ACTIVE SUBSTANCE / INN

FONDAPARINUX SODIUM

Brand name(s): FONDAPARINUX SODIUM, Quixidar, ARIXTRA, Arixtra
FDA LISTED
EMA LISTED
PRESCRIPTION
WITHDRAWN
DISCONTINUED
ANDA206812
NDA021345
ACTIVE SUBSTANCE
Fondaparinux Sodium
REGULATORS
FDA · EMA
SPONSORS / MAH
HANGZHOU ZHONGMEI, HENGRUI PHARMA, MYLAN IRELAND LTD
TOTAL APPLICATIONS
5
FDA APPLICATIONS (DRUGS@FDA)
BRAND NAMEAPPLICATIONSPONSORSTATUS
FONDAPARINUX SODIUMANDA206812HENGRUI PHARMAPrescription
ARIXTRANDA021345MYLAN IRELAND LTDPrescription
FONDAPARINUX SODIUMANDA216493HANGZHOU ZHONGMEIDiscontinued
EMA AUTHORISATIONS
PRODUCT NAMEHOLDERSTATUSDATEINDICATION
ArixtraViatris Healthcare LimitedAuthorised20/03/2002Venous Thrombosis;Pulmonary Embolism;Myocardial Infarction;Angina, Unstable
QuixidarGlaxo Group Ltd.Withdrawn21/03/2002Venous Thrombosis;Pulmonary Embolism;Myocardial Infarction;Angina, Unstable

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