← FDA DRUG APPROVALS

FDA NDA · NDA021938

SUTENT

sunitinib malate

Sponsor: CPPI CV

APPLICATION
NDA021938
TYPE
NDA
ORIGINAL APPROVAL
2006-01-26
LATEST ACTION
2021-08-30
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Prescription

Products

SUTENT · ReferencePrescription
SUNITINIB MALATE EQ 50MG BASE · CAPSULE · ORAL
SUTENT · ReferencePrescription
SUNITINIB MALATE EQ 12.5MG BASE · CAPSULE · ORAL
SUTENT · ReferencePrescription
SUNITINIB MALATE EQ 37.5MG BASE · CAPSULE · ORAL
SUTENT · ReferencePrescription
SUNITINIB MALATE EQ 25MG BASE · CAPSULE · ORAL

Approval history

2021-08-30Efficacy · Supplement 39 · standard — Letter ↗AP
2020-08-14Labeling · Supplement 37 · standard — Label ↗AP
2020-07-10Labeling · Supplement 38 · standard — Letter ↗AP
2019-05-07Efficacy · Supplement 36 · priority — Label ↗AP
2018-12-13Labeling · Supplement 35 · standard — Letter ↗AP
2017-11-16Efficacy · Supplement 33 · standard — Label ↗AP
2015-11-16Labeling · Supplement 31 · standard — Label ↗AP
2015-10-08Manufacturing (CMC) · Supplement 30 · priorityAP
2015-04-24Labeling · Supplement 29 · standard — Letter ↗AP
2015-04-24Labeling · Supplement 28 · standard — Label ↗AP
2014-12-19Labeling · Supplement 27 · standard — Label ↗AP
2014-06-11Labeling · Supplement 26 · standard — Letter ↗AP
2013-08-30Labeling · Supplement 25 · standard — Label ↗AP
2013-08-30Labeling · Supplement 24 · standard — Label ↗AP
2012-11-16Labeling · Supplement 23 · standard — Label ↗AP
2012-11-16Labeling · Supplement 21 · standard — Letter ↗AP
2012-11-16Labeling · Supplement 22 · standard — Letter ↗AP
2012-04-20Labeling · Supplement 19 · unknown — Letter ↗AP
2012-04-20Labeling · Supplement 20 · unknown — Letter ↗AP
2011-05-20Labeling · Supplement 17 · standard — Letter ↗AP
2011-05-20Efficacy · Supplement 13 · priority — FDA Press Release ↗AP
2011-05-20Labeling · Supplement 18 · unknown — Label ↗AP
2010-07-01Labeling · Supplement 15 · 901 required — Letter ↗AP
2010-07-01Labeling · Supplement 11 · unknown — Label ↗AP
2010-07-01Labeling · Supplement 14 · unknown — Label ↗AP
2010-07-01Efficacy · Supplement 10 · standard — Letter ↗AP
2009-03-31Manufacturing (CMC) · Supplement 9 — Label ↗AP
2008-11-07Labeling · Supplement 7 · standard — Label ↗AP
2008-11-07Labeling · Supplement 8 · standard — Label ↗AP
2008-11-07Labeling · Supplement 6 · standard — Label ↗AP
2007-02-02Efficacy · Supplement 5 · priority — Label ↗AP
2007-02-02Efficacy · Supplement 3 · unknown — Label ↗AP
2007-02-02Efficacy · Supplement 4 · priority — Letter ↗AP
2007-02-02Labeling · Supplement 2 · standard — Label ↗AP
2006-05-10Manufacturing (CMC) · Supplement 1AP
2006-01-26Type 1 - New Molecular Entity · Original · priority — Label ↗AP
VIEW ON DRUGS@FDA ↗

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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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