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Acceptance No. Drug Name Active Ingredient Dosage Form Classification Submission Acceptance Date Manufacturers Manufacturers Review Status Status Date View
AS20000032 甘精胰岛素注射液 insulin glargine Injection Biological Products New Drug Application 2000-10-31 安万特(中国)投资有限公司 Sanofi (China) Investment Co Ltd Approval Completed-Pending Certificated view
CXSB2101014 甘精胰岛素注射液 insulin glargine Injection Biological Products Supplementary Application 2021-05-21 Gan & Lee Pharmaceuticals view
CXSL1200026 甘精胰岛素注射液 insulin glargine Injection Biological Products(15) New Drug Application 2012-05-17 通化东宝药业股份有限公司 Tonghua Dongbao Pharmaceutical Co Ltd Certificate Issued 2013-01-30 view
CXSL1200027 甘精胰岛素注射液 insulin glargine Injection Biological Products(15) New Drug Application 2012-05-17 通化东宝药业股份有限公司 Tonghua Dongbao Pharmaceutical Co Ltd Certificate Issued 2013-01-30 view
CXSL1200108 甘精胰岛素注射液 insulin glargine Injection Biological Products(15) New Drug Application 2013-02-19 通化东宝药业股份有限公司 Tonghua Dongbao Pharmaceutical Co Ltd Certificate Issued 2014-06-17 view
CXSL1200109 甘精胰岛素注射液 insulin glargine Injection Biological Products(15) New Drug Application 2013-02-19 通化东宝药业股份有限公司 Tonghua Dongbao Pharmaceutical Co Ltd Certificate Issued 2014-06-17 view
CXSL1400035 甘精胰岛素注射液 insulin glargine Injection Biological Products(15) New Drug Application 2014-04-28 宜昌长江药业有限公司 Yichang HEC Changjiang Pharmaceutical Co Ltd Certificate Issued 2016-08-01 view
CXSL1500050 甘精胰岛素注射液 insulin glargine Injection Biological Products(15) New Drug Application 2015-10-23 辽宁博鳌生物制药有限公司 Liaoning Boao Biological Pharmaceutical Co Ltd Certificate Issued 2017-04-07 view
CXSL1600006 甘精胰岛素注射液 insulin glargine Injection Biological Products(15) New Drug Application 2016-03-17 浙江海正药业股份有限公司 Zhejiang Hisun Pharmaceutical Co Ltd Certificate Issued 2017-01-11 view
CXSS1300001 甘精胰岛素注射液 insulin glargine Injection Biological Products(15) New Drug Application 2013-02-27 珠海联邦制药股份有限公司 Zhuhai United Laboratories Co Ltd Certificate Issued 2017-01-11 view
CXSS1700021 甘精胰岛素注射液 insulin glargine Injection Biological Products(15) New Drug Application 2017-12-08 通化东宝药业股份有限公司 Tonghua Dongbao Pharmaceutical Co Ltd Certificate Issued 2019-12-11 view
CXSS1700022 甘精胰岛素注射液 insulin glargine Injection Biological Products(15) New Drug Application 2017-12-08 通化东宝药业股份有限公司 Tonghua Dongbao Pharmaceutical Co Ltd Certificate Issued 2019-12-11 view
CXSS1900028 甘精胰岛素注射液 insulin glargine Injection Biological Products(15) New Drug Application 2019-07-02 辽宁博鳌生物制药有限公司 Liaoning Boao Biological Pharmaceutical Co Ltd In Review 2019-07-01 view
CXSS2000052 甘精胰岛素注射液 insulin glargine Injection Biological Products(3.3) New Drug Application 2020-10-15 宜昌东阳光长江药业股份有限公司 Yichang HEC Changjiang Pharmaceutical Co Ltd Certificate Issued 2021-11-02 view
CXSS2200079 甘精胰岛素注射液 insulin glargine Injection Biological Products(3.3) New Drug Application 2022-09-17 Hefei Tianmai BIOTECHNOLOGY Development Co Ltd view
CYSB1400069 甘精胰岛素注射液 insulin glargine Injection Biological Products Supplementary Application 2014-05-19 珠海联邦制药股份有限公司 Zhuhai United Laboratories Co Ltd Certificate Issued 2017-01-23 view
CYSB1700251 甘精胰岛素注射液 insulin glargine Injection Biological Products Supplementary Application 2018-10-25 赛诺菲(北京)制药有限公司 Sanofi (Beijing) Pharmaceuticals Co Ltd Certificate Issued 2020-02-14 view
CYSB1700252 甘精胰岛素注射液 insulin glargine Injection Biological Products Supplementary Application 2018-10-25 赛诺菲(北京)制药有限公司 Sanofi (Beijing) Pharmaceuticals Co Ltd Certificate Issued 2020-02-14 view
CYSB2000379 甘精胰岛素注射液 insulin glargine Injection Biological Products Supplementary Application 2020-12-23 赛诺菲(北京)制药有限公司 Sanofi (Beijing) Pharmaceuticals Co Ltd Certificate Issued 2021-10-18 view
CYSB2000380 甘精胰岛素注射液 insulin glargine Injection Biological Products Supplementary Application 2020-12-23 赛诺菲(北京)制药有限公司 Sanofi (Beijing) Pharmaceuticals Co Ltd Certificate Issued 2021-10-18 view