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Acceptance No. Drug Name Active Ingredient Dosage Form Classification Submission Acceptance Date Manufacturers Manufacturers Review Status Status Date View
CXSL1400051 人凝血因子Ⅷ Recombinant Coagulation Factor Ⅷ Lyophilized Biological Products(15) New Drug Application 2014-06-27 江西博雅生物制药股份有限公司 China Resources Boya Bio-pharmaceutical Group Co Ltd Certificate Issued 2015-04-22 view
CXSL1400057 手足口病(EV71型)人免疫球蛋白 Other Biological Products(1) New Drug Application 2014-06-27 江西博雅生物制药股份有限公司 China Resources Boya Bio-pharmaceutical Group Co Ltd Certificate Issued 2016-04-07 view
CXSL1600021 人凝血酶原复合物 human prothrombin complex Lyophilized Biological Products(15) New Drug Application 2016-05-16 江西博雅生物制药股份有限公司 China Resources Boya Bio-pharmaceutical Group Co Ltd Certificate Issued 2016-12-08 view
CXSL2101101 人血管性血友病因子 Other Biological Products(3.2) New Drug Application 2021-06-02 China Resources Boya Bio-pharmaceutical Group Co Ltd view
CXSL2101366 静注人免疫球蛋白(10%) human immunoglobulin(PH4) Injection Biological Products(3.2) New Drug Application 2021-10-14 China Resources Boya Bio-pharmaceutical Group Co Ltd view
CXSL2300226 C1酯酶抑制剂 Injection Biological Products(3.2) New Drug Application 2023-04-05 China Resources Boya Bio-pharmaceutical Group Co Ltd view
CXSS1700032 人凝血因子Ⅷ Recombinant Coagulation Factor Ⅷ Lyophilized Biological Products(15) New Drug Application 2018-03-28 博雅生物制药集团股份有限公司 China Resources Boya Bio-pharmaceutical Group Co Ltd Certificate Issued 2019-05-20 view
CXSS1900026 人凝血酶原复合物 human prothrombin complex Lyophilized Biological Products(15) New Drug Application 2019-06-27 博雅生物制药集团股份有限公司 China Resources Boya Bio-pharmaceutical Group Co Ltd Certificate Issued 2020-12-10 view
CXSS2101006 人凝血因子Ⅷ Recombinant Coagulation Factor Ⅷ Lyophilized Biological Products(3.4) New Drug Application 2021-07-01 China Resources Boya Bio-pharmaceutical Group Co Ltd view
CXSS2400081 破伤风人免疫球蛋白 human tetanus immunoglobulin Injection Biological Products(3.4) New Drug Application 2024-07-31 China Resources Boya Bio-pharmaceutical Group Co Ltd view
CYSB0500046 人血白蛋白 human albumin Injection Biological Products Supplementary Application 2005-04-27 江西博雅生物制药股份有限公司 China Resources Boya Bio-pharmaceutical Group Co Ltd Certificate Issued 2005-09-20 view
CYSB0500047 人血白蛋白 human albumin Injection Biological Products Supplementary Application 2005-04-27 江西博雅生物制药股份有限公司 China Resources Boya Bio-pharmaceutical Group Co Ltd Certificate Issued 2005-09-09 view
CYSB0500048 人血白蛋白 human albumin Injection Biological Products Supplementary Application 2005-04-27 江西博雅生物制药股份有限公司 China Resources Boya Bio-pharmaceutical Group Co Ltd Certificate Issued 2005-09-09 view
CYSB0600005 人纤维蛋白原 Human fibrinogen Lyophilized Biological Products Supplementary Application 2006-07-11 江西博雅生物制药股份有限公司 China Resources Boya Bio-pharmaceutical Group Co Ltd Certificate Issued 2007-11-05 view
CYSB1200311 人纤维蛋白原 Human fibrinogen Lyophilized Biological Products Supplementary Application 2013-04-01 江西博雅生物制药股份有限公司 China Resources Boya Bio-pharmaceutical Group Co Ltd Certificate Issued 2013-10-23 view
CYSB1500070 狂犬病人免疫球蛋白 human rabies immunoglobulin Injection Biological Products Supplementary Application 2016-04-15 江西博雅生物制药股份有限公司 China Resources Boya Bio-pharmaceutical Group Co Ltd Certificate Issued 2016-10-11 view
CYSB1600254 狂犬病人免疫球蛋白 human rabies immunoglobulin Injection Biological Products Supplementary Application 2017-02-22 江西博雅生物制药股份有限公司 China Resources Boya Bio-pharmaceutical Group Co Ltd Certificate Issued 2017-04-17 view
CYSB2000261 冻干静注人免疫球蛋白(pH4) human immunoglobulin(PH4) Lyophilized Biological Products(原15) Supplementary Application 2020-11-07 博雅生物制药集团股份有限公司 China Resources Boya Bio-pharmaceutical Group Co Ltd In Review 2020-11-06 view
CYSB2000262 冻干静注人免疫球蛋白(pH4) human immunoglobulin(PH4) Lyophilized Biological Products(原15) Supplementary Application 2020-11-07 博雅生物制药集团股份有限公司 China Resources Boya Bio-pharmaceutical Group Co Ltd Certificate Issued 2021-08-27 view
CYSB2000264 静注人免疫球蛋白(pH4) human immunoglobulin(PH4) Injection Biological Products(原15) Supplementary Application 2020-11-07 博雅生物制药集团股份有限公司 China Resources Boya Bio-pharmaceutical Group Co Ltd In Review 2020-11-06 view