← FDA DRUG APPROVALS

FDA NDA · NDA021968

SUTENT

Sponsor: CPPI CV

APPLICATION
NDA021968
TYPE
NDA
ORIGINAL APPROVAL
2006-01-26
LATEST ACTION
2007-02-02
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Prescription

Products

SUTENTPrescription
SUNITINIB MALATE EQ 50MG BASE · CAPSULE · ORAL
SUTENTPrescription
SUNITINIB MALATE EQ 12.5MG BASE · CAPSULE · ORAL
SUTENTPrescription
SUNITINIB MALATE EQ 25MG BASE · CAPSULE · ORAL

Approval history

2007-02-02Efficacy · Supplement 4 · standard — Label ↗AP
2007-02-02Labeling · Supplement 2 · standard — Letter ↗AP
2007-02-02Efficacy · Supplement 5 · priority — Label ↗AP
2007-02-02Efficacy · Supplement 3 · standard — Review ↗AP
2007-02-02Efficacy · Supplement 6 · priority — Label ↗AP
2006-05-10Manufacturing (CMC) · Supplement 1AP
2006-01-26Type 6 - New Indication (no longer used) · Original · priority — Label ↗AP
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.

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