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ACTIVE SUBSTANCE / INN

FIDAXOMICIN

Brand name(s): DIFICID, Dificlir, FIDAXOMICIN
FDA LISTED
EMA LISTED
PRESCRIPTION
AUTHORISED
NDA201699
Clostridium Infections
ACTIVE SUBSTANCE
Fidaxomicin
REGULATORS
FDA · EMA
SPONSORS / MAH
CUBIST PHARMS LLC, Tillotts Pharma GmbH, APOTEX
TOTAL APPLICATIONS
3
FDA APPLICATIONS (DRUGS@FDA)
BRAND NAMEAPPLICATIONSPONSORSTATUS
DIFICIDNDA201699CUBIST PHARMS LLCPrescription
FIDAXOMICINANDA219559APOTEXPrescription
EMA AUTHORISATIONS
PRODUCT NAMEHOLDERSTATUSDATEINDICATION
DificlirTillotts Pharma GmbHAuthorised05/12/2011Clostridium Infections

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