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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
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
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
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
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
CYSB2000365 静注人免疫球蛋白(pH4) human immunoglobulin(PH4) Injection Biological Products Supplementary Application 2020-12-18 同路生物制药有限公司 Tonrol Bio-Pharmaceutical Co Limited In Review 2020-12-17 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
CYSB2000364 静注人免疫球蛋白(pH4) human immunoglobulin(PH4) Injection Biological Products Supplementary Application 2020-12-18 同路生物制药有限公司 Tonrol Bio-Pharmaceutical Co Limited Certificate Issued 2021-08-27 view
CYSB1600195 静注人免疫球蛋白(pH4) human immunoglobulin(PH4) Injection Biological Products Supplementary Application 2017-02-23 同路生物制药有限公司 Tonrol Bio-Pharmaceutical Co Limited Certificate Issued 2017-07-06 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
CYSB2000363 静注人免疫球蛋白(pH4) human immunoglobulin(PH4) Injection Biological Products Supplementary Application 2020-12-18 同路生物制药有限公司 Tonrol Bio-Pharmaceutical Co Limited In Review 2020-12-17 view
CYSB2000367 静注人免疫球蛋白(pH4) human immunoglobulin(PH4) Injection Biological Products Supplementary Application 2020-12-18 同路生物制药有限公司 Tonrol Bio-Pharmaceutical Co Limited In Review 2020-12-17 view
CYSB2000366 静注人免疫球蛋白(pH4) human immunoglobulin(PH4) Injection Biological Products Supplementary Application 2020-12-18 同路生物制药有限公司 Tonrol Bio-Pharmaceutical Co Limited Certificate Issued 2021-09-02 view
CYSB0600119 静注人免疫球蛋白(pH4) human immunoglobulin(PH4) Injection Biological Products Supplementary Application 2007-04-19 同路生物制药有限公司 Tonrol Bio-Pharmaceutical Co Limited Certificate Issued 2008-07-21 view
CYSB0600117 静注人免疫球蛋白(pH4) human immunoglobulin(PH4) Injection Biological Products Supplementary Application 2007-04-19 同路生物制药有限公司 Tonrol Bio-Pharmaceutical Co Limited Certificate Issued 2008-07-21 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
CYSB1800194 破伤风人免疫球蛋白 human tetanus immunoglobulin Injection Biological Products Supplementary Application 2018-09-28 同路生物制药有限公司 Tonrol Bio-Pharmaceutical Co Limited Certificate Issued 2020-10-21 view
CYSB1000702 破伤风人免疫球蛋白 human tetanus immunoglobulin Injection Biological Products Supplementary Application 2011-03-29 同路生物制药有限公司 Tonrol Bio-Pharmaceutical Co Limited Certificate Issued 2013-01-10 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
CXSS0800015 狂犬病人免疫球蛋白 human rabies immunoglobulin Injection Biological Products(15) New Drug Application 2008-05-27 同路生物制药有限公司 Tonrol Bio-Pharmaceutical Co Limited Certificate Issued 2011-07-27 view