ACTIVE SUBSTANCE / INN

DOCETAXEL

Brand name(s): Taxespira (previously Docetaxel Hospira UK Limited ), Docetaxel Teva, Docetaxel Zentiva (previously Docetaxel Winthrop), DOCIVYX, Docetaxel Kabi, Docetaxel SUN, TAXOTERE, BEIZRAY, DOCETAXEL, Docetaxel Accord, DOCEFREZ, Taxotere, Docefrez, Docetaxel Mylan, Docetaxel Teva Pharma
FDA LISTED
EMA LISTED
DISCONTINUED
PRESCRIPTION
WITHDRAWN
NDA215813
Head and Neck Neoplasms;Carcinoma, Non-Small-Cell Lung;Adeno…
ACTIVE SUBSTANCE
Docetaxel
REGULATORS
FDA · EMA
SPONSORS / MAH
ZHUHAI, Sun Pharmaceutical Industries Europe B.V., Teva Pharma B.V.
TOTAL APPLICATIONS
18
FDA APPLICATIONS (DRUGS@FDA)
BRAND NAMEAPPLICATIONSPONSORSTATUS
TAXOTERENDA020449SANOFI AVENTIS USDiscontinued
TAXOTERENDA020449SANOFI AVENTIS USPrescription
DOCETAXELNDA022234HOSPIRA INCDiscontinued
DOCETAXELNDA022234HOSPIRA INCPrescription
BEIZRAYNDA218711ZHUHAIPrescription
DOCIVYXNDA215813AVYXA HOLDINGSPrescription
DOCEFREZNDA022534SUN PHARMDiscontinued
EMA AUTHORISATIONS
PRODUCT NAMEHOLDERSTATUSDATEINDICATION
Docetaxel KabiFresenius Kabi Deutschland GmbHAuthorised22/05/2012Head and Neck Neoplasms;Carcinoma, Non-Small-Cell Lung;Adenocarcinoma;Prostatic …
Docetaxel AccordAccord Healthcare S.L.U.Authorised22/05/2012Head and Neck Neoplasms;Carcinoma, Non-Small-Cell Lung;Adenocarcinoma;Prostatic …
TaxotereSanofi Winthrop IndustrieAuthorised27/11/1995Head and Neck Neoplasms;Carcinoma, Non-Small-Cell Lung;Adenocarcinoma;Prostatic …
Docetaxel Zentiva (previously Docetaxel Winthrop)Zentiva k.s.Withdrawn20/04/2007Head and Neck Neoplasms;Carcinoma, Non-Small-Cell Lung;Adenocarcinoma;Prostatic …
Docetaxel TevaTeva B.V. Withdrawn26/01/2010Head and Neck Neoplasms;Carcinoma, Non-Small-Cell Lung;Adenocarcinoma;Prostatic …
Taxespira (previously Docetaxel Hospira UK Limited )Hospira UK LimitedWithdrawn28/08/2015Stomach Neoplasms;Prostatic Neoplasms;Breast Neoplasms;Head and Neck Neoplasms;C…
Docetaxel SUNSun Pharmaceutical Industries Europe B.V.Application withdrawnProstatic Neoplasms;Carcinoma, Non-Small-Cell Lung;Gastrointestinal Neoplasms;Br…
Docetaxel MylanMylan S.A.S.Lapsed31/01/2012Head and Neck Neoplasms;Carcinoma, Non-Small-Cell Lung;Adenocarcinoma;Prostatic …
Docetaxel Teva PharmaTeva Pharma B.V.Lapsed21/01/2011Carcinoma, Non-Small-Cell Lung;Breast Neoplasms;Prostatic Neoplasms
DocefrezSun Pharmaceutical Industries Europe B.V.Withdrawn10/05/2010Stomach Neoplasms;Adenoma;Breast Neoplasms;Carcinoma, Non-Small-Cell Lung;Prosta…

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