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ACTIVE SUBSTANCE / INN

RIBAVIRIN

Brand name(s): RIBASPHERE, Rebetol, Cotronak, Ribavirin BioPartners, Ribavirin Mylan (previously Ribavirin Three Rivers), VIRAZOLE, Ribavirin Teva, COPEGUS, RIBAVIRIN, Ribavirin Teva Pharma B.V., REBETOL
FDA LISTED
EMA LISTED
DISCONTINUED
PRESCRIPTION
WITHDRAWN
NDA021511
ANDA077611
ACTIVE SUBSTANCE
Ribavirin
REGULATORS
FDA · EMA
SPONSORS / MAH
TEVA PHARMS, ROCHE, SANDOZ
TOTAL APPLICATIONS
13
FDA APPLICATIONS (DRUGS@FDA)
BRAND NAMEAPPLICATIONSPONSORSTATUS
RIBASPHEREANDA076203CHARTWELL RXDiscontinued
RIBAVIRINANDA077743SANDOZPrescription
RIBAVIRINANDA077611TEVA PHARMSNone (Tentative Approval)
RIBAVIRINANDA076192CHARTWELL RXDiscontinued
REBETOLNDA020903MERCK SHARP DOHMEDiscontinued
VIRAZOLENDA018859BAUSCHDiscontinued
COPEGUSNDA021511ROCHEDiscontinued
EMA AUTHORISATIONS
PRODUCT NAMEHOLDERSTATUSDATEINDICATION
RebetolMerck Sharp and Dohme B.VWithdrawn06/05/1999Hepatitis C, Chronic
Ribavirin Teva Pharma B.V.Teva B.V.Withdrawn01/07/2009Hepatitis C, Chronic
Ribavirin TevaTeva B.V.Withdrawn31/03/2009Hepatitis C, Chronic
Ribavirin Mylan (previously Ribavirin Three Rivers)Mylan S.A.SWithdrawn10/06/2010Hepatitis C, Chronic
Ribavirin BioPartnersBioPartners GmbHLapsed06/04/2010Hepatitis C, Chronic
CotronakSchering-Plough EuropeWithdrawn07/05/1999Hepatitis C, Chronic

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