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Acceptance No. Drug Name Active Ingredient Dosage Form Classification Submission Acceptance Date Manufacturers Manufacturers Review Status Status Date View
CSL20020052 静脉注射用人乙型肝炎免疫球蛋白 Injection Biological Products(4) New Drug Application 2002-07-10 成都蓉生药业有限责任公司 Chengdu Rongsheng Pharmaceuticals Co Ltd Certificate Issued 2003-11-14 view
CSL20020078 静脉注射用人乙型肝炎免疫球蛋白(pH4) human hepatitis B immunoglobulin(pH4) Injection Biological Products(4) New Drug Application 2002-11-13 华兰生物工程股份有限公司 Hualan Biological Engineering Inc Certificate Issued 2003-11-28 view
CXSB2100004 冻干静注乙型肝炎人免疫球蛋白(pH4) human hepatitis B immunoglobulin(pH4) Lyophilized Biological Products Supplementary Application 2021-01-11 成都蓉生药业有限责任公司 Chengdu Rongsheng Pharmaceuticals Co Ltd Certificate Issued 2021-10-08 view
CXSL0500004 静脉注射用人乙型肝炎免疫球蛋白(pH4) human hepatitis B immunoglobulin(pH4) Injection Biological Products(7) New Drug Application 2005-02-22 上海新兴医药股份有限公司 Shanghai Xinxing MEDICINE Co Ltd Certificate Issued 2005-11-23 view
CXSL0500024 静脉注射用人乙型肝炎免疫球蛋白(pH4) human hepatitis B immunoglobulin(pH4) Injection Biological Products(7) New Drug Application 2005-04-01 上海莱士血制品有限公司 Shanghai RAAS Blood Products Co Ltd Certificate Issued 2006-04-19 view
CXSL0500032 静脉注射用人乙型肝炎免疫球蛋白(pH4) human hepatitis B immunoglobulin(pH4) Injection Biological Products(14) New Drug Application 2005-06-25 河南省中泰药业有限公司 Henan Xintai Pharmaceutical Co Ltd Certificate Issued 2006-02-08 view
CXSL0500034 静脉注射用人乙型肝炎免疫球蛋白(pH4) human hepatitis B immunoglobulin(pH4) Injection Biological Products(14) New Drug Application 2005-05-30 河南省中泰药业有限公司 Henan Xintai Pharmaceutical Co Ltd Certificate Completed-Pending Issued 2006-01-20 view
CXSL0500042 静脉注射用人乙型肝炎免疫球蛋白 Injection Biological Products(7) New Drug Application 2005-06-03 河北大安制药有限公司 Bohui Biopharmaceutical (Hebei) Co Ltd Certificate Issued 2006-06-21 view
CXSL0500043 静脉注射用人乙型肝炎免疫球蛋白 Injection Biological Products(7) New Drug Application 2005-06-03 河北大安制药有限公司 Bohui Biopharmaceutical (Hebei) Co Ltd Certificate Issued 2006-06-21 view
CXSL0500044 静脉注射用人乙型肝炎免疫球蛋白 Injection Biological Products(7) New Drug Application 2005-06-03 河北大安制药有限公司 Bohui Biopharmaceutical (Hebei) Co Ltd Certificate Issued 2006-06-21 view
CXSL0500107 静注乙型肝炎人免疫球蛋白(pH4) human hepatitis B immunoglobulin(pH4) Injection Biological Products(7) New Drug Application 2006-01-05 山东米歇尔生物制品有限公司 Shandong Taibang Biological Products Co Ltd Certificate Issued 2007-04-27 view
CXSL0700003 静注乙型肝炎人免疫球蛋白(pH4) human hepatitis B immunoglobulin(pH4) Injection Biological Products(7) New Drug Application 2007-05-11 武汉生物制品研究所 Wuhan Institute of Biological Products Co Ltd Certificate Issued 2008-06-27 view
CXSL1100046 冻干静注乙型肝炎人免疫球蛋白(pH4) human hepatitis B immunoglobulin(pH4) Lyophilized Biological Products(15) New Drug Application 2011-09-21 同路生物制药股份有限公司 Tonrol Bio-Pharmaceutical Co Limited Certificate Issued 2013-04-11 view
CXSS0800003 静脉注射用人乙型肝炎免疫球蛋白(pH4) human hepatitis B immunoglobulin(pH4) Injection Biological Products(7) New Drug Application 哈尔滨世亨生物工程药业股份有限公司 Harbin Pacific Biopharmaceutical Co Ltd Certificate Issued 2011-11-22 view
CXSS0800032 静注乙型肝炎人免疫球蛋白(pH4) human hepatitis B immunoglobulin(pH4) Injection Biological Products(14) New Drug Application 2009-06-22 成都蓉生药业有限责任公司 Chengdu Rongsheng Pharmaceuticals Co Ltd Certificate Issued 2012-06-27 view
CXSS1300025 静注乙型肝炎人免疫球蛋白(pH4) human hepatitis B immunoglobulin(pH4) Injection Biological Products(7) New Drug Application 2014-01-13 山东泰邦生物制品有限公司 Shandong Taibang Biological Products Co Ltd Certificate Issued 2016-03-10 view
CXSS1500001 静脉注射用人乙型肝炎免疫球蛋白(pH4) human hepatitis B immunoglobulin(pH4) Injection Biological Products(7) New Drug Application 2015-10-28 上海莱士血液制品股份有限公司 Shanghai RAAS Blood Products Co Ltd Certificate Issued 2016-12-08 view
CXSS1900045 冻干静注乙型肝炎人免疫球蛋白(pH4) human hepatitis B immunoglobulin(pH4) Lyophilized Biological Products(15) New Drug Application 2019-12-11 同路生物制药有限公司 Tonrol Bio-Pharmaceutical Co Limited Certificate Issued 2021-08-04 view
CYSB1400171 静注乙型肝炎人免疫球蛋白(pH4) human hepatitis B immunoglobulin(pH4) Injection Biological Products Supplementary Application 2014-12-30 哈尔滨派斯菲科生物制药股份有限公司 Harbin Pacific Biopharmaceutical Co Ltd Certificate Issued 2015-06-10 view
CYSB2000239 静注乙型肝炎人免疫球蛋白(pH4) human hepatitis B immunoglobulin(pH4) Injection Biological Products Supplementary Application 2020-10-29 四川远大蜀阳药业有限责任公司 Sichuan Yuanda Shuyang Pharmaceutical Co Ltd Certificate Issued 2021-01-15 view