APPLICATION
ANDA078409
TYPE
ANDA
ORIGINAL APPROVAL
2009-01-22
LATEST ACTION
2022-01-18
ROUTE
ORAL
DOSAGE FORM
TABLET, FOR SUSPENSION, TABLET
MARKETING STATUS
Discontinued, Prescription
Products
LAMOTRIGINEDiscontinued
LAMOTRIGINE 5MG · TABLET, FOR SUSPENSION · ORAL
LAMOTRIGINEDiscontinued
LAMOTRIGINE 25MG · TABLET, FOR SUSPENSION · ORAL
LAMOTRIGINEPrescription
LAMOTRIGINE 2MG · TABLET · ORAL
Approval history
2022-01-18Labeling · Supplement 8 · standardAP
2022-01-18Labeling · Supplement 9 · standardAP
2022-01-18Labeling · Supplement 10 · standardAP
2009-01-22OriginalAP
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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