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Generated: June 18, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 090816

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NDA 090816 describes BIVALIRUDIN, which is a drug marketed by Accord Hlthcare, Apotex Inc, Dr Reddys Labs Ltd, Fresenius Kabi Usa, Hospira Inc, Mylan Institutional, and Baxter Hlthcare Corp, and is included in eight NDAs. It is available from five suppliers. Additional details are available on the BIVALIRUDIN profile page.

The generic ingredient in BIVALIRUDIN is bivalirudin. There are thirteen drug master file entries for this compound. Eight suppliers are listed for this compound. Additional details are available on the bivalirudin profile page.
Summary for 090816
Tradename:BIVALIRUDIN
Applicant:Hospira Inc
Ingredient:bivalirudin
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 090816
Mechanism of ActionThrombin Inhibitors
Suppliers and Packaging for NDA: 090816
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
BIVALIRUDIN bivalirudin INJECTABLE;INTRAVENOUS 090816 ANDA Hospira, Inc. 0409-8300 N 0409-8300-10
BIVALIRUDIN bivalirudin INJECTABLE;INTRAVENOUS 090816 ANDA Hospira, Inc. 0409-8300 N 0409-8300-15

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INTRAVENOUSStrength250MG/VIAL
Approval Date:Jul 14, 2015TE:APRLD:No

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