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Generated: June 26, 2019

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Details for New Drug Application (NDA): 206551

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NDA 206551 describes BIVALIRUDIN, which is a drug marketed by Accord Hlthcare, Apotex Inc, Aurobindo Pharma Ltd, Cipla, Dr Reddys Labs Ltd, Fresenius Kabi Usa, Hospira Inc, Mylan Institutional, and Baxter Hlthcare Corp, and is included in ten NDAs. It is available from nine suppliers. Additional details are available on the BIVALIRUDIN profile page.

The generic ingredient in BIVALIRUDIN is bivalirudin. There are fourteen drug master file entries for this compound. Twelve suppliers are listed for this compound. Additional details are available on the bivalirudin profile page.
Summary for 206551
Tradename:BIVALIRUDIN
Applicant:Accord Hlthcare
Ingredient:bivalirudin
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 206551
Mechanism of ActionThrombin Inhibitors
Suppliers and Packaging for NDA: 206551
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
BIVALIRUDIN bivalirudin INJECTABLE;INTRAVENOUS 206551 ANDA Accord Healthcare, Inc. 16729-275 16729-275-67 10 VIAL, SINGLE-USE in 1 CARTON (16729-275-67) > 5 mL in 1 VIAL, SINGLE-USE (16729-275-03)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INTRAVENOUSStrength250MG/VIAL
Approval Date:Nov 22, 2017TE:APRLD:No

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