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Acceptance No. Drug Name Active Ingredient Dosage Form Classification Submission Acceptance Date Manufacturers Manufacturers Review Status Status Date View
CXSL1200077 重组人胰岛素 human insulin Active ingredient Biological Products(15) New Drug Application 2012-10-23 合肥天麦生物科技发展有限公司 Hefei Tianmai BIOTECHNOLOGY Development Co Ltd Certificate Issued 2014-10-24 view
CXSL1200078 重组人胰岛素注射液 human insulin Injection Biological Products(15) New Drug Application 2012-10-23 合肥天麦生物科技发展有限公司 Hefei Tianmai BIOTECHNOLOGY Development Co Ltd Certificate Issued 2014-10-24 view
CXSL1200079 精蛋白重组人胰岛素注射液 Isophane Protamine Recombinant Human Insulin Injection Biological Products(15) New Drug Application 2012-10-23 合肥天麦生物科技发展有限公司 Hefei Tianmai BIOTECHNOLOGY Development Co Ltd Certificate Issued 2014-10-24 view
CXSL1200105 精蛋白重组人胰岛素注射液(预混50/50) Injection Biological Products(15) New Drug Application 2013-02-20 合肥天麦生物科技发展有限公司 Hefei Tianmai BIOTECHNOLOGY Development Co Ltd Certificate Issued 2015-02-25 view
CXSL1200106 精蛋白重组人胰岛素注射液(预混30/70) Isophane Protamine Recombinant Human Insulin Injection Biological Products(15) New Drug Application 2013-02-20 合肥天麦生物科技发展有限公司 Hefei Tianmai BIOTECHNOLOGY Development Co Ltd Certificate Issued 2015-02-25 view
CXSL1700015 重组甘精胰岛素 insulin glargine Injection Biological Products(15) New Drug Application 2017-03-24 合肥天麦生物科技发展有限公司 Hefei Tianmai BIOTECHNOLOGY Development Co Ltd In Review 2018-11-07 view
CXSL1700016 重组甘精胰岛素注射液 insulin glargine Injection Biological Products(15) New Drug Application 2017-03-30 合肥天麦生物科技发展有限公司 Hefei Tianmai BIOTECHNOLOGY Development Co Ltd Certificate Issued 2018-04-10 view
CXSL1700068 重组赖精胰岛素 Active ingredient Biological Products(1) New Drug Application 2017-09-18 合肥天麦生物科技发展有限公司 Hefei Tianmai BIOTECHNOLOGY Development Co Ltd In Review 2017-09-15 view
CXSL1700069 重组赖精胰岛素注射液 Injection Biological Products(1) New Drug Application 2017-09-18 合肥天麦生物科技发展有限公司 Hefei Tianmai BIOTECHNOLOGY Development Co Ltd Certificate Issued 2018-08-07 view
CXSS1500015 重组人胰岛素 human insulin Active ingredient Biological Products(15) New Drug Application 2015-09-14 合肥天麦生物科技发展有限公司 Hefei Tianmai BIOTECHNOLOGY Development Co Ltd In Review 2019-12-06 view
CXSS1500016 重组人胰岛素注射液 human insulin Injection Biological Products(15) New Drug Application 2015-09-14 合肥天麦生物科技发展有限公司 Hefei Tianmai BIOTECHNOLOGY Development Co Ltd Certificate Issued 2018-05-08 view
CXSS1600012 精蛋白重组人胰岛素注射液 Isophane Protamine Recombinant Human Insulin Injection Biological Products(15) New Drug Application 2018-02-26 合肥天麦生物科技发展有限公司 Hefei Tianmai BIOTECHNOLOGY Development Co Ltd Certificate Issued 2019-09-16 view
CXSS1600013 精蛋白重组人胰岛素注射液(预混30/70) Isophane Protamine Recombinant Human Insulin Injection Biological Products(15) New Drug Application 2018-02-26 合肥天麦生物科技发展有限公司 Hefei Tianmai BIOTECHNOLOGY Development Co Ltd Certificate Issued 2019-09-16 view
CYSB1800162 重组人胰岛素注射液 human insulin Injection Biological Products Supplementary Application 2018-08-14 合肥天麦生物科技发展有限公司 Hefei Tianmai BIOTECHNOLOGY Development Co Ltd Certificate Issued 2019-07-10 view
CYSB1900395 精蛋白重组人胰岛素注射液(预混30/70) Isophane Protamine Recombinant Human Insulin Injection Biological Products Supplementary Application 2019-11-20 合肥天麦生物科技发展有限公司 Hefei Tianmai BIOTECHNOLOGY Development Co Ltd Certificate Issued 2020-09-27 view
CYSB1900400 重组人胰岛素注射液 human insulin Injection Biological Products Supplementary Application 2019-11-28 合肥天麦生物科技发展有限公司 Hefei Tianmai BIOTECHNOLOGY Development Co Ltd Certificate Issued 2020-02-05 view