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ACTIVE SUBSTANCE / INN

CAPECITABINE

Brand name(s): Capecitabine Accord, Capecitabine SUN, Xeloda, Capecitabine Teva, CAPECITABINE, Capecitabine Medac, XELODA, Ecansya (previously Capecitabine Krka)
FDA LISTED
EMA LISTED
PRESCRIPTION
WITHDRAWN
DISCONTINUED
Colorectal Neoplasms
ANDA200483
ACTIVE SUBSTANCE
Capecitabine
REGULATORS
FDA · EMA
SPONSORS / MAH
CHEPLAPHARM, ACCORD HLTHCARE, CHEPLAPHARM Arzneimittel GmbH
TOTAL APPLICATIONS
9
FDA APPLICATIONS (DRUGS@FDA)
BRAND NAMEAPPLICATIONSPONSORSTATUS
CAPECITABINEANDA202593ACCORD HLTHCAREPrescription
XELODANDA020896CHEPLAPHARMDiscontinued
CAPECITABINEANDA200483HIKMADiscontinued
EMA AUTHORISATIONS
PRODUCT NAMEHOLDERSTATUSDATEINDICATION
Capecitabine TevaTeva Pharma B.V.Authorised20/04/2012Colonic Neoplasms;Breast Neoplasms;Colorectal Neoplasms;Stomach Neoplasms
Ecansya (previously Capecitabine Krka)Krka, d.d., Novo mestoAuthorised20/04/2012Colonic Neoplasms;Breast Neoplasms;Colorectal Neoplasms;Stomach Neoplasms
Capecitabine AccordAccord Healthcare S.L.U.Authorised20/04/2012Colonic Neoplasms;Breast Neoplasms;Colorectal Neoplasms;Stomach Neoplasms
Capecitabine Medacmedac Gesellschaft für klinische Spezialpräparate mbHAuthorised19/11/2012Colorectal Neoplasms
XelodaCHEPLAPHARM Arzneimittel GmbHAuthorised02/02/2001Colonic Neoplasms;Breast Neoplasms;Colorectal Neoplasms;Stomach Neoplasms
Capecitabine SUNSun Pharmaceutical Industries Europe B.V.Withdrawn21/06/2013Stomach Neoplasms;Breast Neoplasms;Colonic Neoplasms;Colorectal Neoplasms

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