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Acceptance No. Drug Name Active Ingredient Dosage Form Classification Submission Acceptance Date Manufacturers Manufacturers Review Status Status Date View
CSL20020033 重组赖脯胰岛素 Biological Products(2) New Drug Application 2002-06-03 北京甘李生物技术有限公司 Gan & Lee Pharmaceuticals Certificate Issued 2003-06-20 view
CSL20020034 重组赖脯胰岛素注射液 insulin lispro Injection Biological Products(2) New Drug Application 2002-06-03 北京甘李生物技术有限公司 Gan & Lee Pharmaceuticals Certificate Issued 2003-06-20 view
CSL20020035 双时相重组赖脯胰岛素注射液75/25 Injection Biological Products(2) New Drug Application 2002-06-03 北京甘李生物技术有限公司 Gan & Lee Pharmaceuticals Approval Completed-Pending Certificated 2003-01-23 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
CXHL2000605 GLR2007 GLR2007 Active ingredient Chemical Drugs(1) New Drug Application 2020-11-28 甘李药业股份有限公司 Gan & Lee Pharmaceuticals In Review 2020-11-27 view
CXHL2000606 GLR2007 GLR2007 Active ingredient Chemical Drugs(1) New Drug Application 2020-11-28 甘李药业股份有限公司 Gan & Lee Pharmaceuticals In Review 2020-11-27 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
CXSB0700036 重组赖脯胰岛素注射液 insulin lispro Injection Biological Products Supplementary Application 2007-09-12 甘李药业有限公司 Gan & Lee Pharmaceuticals Certificate Issued 2008-06-20 view
CXSB2101014 甘精胰岛素注射液 insulin glargine Injection Biological Products Supplementary Application 2021-05-21 Gan & Lee Pharmaceuticals view
CXSB2300028 GZR18 GZR-18 Injection Biological Products(1) Supplementary Application 2023-03-31 Gan & Lee Pharmaceuticals view
CXSB2300051 GZR18 GZR-18 Injection Biological Products(1) Supplementary Application 2023-05-11 Gan & Lee Pharmaceuticals view
CXSL0900032 门冬胰岛素 insulin aspart Other Biological Products(7) New Drug Application 2010-01-15 甘李药业有限公司 Gan & Lee Pharmaceuticals Certificate Issued 2011-08-03 view
CXSL0900033 门冬胰岛素注射液 insulin aspart Injection Biological Products(15) New Drug Application 2010-01-15 甘李药业有限公司 Gan & Lee Pharmaceuticals Certificate Issued 2011-08-03 view
CXSL0900034 门冬胰岛素注射液 insulin aspart Injection Biological Products(15) New Drug Application 2010-01-15 甘李药业有限公司 Gan & Lee Pharmaceuticals Certificate Issued 2011-08-03 view
CXSL0900035 门冬胰岛素30注射液 Insulin aspart protamine recombinant;insulin aspart recombinant Injection Biological Products(15) New Drug Application 2010-01-15 甘李药业有限公司 Gan & Lee Pharmaceuticals Certificate Issued 2011-11-07 view
CXSL0900036 门冬胰岛素30注射液 Insulin aspart protamine recombinant;insulin aspart recombinant Injection Biological Products(15) New Drug Application 2010-01-15 甘李药业有限公司 Gan & Lee Pharmaceuticals Certificate Issued 2011-11-07 view
CXSL1400054 精蛋白锌重组赖脯胰岛素混合注射液(40R) Injection Biological Products(6) New Drug Application 2014-10-11 甘李药业股份有限公司 Gan & Lee Pharmaceuticals Certificate Issued 2016-06-20 view
CXSL1400055 门冬胰岛素50注射液 Insulin aspart protamine recombinant;insulin aspart recombinant Injection Biological Products(15) New Drug Application 2014-10-11 甘李药业股份有限公司 Gan & Lee Pharmaceuticals Certificate Issued 2016-05-19 view
CXSL1400056 精蛋白锌重组赖脯胰岛素混合注射液(50R) Injection Biological Products(15) New Drug Application 2014-10-11 甘李药业股份有限公司 Gan & Lee Pharmaceuticals Certificate Issued 2016-05-19 view