APPLICATION
ANDA078525
TYPE
ANDA
ORIGINAL APPROVAL
2009-01-27
LATEST ACTION
2026-04-01
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
LAMOTRIGINEPrescription
LAMOTRIGINE 150MG · TABLET · ORAL
LAMOTRIGINEPrescription
LAMOTRIGINE 25MG · TABLET · ORAL
LAMOTRIGINEPrescription
LAMOTRIGINE 200MG · TABLET · ORAL
LAMOTRIGINEPrescription
LAMOTRIGINE 100MG · TABLET · ORAL
Approval history
2026-04-01Labeling · Supplement 36 · standardAP
2026-04-01Labeling · Supplement 32 · standardAP
2026-03-30Labeling · Supplement 27 · standardAP
2026-03-30Labeling · Supplement 28 · standardAP
2020-01-29Labeling · Supplement 25 · standardAP
2020-01-29Labeling · Supplement 23 · standardAP
2020-01-29Labeling · Supplement 15 · standardAP
2020-01-29Labeling · Supplement 16 · standardAP
2020-01-29Labeling · Supplement 14 · standardAP
2014-12-13Labeling · Supplement 13 · standardAP
2014-12-13Labeling · Supplement 11 · standardAP
2014-12-13Labeling · Supplement 8 · standardAP
2012-03-14Labeling · Supplement 6AP
2011-09-29Labeling · Supplement 4AP
2010-05-14REMS · Supplement 2AP
2009-03-25Labeling · Supplement 1AP
2009-01-27OriginalAP
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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