← FDA DRUG APPROVALS

FDA NDA · NDA022251

LAMICTAL ODT

lamotrigine

Sponsor: GLAXOSMITHKLINE LLC

APPLICATION
NDA022251
TYPE
NDA
ORIGINAL APPROVAL
2009-05-08
LATEST ACTION
2025-10-10
ROUTE
ORAL
DOSAGE FORM
TABLET, ORALLY DISINTEGRATING
MARKETING STATUS
Prescription

Products

LAMICTAL ODT · ReferencePrescription
LAMOTRIGINE 100MG · TABLET, ORALLY DISINTEGRATING · ORAL
LAMICTAL ODT · ReferencePrescription
LAMOTRIGINE 25MG · TABLET, ORALLY DISINTEGRATING · ORAL
LAMICTAL ODT · ReferencePrescription
LAMOTRIGINE 200MG · TABLET, ORALLY DISINTEGRATING · ORAL
LAMICTAL ODT · ReferencePrescription
LAMOTRIGINE 50MG · TABLET, ORALLY DISINTEGRATING · ORAL

Approval history

2025-10-10Labeling · Supplement 32 · standard — Label ↗AP
2025-10-10Labeling · Supplement 33 · standard — Label ↗AP
2025-04-25Labeling · Supplement 30 · standard — Label ↗AP
2025-04-25Labeling · Supplement 31 · standard — Label ↗AP
2021-03-31Labeling · Supplement 28 · standard — Letter ↗AP
2020-10-09Labeling · Supplement 22 · standard — Letter ↗AP
2020-08-31Labeling · Supplement 26 · standard — Letter ↗AP
2020-08-19Labeling · Supplement 25 · standard — Letter ↗AP
2019-09-25Labeling · Supplement 24 · standard — Letter ↗AP
2019-08-14Labeling · Supplement 23 · standard — Letter ↗AP
2018-07-23Labeling · Supplement 20 · standard — Letter ↗AP
2018-06-27Labeling · Supplement 21 · standard — Label ↗AP
2015-05-18Efficacy · Supplement 17 · standard — Pediatric Medical Review ↗AP
2015-03-24Labeling · Supplement 14 · standard — Label ↗AP
2015-03-24Labeling · Supplement 7 · unknown — Letter ↗AP
2014-12-30Labeling · Supplement 2 · unknown — Label ↗AP
2014-12-30Labeling · Supplement 9 · unknown — Label ↗AP
2014-06-10Labeling · Supplement 16 · standard — Label ↗AP
2013-12-20Labeling · Supplement 1 · unknown — Label ↗AP
2012-08-01Labeling · Supplement 13 · unknown — Letter ↗AP
2011-11-29Labeling · Supplement 12 · unknown — Label ↗AP
2011-08-04Labeling · Supplement 10 · unknown — Letter ↗AP
2011-05-31REMS · Supplement 11 — Letter ↗AP
2010-10-24Labeling · Supplement 6 · unknown — Letter ↗AP
2010-10-24REMS · Supplement 5 — Label ↗AP
2009-05-08Type 3 - New Dosage Form · Original · standard — Review ↗AP
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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