APPLICATION
ANDA207763
TYPE
ANDA
ORIGINAL APPROVAL
2020-04-01
LATEST ACTION
2026-03-16
ROUTE
ORAL
DOSAGE FORM
TABLET, EXTENDED RELEASE
MARKETING STATUS
Prescription
Products
LAMOTRIGINEPrescription
LAMOTRIGINE 250MG · TABLET, EXTENDED RELEASE · ORAL
LAMOTRIGINEPrescription
LAMOTRIGINE 100MG · TABLET, EXTENDED RELEASE · ORAL
LAMOTRIGINEPrescription
LAMOTRIGINE 25MG · TABLET, EXTENDED RELEASE · ORAL
LAMOTRIGINEPrescription
LAMOTRIGINE 300MG · TABLET, EXTENDED RELEASE · ORAL
LAMOTRIGINEPrescription
LAMOTRIGINE 200MG · TABLET, EXTENDED RELEASE · ORAL
LAMOTRIGINEPrescription
LAMOTRIGINE 50MG · TABLET, EXTENDED RELEASE · ORAL
Approval history
2026-03-16Labeling · Supplement 12 · standardAP
2026-03-16Labeling · Supplement 13 · standardAP
2025-01-08Labeling · Supplement 4 · standardAP
2021-03-10Labeling · Supplement 2 · standardAP
2020-04-01UNKNOWN · 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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