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=BLA761161"
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
10122-160-10 10122-160 HUMAN PRESCRIPTION DRUG ELFABRIO pegunigalsidase alfa INJECTION, SOLUTION, CONCENTRATE INTRAVENOUS 20230523 N/A BLA BLA761161 Chiesi USA, Inc. PEGUNIGALSIDASE ALFA 20 mg/10mL 10 VIAL, SINGLE-DOSE in 1 CARTON (10122-160-10) / 10 mL in 1 VIAL, SINGLE-DOSE (10122-160-01)
10122-160-05 10122-160 HUMAN PRESCRIPTION DRUG ELFABRIO pegunigalsidase alfa INJECTION, SOLUTION, CONCENTRATE INTRAVENOUS 20230523 N/A BLA BLA761161 Chiesi USA, Inc. PEGUNIGALSIDASE ALFA 20 mg/10mL 5 VIAL, SINGLE-DOSE in 1 CARTON (10122-160-05) / 10 mL in 1 VIAL, SINGLE-DOSE (10122-160-01)
10122-160-02 10122-160 HUMAN PRESCRIPTION DRUG ELFABRIO pegunigalsidase alfa INJECTION, SOLUTION, CONCENTRATE INTRAVENOUS 20230523 N/A BLA BLA761161 Chiesi USA, Inc. PEGUNIGALSIDASE ALFA 20 mg/10mL 1 VIAL, SINGLE-DOSE in 1 CARTON (10122-160-02) / 10 mL in 1 VIAL, SINGLE-DOSE (10122-160-01)
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