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Acceptance No. Drug Name Active Ingredient Dosage Form Classification Submission Acceptance Date Manufacturers Manufacturers Review Status Status Date 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
CYSB0600023 人血白蛋白 human albumin Injection Biological Products Supplementary Application 2006-09-01 安徽大安生物制品药业有限公司 Tonrol Bio-Pharmaceutical Co Limited Certificate Issued 2007-02-08 view
FS20020006 人乙型肝炎免疫球蛋白 human hepatitis B immunoglobulin Injection Biological Products Generic Drug 2002-04-01 安徽大安生物制品药业有限公司 Tonrol Bio-Pharmaceutical Co Limited Approval Completed-Pending Certificated view
CYSS0500084 静注人免疫球蛋白(pH4) human immunoglobulin(PH4) Injection Biological Products(15) Generic Drug 2005-10-08 安徽大安生物制品药业有限公司 Tonrol Bio-Pharmaceutical Co Limited Certificate Issued 2006-08-29 view
CYSS0500082 静注人免疫球蛋白(pH4) human immunoglobulin(PH4) Injection Biological Products(15) Generic Drug 2006-04-10 安徽大安生物制品药业有限公司 Tonrol Bio-Pharmaceutical Co Limited Certificate Issued 2006-12-30 view
Y0408115 人乙型肝炎免疫球蛋白 human hepatitis B immunoglobulin Injection Biological Products Supplementary Application 2004-08-16 安徽大安生物制品药业有限公司 Tonrol Bio-Pharmaceutical Co Limited Approval Completed-Pending Certificated 2005-01-31 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
Y0408112 人乙型肝炎免疫球蛋白 human hepatitis B immunoglobulin Injection Biological Products Supplementary Application 2004-08-16 安徽大安生物制品药业有限公司 Tonrol Bio-Pharmaceutical Co Limited Certificate Issued 2005-02-08 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
CYSS0500129 破伤风人免疫球蛋白 human tetanus immunoglobulin Injection Biological Products(15) Generic Drug 2006-01-24 安徽大安生物制品药业有限公司 Tonrol Bio-Pharmaceutical Co Limited Certificate Issued 2007-01-11 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
CYSB0600024 人血白蛋白 human albumin Injection Biological Products Supplementary Application 2006-09-01 安徽大安生物制品药业有限公司 Tonrol Bio-Pharmaceutical Co Limited Certificate Issued 2009-04-16 view
X0403642 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
CYSS0500109 组织胺人免疫球蛋白 Human Histaglobulin Lyophilized Biological Products(15) Generic Drug 2005-12-12 安徽大安生物制品药业有限公司 Tonrol Bio-Pharmaceutical Co Limited Certificate Issued 2006-07-27 view
CYSB1200350 人免疫球蛋白 human immunoglobulin Injection Biological Products Supplementary Application 2013-04-11 同路生物制药股份有限公司 Tonrol Bio-Pharmaceutical Co Limited Certificate Issued 2014-07-24 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
CXSS1200019 人凝血酶原复合物 human prothrombin complex Lyophilized Biological Products(15) New Drug Application 2013-01-08 同路生物制药股份有限公司 Tonrol Bio-Pharmaceutical Co Limited Certificate Issued 2013-03-22 view
CXSS1200010 人凝血因子Ⅷ Recombinant Coagulation Factor Ⅷ Lyophilized Biological Products(15) New Drug Application 2012-07-03 同路生物制药股份有限公司 Tonrol Bio-Pharmaceutical Co Limited Certificate Issued 2013-09-02 view
CYSB2000369 冻干静注人免疫球蛋白(pH4) human immunoglobulin(PH4) Lyophilized Biological Products Supplementary Application 2020-12-18 同路生物制药有限公司 Tonrol Bio-Pharmaceutical Co Limited Certificate Issued 2021-08-06 view
CXSS1300012 人凝血酶原复合物 human prothrombin complex Lyophilized Biological Products(15) New Drug Application 2013-05-10 同路生物制药有限公司 Tonrol Bio-Pharmaceutical Co Limited Certificate Issued 2016-03-11 view