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Acceptance No. Drug Name Active Ingredient Dosage Form Classification Submission Acceptance Date Manufacturers Manufacturers Review Status Status Date View
CYSB0700083 乙型肝炎人免疫球蛋白 Human Hepatitis B Immunoglobulin Injection Biological Products Supplementary Application 2008-01-22 同路生物制药有限公司 Tonrol Bio-Pharmaceutical Co Limited Certificate Issued 2008-09-19 view
CYSB1700014 乙型肝炎人免疫球蛋白 Human Hepatitis B Immunoglobulin Injection Biological Products Supplementary Application 2017-09-11 同路生物制药有限公司 Tonrol Bio-Pharmaceutical Co Limited Certificate Issued 2019-08-13 view
CYSB1700015 乙型肝炎人免疫球蛋白 Human Hepatitis B Immunoglobulin Injection Biological Products Supplementary Application 2017-09-11 同路生物制药有限公司 Tonrol Bio-Pharmaceutical Co Limited Certificate Issued 2019-08-13 view
FS20020006 人乙型肝炎免疫球蛋白 Human Hepatitis B Immunoglobulin Injection Biological Products Generic Drug 2002-04-01 安徽大安生物制品药业有限公司 Tonrol Bio-Pharmaceutical Co Limited Approval Completed-Pending Certificated view
Y0408115 人乙型肝炎免疫球蛋白 Human Hepatitis B Immunoglobulin Injection Biological Products Supplementary Application 2004-08-16 安徽大安生物制品药业有限公司 Tonrol Bio-Pharmaceutical Co Limited Approval Completed-Pending Certificated 2005-01-31 view
Y0408112 人乙型肝炎免疫球蛋白 Human Hepatitis B Immunoglobulin Injection Biological Products Supplementary Application 2004-08-16 安徽大安生物制品药业有限公司 Tonrol Bio-Pharmaceutical Co Limited Certificate Issued 2005-02-08 view
CYSB1200350 人免疫球蛋白 human immunoglobulin Injection Biological Products Supplementary Application 2013-04-11 同路生物制药股份有限公司 Tonrol Bio-Pharmaceutical Co Limited Certificate Issued 2014-07-24 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
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
CYSB2100038 人凝血因子Ⅷ Recombinant Coagulation Factor Ⅷ Lyophilized Biological Products Supplementary Application 2021-01-23 同路生物制药有限公司 Tonrol Bio-Pharmaceutical Co Limited Certificate Issued 2021-08-19 view
CYSB1600083 人凝血因子Ⅷ Recombinant Coagulation Factor Ⅷ Lyophilized Biological Products Supplementary Application 2016-06-29 同路生物制药有限公司 Tonrol Bio-Pharmaceutical Co Limited Certificate Issued 2017-12-11 view
CYSB2100039 人凝血因子Ⅷ Recombinant Coagulation Factor Ⅷ Lyophilized Biological Products Supplementary Application 2021-01-23 同路生物制药有限公司 Tonrol Bio-Pharmaceutical Co Limited Certificate Issued 2021-08-19 view
CYSB1800221 人凝血因子Ⅷ Recombinant Coagulation Factor Ⅷ Lyophilized Biological Products Supplementary Application 2018-10-25 同路生物制药有限公司 Tonrol Bio-Pharmaceutical Co Limited Certificate Issued 2019-09-30 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
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
CYSB1800008 人凝血酶原复合物 human prothrombin complex Lyophilized Biological Products Supplementary Application 2018-01-29 同路生物制药有限公司 Tonrol Bio-Pharmaceutical Co Limited Certificate Issued 2018-05-24 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
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
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
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