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Last Updated: December 18, 2025

Details for New Drug Application (NDA): 204876

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NDA 204876 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 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. Thirteen suppliers are listed for this compound. Additional details are available on the bivalirudin profile page.

Summary for 204876

Tradename:	BIVALIRUDIN
Applicant:	Apotex
Ingredient:	bivalirudin
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	INJECTABLE;INTRAVENOUS			Strength	250MG/VIAL
Approval Date:	Jul 6, 2017	TE:		RLD:	No

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