← FDA DRUG APPROVALS

FDA NDA · NDA020241

LAMICTAL

lamotrigine

Sponsor: GLAXOSMITHKLINE LLC

APPLICATION
NDA020241
TYPE
NDA
ORIGINAL APPROVAL
1994-12-27
LATEST ACTION
2025-10-10
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription, Discontinued

Products

LAMICTAL · ReferencePrescription
LAMOTRIGINE 150MG · TABLET · ORAL
LAMICTAL · ReferencePrescription
LAMOTRIGINE 25MG · TABLET · ORAL
LAMICTAL · ReferencePrescription
LAMOTRIGINE 200MG · TABLET · ORAL
LAMICTAL · ReferencePrescription
LAMOTRIGINE 100MG · TABLET · ORAL
LAMICTAL · ReferenceDiscontinued
LAMOTRIGINE 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL
LAMICTAL · ReferenceDiscontinued
LAMOTRIGINE 250MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL

Approval history

2025-10-10Labeling · Supplement 68 · standard — Label ↗AP
2025-10-10Labeling · Supplement 69 · standard — Label ↗AP
2025-04-25Labeling · Supplement 67 · standard — Label ↗AP
2025-04-25Labeling · Supplement 66 · standard — Label ↗AP
2021-03-31Labeling · Supplement 64 · standard — Letter ↗AP
2020-10-09Labeling · Supplement 58 · standard — Letter ↗AP
2020-08-31Labeling · Supplement 62 · standard — Letter ↗AP
2020-08-19Labeling · Supplement 61 · standard — Label ↗AP
2019-09-25Labeling · Supplement 60 · standard — Letter ↗AP
2019-08-14Labeling · Supplement 59 · standard — Letter ↗AP
2018-07-23Labeling · Supplement 56 · standard — Letter ↗AP
2018-06-27Labeling · Supplement 57 · standard — Label ↗AP
2015-05-18Efficacy · Supplement 53 · standard — Label ↗AP
2015-03-24Labeling · Supplement 45 · standard — Label ↗AP
2015-03-24Labeling · Supplement 51 · standard — Label ↗AP
2014-12-30Labeling · Supplement 35 · standard — Label ↗AP
2014-12-30Labeling · Supplement 40 · unknown — Letter ↗AP
2014-06-10Labeling · Supplement 52 · standard — Letter ↗AP
2013-12-20Labeling · Supplement 39 · unknown — Letter ↗AP
2012-08-01Labeling · Supplement 50 · unknown — Letter ↗AP
2011-11-29Labeling · Supplement 49 · unknown — Letter ↗AP
2011-08-04Labeling · Supplement 47 · unknown — Letter ↗AP
2011-05-31REMS · Supplement 48 — Letter ↗AP
2010-10-24REMS · Supplement 43 — Label ↗AP
2010-10-24Labeling · Supplement 44 · unknown — Letter ↗AP
2009-05-08Labeling · Supplement 36 · standard — Letter ↗AP
2009-04-23Labeling · Supplement 37 · 901 required — Letter ↗AP
2009-04-23Labeling · Supplement 38 · standard — Label ↗AP
2006-09-25Labeling · Supplement 10 · standard — Label ↗AP
2006-09-25Labeling · Supplement 25 · standard — Letter ↗AP
2006-09-25Labeling · Supplement 21 · standard — Label ↗AP
2006-09-25Labeling · Supplement 26 · standard — Label ↗AP
2006-09-22Efficacy · Supplement 27 · standard — Review ↗AP
2006-03-17Labeling · Supplement 29 · standardAP
2004-01-14Efficacy · Supplement 16 · standard — Letter ↗AP
2003-06-20Efficacy · Supplement 17 · standard — Review ↗AP
2003-04-04Labeling · Supplement 18 · standard — Letter ↗AP
2003-01-17Efficacy · Supplement 8 · standard — Label ↗AP
2001-05-25Efficacy · Supplement 11 · standard — Review ↗AP
2001-02-23Labeling · Supplement 15 · standardAP
VIEW ON DRUGS@FDA ↗

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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.

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