Details for New Drug Application (NDA): 210031

NDA 210031 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 210031

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

Pharmacology for NDA: 210031

Mechanism of Action

Thrombin Inhibitors

Suppliers and Packaging for NDA: 210031

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
BIVALIRUDIN	bivalirudin	INJECTABLE;INTRAVENOUS	210031	ANDA	Hainan Shuangcheng Pharmaceuticals Co., Ltd.	52958-034	52958-034-01	10 VIAL, SINGLE-USE in 1 CARTON (52958-034-01) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-USE
BIVALIRUDIN	bivalirudin	INJECTABLE;INTRAVENOUS	210031	ANDA	Avenacy, Inc.	83634-400	83634-400-10	10 VIAL, SINGLE-DOSE in 1 CARTON (83634-400-10) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-DOSE (83634-400-41)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INTRAVENOUS			Strength	250MG/VIAL
Approval Date:	Oct 23, 2019	TE:	AP	RLD:	No

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