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Acceptance No. Drug Name Active Ingredient Dosage Form Classification Submission Acceptance Date Manufacturers Manufacturers Review Status Status Date View
Y0412676 重组甘精胰岛素注射液 insulin glargine Injection Biological Products(15) Generic Drug 2004-10-28 重庆富进生物医药有限公司 Chongqing Fujin Biological Medicine Co Ltd Certificate Issued 2006-05-29 view
Y0412675 重组甘精胰岛素注射液 insulin glargine Injection Biological Products(15) Generic Drug 2004-10-28 重庆富进生物医药有限公司 Chongqing Fujin Biological Medicine Co Ltd Certificate Completed-Pending Issued 2006-05-17 view
X0406116 重组甘精胰岛素原料药 insulin glargine Active ingredient Biological Products(7) New Drug Application 2004-10-28 重庆富进生物医药有限公司 Chongqing Fujin Biological Medicine Co Ltd Certificate Issued 2006-05-29 view
X0405013 重组甘精胰岛素注射液 insulin glargine Injection Biological Products(7) New Drug Application 2004-09-05 北京甘李生物技术有限公司 Gan & Lee Pharmaceuticals Certificate Issued 2005-05-27 view
X0405012 重组甘精胰岛素注射液 insulin glargine Injection Biological Products(7) New Drug Application 2004-09-05 北京甘李生物技术有限公司 Gan & Lee Pharmaceuticals Certificate Issued 2005-05-27 view
X0405011 重组甘精胰岛素 insulin glargine Injection Biological Products(7) New Drug Application 2004-09-03 北京甘李生物技术有限公司 Gan & Lee Pharmaceuticals Certificate Issued 2013-04-25 view
JXSL1200009 重组甘精胰岛素注射液 insulin glargine Injection Biological Products Import Drug Application 2012-02-14 杭州泰格医药科技股份有限公司 Hangzhou Tigermed Consulting Co Ltd Certificate Issued 2014-01-30 view
CYSB2000360 重组甘精胰岛素注射液 insulin glargine Injection Biological Products(原7) Supplementary Application 2020-12-18 甘李药业股份有限公司 Gan & Lee Pharmaceuticals In Review 2020-12-16 view
CYSB2000359 重组甘精胰岛素注射液 insulin glargine Injection Biological Products(原7) Supplementary Application 2020-12-18 甘李药业股份有限公司 Gan & Lee Pharmaceuticals In Review 2020-12-16 view
CYSB2000073 重组甘精胰岛素注射液 insulin glargine Injection Biological Products Supplementary Application 2020-04-22 甘李药业股份有限公司 Gan & Lee Pharmaceuticals Certificate Issued 2020-07-16 view
CYSB2000072 重组甘精胰岛素注射液 insulin glargine Injection Biological Products Supplementary Application 2020-04-22 甘李药业股份有限公司 Gan & Lee Pharmaceuticals Certificate Issued 2020-07-16 view
CYSB2000016 重组甘精胰岛素注射液 insulin glargine Injection Biological Products Supplementary Application 2020-02-14 甘李药业股份有限公司 Gan & Lee Pharmaceuticals Certificate Issued 2020-03-26 view
CYSB1700216 重组甘精胰岛素注射液 insulin glargine Injection Biological Products Supplementary Application 2018-06-15 甘李药业股份有限公司 Gan & Lee Pharmaceuticals Certificate Issued 2019-06-26 view
CYSB1700181 重组甘精胰岛素注射液 insulin glargine Injection Biological Products Supplementary Application 2017-11-16 甘李药业股份有限公司 Gan & Lee Pharmaceuticals In Review 2017-11-14 view
CYSB1500535 重组甘精胰岛素注射液 insulin glargine Injection Biological Products Supplementary Application 2016-09-18 甘李药业股份有限公司 Gan & Lee Pharmaceuticals Certificate Issued 2017-09-14 view
CYSB1100044 重组甘精胰岛素注射液 insulin glargine Injection Biological Products Supplementary Application 2011-06-07 甘李药业有限公司 Gan & Lee Pharmaceuticals Certificate Issued 2014-06-05 view
CXSS2000058 重组甘精胰岛素注射液 insulin glargine Injection Biological Products(3.4) New Drug Application 2020-11-27 山东新时代药业有限公司 Shandong New Time Pharmaceutical Co Ltd In Review 2020-11-26 view
CXSS2000009 重组甘精胰岛素注射液 insulin glargine Injection Biological Products(15) New Drug Application 2020-03-19 江苏万邦生化医药集团有限责任公司 Wanbang Biopharmaceuticals In Review 2020-03-17 view
CXSS1100016 重组甘精胰岛素注射液 insulin glargine Injection Biological Products(15) New Drug Application 2011-08-31 山东新时代药业有限公司 Shandong New Time Pharmaceutical Co Ltd Certificate Issued 2016-03-10 view
CXSS1100015 重组甘精胰岛素原料药 insulin glargine Active ingredient Biological Products(7) New Drug Application 2011-08-31 山东新时代药业有限公司 Shandong New Time Pharmaceutical Co Ltd Certificate Issued 2016-08-01 view