Lamotrigine

ANDA 202887, held by Rubicon Research. Lamotrigine.

As of Nov 14, 2026, ANDA 202887 (Lamotrigine), held by Rubicon Research, was first approved by FDA on Jun 17, 2013, with 7 approved supplements and 0 published complete response letters.

First approved: Jun 17, 2013
Supplements approved: 7
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 8 submissions below

Date	Submission	Status	Documents
Jun 17, 2013	Original application	Approved	None posted

Products

4 strengths and forms


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

All 8 submissions, including labeling and manufacturing supplements


Feb 1, 2021	Supplement 17Labeling · Standard review	Approved	None posted
Nov 22, 2019	Supplement 8Labeling · Standard review	Approved	None posted
Nov 22, 2019	Supplement 11Labeling · Standard review	Approved	None posted
Feb 24, 2016	Supplement 1Labeling · Standard review	Approved	None posted
Feb 24, 2016	Supplement 2Labeling · Standard review	Approved	None posted
Feb 24, 2016	Supplement 3Labeling · Standard review	Approved	None posted
Feb 24, 2016	Supplement 4Labeling · Standard review	Approved	None posted
Jun 17, 2013	Original application	Approved	None posted

Identifiers

Application: ANDA 202887
Drugs@FDA: Overview at FDA
Company: Rubicon Research

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