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ACTIVE SUBSTANCE / INN

FULVESTRANT

Brand name(s): Fulvestrant Mylan, FASLODEX, Faslodex, FULVESTRANT
FDA LISTED
EMA LISTED
PRESCRIPTION
DISCONTINUED
AUTHORISED
NDA021344
ANDA215077
ACTIVE SUBSTANCE
Fulvestrant
REGULATORS
FDA · EMA
SPONSORS / MAH
AstraZeneca AB, ASTRAZENECA, ALEMBIC
TOTAL APPLICATIONS
6
FDA APPLICATIONS (DRUGS@FDA)
BRAND NAMEAPPLICATIONSPONSORSTATUS
FULVESTRANTNDA210063AVYXA HOLDINGSDiscontinued
FULVESTRANTANDA215077ALEMBICPrescription
FASLODEXNDA021344ASTRAZENECAPrescription
FASLODEXNDA021344ASTRAZENECADiscontinued
EMA AUTHORISATIONS
PRODUCT NAMEHOLDERSTATUSDATEINDICATION
Fulvestrant MylanMylan Pharmaceuticals LimitedAuthorised08/01/2018Breast Neoplasms
FaslodexAstraZeneca ABAuthorised09/03/2004Breast Neoplasms

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