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=NDA214375"
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
80534-0300-1 80534-0300 HUMAN PRESCRIPTION DRUG XENOVIEW xenon Xe 129 hyperpolarized GAS RESPIRATORY (INHALATION) 20250530 N/A NDA NDA214375 Polarean, Inc. XENON XE-129, HYPERPOLARIZED 75 mL/300mL 50 BAG in 1 CARTON (80534-0300-1) / 300 mL in 1 BAG
80534-6350-1 80534-6350 HUMAN PRESCRIPTION DRUG XENOVIEW xenon Xe 129 hyperpolarized GAS RESPIRATORY (INHALATION) 20221223 N/A NDA NDA214375 Polarean, Inc. HELIUM; NITROGEN; XENON XE-129 5651.5 L/1; 635 L/1; 63.5 L/1 1 GAS in 1 CYLINDER (80534-6350-1)
80534-1000-1 80534-1000 HUMAN PRESCRIPTION DRUG XENOVIEW xenon Xe 129 hyperpolarized GAS RESPIRATORY (INHALATION) 20221223 N/A NDA NDA214375 Polarean, Inc. XENON XE-129, HYPERPOLARIZED 75 mL/L 50 BAG in 1 CARTON (80534-1000-1) / 1 L in 1 BAG
80534-1000-2 80534-1000 HUMAN PRESCRIPTION DRUG XENOVIEW xenon Xe 129 hyperpolarized GAS RESPIRATORY (INHALATION) 20250530 N/A NDA NDA214375 Polarean, Inc. XENON XE-129, HYPERPOLARIZED 75 mL/L 50 BAG in 1 CARTON (80534-1000-2) / 1 L in 1 BAG
80534-0750-1 80534-0750 HUMAN PRESCRIPTION DRUG XENOVIEW xenon Xe 129 hyperpolarized GAS RESPIRATORY (INHALATION) 20250530 N/A NDA NDA214375 Polarean, Inc. XENON XE-129, HYPERPOLARIZED 75 mL/750mL 50 BAG in 1 CARTON (80534-0750-1) / 750 mL in 1 BAG
80534-0500-1 80534-0500 HUMAN PRESCRIPTION DRUG XENOVIEW xenon Xe 129 hyperpolarized GAS RESPIRATORY (INHALATION) 20250530 N/A NDA NDA214375 Polarean, Inc. XENON XE-129, HYPERPOLARIZED 75 mL/500mL 50 BAG in 1 CARTON (80534-0500-1) / 500 mL in 1 BAG
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