← FDA DRUG APPROVALS

FDA NDA · NDA020764

LAMICTAL

lamotrigine

Sponsor: GLAXOSMITHKLINE LLC

APPLICATION
NDA020764
TYPE
NDA
ORIGINAL APPROVAL
1998-08-24
LATEST ACTION
2025-10-10
ROUTE
ORAL
DOSAGE FORM
TABLET, FOR SUSPENSION
MARKETING STATUS
Discontinued, Prescription

Products

LAMICTAL CDDiscontinued
LAMOTRIGINE 100MG · TABLET, FOR SUSPENSION · ORAL
LAMICTAL CD · ReferencePrescription
LAMOTRIGINE 5MG · TABLET, FOR SUSPENSION · ORAL
LAMICTAL CD · ReferencePrescription
LAMOTRIGINE 2MG · TABLET, FOR SUSPENSION · ORAL
LAMICTAL CD · ReferencePrescription
LAMOTRIGINE 25MG · TABLET, FOR SUSPENSION · ORAL

Approval history

2025-10-10Labeling · Supplement 61 · standardLabelAP
2025-10-10Labeling · Supplement 62 · standardLabelAP
2025-04-25Labeling · Supplement 59 · standardLabelAP
2025-04-25Labeling · Supplement 60 · standardLabelAP
2021-03-31Labeling · Supplement 57 · standardLetterAP
2020-10-09Labeling · Supplement 51 · standardLetterAP
2020-08-31Labeling · Supplement 55 · standardLetterAP
2020-08-19Labeling · Supplement 54 · standardLetterAP
2019-09-25Labeling · Supplement 53 · standardLetterAP
2019-08-14Labeling · Supplement 52 · standardLetterAP
2018-07-23Labeling · Supplement 49 · standardLetterAP
2018-06-27Labeling · Supplement 50 · standardLabelAP
2015-05-18Efficacy · Supplement 46 · standardLabelAP
2015-03-24Labeling · Supplement 38 · standardLabelAP
2015-03-24Labeling · Supplement 44 · standardLetterAP
2014-12-30Labeling · Supplement 33 · unknownLabelAP
2014-12-30Labeling · Supplement 28 · standardLabelAP
2014-06-10Labeling · Supplement 45 · standardLetterAP
2013-12-20Labeling · Supplement 32 · unknownLabelAP
2012-08-01Labeling · Supplement 43 · unknownLetterAP
2011-11-29Labeling · Supplement 42 · unknownLabelAP
2011-08-04Labeling · Supplement 40 · unknownLabelAP
2011-05-31REMS · Supplement 41LetterAP
2010-10-24Labeling · Supplement 37 · unknownLetterAP
2010-10-24REMS · Supplement 36LetterAP
2009-05-08Labeling · Supplement 29 · standardLetterAP
2009-04-23Labeling · Supplement 30 · 901 requiredLabelAP
2009-04-23Labeling · Supplement 31 · standardLabelAP
2006-09-25Labeling · Supplement 14 · standardLetterAP
2006-09-25Labeling · Supplement 3 · standardLabelAP
2006-09-25Labeling · Supplement 19 · standardLabelAP
2006-09-25Labeling · Supplement 18 · standardLabelAP
2006-09-22Efficacy · Supplement 20 · standardReviewAP
2006-03-17Labeling · Supplement 22 · standardAP
2004-01-14Efficacy · Supplement 9 · standardLetterAP
2003-06-20Efficacy · Supplement 11 · standardReviewAP
2003-01-17Efficacy · Supplement 2 · standardLabelAP
2001-05-25Efficacy · Supplement 5 · standardReviewAP
2001-02-23Labeling · Supplement 8 · standardAP
2000-09-08Manufacturing (CMC) · Supplement 6 · standardAP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industryGMP disciplineFDA drug shortagesFDA enforcement & recalls

Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

Weekly Briefing

Get the Weekly GxP Briefing

Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.

Read a past issue →