APPLICATION
ANDA078947
TYPE
ANDA
ORIGINAL APPROVAL
2009-01-27
LATEST ACTION
2026-04-10
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
LAMOTRIGINEPrescription
LAMOTRIGINE 200MG · TABLET · ORAL
LAMOTRIGINEPrescription
LAMOTRIGINE 100MG · TABLET · ORAL
LAMOTRIGINEPrescription
LAMOTRIGINE 150MG · TABLET · ORAL
LAMOTRIGINEPrescription
LAMOTRIGINE 25MG · TABLET · ORAL
Approval history
2026-04-10Labeling · Supplement 43 · standardAP
2026-04-10Labeling · Supplement 41 · standardAP
2026-04-10Labeling · Supplement 42 · standardAP
2026-04-10Labeling · Supplement 40 · standardAP
2022-06-30Labeling · Supplement 37 · standardAP
2022-06-30Labeling · Supplement 38 · standardAP
2019-12-06Labeling · Supplement 33 · standardAP
2019-12-06Labeling · Supplement 34 · standardAP
2019-12-06Labeling · Supplement 32 · standardAP
2018-01-29Labeling · Supplement 26 · standardAP
2017-06-16Labeling · Supplement 22 · standardAP
2017-06-16Labeling · Supplement 23 · standardAP
2014-12-10Labeling · Supplement 21 · standardAP
2014-12-10Labeling · Supplement 18 · standardAP
2012-03-14Labeling · Supplement 15AP
2012-01-31Labeling · Supplement 14AP
2011-09-29Labeling · Supplement 11AP
2010-07-28Labeling · Supplement 9AP
2010-01-21REMS · Supplement 8AP
2009-09-21Labeling · Supplement 5AP
2009-09-21Labeling · Supplement 6AP
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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