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Acceptance No. Drug Name Active Ingredient Dosage Form Classification Submission Acceptance Date Manufacturers Manufacturers Review Status Status Date View
CXSL2100101 重组人GLP-1-Fc融合蛋白注射液 Injection Biological Products(3.3) New Drug Application 2021-03-23 华润昂德生物药业有限公司 Shandong E Hua Biology Medicine Co Ltd In Review 2021-03-22 view
CXSL2100102 重组人GLP-1-Fc融合蛋白注射液 Injection Biological Products(3.3) New Drug Application 2021-03-23 华润昂德生物药业有限公司 Shandong E Hua Biology Medicine Co Ltd In Review 2021-03-22 view
CXSB2100006 聚乙二醇重组人促红素注射液(CHO细胞) Injection Biological Products(原7) Supplementary Application 2021-01-14 华润昂德生物药业有限公司 Shandong E Hua Biology Medicine Co Ltd In Review 2021-01-13 view
CXSL1600127 注射用重组人组织型纤溶酶原激酶衍生物 Recombinant Human Tissue-type Plasminogen Activator Derivative Lyophilized Biological Products(1) New Drug Application 2017-03-27 昂德生物药业有限公司 Shandong E Hua Biology Medicine Co Ltd Certificate Issued 2017-08-21 view
CXSL2000082 注射用重组人组织型纤溶酶原激酶衍生物 Recombinant Human Tissue-type Plasminogen Activator Derivative Lyophilized Biological Products(1) New Drug Application 2020-05-06 华润昂德生物药业有限公司 Shandong E Hua Biology Medicine Co Ltd In Review 2020-05-01 view
CXSL1700192 注射用重组人组织型纤溶酶原激酶衍生物 Recombinant Human Tissue-type Plasminogen Activator Derivative Lyophilized Biological Products(1) New Drug Application 2018-03-12 昂德生物药业有限公司 Shandong E Hua Biology Medicine Co Ltd Certificate Issued 2018-11-19 view
CXSL1900092 地特胰岛素注射液 insulin detemir Injection Biological Products(15) New Drug Application 2019-08-28 华润昂德生物药业有限公司 Shandong E Hua Biology Medicine Co Ltd In Review 2019-08-27 view