ACTIVE SUBSTANCE / INN

BIVALIRUDIN

Brand name(s): BIVALIRUDIN IN 0.9% SODIUM CHLORIDE, Angiox, ANGIOMAX, ANGIOMAX RTU, BIVALIRUDIN
FDA LISTED
EMA LISTED
PRESCRIPTION
WITHDRAWN
DISCONTINUED
ANDA210031
ANDA091206
ACTIVE SUBSTANCE
Bivalirudin
REGULATORS
FDA · EMA
SPONSORS / MAH
HOSPIRA, MAIA PHARMS INC, BAXTER HLTHCARE CORP
TOTAL APPLICATIONS
7
FDA APPLICATIONS (DRUGS@FDA)
BRAND NAMEAPPLICATIONSPONSORSTATUS
BIVALIRUDINANDA210031SHUANGCHENGPrescription
BIVALIRUDINANDA091206PLIVA HRVATSKA DOONone (Tentative Approval)
BIVALIRUDINANDA090811HOSPIRADiscontinued
ANGIOMAX RTUNDA211215MAIA PHARMS INCPrescription
ANGIOMAXNDA020873SANDOZPrescription
BIVALIRUDIN IN 0.9% SODIUM CHLORIDENDA208374BAXTER HLTHCARE CORPDiscontinued
EMA AUTHORISATIONS
PRODUCT NAMEHOLDERSTATUSDATEINDICATION
AngioxThe Medicines Company UK LtdWithdrawn20/09/2004Acute Coronary Syndrome

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