美国药品NDC(国家药品编码)与药品说明书数据库(U.S. FDA National Drug Code DataBase)
检索条件:" 注册申请号=NDA020873"
NDC包装代码 产品NDC 产品类型 商品名 通用名 剂型 给药途径 上市日期 结束日期 市场类别 申请号 标签持有者 活性成分 规格 包装描述
0781-3158-95 0781-3158 HUMAN PRESCRIPTION DRUG bivalirudin bivalirudin INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20150615 N/A NDA AUTHORIZED GENERIC NDA020873 Sandoz Inc BIVALIRUDIN 250 mg/1 10 VIAL, SINGLE-USE in 1 CARTON (0781-3158-95) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-USE (0781-3158-94)
75929-217-01 75929-217 HUMAN PRESCRIPTION DRUG bivalirudin bivalirudin INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20201221 N/A NDA AUTHORIZED GENERIC NDA020873 Pharma Packaging Solutions, LLC dba Tjoapack LLC BIVALIRUDIN 250 mg/1 10 VIAL, SINGLE-USE in 1 CARTON (75929-217-01) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-USE
0781-9158-95 0781-9158 HUMAN PRESCRIPTION DRUG bivalirudin bivalirudin INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20151023 N/A NDA AUTHORIZED GENERIC NDA020873 Sandoz Inc BIVALIRUDIN 250 mg/1 10 VIAL, SINGLE-USE in 1 CARTON (0781-9158-95) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-USE (0781-9158-94)
0781-3447-95 0781-3447 HUMAN PRESCRIPTION DRUG Angiomax bivalirudin INJECTION INTRAVENOUS 20190801 N/A NDA NDA020873 Sandoz Inc BIVALIRUDIN 250 mg/1 10 VIAL, SINGLE-USE in 1 CARTON (0781-3447-95) / 1 INJECTION in 1 VIAL, SINGLE-USE
72572-035-10 72572-035 HUMAN PRESCRIPTION DRUG bivalirudin bivalirudin INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION INTRAVENOUS 20201221 N/A NDA AUTHORIZED GENERIC NDA020873 Civica, Inc. BIVALIRUDIN 250 mg/1 10 VIAL, SINGLE-USE in 1 CARTON (72572-035-10) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-USE (72572-035-01)
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