Details for New Drug Application (NDA): 090189

NDA 090189 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 090189

Tradename:	BIVALIRUDIN
Applicant:	Fresenius Kabi Usa
Ingredient:	bivalirudin
Patents:	0

Pharmacology for NDA: 090189

Mechanism of Action

Thrombin Inhibitors

Suppliers and Packaging for NDA: 090189

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
BIVALIRUDIN	bivalirudin	INJECTABLE;INTRAVENOUS	090189	ANDA	Fresenius Kabi USA, LLC	63323-562	63323-562-15	10 VIAL, SINGLE-USE in 1 CARTON (63323-562-15) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-USE (63323-562-41)
BIVALIRUDIN	bivalirudin	INJECTABLE;INTRAVENOUS	090189	ANDA	Fresenius Kabi USA, LLC	63323-562	63323-562-10	10 VIAL, SINGLE-USE in 1 CARTON (63323-562-10) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-USE

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INTRAVENOUS			Strength	250MG/VIAL
Approval Date:	Oct 28, 2016	TE:	AP	RLD:	No

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