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Acceptance No. Drug Name Active Ingredient Dosage Form Classification Submission Acceptance Date Manufacturers Manufacturers Review Status Status Date 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
FS20010011 人乙型肝炎免疫球蛋白 human hepatitis B immunoglobulin Injection Biological Products Generic Drug 2001-06-13 广东省血液制品所 Guangdong Danxia Biology Pharmcy Co Ltd Approval Completed-Pending Certificated view
CXSS1000017 人免疫球蛋白 human immunoglobulin 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
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
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
Y0416241 人狂犬病免疫球蛋白 human rabies immunoglobulin Injection Biological Products(15) Generic Drug 2004-12-22 广东佰易药业有限公司 Guangdong Danxia Biology Pharmcy Co Ltd Certificate Issued 2006-06-14 view
Y0416240 人狂犬病免疫球蛋白 human rabies immunoglobulin Injection Biological Products(15) Generic Drug 2004-12-22 广东佰易药业有限公司 Guangdong Danxia Biology Pharmcy Co Ltd Certificate Issued 2006-06-14 view
Y0401178 人狂犬病免疫球蛋白 human rabies immunoglobulin Injection Biological Products(15) Generic Drug 2004-02-29 广东佰易药业有限公司 Guangdong Danxia Biology Pharmcy Co Ltd Certificate Issued 2004-07-29 view
Y0416239 人狂犬病免疫球蛋白 human rabies immunoglobulin Injection Biological Products(15) Generic Drug 2004-12-22 广东佰易药业有限公司 Guangdong Danxia Biology Pharmcy Co Ltd Certificate Issued 2006-06-14 view
Y0401177 人狂犬病免疫球蛋白 human rabies immunoglobulin Injection Biological Products(15) Generic Drug 2004-02-29 广东佰易药业有限公司 Guangdong Danxia Biology Pharmcy Co Ltd Certificate Issued 2004-07-29 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
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
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
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
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
Y0401610 人血白蛋白 human albumin Injection Biological Products Supplementary Application 2004-07-17 广东佰易药业有限公司 Guangdong Danxia Biology Pharmcy Co Ltd Certificate Issued 2004-09-20 view
Y0416336 人血白蛋白 human albumin Injection Biological Products Supplementary Application 2004-12-27 广东佰易药业有限公司 Guangdong Danxia Biology Pharmcy Co Ltd Certificate Issued 2005-07-15 view