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Last Updated: August 7, 2020

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Details for New Drug Application (NDA): 210031

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NDA 210031 describes BIVALIRUDIN, which is a drug marketed by Accord Hlthcare, Apotex, Aurobindo Pharma Ltd, Cipla, Dr Reddys Labs Ltd, Fresenius Kabi Usa, Hospira Inc, Mylan Institutional, Shuangcheng, and Baxter Hlthcare Corp, and is included in eleven 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. Fourteen 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
Formulation / Manufacturing:see details
Pharmacology for NDA: 210031
Mechanism of ActionThrombin 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 Athenex Pharmaceutical Division, LLC. 70860-402 70860-402-10 10 VIAL, SINGLE-DOSE in 1 CARTON (70860-402-10) > 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-DOSE (70860-402-41)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INTRAVENOUSStrength250MG/VIAL
Approval Date:Oct 23, 2019TE:APRLD:No

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