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ACTIVE SUBSTANCE / INN

APALUTAMIDE

Brand name(s): Erleada, APALUTAMIDE, ERLEADA
FDA LISTED
EMA LISTED
PRESCRIPTION
AUTHORISED
Prostatic Neoplasms
NDA210951
ACTIVE SUBSTANCE
Apalutamide
REGULATORS
FDA · EMA
SPONSORS / MAH
JANSSEN BIOTECH, Janssen-Cilag International NV, ZYDUS
TOTAL APPLICATIONS
3
FDA APPLICATIONS (DRUGS@FDA)
BRAND NAMEAPPLICATIONSPONSORSTATUS
ERLEADANDA210951JANSSEN BIOTECHPrescription
APALUTAMIDEANDA217113ZYDUSPrescription
EMA AUTHORISATIONS
PRODUCT NAMEHOLDERSTATUSDATEINDICATION
ErleadaJanssen-Cilag International NVAuthorised14/01/2019Prostatic Neoplasms

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