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Acceptance No. Drug Name Active Ingredient Dosage Form Classification Submission Acceptance Date Manufacturers Manufacturers Review Status Status Date 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
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
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
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
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
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
CYSB2200158 静注乙型肝炎人免疫球蛋白(pH4) human hepatitis B immunoglobulin(pH4) Injection Biological Products Supplementary Application 2022-06-20 Sichuan Yuanda Shuyang Pharmaceutical Co Ltd view
CYSB2101229 静注乙型肝炎人免疫球蛋白(pH4) human hepatitis B immunoglobulin(pH4) Injection Biological Products Supplementary Application 2021-10-19 Sichuan Yuanda Shuyang Pharmaceutical Co Ltd 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
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
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
CYSS0500128 静注乙型肝炎人免疫球蛋白(pH4) human hepatitis B immunoglobulin(pH4) Injection Biological Products(15) Generic Drug 2005-12-23 四川远大蜀阳药业有限公司 Sichuan Yuanda Shuyang Pharmaceutical Co Ltd Certificate Issued 2008-02-22 view
X0403645 静脉注射用人乙型肝炎免疫球蛋白 Injection Biological Products(7) New Drug Application 2004-07-07 安徽大安生物制品药业有限公司 Tonrol Bio-Pharmaceutical Co Limited Approval Completed-Pending Certificated 2004-12-30 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
X0403644 静脉注射用人乙型肝炎免疫球蛋白 Injection Biological Products(7) New Drug Application 2004-07-07 安徽大安生物制品药业有限公司 Tonrol Bio-Pharmaceutical Co Limited Approval Completed-Pending Certificated 2004-12-30 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
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
X0403643 静脉注射用人乙型肝炎免疫球蛋白 Injection Biological Products(7) New Drug Application 2004-07-07 安徽大安生物制品药业有限公司 Tonrol Bio-Pharmaceutical Co Limited Approval Completed-Pending Certificated 2004-12-30 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
X0403641 静脉注射用人乙型肝炎免疫球蛋白 Injection Biological Products(7) New Drug Application 2004-07-07 安徽大安生物制品药业有限公司 Tonrol Bio-Pharmaceutical Co Limited Certificate Issued 2005-01-17 view