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Acceptance No. Drug Name Active Ingredient Dosage Form Classification Submission Acceptance Date Manufacturers Manufacturers Review Status Status Date 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
JYSB1900213 碳[13C]尿素呼气试验诊断试剂 Diagnostic reagent IVD Supplementary Application 2019-08-27 北京康利华咨询服务有限公司 Beijing Canny Consulting Inc In Review 2019-08-26 view
JYSB1900212 碳[13C]尿素呼气试验诊断试剂 Diagnostic reagent IVD Supplementary Application 2019-08-27 北京康利华咨询服务有限公司 Beijing Canny Consulting Inc Certificate Issued 2021-07-15 view
JYSB1900210 碳[13C]尿素呼气试验诊断试剂 Diagnostic reagent IVD Supplementary Application 2019-08-10 北京康利华咨询服务有限公司 Beijing Canny Consulting Inc Filed 2019-08-28 view
JYSB1900209 碳[13C]尿素呼气试验诊断试剂 Diagnostic reagent IVD Supplementary Application 2019-08-10 北京康利华咨询服务有限公司 Beijing Canny Consulting Inc Filed 2019-08-28 view
JXHS1400073 尿素[碳13] 13C-urea Active ingredient Chemical Drugs Import Drug Application 2014-07-30 北京华亘安邦科技有限公司 Beijing Richen-force Science & Technology Co Ltd In Review 2014-07-29 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
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
JTH2100711 碳[13C]-尿素 13C-urea Active ingredient Chemical Drugs Disposable Import Drug Application 2021-12-03 view
JTH1800319 碳[13C]-尿素 13C-urea Active ingredient Chemical Drugs Disposable Import Drug Application 2018-09-18 Cambridge Isotope Laboratories. Inc. Cambridge Isotope Laboratories Inc Certificate Issued 2018-12-12 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
CYHS1700194 碳[13C]-尿素 13C-urea Active ingredient Chemical Drugs(4) Generic Drug 2017-12-13 深圳市中核海得威生物科技有限公司 Shenzhen Zhonghe Headway Bio-Sci & Tech Co Ltd In Review 2017-12-12 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
CYHL2400204 尿素[13C]片呼气试验药盒 Diagnostic reagent Chemical Drugs(3) Generic Drug 2024-10-18 Chengdu Brilliant Pharmaceutical 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
CYHB2400701 尿素[13C]呼气试验诊断试剂盒 Diagnostic reagent Chemical Drugs Supplementary Application 2024-05-23 view
CYHB2400700 尿素[13C]呼气试验诊断试剂盒 Diagnostic reagent Chemical Drugs Supplementary Application 2024-05-23 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
CYHB2102259 尿素[13C]呼气试验诊断试剂盒 Diagnostic reagent Chemical Drugs Supplementary Application 2021-12-10 view
CYHB2102258 尿素[13C]呼气试验诊断试剂盒 Diagnostic reagent Chemical Drugs Supplementary Application 2021-12-10 view