Lamotrigine

ANDA 200672, held by Actavis Elizabeth. Lamotrigine.

As of Nov 14, 2026, ANDA 200672 (Lamotrigine), held by Actavis Elizabeth, was first approved by FDA on Oct 17, 2013, with 6 approved supplements and 0 published complete response letters.

First approved: Oct 17, 2013
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
Oct 17, 2013	Original application	Approved	None posted

Products

6 strengths and forms


Lamotrigine25MG · tablet, extended release;oral	Lamotrigine	Rx
Lamotrigine50MG · tablet, extended release;oral	Lamotrigine	Rx
Lamotrigine100MG · tablet, extended release;oral	Lamotrigine	Rx
Lamotrigine200MG · tablet, extended release;oral	Lamotrigine	Rx
Lamotrigine300MG · tablet, extended release;oral	Lamotrigine	Rx
Lamotrigine250MG · tablet, extended release;oral	Lamotrigine	Rx

All 7 submissions, including labeling and manufacturing supplements


May 19, 2023	Supplement 12Labeling · Standard review	Approved	None posted
May 19, 2023	Supplement 13Labeling · Standard review	Approved	None posted
Nov 21, 2019	Supplement 3Labeling · Standard review	Approved	None posted
Nov 21, 2019	Supplement 6Labeling · Standard review	Approved	None posted
Nov 21, 2019	Supplement 8Labeling · Standard review	Approved	None posted
Nov 21, 2019	Supplement 9Labeling · Standard review	Approved	None posted
Oct 17, 2013	Original application	Approved	None posted

Identifiers

Application: ANDA 200672
Drugs@FDA: Overview at FDA
Company: Actavis Elizabeth

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