← FDA DRUG APPROVALS

FDA ANDA · ANDA077757

LAMOTRIGINE

Sponsor: CARACO

APPLICATION
ANDA077757
TYPE
ANDA
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
None (Tentative Approval)

Products

LAMOTRIGINENone (Tentative Approval)
LAMOTRIGINE 200MG · TABLET · ORAL
LAMOTRIGINENone (Tentative Approval)
LAMOTRIGINE 100MG · TABLET · ORAL
LAMOTRIGINENone (Tentative Approval)
LAMOTRIGINE 150MG · TABLET · ORAL
LAMOTRIGINENone (Tentative Approval)
LAMOTRIGINE 25MG · TABLET · ORAL

Approval history

2007-11-09OriginalTA
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industry →GMP discipline →FDA drug shortages →FDA 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 →