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ACTIVE SUBSTANCE / INN

CABAZITAXEL

Brand name(s): Cabazitaxel Teva, JEVTANA KIT, CABAZITAXEL, Cabazitaxel Accord, Jevtana
FDA LISTED
EMA LISTED
DISCONTINUED
PRESCRIPTION
REFUSED
ANDA207735
NDA201023
ACTIVE SUBSTANCE
Cabazitaxel
REGULATORS
FDA · EMA
SPONSORS / MAH
MYLAN LABS LTD, DR REDDYS, BPI LABS LLC
TOTAL APPLICATIONS
7
FDA APPLICATIONS (DRUGS@FDA)
BRAND NAMEAPPLICATIONSPONSORSTATUS
CABAZITAXELANDA207735BPI LABS LLCNone (Tentative Approval)
JEVTANA KITNDA201023SANOFI AVENTIS USPrescription
CABAZITAXELANDA207381MYLAN LABS LTDDiscontinued
CABAZITAXELANDA207718DR REDDYSPrescription
EMA AUTHORISATIONS
PRODUCT NAMEHOLDERSTATUSDATEINDICATION
Cabazitaxel AccordAccord Healthcare S.L.U.Authorised28/08/2020Prostatic Neoplasms, Castration-Resistant
JevtanaSanofi Winthrop IndustrieAuthorised17/03/2011Prostatic Neoplasms
Cabazitaxel TevaTeva B.V.RefusedProstatic Neoplasms

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