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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
X0401022 双时相重组赖脯胰岛素注射液75/25 Injection Biological Products Supplementary Application 2004-03-16 北京甘李生物技术有限公司 Gan & Lee Pharmaceuticals Certificate Issued 2004-07-19 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
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
CYSS0500017 重组人胰岛素注射液 human insulin Injection Biological Products(15) Generic Drug 2005-03-02 北京甘李生物技术有限公司 Gan & Lee Pharmaceuticals Certificate Issued 2005-12-28 view
CYSS0500011 重组赖脯胰岛素注射液 insulin lispro Injection Biological Products(15) Generic Drug 2005-03-02 北京甘李生物技术有限公司 Gan & Lee Pharmaceuticals Certificate Issued 2006-02-05 view
CYSS0500016 精蛋白重组人胰岛素注射液(预混30R) Injection Biological Products(15) Generic Drug 2005-03-02 北京甘李生物技术有限公司 Gan & Lee Pharmaceuticals Certificate Issued 2005-12-22 view
CYSS0500010 重组赖脯胰岛素 Biological Products(15) Generic Drug 2005-03-02 北京甘李生物技术有限公司 Gan & Lee Pharmaceuticals Certificate Issued 2006-04-04 view
CYSS0500015 精蛋白重组人胰岛素注射液(预混30R) Injection Biological Products(15) Generic Drug 2005-03-02 北京甘李生物技术有限公司 Gan & Lee Pharmaceuticals Certificate Issued 2005-12-22 view
CYSS0500014 精蛋白重组人胰岛素注射液 Isophane Protamine Recombinant Human Insulin Injection Biological Products(15) Generic Drug 2005-03-02 北京甘李生物技术有限公司 Gan & Lee Pharmaceuticals Certificate Issued 2005-12-28 view
CYSS0500013 重组人胰岛素 human insulin Active ingredient Biological Products(15) Generic Drug 2005-03-02 北京甘李生物技术有限公司 Gan & Lee Pharmaceuticals Certificate Issued 2006-04-10 view
CYSS0500018 重组人胰岛素注射液 human insulin Injection Biological Products(15) Generic Drug 2005-03-02 北京甘李生物技术有限公司 Gan & Lee Pharmaceuticals Certificate Completed-Pending Issued 2005-12-13 view
CYSS0500012 重组赖脯胰岛素注射液 insulin lispro Injection Biological Products(15) Generic Drug 2005-03-02 北京甘李生物技术有限公司 Gan & Lee Pharmaceuticals Certificate Issued 2006-02-05 view
CYSS0500020 精蛋白重组人胰岛素注射液 Isophane Protamine Recombinant Human Insulin Injection Biological Products(15) Generic Drug 2005-03-13 北京甘李生物技术有限公司 Gan & Lee Pharmaceuticals Certificate Issued 2005-12-22 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