← FDA DRUG APPROVALS

FDA ANDA · ANDA078669

LAMOTRIGINE

Sponsor: ACTAVIS TOTOWA

APPLICATION
ANDA078669
TYPE
ANDA
ORIGINAL APPROVAL
2011-04-08
LATEST ACTION
2011-04-08
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

LAMOTRIGINEDiscontinued
LAMOTRIGINE 150MG · TABLET · ORAL
LAMOTRIGINEDiscontinued
LAMOTRIGINE 25MG · TABLET · ORAL
LAMOTRIGINEDiscontinued
LAMOTRIGINE 200MG · TABLET · ORAL
LAMOTRIGINEDiscontinued
LAMOTRIGINE 100MG · TABLET · ORAL

Approval history

2011-04-08OriginalLetterAP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industryGMP disciplineFDA drug shortagesFDA enforcement & recalls

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

Get the Weekly GxP Briefing

Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.

Read a past issue →