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FDA NDA · NDA201023

JEVTANA

cabazitaxel

Sponsor: SANOFI AVENTIS US

APPLICATION
NDA201023
TYPE
NDA
ORIGINAL APPROVAL
2010-06-17
LATEST ACTION
2023-07-07
ROUTE
INTRAVENOUS
DOSAGE FORM
SOLUTION
MARKETING STATUS
Prescription

Products

JEVTANA KIT · ReferencePrescription
CABAZITAXEL 60MG/1.5ML (40MG/ML) · SOLUTION · INTRAVENOUS

Approval history

2023-07-07Labeling · Supplement 26 · standard — Letter ↗AP
2021-02-12Labeling · Supplement 25 · standard — Letter ↗AP
2020-12-18Efficacy · Supplement 24 · priority — Letter ↗AP
2020-03-05Labeling · Supplement 23 · standard — Label ↗AP
2018-01-09Labeling · Supplement 21 · standard — Label ↗AP
2017-09-14Efficacy · Supplement 19 · standard — Label ↗AP
2017-05-17Efficacy · Supplement 20 · priority — Label ↗AP
2016-09-12Labeling · Supplement 17 · standard — Letter ↗AP
2016-05-27Manufacturing (CMC) · Supplement 16 · priorityAP
2015-06-18Labeling · Supplement 15 · standard — Label ↗AP
2015-06-11Manufacturing (CMC) · Supplement 14 · priorityAP
2015-01-05Manufacturing (CMC) · Supplement 13 · priorityAP
2014-11-19Labeling · Supplement 11 · standard — Label ↗AP
2014-03-14Labeling · Supplement 12 · standardAP
2014-03-14Labeling · Supplement 10 · standardAP
2013-09-11Manufacturing (CMC) · Supplement 9 · priorityAP
2013-04-25Labeling · Supplement 7 · standard — Letter ↗AP
2013-03-13Manufacturing (CMC) · Supplement 8 · priorityAP
2012-10-04Labeling · Supplement 3 · standard — Letter ↗AP
2010-06-17Type 1 - New Molecular Entity · Original · priority — Summary Review ↗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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