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Acceptance No. Drug Name Active Ingredient Dosage Form Classification Submission Acceptance Date Manufacturers Manufacturers Review Status Status Date View
BFS20020020 人乙型肝炎免疫球蛋白 Human Hepatitis B Immunoglobulin Injection Biological Products Generic Drug 2002-07-08 山东省生物制品研究所 Shandong Institute of Biological Products Approval Completed-Pending Certificated 2002-11-21 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
CSS01054 人免疫球蛋白IgA免疫比浊法测定试剂盒 Diagnostic reagent IVD(2) New Drug Application 2001-11-19 上海科华生物工程股份有限公司 Shanghai Kehua Bio-Engineering Co Ltd Certificate Issued 2003-06-15 view
CSS01055 人免疫球蛋白IgG免疫比浊法测定试剂盒 Diagnostic reagent IVD(2) New Drug Application 2001-11-19 上海科华生物工程股份有限公司 Shanghai Kehua Bio-Engineering Co Ltd Certificate Issued 2003-05-30 view
CSS01056 人免疫球蛋白IgM免疫比浊法测定试剂盒 Diagnostic reagent IVD(2) New Drug Application 2001-11-19 上海科华生物工程股份有限公司 Shanghai Kehua Bio-Engineering Co Ltd Certificate Issued 2003-08-25 view
CXSB0500073 冻干静脉注射用人免疫球蛋白(S/D) Lyophilized Biological Products Supplementary Application 2005-06-15 兰州生物制品研究所 Lanzhou Institute of Biological Products Co Ltd Certificate Issued 2006-02-10 view
CXSB0700077 人免疫球蛋白 human immunoglobulin Injection Biological Products Supplementary Application 2007-11-23 同路生物制药有限公司 Tonrol Bio-Pharmaceutical Co Limited Certificate Issued 2008-10-29 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
CXSB2100005 静注人免疫球蛋白(pH4) Human Immunoglobulin(pH4) Injection Biological Products(原15) Supplementary Application 2021-01-11 新疆德源生物工程有限公司 Xinjiang Deyuan Biological Engineering Co Ltd Certificate Issued 2021-07-13 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
CXSL1000018 冻干静注肠道病毒71型人免疫球蛋白(PH4) Other Biological Products(1) New Drug Application 2010-06-12 同路生物制药有限公司 Tonrol Bio-Pharmaceutical Co Limited Certificate Issued 2015-04-08 view