APPLICATION
ANDA200220
TYPE
ANDA
ORIGINAL APPROVAL
2011-02-28
LATEST ACTION
2025-02-07
ROUTE
ORAL
DOSAGE FORM
TABLET, FOR SUSPENSION
MARKETING STATUS
Discontinued
Products
LAMOTRIGINEDiscontinued
LAMOTRIGINE 25MG · TABLET, FOR SUSPENSION · ORAL
LAMOTRIGINEDiscontinued
LAMOTRIGINE 5MG · TABLET, FOR SUSPENSION · ORAL
Approval history
2025-02-07Labeling · Supplement 11 · standardAP
2025-02-07Labeling · Supplement 10 · standardAP
2019-12-06Labeling · Supplement 7 · standardAP
2019-12-06Labeling · Supplement 6 · standardAP
2015-01-05Labeling · Supplement 5 · standardAP
2015-01-05Labeling · Supplement 3 · standardAP
2012-05-31Labeling · Supplement 2 · standardAP
2011-02-28OriginalAP
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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