Lamictal Odt

Treats bipolar I disorder. NDA 22251, held by Glaxosmithkline LLC. Lamotrigine.

As of Nov 14, 2026, NDA 22251 (Lamictal Odt), held by Glaxosmithkline LLC, was first approved by FDA on May 8, 2009, with 25 approved supplements and 0 published complete response letters.

First approved: May 8, 2009
Review: Standard
Supplements approved: 25
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 26 submissions below


May 18, 2015	Supplement 17Efficacy (new indication or use) · Standard review	Approved	Label Letter Pediatric Medical Review Pediatric Clinical Pharmacology Review
May 8, 2009	Original applicationNew dosage form · Standard review	Approved	Review Summary Review Label Letter

Products

4 strengths and forms


Lamictal Odt25MG · tablet, orally disintegrating;oral	Lamotrigine	RxReference drug
Lamictal Odt50MG · tablet, orally disintegrating;oral	Lamotrigine	RxReference drug
Lamictal Odt100MG · tablet, orally disintegrating;oral	Lamotrigine	RxReference drug
Lamictal Odt200MG · tablet, orally disintegrating;oral	Lamotrigine	RxReference drug

All 26 submissions, including labeling and manufacturing supplements


Oct 10, 2025	Supplement 33Labeling · Standard review	Approved	Letter Label Medication Guide
Oct 10, 2025	Supplement 32Labeling · Standard review	Approved	Letter Label
Apr 25, 2025	Supplement 31Labeling · Standard review	Approved	Letter Label
Apr 25, 2025	Supplement 30Labeling · Standard review	Approved	Letter Label
Mar 31, 2021	Supplement 28Labeling · Standard review	Approved	Letter Label
Oct 9, 2020	Supplement 22Labeling · Standard review	Approved	Letter Label
Aug 31, 2020	Supplement 26Labeling · Standard review	Approved	Label Letter
Aug 19, 2020	Supplement 25Labeling · Standard review	Approved	Letter Label
Sep 25, 2019	Supplement 24Labeling · Standard review	Approved	Letter Label
Aug 14, 2019	Supplement 23Labeling · Standard review	Approved	Letter Label
Jul 23, 2018	Supplement 20Labeling · Standard review	Approved	Label Medication Guide Letter
Jun 27, 2018	Supplement 21Labeling · Standard review	Approved	Letter Label
May 18, 2015	Supplement 17Efficacy (new indication or use) · Standard review	Approved	Label Letter Pediatric Medical Review Pediatric Clinical Pharmacology Review
Mar 24, 2015	Supplement 14Labeling · Standard review	Approved	Letter Label
Mar 24, 2015	Supplement 7Labeling	Approved	Letter Label
Dec 30, 2014	Supplement 9Labeling	Approved	Letter Label
Dec 30, 2014	Supplement 2Labeling	Approved	Letter Label
Jun 10, 2014	Supplement 16Labeling · Standard review	Approved	Label Letter
Dec 20, 2013	Supplement 1Labeling	Approved	Letter Label
Aug 1, 2012	Supplement 13Labeling	Approved	Letter Label
Nov 29, 2011	Supplement 12Labeling	Approved	Label Letter
Aug 4, 2011	Supplement 10Labeling	Approved	Letter Label
May 31, 2011	Supplement 11REMS	Approved	Letter
Oct 24, 2010	Supplement 6Labeling	Approved	Letter Label
Oct 24, 2010	Supplement 5REMS	Approved	Letter Label
May 8, 2009	Original applicationNew dosage form · Standard review	Approved	Review Summary Review Label Letter

Identifiers

Application: NDA 22251
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