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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
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
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
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
CXSL1400159 聚乙二醇重组人促红素注射液(CHO细胞) Injection Biological Products(7) New Drug Application 2015-03-13 山东阿华生物药业有限公司 Shandong E Hua Biology Medicine Co Ltd Certificate Issued 2018-01-23 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
CXSL1500077 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 2015-09-23 山东阿华生物药业有限公司 Shandong E Hua Biology Medicine Co Ltd Certificate Issued 2017-01-23 view
CYSB1000568 重组人促红素注射液(CHO细胞) Human Erythropoietin Injection Biological Products Supplementary Application 2011-01-18 山东阿华生物药业有限公司 Shandong E Hua Biology Medicine Co Ltd Certificate Issued 2014-06-25 view
CXSB0800049 注射用重组人白介素-11(Ⅰ) recombinant human interleukin-11 Lyophilized Biological Products Supplementary Application 2008-08-01 山东阿华生物药业有限公司 Shandong E Hua Biology Medicine Co Ltd Certificate Issued 2009-04-03 view
CXSS0500139 注射用重组人白介素-11衍生物 Lyophilized Biological Products New Drug Application 2005-12-02 山东阿华生物药业有限公司 Shandong E Hua Biology Medicine Co Ltd Certificate Issued 2008-05-21 view
CXSS0500140 注射用重组人白介素-11衍生物 Lyophilized Biological Products New Drug Application 2005-12-02 山东阿华生物药业有限公司 Shandong E Hua Biology Medicine Co Ltd Certificate Issued 2008-03-24 view
CXSS0500176 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 New Drug Application 2006-03-01 山东阿华生物药业有限公司 Shandong E Hua Biology Medicine Co Ltd Certificate Issued 2007-10-10 view
CXSS0500175 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 New Drug Application 2006-03-01 山东阿华生物药业有限公司 Shandong E Hua Biology Medicine Co Ltd Certificate Issued 2007-03-28 view
Y0404283 重组人红细胞生成素注射液 Human Erythropoietin Injection Biological Products Supplementary Application 2004-07-09 山东阿华生物药业有限公司 Shandong E Hua Biology Medicine Co Ltd Certificate Issued 2004-11-01 view
Y0404282 重组人红细胞生成素注射液 Human Erythropoietin Injection Biological Products Supplementary Application 2004-07-09 山东阿华生物药业有限公司 Shandong E Hua Biology Medicine Co Ltd Certificate Issued 2004-11-01 view
CSS20020002 重组人红细胞生成素注射液 Human Erythropoietin Injection Biological Products(5) New Drug Application 2002-01-31 山东阿华生物药业有限公司 Shandong E Hua Biology Medicine Co Ltd Certificate Issued 2003-05-09 view
CSS20020004 重组人红细胞生成素注射液 Human Erythropoietin Injection Biological Products(5) New Drug Application 2002-01-31 山东阿华生物药业有限公司 Shandong E Hua Biology Medicine Co Ltd Certificate Issued 2003-05-09 view
CSS20020005 重组人红细胞生成素注射液 Human Erythropoietin Injection Biological Products(5) New Drug Application 2002-01-31 山东阿华生物药业有限公司 Shandong E Hua Biology Medicine Co Ltd Certificate Issued 2003-05-09 view