Lamotrigine

ANDA 78982, held by Granules. Lamotrigine.

As of Nov 14, 2026, ANDA 78982 (Lamotrigine), held by Granules, was first approved by FDA on Jan 27, 2009, with 6 approved supplements and 0 published complete response letters.

First approved: Jan 27, 2009
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
Jan 27, 2009	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


Apr 30, 2026	Supplement 7Labeling · Standard review	Approved	None posted
Apr 30, 2026	Supplement 8Labeling · Standard review	Approved	None posted
Aug 22, 2022	Supplement 3Labeling · Standard review	Approved	None posted
Aug 22, 2022	Supplement 4Labeling · Standard review	Approved	None posted
Aug 22, 2022	Supplement 5Labeling · Standard review	Approved	None posted
Oct 17, 2016	Supplement 2Labeling · Standard review	Approved	None posted
Jan 27, 2009	Original application	Approved	None posted

Identifiers

Application: ANDA 78982
Drugs@FDA: Overview at FDA
Company: Granules India

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