FdaApplication

NDA 208374

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Identifiers

Properties

PropertyValue
applicant_nameBAXTER HEALTHCARE CORP
application_typeNDA
approval_date2017-12-21

Products (2)

ProductActive ingredientStrengthDosage form
BIVALIRUDIN IN 0.9% SODIUM CHLORIDEBIVALIRUDIN500MG/100ML (5MG/ML)SOLUTION;INTRAVENOUS
BIVALIRUDIN IN 0.9% SODIUM CHLORIDEBIVALIRUDIN250MG/50ML (5MG/ML)SOLUTION;INTRAVENOUS

2 products