← FDA DRUG APPROVALS

FDA ANDA · ANDA211821

LAMOTRIGINE

Sponsor: ALEMBIC

APPLICATION
ANDA211821
TYPE
ANDA
ORIGINAL APPROVAL
2024-10-01
LATEST ACTION
2024-10-01
ROUTE
ORAL
DOSAGE FORM
TABLET, EXTENDED RELEASE
MARKETING STATUS
Prescription

Products

LAMOTRIGINEPrescription
LAMOTRIGINE 300MG · TABLET, EXTENDED RELEASE · ORAL
LAMOTRIGINEPrescription
LAMOTRIGINE 200MG · TABLET, EXTENDED RELEASE · ORAL
LAMOTRIGINEPrescription
LAMOTRIGINE 250MG · TABLET, EXTENDED RELEASE · ORAL

Approval history

2024-10-01UNKNOWN · Original · standardAP
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 →