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Acceptance No. Drug Name Active Ingredient Dosage Form Classification Submission Acceptance Date Manufacturers Manufacturers Review Status Status Date View
CXSL2300592 人纤维蛋白原 Human fibrinogen Lyophilized Biological Products(3.4) New Drug Application 2023-09-02 Guangdong Danxia Biology Pharmcy Co Ltd view
CXSL2300593 人纤维蛋白原 Human fibrinogen Lyophilized Biological Products(3.4) New Drug Application 2023-09-02 Guangdong Danxia Biology Pharmcy Co Ltd view
CXSL2200603 静注人免疫球蛋白(pH4) human immunoglobulin(PH4) Injection Biological Products(3.4) New Drug Application 2022-12-16 Guangdong Danxia Biology Pharmcy Co Ltd view
CXSL2200604 静注人免疫球蛋白(pH4) human immunoglobulin(PH4) Injection Biological Products(3.4) New Drug Application 2022-12-16 Guangdong Danxia Biology Pharmcy Co Ltd view
CXSL2200012 静注人免疫球蛋白(pH4) human immunoglobulin(PH4) Injection Biological Products(3.4) New Drug Application 2022-01-12 Guangdong Danxia Biology Pharmcy Co Ltd view
CXSL2200013 静注人免疫球蛋白(pH4) human immunoglobulin(PH4) Injection Biological Products(3.4) New Drug Application 2022-01-12 Guangdong Danxia Biology Pharmcy Co Ltd view
CYSB2000384 人免疫球蛋白 human immunoglobulin Injection Biological Products(原15) Supplementary Application 2020-12-24 博雅生物制药(广东)有限公司 Guangdong Danxia Biology Pharmcy Co Ltd Certificate Completed-Pending Issued 2021-11-19 view
CYSB2000173 人免疫球蛋白 human immunoglobulin Injection Biological Products Supplementary Application 2020-07-04 博雅生物制药(广东)有限公司 Guangdong Danxia Biology Pharmcy Co Ltd Certificate Issued 2020-09-21 view
CYSB1600001 人免疫球蛋白 human immunoglobulin Injection Biological Products Supplementary Application 2016-01-20 广东丹霞生物制药有限公司 Guangdong Danxia Biology Pharmcy Co Ltd Certificate Issued 2016-05-04 view
CXSS1500017 狂犬病人免疫球蛋白 human rabies immunoglobulin Injection Biological Products(15) New Drug Application 2015-10-10 广东丹霞生物制药有限公司 Guangdong Danxia Biology Pharmcy Co Ltd Certificate Issued 2018-09-13 view
CXSL1500016 人纤维蛋白原 Human fibrinogen Lyophilized Biological Products(15) New Drug Application 2015-03-07 广东丹霞生物制药有限公司 Guangdong Danxia Biology Pharmcy Co Ltd Certificate Issued 2016-05-11 view
CXSS1400011 静注人免疫球蛋白(pH4) human immunoglobulin(PH4) Injection Biological Products(15) New Drug Application 2014-06-16 广东丹霞生物制药有限公司 Guangdong Danxia Biology Pharmcy Co Ltd Certificate Issued 2016-03-10 view
CXSL1400011 人纤维蛋白原 Human fibrinogen Lyophilized Biological Products(15) New Drug Application 2014-02-20 广东丹霞生物制药有限公司 Guangdong Danxia Biology Pharmcy Co Ltd Certificate Issued 2014-11-21 view
CXSL1400012 人凝血因子VIII Recombinant Coagulation Factor Ⅷ Lyophilized Biological Products(15) New Drug Application 2014-02-20 广东丹霞生物制药有限公司 Guangdong Danxia Biology Pharmcy Co Ltd Certificate Issued 2015-01-07 view
CXSS1300026 狂犬病人免疫球蛋白 human rabies immunoglobulin Injection Biological Products(15) New Drug Application 2014-01-08 广东丹霞生物制药有限公司 Guangdong Danxia Biology Pharmcy Co Ltd Certificate Issued 2015-01-07 view
CXSS1200012 乙型肝炎人免疫球蛋白 human hepatitis B immunoglobulin Injection Biological Products(15) New Drug Application 2012-09-17 广东丹霞生物制药有限公司 Guangdong Danxia Biology Pharmcy Co Ltd Certificate Issued 2015-06-17 view
CXSS1200013 乙型肝炎人免疫球蛋白 human hepatitis B immunoglobulin Injection Biological Products(15) New Drug Application 2012-09-17 广东丹霞生物制药有限公司 Guangdong Danxia Biology Pharmcy Co Ltd Certificate Issued 2015-06-17 view
CXSL1200069 人纤维蛋白原 Human fibrinogen Lyophilized Biological Products(15) New Drug Application 2012-09-07 广东丹霞生物制药有限公司 Guangdong Danxia Biology Pharmcy Co Ltd Certificate Issued 2013-05-31 view
CXSS1000015 人血白蛋白 human albumin Injection Biological Products(15) New Drug Application 2010-08-03 广东丹霞生物制药有限公司 Guangdong Danxia Biology Pharmcy Co Ltd Certificate Issued 2012-11-06 view
CXSS1000013 人血白蛋白 human albumin Injection Biological Products(15) New Drug Application 2010-08-03 广东丹霞生物制药有限公司 Guangdong Danxia Biology Pharmcy Co Ltd Certificate Issued 2012-11-06 view