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Acceptance No. Drug Name Active Ingredient Dosage Form Classification Submission Acceptance Date Manufacturers Manufacturers Review Status Status Date View
CXSB0600048 重组(大肠杆菌)戊型肝炎疫苗 Hepatitis E Vaccine(E.coli) Injection Biological Products Supplementary Application 2006-07-18 北京万泰生物药业有限公司 Beijing Wantai Biological Pharmacy Enterprise Co Ltd;Xiamen University Certificate Issued 2007-07-11 view
X0304380 重组(大肠杆菌)戊型肝炎疫苗 Hepatitis E Vaccine(E.coli) Injection Biological Products(1) New Drug Application 2004-09-17 北京万泰生物药业有限公司 Beijing Wantai Biological Pharmacy Enterprise Co Ltd;Xiamen University Certificate Issued 2004-12-06 view
X0306828 轮状病毒诊断试剂盒(胶体金法) Diagnostic reagent IVD New Drug Application 2004-12-07 北京万泰生物药业有限公司 Beijing Wantai Biological Pharmacy Enterprise Co Ltd Certificate Issued 2005-04-11 view
CYSS0700009 甲胎蛋白诊断试剂盒(酶联免疫法) Diagnostic reagent IVD Generic Drug 2007-06-27 北京万泰生物药业有限公司 Beijing Wantai Biological Pharmacy Enterprise Co Ltd Approval Completed-Pending Certificated view
CXSL1700109 注射用重组人Ⅰ型单纯疱疹病毒 Other Biological Products(3) New Drug Application 2018-02-06 北京万泰生物药业股份有限公司 Beijing Wantai Biological Pharmacy Enterprise Co Ltd In Review 2018-02-05 view
CYFB1000083 梅毒螺旋体抗体诊断试剂盒(酶联免疫法) Diagnostic reagent IVD Supplementary Application 2011-03-03 北京万泰生物药业股份有限公司 Beijing Wantai Biological Pharmacy Enterprise Co Ltd Certificate Issued 2011-06-10 view
CYFB0900059 梅毒螺旋体抗体诊断试剂盒(双抗原夹心酶联免疫法) Diagnostic reagent IVD Supplementary Application 2010-06-13 北京万泰生物药业股份有限公司 Beijing Wantai Biological Pharmacy Enterprise Co Ltd Certificate Issued 2010-11-12 view
CYFB1000074 梅毒甲苯胺红不加热血清试验诊断试剂 Diagnostic reagent IVD Supplementary Application 2011-02-12 北京万泰生物药业股份有限公司 Beijing Wantai Biological Pharmacy Enterprise Co Ltd Certificate Issued 2011-06-10 view
CXSS0600074 戊型肝炎病毒抗原(HEV-Ag)诊断试剂盒(酶联免疫法) Diagnostic reagent IVD New Drug Application 2006-09-18 北京万泰生物药业有限公司 Beijing Wantai Biological Pharmacy Enterprise Co Ltd;Xiamen University In Approval 2008-10-29 view
X0302344 戊型肝炎病毒IgM抗体酶联免疫诊断试剂盒(捕获法) Diagnostic reagent IVD New Drug Application 2003-12-24 北京万泰生物药业有限公司 Beijing Wantai Biological Pharmacy Enterprise Co Ltd;Xiamen University Certificate Issued 2004-07-19 view
CXSL1600134 冻干水痘减毒活疫苗(VZV-7D) Lyophilized Biological Products(5) New Drug Application 2017-04-07 北京万泰生物药业股份有限公司 Beijing Wantai Biological Pharmacy Enterprise Co Ltd Certificate Issued 2017-11-21 view
CXSS1200009 冻干水痘减毒活疫苗 Lyophilized Biological Products(15) New Drug Application 2012-09-14 北京万泰生物药业股份有限公司 Beijing Wantai Biological Pharmacy Enterprise Co Ltd Certificate Issued 2015-09-23 view
CYSL0700002 冻干水痘减毒活疫苗 Lyophilized Biological Products(15) Generic Drug 2008-01-22 北京万泰生物药业有限公司 Beijing Wantai Biological Pharmacy Enterprise Co Ltd Certificate Issued 2008-12-22 view
CXSL1300054 冻干带状疱疹减毒活疫苗 Herpes zoster vaccine,Live Lyophilized Biological Products(6) New Drug Application 2013-11-13 北京万泰生物药业股份有限公司 Beijing Wantai Biological Pharmacy Enterprise Co Ltd Certificate Issued 2015-10-13 view
CXSS0600075 人类免疫缺陷病毒抗原抗体(HIV-Ag/Ab)诊断试剂盒(酶联免疫法) Diagnostic reagent IVD New Drug Application 2006-09-18 北京万泰生物药业有限公司 Beijing Wantai Biological Pharmacy Enterprise Co Ltd;Xiamen University Certificate Issued 2008-04-30 view
CYSB1100050 人类免疫缺陷病毒抗原抗体诊断试剂盒(酶联免疫法) Diagnostic reagent IVD Supplementary Application 2011-03-03 北京万泰生物药业股份有限公司 Beijing Wantai Biological Pharmacy Enterprise Co Ltd Certificate Issued 2011-06-10 view
CYSB1700121 人类免疫缺陷病毒抗原抗体诊断试剂盒(酶联免疫法) Diagnostic reagent IVD Supplementary Application 2017-11-16 北京万泰生物药业股份有限公司 Beijing Wantai Biological Pharmacy Enterprise Co Ltd Certificate Issued 2018-07-24 view
CYFB0900060 人类免疫缺陷病毒抗原抗体诊断试剂盒(酶联免疫法) Diagnostic reagent IVD Supplementary Application 2010-06-13 北京万泰生物药业股份有限公司 Beijing Wantai Biological Pharmacy Enterprise Co Ltd Certificate Issued 2010-11-12 view
CYSB1100174 人类免疫缺陷病毒抗原抗体诊断试剂盒(酶联免疫法) Diagnostic reagent IVD Supplementary Application 2011-06-07 北京万泰生物药业股份有限公司 Beijing Wantai Biological Pharmacy Enterprise Co Ltd Certificate Issued 2011-10-20 view
CYSB1100173 人类免疫缺陷病毒抗体诊断试剂盒(酶联免疫法) Diagnostic reagent IVD Supplementary Application 2011-06-22 北京万泰生物药业股份有限公司 Beijing Wantai Biological Pharmacy Enterprise Co Ltd Certificate Issued 2011-10-20 view