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ACTIVE SUBSTANCE / INN

ABIRATERONE ACETATE

Brand name(s): Abiraterone Krka, ABIRATERONE ACETATE, ZYTIGA, Abiraterone Mylan, YONSA, AKEEGA
FDA LISTED
EMA LISTED
PRESCRIPTION
DISCONTINUED
AUTHORISED
NDA210308
ANDA210726
ACTIVE SUBSTANCE
Abiraterone Acetate
REGULATORS
FDA · EMA
SPONSORS / MAH
JANSSEN BIOTECH, TEVA PHARMS USA, SUN PHARM
TOTAL APPLICATIONS
7
FDA APPLICATIONS (DRUGS@FDA)
BRAND NAMEAPPLICATIONSPONSORSTATUS
ZYTIGANDA202379JANSSEN BIOTECHPrescription
ABIRATERONE ACETATEANDA208339HIKMAPrescription
ABIRATERONE ACETATEANDA210726TEVA PHARMS USADiscontinued
YONSANDA210308SUN PHARMPrescription
AKEEGANDA216793JANSSEN BIOTECHPrescription
EMA AUTHORISATIONS
PRODUCT NAMEHOLDERSTATUSDATEINDICATION
Abiraterone MylanMylan Pharmaceuticals LimitedAuthorised20/08/2021Prostatic Neoplasms
Abiraterone KrkaKrka, d.d., Novo mestoAuthorised24/06/2021Prostatic Neoplasms

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