APPLICATION
ANDA201791
TYPE
ANDA
ORIGINAL APPROVAL
2013-01-18
LATEST ACTION
2021-11-09
ROUTE
ORAL
DOSAGE FORM
TABLET, EXTENDED RELEASE
MARKETING STATUS
Discontinued
Products
LAMOTRIGINEDiscontinued
LAMOTRIGINE 250MG · TABLET, EXTENDED RELEASE · ORAL
LAMOTRIGINEDiscontinued
LAMOTRIGINE 100MG · TABLET, EXTENDED RELEASE · ORAL
LAMOTRIGINEDiscontinued
LAMOTRIGINE 25MG · TABLET, EXTENDED RELEASE · ORAL
LAMOTRIGINEDiscontinued
LAMOTRIGINE 300MG · TABLET, EXTENDED RELEASE · ORAL
LAMOTRIGINEDiscontinued
LAMOTRIGINE 200MG · TABLET, EXTENDED RELEASE · ORAL
LAMOTRIGINEDiscontinued
LAMOTRIGINE 50MG · TABLET, EXTENDED RELEASE · ORAL
Approval history
2021-11-09Labeling · Supplement 8 · standardAP
2020-02-10Labeling · Supplement 6 · standardAP
2020-02-10Labeling · Supplement 7 · standardAP
2015-06-19Labeling · Supplement 4 · standardAP
2015-06-19Labeling · Supplement 5 · standardAP
2015-06-19Labeling · Supplement 3 · standardAP
2014-04-24Labeling · Supplement 1 · standardAP
2013-01-18UNKNOWN · 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.