Lamotrigine

Treats bipolar I disorder. ANDA 79099, held by Glenmark Pharms Ltd. Lamotrigine.

As of Nov 14, 2026, ANDA 79099 (Lamotrigine), held by Glenmark Pharms Ltd, was first approved by FDA on Feb 19, 2009, with 16 approved supplements and 0 published complete response letters.

First approved: Feb 19, 2009
Supplements approved: 16
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

Lamotrigine tablets for oral suspension (chewable, dispersible tablets) are indicated for: Epilepsy – adjunctive therapy in patients aged 2 years and older:

partial-onset seizures.
primary generalized tonic-clonic (PGTC) seizures.
generalized seizures of Lennox-Gastaut syndrome. Epilepsy – monotherapy in patients aged 16 years and older: Conversion to monotherapy in patients with partial-onset seizures who are receiving treatment with carbamazepine, phenytoin, phenobarbital, primidone, or valproate as the single antiepileptic drug.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 17 submissions below

Date	Submission	Status	Documents
Feb 19, 2009	Original application	Approved	Letter

Products

2 strengths and forms


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

All 17 submissions, including labeling and manufacturing supplements


Apr 17, 2026	Supplement 23Labeling · Standard review	Approved	None posted
Apr 17, 2026	Supplement 21Labeling · Standard review	Approved	None posted
Apr 11, 2024	Supplement 16Labeling · Standard review	Approved	None posted
Apr 11, 2024	Supplement 15Labeling · Standard review	Approved	None posted
Feb 10, 2020	Supplement 14Labeling · Standard review	Approved	None posted
Feb 10, 2020	Supplement 13Labeling · Standard review	Approved	None posted
Feb 10, 2020	Supplement 12Labeling · Standard review	Approved	None posted
Feb 10, 2020	Supplement 11Labeling · Standard review	Approved	None posted
Feb 10, 2020	Supplement 10Labeling · Standard review	Approved	None posted
Feb 10, 2020	Supplement 9Labeling · Standard review	Approved	None posted
Feb 10, 2020	Supplement 8Labeling · Standard review	Approved	None posted
Feb 10, 2020	Supplement 7Labeling · Standard review	Approved	None posted
Dec 8, 2014	Supplement 6Labeling · Standard review	Approved	None posted
May 31, 2012	Supplement 5Labeling · Standard review	Approved	None posted
Mar 26, 2012	Supplement 4Labeling	Approved	None posted
Jul 28, 2010	Supplement 1Labeling	Approved	None posted
Feb 19, 2009	Original application	Approved	Letter

Identifiers

Application: ANDA 79099
Drugs@FDA: Overview at FDA
Company: Glenmark Pharmaceuticals

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