Lamotrigine

ANDA 200220, held by Jubilant Generics. Lamotrigine.

As of Nov 14, 2026, ANDA 200220 (Lamotrigine), held by Jubilant Generics, was first approved by FDA on Feb 28, 2011, with 7 approved supplements and 0 published complete response letters.

First approved: Feb 28, 2011
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
Feb 28, 2011	Original application	Approved	None posted

Products

2 strengths and forms


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

All 8 submissions, including labeling and manufacturing supplements


Feb 7, 2025	Supplement 10Labeling · Standard review	Approved	None posted
Feb 7, 2025	Supplement 11Labeling · Standard review	Approved	None posted
Dec 6, 2019	Supplement 6Labeling · Standard review	Approved	None posted
Dec 6, 2019	Supplement 7Labeling · Standard review	Approved	None posted
Jan 5, 2015	Supplement 3Labeling · Standard review	Approved	None posted
Jan 5, 2015	Supplement 5Labeling · Standard review	Approved	None posted
May 31, 2012	Supplement 2Labeling · Standard review	Approved	None posted
Feb 28, 2011	Original application	Approved	None posted

Identifiers

Application: ANDA 200220
Drugs@FDA: Overview at FDA
Company: Jubilant Generics

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