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Generated: December 10, 2018

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Details for New Drug Application (NDA): 208374

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NDA 208374 describes BIVALIRUDIN IN 0.9% SODIUM CHLORIDE, which is a drug marketed by Baxter Hlthcare Corp and is included in one NDA. It is available from one supplier. Additional details are available on the BIVALIRUDIN IN 0.9% SODIUM CHLORIDE profile page.

The generic ingredient in BIVALIRUDIN IN 0.9% SODIUM CHLORIDE is bivalirudin. There are fourteen drug master file entries for this compound. Ten suppliers are listed for this compound. Additional details are available on the bivalirudin profile page.
Summary for 208374
Tradename:BIVALIRUDIN IN 0.9% SODIUM CHLORIDE
Applicant:Baxter Hlthcare Corp
Ingredient:bivalirudin
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 208374
Mechanism of ActionThrombin Inhibitors
Suppliers and Packaging for NDA: 208374
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
BIVALIRUDIN IN 0.9% SODIUM CHLORIDE bivalirudin SOLUTION;INTRAVENOUS 208374 NDA Baxter Healthcare Corporation 0338-9572 0338-9572-24 24 BAG in 1 CARTON (0338-9572-24) > 50 mL in 1 BAG
BIVALIRUDIN IN 0.9% SODIUM CHLORIDE bivalirudin SOLUTION;INTRAVENOUS 208374 NDA Baxter Healthcare Corporation 0338-9576 0338-9576-12 12 BAG in 1 CARTON (0338-9576-12) > 100 mL in 1 BAG

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;INTRAVENOUSStrength250MG/50ML (5MG/ML)
Approval Date:Dec 21, 2017TE:RLD:Yes

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;INTRAVENOUSStrength500MG/100ML (5MG/ML)
Approval Date:Dec 21, 2017TE:RLD:Yes

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