APPLICATION
ANDA078645
TYPE
ANDA
ORIGINAL APPROVAL
2009-01-27
LATEST ACTION
2022-01-18
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
LAMOTRIGINEDiscontinued
LAMOTRIGINE 200MG · TABLET · ORAL
LAMOTRIGINEDiscontinued
LAMOTRIGINE 100MG · TABLET · ORAL
LAMOTRIGINEDiscontinued
LAMOTRIGINE 150MG · TABLET · ORAL
LAMOTRIGINEDiscontinued
LAMOTRIGINE 25MG · TABLET · ORAL
Approval history
2022-01-18Labeling · Supplement 12 · standardAP
2022-01-18Labeling · Supplement 10 · standardAP
2022-01-18Labeling · Supplement 11 · standardAP
2015-02-18Labeling · Supplement 7 · standardAP
2011-09-29Labeling · 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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