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Acceptance No. Drug Name Active Ingredient Dosage Form Classification Submission Acceptance Date Manufacturers Manufacturers Review Status Status Date View
JTH2100711 碳[13C]-尿素 13C-urea Active ingredient Chemical Drugs Disposable Import Drug Application 2021-12-03 view
CYHB2102258 尿素[13C]呼气试验诊断试剂盒 Diagnostic reagent Chemical Drugs Supplementary Application 2021-12-10 view
CYHB2400701 尿素[13C]呼气试验诊断试剂盒 Diagnostic reagent Chemical Drugs Supplementary Application 2024-05-23 view
H20020099 碳13-尿素呼吸试剂 Diagnostic reagent Chemical Drugs Import Drug Application 2002-04-22 美国普特股份有限公司(北京代表处) Approval Completed-Pending Certificated view
CYHB2102259 尿素[13C]呼气试验诊断试剂盒 Diagnostic reagent Chemical Drugs Supplementary Application 2021-12-10 view
CYHB2400700 尿素[13C]呼气试验诊断试剂盒 Diagnostic reagent Chemical Drugs Supplementary Application 2024-05-23 view
CXL01C79G 13C-尿素呼气试验诊断试剂盒 Diagnostic reagent Chemical Drugs(4) New Drug Application 2002-02-23 北京嘉汇彬医药技术有限公司 Beijing Jiahuibin Pharmaceutical Technology Co Ltd In Approval view
CYHB2101542 尿素[13C]胶囊呼气试验药盒 Diagnostic reagent Chemical Drugs Supplementary Application 2021-07-15 Shenzhen Zhonghe Headway Bio-Sci & Tech Co Ltd view
CYHB2400321 尿素[13C]胶囊呼气试验药盒 Diagnostic reagent Chemical Drugs Supplementary Application 2024-02-29 Shenzhen Zhonghe Headway Bio-Sci & Tech Co Ltd view
CXL01509 [13c]-尿素 13C-urea Active ingredient Chemical Drugs(2) New Drug Application 2001-06-27 深圳市海得威生物科技有限公司 Shenzhen Zhonghe Headway Bio-Sci & Tech Co Ltd view
CYHL2300151 尿素[13C]呼气试验药盒 Diagnostic reagent Chemical Drugs(3) Generic Drug 2023-12-14 Shenzhen Zhonghe Headway Bio-Sci & Tech Co Ltd view
CXL01510 [13c]-尿素胶囊 13C-urea Capsule Chemical Drugs(2) New Drug Application 2001-06-27 深圳市海得威生物科技有限公司 Shenzhen Zhonghe Headway Bio-Sci & Tech Co Ltd Approval Completed-Pending Certificated 2003-03-07 view
X0401546 尿素[13C]-胶囊呼气试验药盒 Diagnostic reagent Chemical Drugs New Drug Application 2004-04-01 北京原子高科核技术应用股份有限公司 HTA Co Ltd Certificate Issued 2005-03-03 view
CXHS0500967 尿素[13C]呼气试验诊断试剂盒 Diagnostic reagent Chemical Drugs(3.1) New Drug Application 2005-04-27 北京勃然制药有限公司 Beijing Boran Pharmaceutical Co Ltd Certificate Issued 2006-07-13 view
CXHS0503272 尿素[13C]胶囊 13C-urea Capsule Chemical Drugs(5) New Drug Application 2006-03-17 深圳市中核海得威生物科技有限公司 Shenzhen Zhonghe Headway Bio-Sci & Tech Co Ltd Certificate Issued 2007-08-29 view
CXHS0503273 尿素[13C]呼气试验药盒 Diagnostic reagent Chemical Drugs(5) New Drug Application 2006-03-17 深圳市中核海得威生物科技有限公司 Shenzhen Zhonghe Headway Bio-Sci & Tech Co Ltd Certificate Issued 2007-09-18 view
CXHS0502703 尿素[13C]呼吸试验药盒 Diagnostic reagent Chemical Drugs New Drug Application 2005-11-20 北京优你特制药有限公司 Beijing Youyoute Pharmaceutical Co Ltd Certificate Issued 2008-05-09 view
JXHL0500265 碳[13C]-尿素 13C-urea Active ingredient Chemical Drugs(3.1) Import Drug Application 2005-12-22 Isotec公司 Isotec AB Certificate Issued 2008-05-22 view
CYHS0600685 碳[13C]-尿素散剂呼气试验药盒 Diagnostic reagent Chemical Drugs(6) Generic Drug 2006-03-31 协和药业有限公司 PUMC Pharmaceutical Co Ltd Certificate Issued 2008-11-05 view
JXHL0900076 [13C]尿素片 13C-urea Tablet Chemical Drugs Import Drug Application 2009-03-26 大?V制药株式会社 Otsuka Pharmaceutical Co Ltd Certificate Issued 2010-01-12 view