APPLICATION
ANDA213271
TYPE
ANDA
ORIGINAL APPROVAL
2021-01-19
LATEST ACTION
2025-08-15
ROUTE
ORAL
DOSAGE FORM
TABLET, ORALLY DISINTEGRATING
MARKETING STATUS
Prescription
Products
LAMOTRIGINEPrescription
LAMOTRIGINE 100MG · TABLET, ORALLY DISINTEGRATING · ORAL
LAMOTRIGINEPrescription
LAMOTRIGINE 25MG · TABLET, ORALLY DISINTEGRATING · ORAL
LAMOTRIGINEPrescription
LAMOTRIGINE 200MG · TABLET, ORALLY DISINTEGRATING · ORAL
LAMOTRIGINEPrescription
LAMOTRIGINE 50MG · TABLET, ORALLY DISINTEGRATING · ORAL
Approval history
2025-08-15Labeling · Supplement 17 · standardAP
2024-04-15Labeling · Supplement 2 · standardAP
2021-01-19UNKNOWN · Original · standardAP
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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