Last Updated: September 24, 2026

Details for New Drug Application (NDA): 201577

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NDA 201577 describes BIVALIRUDIN, which is a drug marketed by Accord Hlthcare, Apotex, Dr Reddys, Eugia Pharma, Fresenius Kabi Usa, Hainan Poly, Hospira, Meitheal, Mylan Institutional, Shuangcheng, 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 is one drug master file entry for this compound. Thirteen suppliers are listed for this compound. Additional details are available on the bivalirudin profile page.

Summary for 201577

Tradename:	BIVALIRUDIN
Applicant:	Dr Reddys
Ingredient:	bivalirudin
Patents:	0

Pharmacology for NDA: 201577

Mechanism of Action	Thrombin Inhibitors

Suppliers and Packaging for NDA: 201577

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
BIVALIRUDIN	bivalirudin	INJECTABLE;INTRAVENOUS	201577	ANDA	Dr. Reddy's Laboratories Limited	55111-652	55111-652-37	10 VIAL, SINGLE-DOSE in 1 CARTON (55111-652-37) / 1 INJECTION in 1 VIAL, SINGLE-DOSE (55111-652-07)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INTRAVENOUS			Strength	250MG/VIAL
Approval Date:	May 26, 2017	TE:	AP	RLD:	No

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