APPLICATION
ANDA090607
TYPE
ANDA
ORIGINAL APPROVAL
2011-01-13
LATEST ACTION
2026-04-13
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
LAMOTRIGINEPrescription
LAMOTRIGINE 25MG · TABLET · ORAL
LAMOTRIGINEPrescription
LAMOTRIGINE 200MG · TABLET · ORAL
LAMOTRIGINEPrescription
LAMOTRIGINE 100MG · TABLET · ORAL
LAMOTRIGINEPrescription
LAMOTRIGINE 150MG · TABLET · ORAL
Approval history
2026-04-13Labeling · Supplement 38 · standardAP
2026-04-13Labeling · Supplement 41 · standardAP
2022-07-27Labeling · Supplement 28 · standardAP
2022-07-27Labeling · Supplement 26 · standardAP
2022-07-27Labeling · Supplement 29 · standardAP
2020-01-15Labeling · Supplement 20 · standardAP
2020-01-15Labeling · Supplement 19 · standardAP
2020-01-15Labeling · Supplement 17 · standardAP
2016-09-02Labeling · Supplement 9 · standardAP
2016-09-02Labeling · Supplement 10 · standardAP
2016-09-02Labeling · Supplement 8 · standardAP
2016-09-02Labeling · Supplement 11 · standardAP
2014-12-12Labeling · Supplement 7 · standardAP
2014-12-12Labeling · Supplement 5 · standardAP
2014-12-12Labeling · Supplement 6 · standardAP
2014-12-12Labeling · Supplement 4 · standardAP
2012-05-18Labeling · Supplement 3AP
2012-03-15Labeling · Supplement 1AP
2012-03-15Labeling · Supplement 2AP
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
Read a past issue →Get the Weekly GxP Briefing
Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.