APPLICATION
ANDA090401
TYPE
ANDA
ORIGINAL APPROVAL
2009-11-04
LATEST ACTION
2025-12-31
ROUTE
ORAL
DOSAGE FORM
TABLET, FOR SUSPENSION, TABLET
MARKETING STATUS
Prescription
Products
LAMOTRIGINEPrescription
LAMOTRIGINE 25MG · TABLET, FOR SUSPENSION · ORAL
LAMOTRIGINEPrescription
LAMOTRIGINE 5MG · TABLET · ORAL
LAMOTRIGINEPrescription
LAMOTRIGINE 5MG · TABLET, FOR SUSPENSION · ORAL
Approval history
2025-12-31Labeling · Supplement 34 · standardAP
2019-12-06Labeling · Supplement 19 · standardAP
2019-12-06Labeling · Supplement 23 · standardAP
2019-12-06Labeling · Supplement 24 · standardAP
2019-12-06Labeling · Supplement 16 · standardAP
2017-04-18Labeling · Supplement 13 · standardAP
2017-04-18Labeling · Supplement 11 · standardAP
2017-04-18Labeling · Supplement 14 · standardAP
2014-12-05Labeling · Supplement 9 · standardAP
2014-12-05Labeling · Supplement 7 · standardAP
2014-12-05Labeling · Supplement 6 · standardAP
2014-12-05Labeling · Supplement 10 · standardAP
2012-04-25Labeling · Supplement 5AP
2011-09-29Labeling · Supplement 3AP
2010-08-13Labeling · Supplement 2AP
2009-11-04OriginalAP
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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