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Last Updated: November 22, 2024

Details for New Drug Application (NDA): 205962


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NDA 205962 describes BIVALIRUDIN, which is a drug marketed by Accord Hlthcare, Apotex, Dr Reddys, Eugia Pharma, Fresenius Kabi Usa, Hospira, Meitheal, Mylan Institutional, Shuangcheng, Slate Run Pharma, and Baxter Hlthcare Corp, and is included in twelve NDAs. It is available from ten 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. Fifteen suppliers are listed for this compound. Additional details are available on the bivalirudin profile page.
Summary for 205962
Tradename:BIVALIRUDIN
Applicant:Eugia Pharma
Ingredient:bivalirudin
Patents:0
Pharmacology for NDA: 205962
Mechanism of ActionThrombin Inhibitors
Suppliers and Packaging for NDA: 205962
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
BIVALIRUDIN bivalirudin INJECTABLE;INTRAVENOUS 205962 ANDA Eugia US LLC 55150-210 55150-210-10 10 VIAL, SINGLE-DOSE in 1 CARTON (55150-210-10) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-DOSE

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INTRAVENOUSStrength250MG/VIAL
Approval Date:Jul 27, 2018TE:APRLD:No

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