APPLICATION
ANDA078625
TYPE
ANDA
ORIGINAL APPROVAL
2009-01-27
LATEST ACTION
2026-05-12
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
LAMOTRIGINEPrescription
LAMOTRIGINE 100MG · TABLET · ORAL
LAMOTRIGINEPrescription
LAMOTRIGINE 150MG · TABLET · ORAL
LAMOTRIGINEPrescription
LAMOTRIGINE 25MG · TABLET · ORAL
LAMOTRIGINEPrescription
LAMOTRIGINE 200MG · TABLET · ORAL
Approval history
2026-05-12Labeling · Supplement 17 · standardAP
2021-10-29Labeling · Supplement 14 · standardAP
2020-01-29Labeling · Supplement 12 · standardAP
2020-01-29Labeling · Supplement 10 · standardAP
2020-01-29Labeling · Supplement 11 · standardAP
2015-12-23Labeling · Supplement 9 · standardAP
2015-12-23Labeling · Supplement 7 · standardAP
2015-12-23Labeling · Supplement 1AP
2015-12-23Labeling · Supplement 8 · standardAP
2015-02-18Labeling · Supplement 5 · standardAP
2015-02-18Labeling · Supplement 6 · standardAP
2015-02-18Labeling · Supplement 4 · standardAP
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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