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Acceptance No. Drug Name Active Ingredient Dosage Form Classification Submission Acceptance Date Manufacturers Manufacturers Review Status Status Date View
CSL01009 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(2) New Drug Application 2001-02-16 上海复旦张江生物医药股份有限公司 Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co Ltd Approval Completed-Pending Certificated 2002-06-10 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
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
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
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
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
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
CXSS2400016 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(2.2) New Drug Application 2024-02-05 Shandong E Hua Biology Medicine Co Ltd view