APPLICATION
ANDA078691
TYPE
ANDA
ORIGINAL APPROVAL
2010-06-01
LATEST ACTION
2024-05-31
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
2024-05-31Labeling · Supplement 11 · standardAP
2024-05-31Labeling · Supplement 9 · standardAP
2024-05-31Labeling · Supplement 10 · standardAP
2020-01-21Labeling · Supplement 6 · standardAP
2020-01-21Labeling · Supplement 7 · standardAP
2020-01-21Labeling · Supplement 5 · standardAP
2020-01-21Labeling · Supplement 8 · standardAP
2016-08-22Labeling · Supplement 4 · standardAP
2013-04-12Labeling · Supplement 3AP
2011-06-17Labeling · Supplement 2AP
2010-06-01OriginalAP
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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