APPLICATION
ANDA204158
TYPE
ANDA
ORIGINAL APPROVAL
2015-10-27
LATEST ACTION
2026-06-26
ROUTE
ORAL
DOSAGE FORM
TABLET, ORALLY DISINTEGRATING
MARKETING STATUS
Prescription
Products
LAMOTRIGINEPrescription
LAMOTRIGINE 100MG · TABLET, ORALLY DISINTEGRATING · ORAL
LAMOTRIGINEPrescription
LAMOTRIGINE 25MG · TABLET, ORALLY DISINTEGRATING · ORAL
LAMOTRIGINEPrescription
LAMOTRIGINE 200MG · TABLET, ORALLY DISINTEGRATING · ORAL
LAMOTRIGINEPrescription
LAMOTRIGINE 50MG · TABLET, ORALLY DISINTEGRATING · ORAL
Approval history
2026-06-26Labeling · Supplement 8 · standardAP
2026-06-26Labeling · Supplement 13 · standardAP
2026-06-26Labeling · Supplement 11 · standardAP
2026-06-26Labeling · Supplement 7 · standardAP
2020-02-12Labeling · Supplement 4 · standardAP
2020-02-12Labeling · Supplement 2 · standardAP
2020-02-12Labeling · Supplement 3 · standardAP
2015-10-27UNKNOWN · OriginalAP
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.