APPLICATION
ANDA202383
TYPE
ANDA
ORIGINAL APPROVAL
2013-06-19
LATEST ACTION
2021-11-09
ROUTE
ORAL
DOSAGE FORM
TABLET, EXTENDED RELEASE
MARKETING STATUS
Prescription
Products
LAMOTRIGINEPrescription
LAMOTRIGINE 25MG · TABLET, EXTENDED RELEASE · ORAL
LAMOTRIGINEPrescription
LAMOTRIGINE 250MG · TABLET, EXTENDED RELEASE · ORAL
LAMOTRIGINEPrescription
LAMOTRIGINE 200MG · TABLET, EXTENDED RELEASE · ORAL
LAMOTRIGINEPrescription
LAMOTRIGINE 50MG · TABLET, EXTENDED RELEASE · ORAL
LAMOTRIGINEPrescription
LAMOTRIGINE 300MG · TABLET, EXTENDED RELEASE · ORAL
LAMOTRIGINEPrescription
LAMOTRIGINE 100MG · TABLET, EXTENDED RELEASE · ORAL
Approval history
2021-11-09Labeling · Supplement 13 · standardAP
2021-11-09Labeling · Supplement 12 · standardAP
2020-06-09Labeling · Supplement 11 · standardAP
2020-06-09Labeling · Supplement 10 · standardAP
2015-10-01Supplement 2TA
2015-09-24Labeling · Supplement 7 · standardAP
2015-09-24Labeling · Supplement 3 · standardAP
2015-09-24Labeling · Supplement 6 · standardAP
2013-06-19UNKNOWN · 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.
Weekly Briefing
Read a past issue →Get the Weekly GxP Briefing
Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.