HOME › DRUGS › ENTECAVIR
ACTIVE SUBSTANCE / INN

ENTECAVIR

Brand name(s): Entecavir Accord, Entecavir Viatris (previously Entecavir Mylan), BARACLUDE, ENTECAVIR, Baraclude
FDA LISTED
EMA LISTED
PRESCRIPTION
DISCONTINUED
AUTHORISED
NDA021798
ANDA208721
ACTIVE SUBSTANCE
Entecavir
REGULATORS
FDA · EMA
SPONSORS / MAH
BRISTOL MYERS SQUIBB, BRECKENRIDGE, ZYDUS PHARMS
TOTAL APPLICATIONS
6
FDA APPLICATIONS (DRUGS@FDA)
BRAND NAMEAPPLICATIONSPONSORSTATUS
ENTECAVIRANDA206745ZYDUS PHARMSPrescription
ENTECAVIRANDA208721BRECKENRIDGEDiscontinued
BARACLUDENDA021798BRISTOL MYERS SQUIBBPrescription
EMA AUTHORISATIONS
PRODUCT NAMEHOLDERSTATUSDATEINDICATION
Entecavir Viatris (previously Entecavir Mylan)Viatris LimitedAuthorised18/09/2017Hepatitis B
BaracludeBristol-Myers Squibb Pharma EEIGAuthorised26/06/2006Hepatitis B, Chronic
Entecavir AccordAccord Healthcare S.L.U.Authorised25/09/2017Hepatitis B, Chronic

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