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ACTIVE SUBSTANCE / INN

SOFOSBUVIR

Brand name(s): SOFOSBUVIR, Sovaldi, HARVONI, EPCLUSA, VOSEVI, SOVALDI
FDA LISTED
EMA LISTED
PRESCRIPTION
DISCONTINUED
AUTHORISED
NDA212480
ANDA211353
ACTIVE SUBSTANCE
Sofosbuvir
REGULATORS
FDA · EMA
SPONSORS / MAH
GILEAD SCIENCES INC, TEVA PHARMS USA INC, Gilead Sciences Ireland UC
TOTAL APPLICATIONS
6
FDA APPLICATIONS (DRUGS@FDA)
BRAND NAMEAPPLICATIONSPONSORSTATUS
HARVONINDA205834GILEAD SCIENCES INCPrescription
VOSEVINDA209195GILEAD SCIENCES INCPrescription
SOFOSBUVIRANDA211353TEVA PHARMS USA INCDiscontinued
EPCLUSANDA208341GILEAD SCIENCES INCPrescription
SOVALDINDA212480GILEAD SCIENCES INCPrescription
EMA AUTHORISATIONS
PRODUCT NAMEHOLDERSTATUSDATEINDICATION
SovaldiGilead Sciences Ireland UCAuthorised16/01/2014Hepatitis C, Chronic

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