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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
CSL20020063 重组甘精胰岛素 insulin glargine Injection Biological Products(2) New Drug Application 2002-09-16 北京甘李生物技术有限公司 Gan & Lee Pharmaceuticals Certificate Issued 2003-05-09 view
CSL20020064 重组甘精胰岛素注射液 insulin glargine Injection Biological Products(2) New Drug Application 2002-09-16 北京甘李生物技术有限公司 Gan & Lee Pharmaceuticals Certificate Issued 2003-05-09 view
CXSB0500149 重组甘精胰岛素 insulin glargine Injection Biological Products Supplementary Application 2005-11-23 山东新时代药业有限公司 Shandong New Time Pharmaceutical Co Ltd In Approval 2011-08-04 view
CXSB0500150 重组甘精胰岛素注射液 insulin glargine Injection Biological Products Supplementary Application 2005-11-23 山东新时代药业有限公司 Shandong New Time Pharmaceutical Co Ltd In Approval 2011-08-04 view
CXSB0500151 重组甘精胰岛素注射液 insulin glargine Injection Biological Products Supplementary Application 2005-11-23 山东新时代药业有限公司 Shandong New Time Pharmaceutical Co Ltd In Approval 2011-08-04 view
CXSB0700035 重组甘精胰岛素注射液 insulin glargine Injection Biological Products Supplementary Application 2007-09-12 甘李药业有限公司 Gan & Lee Pharmaceuticals Certificate Issued 2008-04-18 view
CXSB2101014 甘精胰岛素注射液 insulin glargine Injection Biological Products Supplementary Application 2021-05-21 Gan & Lee Pharmaceuticals view
CXSL0900029 重组甘精胰岛素 insulin glargine Injection Biological Products(15) New Drug Application 2010-02-08 珠海联邦制药股份有限公司 Zhuhai United Laboratories Co Ltd Certificate Issued 2011-09-29 view
CXSL0900030 重组甘精胰岛素注射液 insulin glargine Injection Biological Products(15) New Drug Application 2010-02-08 珠海联邦制药股份有限公司中山分公司 Zhuhai United Laboratories Co Ltd Certificate Issued 2011-09-29 view
CXSL1200025 甘精胰岛素 insulin glargine Injection Biological Products(7) 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
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
CXSL1200107 甘精胰岛素 insulin glargine Injection Biological Products(7) 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
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
CXSL1300006 重组甘精胰岛素 insulin glargine Injection Biological Products(15) New Drug Application 2013-07-01 江苏万邦生化医药股份有限公司 Fosun Wanbang (Jiangsu) Pharmaceutical Group Co Ltd Certificate Issued 2016-01-13 view
CXSL1300007 重组甘精胰岛素注射液 insulin glargine Injection Biological Products(15) New Drug Application 2013-07-01 江苏万邦生化医药股份有限公司 Fosun Wanbang (Jiangsu) Pharmaceutical Group Co Ltd Certificate Issued 2016-01-13 view
CXSL1300053 重组甘精胰岛素注射液 insulin glargine Injection Biological Products(15) New Drug Application 2013-10-28 浙江海正药业股份有限公司 Zhejiang Hisun Pharmaceutical Co Ltd Certificate Issued 2015-07-13 view
CXSL1400034 甘精胰岛素 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 2016-08-04 view