Lamictal

Treats bipolar I disorder. NDA 20241, held by Glaxosmithkline LLC. Lamotrigine.

As of Nov 13, 2026, NDA 20241 (Lamictal), held by Glaxosmithkline LLC, was first approved by FDA on Dec 27, 1994, with 49 approved supplements and 0 published complete response letters.

First approved: Dec 27, 1994
Review: Priority
Supplements approved: 49
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

LAMICTAL is 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. Bipolar disorder: Maintenance treatment of bipolar I disorder to delay the time to occurrence of mood episodes in patients treated for acute mood episodes with standard therapy.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 50 submissions below


May 18, 2015	Supplement 53Efficacy (new indication or use) · Standard review	Approved	Label Letter
Sep 22, 2006	Supplement 27Efficacy (new indication or use) · Standard review	Approved	Letter Label Review
Jan 14, 2004	Supplement 16Efficacy (new indication or use) · Standard review	Approved	Letter
Jun 20, 2003	Supplement 17Efficacy (new indication or use) · Standard review	Approved	Review Label Letter
Jan 17, 2003	Supplement 8Efficacy (new indication or use) · Standard review	Approved	Label
May 25, 2001	Supplement 11Efficacy (new indication or use) · Standard review	Approved	Review Label
Dec 14, 1998	Supplement 3Efficacy (new indication or use) · Standard review	Approved	Review Letter Label
Aug 24, 1998	Supplement 2Efficacy (new indication or use) · Standard review	Approved	Review Label Letter
Dec 27, 1994	Original applicationNew molecular entity · Priority review	Approved	None posted

Products

6 strengths and forms


Lamictal100MG · tablet;oral	Lamotrigine	RxReference drug
Lamictal150MG · tablet;oral	Lamotrigine	RxReference drug
Lamictal200MG · tablet;oral	Lamotrigine	RxReference drug
Lamictal250MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · tablet;oral	Lamotrigine	DiscontinuedReference drug
Lamictal25MG · tablet;oral	Lamotrigine	RxReference drug
Lamictal50MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · tablet;oral	Lamotrigine	DiscontinuedReference drug

All 50 submissions, including labeling and manufacturing supplements


Oct 10, 2025	Supplement 69Labeling · Standard review	Approved	Label Medication Guide
Oct 10, 2025	Supplement 68Labeling · Standard review	Approved	Letter Label
Apr 25, 2025	Supplement 67Labeling · Standard review	Approved	Letter Label
Apr 25, 2025	Supplement 66Labeling · Standard review	Approved	Letter Label
Mar 31, 2021	Supplement 64Labeling · Standard review	Approved	Letter Label
Oct 9, 2020	Supplement 58Labeling · Standard review	Approved	Letter Label
Aug 31, 2020	Supplement 62Labeling · Standard review	Approved	Label Letter
Aug 19, 2020	Supplement 61Labeling · Standard review	Approved	Label Letter
Sep 25, 2019	Supplement 60Labeling · Standard review	Approved	Letter Label Pediatric Clinical Pharmacology Review Pediatric Written Request
Aug 14, 2019	Supplement 59Labeling · Standard review	Approved	Letter Label
Jul 23, 2018	Supplement 56Labeling · Standard review	Approved	Label Letter
Jun 27, 2018	Supplement 57Labeling · Standard review	Approved	Letter Label
May 18, 2015	Supplement 53Efficacy (new indication or use) · Standard review	Approved	Label Letter
Mar 24, 2015	Supplement 51Labeling · Standard review	Approved	Letter Label
Mar 24, 2015	Supplement 45Labeling · Standard review	Approved	Letter Label
Dec 30, 2014	Supplement 40Labeling	Approved	Letter Label
Dec 30, 2014	Supplement 35Labeling · Standard review	Approved	Letter Label
Jun 10, 2014	Supplement 52Labeling · Standard review	Approved	Label Letter
Dec 20, 2013	Supplement 39Labeling	Approved	Letter Label
Aug 1, 2012	Supplement 50Labeling	Approved	Letter Label
Nov 29, 2011	Supplement 49Labeling	Approved	Letter Label
Aug 4, 2011	Supplement 47Labeling	Approved	Letter Label
May 31, 2011	Supplement 48REMS	Approved	Letter
Oct 24, 2010	Supplement 44Labeling	Approved	Letter Label
Oct 24, 2010	Supplement 43REMS	Approved	Letter Label
May 8, 2009	Supplement 36Labeling · Standard review	Approved	Label Letter
Apr 23, 2009	Supplement 38Labeling · Standard review	Approved	Label Letter
Apr 23, 2009	Supplement 37Labeling	Approved	Label Letter
Sep 25, 2006	Supplement 26Labeling · Standard review	Approved	Letter Label
Sep 25, 2006	Supplement 25Labeling · Standard review	Approved	Letter Label
Sep 25, 2006	Supplement 21Labeling · Standard review	Approved	Letter Label
Sep 25, 2006	Supplement 10Labeling · Standard review	Approved	Letter Label Label
Sep 22, 2006	Supplement 27Efficacy (new indication or use) · Standard review	Approved	Letter Label Review
Mar 17, 2006	Supplement 29Labeling · Standard review	Approved	None posted
Jan 14, 2004	Supplement 16Efficacy (new indication or use) · Standard review	Approved	Letter
Jun 20, 2003	Supplement 17Efficacy (new indication or use) · Standard review	Approved	Review Label Letter
Apr 4, 2003	Supplement 18Labeling · Standard review	Approved	Letter
Jan 17, 2003	Supplement 8Efficacy (new indication or use) · Standard review	Approved	Label
May 25, 2001	Supplement 11Efficacy (new indication or use) · Standard review	Approved	Review Label
Feb 23, 2001	Supplement 15Labeling · Standard review	Approved	None posted
Sep 8, 2000	Supplement 14Labeling · Standard review	Approved	None posted
Jun 12, 2000	Supplement 12Manufacturing · Priority review	Approved	None posted
Jun 8, 1999	Supplement 9Manufacturing · Priority review	Approved	None posted
May 10, 1999	Supplement 7Manufacturing · Priority review	Approved	None posted
Dec 14, 1998	Supplement 3Efficacy (new indication or use) · Standard review	Approved	Review Letter Label
Aug 24, 1998	Supplement 2Efficacy (new indication or use) · Standard review	Approved	Review Label Letter
Mar 16, 1998	Supplement 6Labeling · Standard review	Approved	Letter
Mar 16, 1998	Supplement 5Manufacturing · Priority review	Approved	None posted
Mar 11, 1997	Supplement 4Labeling · Standard review	Approved	None posted
Dec 27, 1994	Original applicationNew molecular entity · Priority review	Approved	None posted

Identifiers

Application: NDA 20241
Drugs@FDA: Overview at FDA
Company: GlaxoSmithKline LLC

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