| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| CYHB0900876 | 尿素[13C]呼气试验诊断试剂盒 | | Diagnostic reagent | Chemical Drugs | Supplementary Application | 2009-10-20 | 北京勃然制药有限公司 | Beijing Boran Pharmaceutical Co Ltd | Certificate Issued | 2010-06-04 | 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 |
| CYHB1102276 | 尿素[13C]呼气试验诊断试剂盒 | | Diagnostic reagent | Chemical Drugs | Supplementary Application | 2011-05-25 | 北京勃然制药有限公司 | Beijing Boran Pharmaceutical Co Ltd | In Approval | 2014-08-11 | 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 |
| 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 |
| 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 |
| 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 |
| 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 |
