov 14, 2026, ANDA 78409 (Lamotrigine), held by Chartwell Rx, was first approved by FDA on Jan 22, 2009, with 3 approved supplements and 0 published complete response letters.

First approved: Jan 22, 2009
Supplements approved: 3
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 4 submissions below

Date	Submission	Status	Documents
Jan 22, 2009	Original application	Approved	None posted

Products

3 strengths and forms


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

All 4 submissions, including labeling and manufacturing supplements


Jan 18, 2022	Supplement 8Labeling · Standard review	Approved	None posted
Jan 18, 2022	Supplement 9Labeling · Standard review	Approved	None posted
Jan 18, 2022	Supplement 10Labeling · Standard review	Approved	None posted
Jan 22, 2009	Original application	Approved	None posted

Identifiers

Application: ANDA 78409
Drugs@FDA: Overview at FDA
Company: Chartwell RX

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