| 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 |
| 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 |
| 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 |
| CYHB1803473 | 尿素[13C]胶囊呼气试验药盒 | | Diagnostic reagent | Chemical Drugs | Supplementary Application | 2018-07-30 | 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 | 2018-10-15 | view |
| CYHB1900148 | 尿素[13C]胶囊呼气试验药盒 | | Diagnostic reagent | Chemical Drugs | Supplementary Application | 2019-01-21 | 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 | 2019-03-26 | 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 |
| CYHB1802523 | 尿素[13C]胶囊呼气试验药盒 | | Diagnostic reagent | Chemical Drugs | Supplementary Application | 2018-05-15 | 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 | 2018-12-17 | 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 |
| CYHB1605991 | 尿素[13C]胶囊呼气试验药盒 | | Diagnostic reagent | Chemical Drugs | Supplementary Application | 2017-01-18 | 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 | 2017-09-27 | 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 |
| CXHB1000406 | 尿素[13C]胶囊呼气试验药盒 | | Diagnostic reagent | Chemical Drugs | Supplementary Application | 2011-05-11 | 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 | 2011-11-07 | view |
| CYHB1407964 | 尿素[13C]呼气试验诊断试剂盒 | | Diagnostic reagent | Chemical Drugs | Supplementary Application | 2014-11-27 | 江苏华亘泰来生物科技有限公司 | Jiangsu Richen-Bases Bio & Sci Co Ltd | Certificate Issued | 2016-03-10 | 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 |
| 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 |
| CYHB2010177 | 尿素[13C]片呼气试验药盒 | | Diagnostic reagent | Chemical Drugs | Supplementary Application | 2020-12-07 | 北京海德润医药集团有限公司 | Beijing Haiderun Pharmaceutical Group Co Ltd | In Review | 2020-12-07 | view |
| CYHB2002629 | 尿素[13C]片呼气试验药盒 | | Diagnostic reagent | Chemical Drugs | Supplementary Application | 2020-04-24 | 北京海德润医药集团有限公司 | Beijing Haiderun Pharmaceutical Group Co Ltd | Certificate Issued | 2021-09-13 | view |
| CYHB1503872 | 尿素[13C]片呼气试验药盒 | | Diagnostic reagent | Chemical Drugs | Supplementary Application | 2015-11-19 | 北京海德润制药有限公司 | Beijing Haiderun Pharmaceutical Group Co Ltd | Certificate Issued | 2017-08-25 | 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 |
