← FDA DRUG APPROVALS

FDA NDA · NDA022115

LAMICTAL XR

lamotrigine

Sponsor: GLAXOSMITHKLINE LLC

APPLICATION
NDA022115
TYPE
NDA
ORIGINAL APPROVAL
2009-05-29
LATEST ACTION
2025-10-10
ROUTE
ORAL
DOSAGE FORM
TABLET, EXTENDED RELEASE
MARKETING STATUS
Prescription

Products

LAMICTAL XR · ReferencePrescription
LAMOTRIGINE 300MG · TABLET, EXTENDED RELEASE · ORAL
LAMICTAL XR · ReferencePrescription
LAMOTRIGINE 100MG · TABLET, EXTENDED RELEASE · ORAL
LAMICTAL XR · ReferencePrescription
LAMOTRIGINE 25MG · TABLET, EXTENDED RELEASE · ORAL
LAMICTAL XR · ReferencePrescription
LAMOTRIGINE 250MG · TABLET, EXTENDED RELEASE · ORAL
LAMICTAL XR · ReferencePrescription
LAMOTRIGINE 200MG · TABLET, EXTENDED RELEASE · ORAL
LAMICTAL XR · ReferencePrescription
LAMOTRIGINE 50MG · TABLET, EXTENDED RELEASE · ORAL

Approval history

2025-10-10Labeling · Supplement 34 · standard — Label ↗AP
2025-10-10Labeling · Supplement 33 · standard — Label ↗AP
2025-04-25Labeling · Supplement 32 · standard — Label ↗AP
2025-04-25Labeling · Supplement 31 · standard — Label ↗AP
2021-03-31Labeling · Supplement 29 · standard — Letter ↗AP
2020-10-09Labeling · Supplement 24 · standard — Letter ↗AP
2020-08-31Labeling · Supplement 27 · standard — Letter ↗AP
2019-09-25Labeling · Supplement 26 · standard — Letter ↗AP
2019-08-14Labeling · Supplement 25 · standard — Letter ↗AP
2018-07-23Labeling · Supplement 22 · standard — Letter ↗AP
2018-06-27Labeling · Supplement 23 · standard — Label ↗AP
2015-03-24Labeling · Supplement 11 · standard — Label ↗AP
2015-03-24Labeling · Supplement 18 · standard — Letter ↗AP
2014-12-30Labeling · Supplement 14 · unknown — Letter ↗AP
2014-12-30Labeling · Supplement 4 · unknown — Letter ↗AP
2014-06-10Labeling · Supplement 19 · standard — Label ↗AP
2013-12-20Labeling · Supplement 3 · unknown — Label ↗AP
2012-08-01Labeling · Supplement 17 · unknown — Label ↗AP
2011-11-29Labeling · Supplement 16 · unknown — Label ↗AP
2011-08-04Labeling · Supplement 13 · unknown — Label ↗AP
2011-06-21Manufacturing (CMC) · Supplement 15 — Letter ↗AP
2011-04-25Efficacy · Supplement 6 · standard — Label ↗AP
2010-10-24Labeling · Supplement 10 · unknown — Label ↗AP
2010-10-24REMS · Supplement 9 — Label ↗AP
2010-04-14REMS · Supplement 5 — Label ↗AP
2010-04-14Manufacturing (CMC) · Supplement 1 · standard — Label ↗AP
2009-05-29Type 3 - New Dosage Form · Original · standard — Review ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

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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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