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ACTIVE SUBSTANCE / INN

ENZALUTAMIDE

Brand name(s): Enzalutamide Accordpharma, Xtandi, ENZALUTAMIDE, Enzalutamide Viatris, XTANDI
FDA LISTED
EMA LISTED
PRESCRIPTION
DISCONTINUED
AUTHORISED
ANDA218731
ANDA209614
ACTIVE SUBSTANCE
Enzalutamide
REGULATORS
FDA · EMA
SPONSORS / MAH
ASTELLAS, Viatris Limited, Accord Healthcare
TOTAL APPLICATIONS
6
FDA APPLICATIONS (DRUGS@FDA)
BRAND NAMEAPPLICATIONSPONSORSTATUS
ENZALUTAMIDEANDA209614ACTAVIS LABS FL INCDiscontinued
XTANDINDA213674ASTELLASPrescription
ENZALUTAMIDEANDA218731HIKMA PHARMACEUTICALS USA INCNone (Tentative Approval)
EMA AUTHORISATIONS
PRODUCT NAMEHOLDERSTATUSDATEINDICATION
Enzalutamide ViatrisViatris LimitedAuthorised22/08/2024Prostatic Neoplasms
XtandiAstellas Pharma Europe B.V.Authorised21/06/2013Prostatic Neoplasms
Enzalutamide AccordpharmaAccord HealthcareAuthorisedProstatic Neoplasms

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