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Acceptance No. Drug Name Active Ingredient Dosage Form Classification Submission Acceptance Date Manufacturers Manufacturers Review Status Status Date 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
CYSB1900431 人血白蛋白 human albumin Injection Biological Products Supplementary Application 2020-01-03 同路生物制药有限公司 Tonrol Bio-Pharmaceutical Co Limited Certificate Issued 2021-01-08 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
CYSB2000369 冻干静注人免疫球蛋白(pH4) Human Immunoglobulin(pH4) Lyophilized Biological Products Supplementary Application 2020-12-18 同路生物制药有限公司 Tonrol Bio-Pharmaceutical Co Limited Certificate Issued 2021-08-06 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
CYSB1800194 破伤风人免疫球蛋白 human tetanus immunoglobulin Injection Biological Products Supplementary Application 2018-09-28 同路生物制药有限公司 Tonrol Bio-Pharmaceutical Co Limited Certificate Issued 2020-10-21 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
CYSB2000365 静注人免疫球蛋白(pH4) Human Immunoglobulin(pH4) Injection Biological Products Supplementary Application 2020-12-18 同路生物制药有限公司 Tonrol Bio-Pharmaceutical Co Limited In Review 2020-12-17 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
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
CYSB0600119 静注人免疫球蛋白(pH4) Human Immunoglobulin(pH4) Injection Biological Products Supplementary Application 2007-04-19 同路生物制药有限公司 Tonrol Bio-Pharmaceutical Co Limited Certificate Issued 2008-07-21 view
CYSB2000368 冻干静注人免疫球蛋白(pH4) Human Immunoglobulin(pH4) Lyophilized Biological Products Supplementary Application 2020-12-18 同路生物制药有限公司 Tonrol Bio-Pharmaceutical Co Limited In Review 2020-12-17 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
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
CYSB2000364 静注人免疫球蛋白(pH4) Human Immunoglobulin(pH4) Injection Biological Products Supplementary Application 2020-12-18 同路生物制药有限公司 Tonrol Bio-Pharmaceutical Co Limited Certificate Issued 2021-08-27 view
CYSB1600195 静注人免疫球蛋白(pH4) Human Immunoglobulin(pH4) Injection Biological Products Supplementary Application 2017-02-23 同路生物制药有限公司 Tonrol Bio-Pharmaceutical Co Limited Certificate Issued 2017-07-06 view
CYSB0600117 静注人免疫球蛋白(pH4) Human Immunoglobulin(pH4) Injection Biological Products Supplementary Application 2007-04-19 同路生物制药有限公司 Tonrol Bio-Pharmaceutical Co Limited Certificate Issued 2008-07-21 view
CYSB1900432 人血白蛋白 human albumin Injection Biological Products Supplementary Application 2020-01-03 同路生物制药有限公司 Tonrol Bio-Pharmaceutical Co Limited Certificate Issued 2021-01-08 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