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=NDA211215"
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
42023-622-01 42023-622 HUMAN PRESCRIPTION DRUG Bivalirudin Bivalirudin INJECTION, SOLUTION INTRAVENOUS 20230619 N/A NDA NDA211215 Par Pharmaceutical, Inc. BIVALIRUDIN 250 mg/1 1 VIAL, SINGLE-DOSE in 1 CARTON (42023-622-01) / 1 INJECTION, SOLUTION in 1 VIAL, SINGLE-DOSE
42023-622-10 42023-622 HUMAN PRESCRIPTION DRUG Bivalirudin Bivalirudin INJECTION, SOLUTION INTRAVENOUS 20230619 N/A NDA NDA211215 Par Pharmaceutical, Inc. BIVALIRUDIN 250 mg/1 10 VIAL, SINGLE-DOSE in 1 CARTON (42023-622-10) / 1 INJECTION, SOLUTION in 1 VIAL, SINGLE-DOSE
70860-403-51 70860-403 HUMAN PRESCRIPTION DRUG Bivalirudin RTU bivalirudin INJECTION, SOLUTION INTRAVENOUS 20200301 20240626 NDA NDA211215 Athenex Pharmaceutical Division, LLC. BIVALIRUDIN 5 mg/mL 10 CARTON in 1 CARTON (70860-403-51) / 1 VIAL, SINGLE-DOSE in 1 CARTON (70860-403-50) / 50 mL in 1 VIAL, SINGLE-DOSE
70511-141-84 70511-141 HUMAN PRESCRIPTION DRUG Angiomax RTU bivalirudin INJECTION, SOLUTION INTRAVENOUS 20190808 N/A NDA NDA211215 MAIA Pharmaceuticals, Inc. BIVALIRUDIN 250 mg/1 1 VIAL in 1 PACKAGE (70511-141-84) / 10 INJECTION, SOLUTION in 1 VIAL
70511-141-50 70511-141 HUMAN PRESCRIPTION DRUG Angiomax RTU bivalirudin INJECTION, SOLUTION INTRAVENOUS 20190808 N/A NDA NDA211215 MAIA Pharmaceuticals, Inc. BIVALIRUDIN 250 mg/1 1 INJECTION, SOLUTION in 1 CARTON (70511-141-50)
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