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Last Updated: December 12, 2025

Details for New Drug Application (NDA): 213078

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NDA 213078 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 213078

Tradename:	BIVALIRUDIN
Applicant:	Slate Run Pharma
Ingredient:	bivalirudin
Patents:	0

Pharmacology for NDA: 213078

Mechanism of Action	Thrombin Inhibitors

Suppliers and Packaging for NDA: 213078

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
BIVALIRUDIN	bivalirudin	INJECTABLE;INTRAVENOUS	213078	ANDA	Slate Run Pharmaceuticals, LLC	70436-025	70436-025-80	1 INJECTION, POWDER, LYOPHILIZED, FOR SUSPENSION in 1 VIAL, SINGLE-DOSE (70436-025-80)
BIVALIRUDIN	bivalirudin	INJECTABLE;INTRAVENOUS	213078	ANDA	Slate Run Pharmaceuticals, LLC	70436-025	70436-025-82	10 INJECTION, POWDER, LYOPHILIZED, FOR SUSPENSION in 1 CARTON (70436-025-82)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INTRAVENOUS			Strength	250MG/VIAL
Approval Date:	May 28, 2021	TE:	AP	RLD:	No

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