APPLICATION
ANDA077420
TYPE
ANDA
ORIGINAL APPROVAL
2009-01-27
LATEST ACTION
2026-05-15
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
LAMOTRIGINEDiscontinued
LAMOTRIGINE 150MG · TABLET · ORAL
LAMOTRIGINEDiscontinued
LAMOTRIGINE 25MG · TABLET · ORAL
LAMOTRIGINEDiscontinued
LAMOTRIGINE 200MG · TABLET · ORAL
LAMOTRIGINEDiscontinued
LAMOTRIGINE 100MG · TABLET · ORAL
Approval history
2026-05-15Labeling · Supplement 21 · standardAP
2025-08-26Labeling · Supplement 20 · standardAP
2019-11-20Labeling · Supplement 18 · standardAP
2019-11-20Labeling · Supplement 17 · standardAP
2017-04-13Labeling · Supplement 16 · standardAP
2017-04-13Labeling · Supplement 12 · standardAP
2017-04-13Labeling · Supplement 15 · standardAP
2017-04-13Labeling · Supplement 13 · standardAP
2012-03-16Labeling · Supplement 11AP
2011-01-10Labeling · Supplement 8AP
2010-10-30Labeling · Supplement 5AP
2009-11-25Labeling · 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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