APPLICATION
ANDA204499
TYPE
ANDA
ORIGINAL APPROVAL
2024-09-26
LATEST ACTION
2025-09-03
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
LAMOTRIGINEPrescription
LAMOTRIGINE 100MG · TABLET · ORAL
LAMOTRIGINEPrescription
LAMOTRIGINE 150MG · TABLET · ORAL
LAMOTRIGINEPrescription
LAMOTRIGINE 25MG · TABLET · ORAL
LAMOTRIGINEPrescription
LAMOTRIGINE 200MG · TABLET · ORAL
Approval history
2025-09-03Labeling · Supplement 2 · standardAP
2024-09-26UNKNOWN · OriginalAP
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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