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Acceptance No. Drug Name Active Ingredient Dosage Form Classification Submission Acceptance Date Manufacturers Manufacturers Review Status Status Date View
CXSL2100099 GZR18 GZR-18 Injection Biological Products(1) New Drug Application 2021-03-24 甘李药业股份有限公司 Gan & Lee Pharmaceuticals In Review 2021-03-23 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
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
CXSS1400003 门冬胰岛素30注射液 Insulin aspart protamine recombinant;insulin aspart recombinant Injection Biological Products(15) New Drug Application 2014-12-25 甘李药业股份有限公司 Gan & Lee Pharmaceuticals Certificate Issued 2018-06-28 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
CYSB2000182 精蛋白锌重组赖脯胰岛素混合注射液(25R) Injection Biological Products Supplementary Application 2020-07-04 甘李药业股份有限公司 Gan & Lee Pharmaceuticals Certificate Issued 2020-12-21 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
CYSB2100018 甘精胰岛素注射液 insulin glargine Injection Biological Products Supplementary Application 2021-01-11 甘李药业股份有限公司 Gan & Lee Pharmaceuticals In Review 2022-01-19 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
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
CXSS1400002 门冬胰岛素30注射液 Insulin aspart protamine recombinant;insulin aspart recombinant Injection Biological Products(15) New Drug Application 2014-12-25 甘李药业股份有限公司 Gan & Lee Pharmaceuticals Certificate Issued 2020-12-10 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
CYSB2000096 重组赖脯胰岛素注射液 insulin lispro Injection Biological Products Supplementary Application 2020-05-18 甘李药业股份有限公司 Gan & Lee Pharmaceuticals Certificate Issued 2020-07-27 view
CYSB2100017 赖脯胰岛素注射液 insulin lispro Injection Biological Products Supplementary Application 2021-01-11 甘李药业股份有限公司 Gan & Lee Pharmaceuticals In Review 2022-01-19 view
CXSS1400015 精蛋白重组人胰岛素注射液(预混30R) Injection Biological Products(15) New Drug Application 2015-01-19 甘李药业股份有限公司 Gan & Lee Pharmaceuticals Certificate Issued 2021-05-31 view
CYSB2000015 重组赖脯胰岛素注射液 insulin lispro 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
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
CXSS1600003 门冬胰岛素注射液 insulin aspart Injection Biological Products(15) New Drug Application 2017-06-02 甘李药业股份有限公司 Gan & Lee Pharmaceuticals Certificate Issued 2020-05-19 view
CYSB2000095 重组赖脯胰岛素注射液 insulin lispro Injection Biological Products Supplementary Application 2020-05-18 甘李药业股份有限公司 Gan & Lee Pharmaceuticals Certificate Issued 2020-07-27 view
CYSB2100016 赖脯胰岛素注射液 insulin lispro Injection Biological Products Supplementary Application 2021-01-11 甘李药业股份有限公司 Gan & Lee Pharmaceuticals In Review 2022-01-19 view