← FDA DRUG APPROVALS

FDA NDA · NDA021430

THALOMID

Sponsor: CELGENE

APPLICATION
NDA021430
TYPE
NDA
ORIGINAL APPROVAL
2006-05-25
LATEST ACTION
2006-05-25
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Prescription

Products

THALOMIDPrescription
THALIDOMIDE 200MG · CAPSULE · ORAL
THALOMIDPrescription
THALIDOMIDE 50MG · CAPSULE · ORAL
THALOMIDPrescription
THALIDOMIDE 100MG · CAPSULE · ORAL

Approval history

2006-05-25Type 6 - New Indication (no longer used) · Original · standardReviewAP
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 →