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Acceptance No. Drug Name Active Ingredient Dosage Form Classification Submission Acceptance Date Manufacturers Manufacturers Review Status Status Date 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
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
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
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
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
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
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
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
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
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
CYSB2400300 门冬胰岛素30注射液 Insulin aspart protamine recombinant;insulin aspart recombinant Injection Biological Products Supplementary Application 2024-11-14 Gan & Lee Pharmaceuticals view
CYSB2400288 门冬胰岛素30注射液 Insulin aspart protamine recombinant;insulin aspart recombinant Injection Biological Products Supplementary Application 2024-11-05 Gan & Lee Pharmaceuticals view
CYSB2400282 门冬胰岛素注射液 insulin aspart Injection Biological Products Supplementary Application 2024-10-26 Gan & Lee Pharmaceuticals view
CYSB2400224 甘精胰岛素注射液 insulin glargine Injection Biological Products Supplementary Application 2024-08-29 Gan & Lee Pharmaceuticals view
CYSB2400141 甘精胰岛素注射液 insulin glargine Injection Biological Products Supplementary Application 2024-06-01 Gan & Lee Pharmaceuticals view
CYSB2400140 甘精胰岛素注射液 insulin glargine Injection Biological Products Supplementary Application 2024-06-01 Gan & Lee Pharmaceuticals view