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Acceptance No. Drug Name Active Ingredient Dosage Form Classification Submission Acceptance Date Manufacturers Manufacturers Review Status Status Date View
CXSB0700077 人免疫球蛋白 human immunoglobulin Injection Biological Products Supplementary Application 2007-11-23 同路生物制药有限公司 Tonrol Bio-Pharmaceutical Co Limited Certificate Issued 2008-10-29 view
CXSL0800024 人纤维蛋白原 Human fibrinogen Lyophilized Biological Products(15) New Drug Application 2010-04-21 同路生物制药有限公司 Tonrol Bio-Pharmaceutical Co Limited Certificate Issued 2011-05-11 view
CXSL0800028 人凝血酶原复合物 human prothrombin complex Lyophilized Biological Products(15) New Drug Application 2010-05-06 同路生物制药有限公司 Tonrol Bio-Pharmaceutical Co Limited Certificate Issued 2011-05-11 view
CXSL0800032 人凝血因子Ⅷ Recombinant Coagulation Factor Ⅷ Lyophilized Biological Products(15) New Drug Application 2010-04-09 同路生物制药有限公司 Tonrol Bio-Pharmaceutical Co Limited Certificate Issued 2010-11-23 view
CXSL1000018 冻干静注肠道病毒71型人免疫球蛋白(PH4) Other Biological Products(1) New Drug Application 2010-06-12 同路生物制药有限公司 Tonrol Bio-Pharmaceutical Co Limited Certificate Issued 2015-04-08 view
CXSL1100046 冻干静注乙型肝炎人免疫球蛋白(pH4) human hepatitis B immunoglobulin(pH4) Lyophilized Biological Products(15) New Drug Application 2011-09-21 同路生物制药股份有限公司 Tonrol Bio-Pharmaceutical Co Limited Certificate Issued 2013-04-11 view
CXSL2200513 人纤维蛋白原 Human fibrinogen Lyophilized Biological Products(3.4) New Drug Application 2022-10-13 Tonrol Bio-Pharmaceutical Co Limited view
CXSL2200514 人纤维蛋白原 Human fibrinogen Lyophilized Biological Products(3.4) New Drug Application 2022-10-13 Tonrol Bio-Pharmaceutical Co Limited view
CXSS0800014 狂犬病人免疫球蛋白 human rabies immunoglobulin Injection Biological Products(15) New Drug Application 2008-05-27 同路生物制药有限公司 Tonrol Bio-Pharmaceutical Co Limited Certificate Issued 2011-07-27 view
CXSS0800015 狂犬病人免疫球蛋白 human rabies immunoglobulin Injection Biological Products(15) New Drug Application 2008-05-27 同路生物制药有限公司 Tonrol Bio-Pharmaceutical Co Limited Certificate Issued 2011-07-27 view
CXSS0800016 狂犬病人免疫球蛋白 human rabies immunoglobulin Injection Biological Products(15) New Drug Application 2008-05-27 同路生物制药有限公司 Tonrol Bio-Pharmaceutical Co Limited Certificate Issued 2011-07-27 view
CXSS1200006 冻干狂犬病人免疫球蛋白 Lyophilized Biological Products(15) New Drug Application 2012-05-21 同路生物制药有限公司 Tonrol Bio-Pharmaceutical Co Limited Certificate Issued 2016-06-20 view
CXSS1200010 人凝血因子Ⅷ Recombinant Coagulation Factor Ⅷ Lyophilized Biological Products(15) New Drug Application 2012-07-03 同路生物制药股份有限公司 Tonrol Bio-Pharmaceutical Co Limited Certificate Issued 2013-09-02 view
CXSS1200019 人凝血酶原复合物 human prothrombin complex Lyophilized Biological Products(15) New Drug Application 2013-01-08 同路生物制药股份有限公司 Tonrol Bio-Pharmaceutical Co Limited Certificate Issued 2013-03-22 view
CXSS1300012 人凝血酶原复合物 human prothrombin complex Lyophilized Biological Products(15) New Drug Application 2013-05-10 同路生物制药有限公司 Tonrol Bio-Pharmaceutical Co Limited Certificate Issued 2016-03-11 view
CXSS1400018 人纤维蛋白原 Human fibrinogen Lyophilized Biological Products(15) New Drug Application 2014-10-08 同路生物制药有限公司 Tonrol Bio-Pharmaceutical Co Limited Certificate Issued 2016-03-11 view
CXSS1900045 冻干静注乙型肝炎人免疫球蛋白(pH4) human hepatitis B immunoglobulin(pH4) Lyophilized Biological Products(15) New Drug Application 2019-12-11 同路生物制药有限公司 Tonrol Bio-Pharmaceutical Co Limited Certificate Issued 2021-08-04 view
CXSS2000037 人凝血酶原复合物 human prothrombin complex Lyophilized Biological Products(15) New Drug Application 2020-07-04 同路生物制药有限公司 Tonrol Bio-Pharmaceutical Co Limited Certificate Issued 2021-07-13 view
CXSS2400108 人纤维蛋白原 Human fibrinogen Lyophilized Biological Products(3.4) New Drug Application 2024-10-09 Tonrol Bio-Pharmaceutical Co Limited view
CYSB0600023 人血白蛋白 human albumin Injection Biological Products Supplementary Application 2006-09-01 安徽大安生物制品药业有限公司 Tonrol Bio-Pharmaceutical Co Limited Certificate Issued 2007-02-08 view