APPLICATION
ANDA077633
TYPE
ANDA
ORIGINAL APPROVAL
2009-01-27
LATEST ACTION
2025-09-29
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
LAMOTRIGINEPrescription
LAMOTRIGINE 200MG · TABLET · ORAL
LAMOTRIGINEPrescription
LAMOTRIGINE 100MG · TABLET · ORAL
LAMOTRIGINEPrescription
LAMOTRIGINE 25MG · TABLET · ORAL
LAMOTRIGINEPrescription
LAMOTRIGINE 250MG · TABLET · ORAL
LAMOTRIGINEPrescription
LAMOTRIGINE 150MG · TABLET · ORAL
LAMOTRIGINEPrescription
LAMOTRIGINE 50MG · TABLET · ORAL
Approval history
2025-09-29Labeling · Supplement 41 · standardAP
2022-06-10Labeling · Supplement 37 · standardAP
2022-06-10Labeling · Supplement 35 · standardAP
2019-10-29Labeling · Supplement 28 · standardAP
2019-10-29Labeling · Supplement 32 · standardAP
2019-10-29Labeling · Supplement 30 · standardAP
2019-10-29Labeling · Supplement 29 · standardAP
2019-10-29Labeling · Supplement 31 · standardAP
2015-12-11Labeling · Supplement 18 · standardAP
2015-12-11Labeling · Supplement 24 · standardAP
2015-12-11Labeling · Supplement 20 · standardAP
2015-12-11Labeling · Supplement 17 · standardAP
2014-09-26Labeling · Supplement 9 · standardAP
2014-09-26Labeling · Supplement 16 · standardAP
2014-09-26Labeling · Supplement 12 · standardAP
2012-02-28REMS · Supplement 6AP
2012-02-27Labeling · Supplement 7AP
2012-02-27Labeling · Supplement 8AP
2011-09-29Labeling · Supplement 5AP
2011-04-25Labeling · Supplement 4AP
2010-02-23Labeling · Supplement 1AP
2010-02-23Labeling · 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.
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