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=BLA125078"
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
57516-113-02 57516-113 PLASMA DERIVATIVE ZEMAIRA alpha-1-proteinase inhibitor human kit KIT INTRAVENOUS 20230731 N/A BLA BLA125078 Fisher Clinical Services Inc. 1 KIT in 1 CARTON (57516-113-02) * 95 mL in 1 VIAL, SINGLE-DOSE (57516-114-01) * 95 mL in 1 VIAL, SINGLE-DOSE (57516-115-20)
57516-110-02 57516-110 PLASMA DERIVATIVE ZEMAIRA alpha-1-proteinase inhibitor human kit KIT INTRAVENOUS 20230731 N/A BLA BLA125078 Fisher Clinical Services Inc. 1 KIT in 1 CARTON (57516-110-02) * 76 mL in 1 VIAL, SINGLE-DOSE (57516-111-01) * 76 mL in 1 VIAL, SINGLE-DOSE (57516-112-20)
57516-101-02 57516-101 PLASMA DERIVATIVE ZEMAIRA alpha-1-proteinase inhibitor human kit KIT INTRAVENOUS 20220222 N/A BLA BLA125078 Fisher Clinical Services Inc. 1 KIT in 1 CARTON (57516-101-02) * 20 mL in 1 VIAL, SINGLE-DOSE (57516-102-01) * 20 mL in 1 VIAL, SINGLE-DOSE (57516-103-20)
0053-7202-02 0053-7202 PLASMA DERIVATIVE ZEMAIRA .ALPHA.1-PROTEINASE INHIBITOR HUMAN KIT 20190424 N/A BLA BLA125078 CSL Behring LLC 1 KIT in 1 CARTON (0053-7202-02) * 76 mL in 1 VIAL, SINGLE-USE (0053-7212-01) * 76 mL in 1 VIAL, SINGLE-USE (0053-7653-80)
0053-7201-02 0053-7201 PLASMA DERIVATIVE Zemaira alpha-1-proteinase inhibitor human KIT 20030708 N/A BLA BLA125078 CSL Behring LLC 1 KIT in 1 CARTON (0053-7201-02) * 20 mL in 1 VIAL, SINGLE-DOSE (0053-7211-01) * 20 mL in 1 VIAL, SINGLE-DOSE (0053-7653-20)
0053-7203-02 0053-7203 PLASMA DERIVATIVE ZEMAIRA .ALPHA.1-PROTEINASE INHIBITOR HUMAN KIT 20190424 N/A BLA BLA125078 CSL Behring LLC 1 KIT in 1 CARTON (0053-7203-02) * 95 mL in 1 VIAL, SINGLE-USE (0053-7213-01) * 95 mL in 1 VIAL, SINGLE-USE (0053-7653-12)
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