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Acceptance No. Drug Name Active Ingredient Dosage Form Classification Submission Acceptance Date Manufacturers Manufacturers Review Status Status Date View
CSB00032 HIV 1+2型抗体试剂盒(双抗原夹心法) Diagnostic reagent IVD(2) Supplementary Application 2000-12-19 北京万泰生物药业有限公司 Beijing Wantai Biological Pharmacy Enterprise Co Ltd Certificate Issued 2008-12-26 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 Certificate Issued 2007-07-11 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
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
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
CXSS0500093 乙型肝炎病毒核心IgM抗体诊断试剂盒(酶联免疫法) Diagnostic reagent IVD New Drug Application 2005-06-19 北京万泰生物药业有限公司 Beijing Wantai Biological Pharmacy Enterprise Co Ltd Certificate Completed-Pending Issued 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 In Approval 2008-10-29 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 Certificate Issued 2008-04-30 view
CXSS0800008 乙型肝炎病毒表面抗原诊断试剂盒(酶联免疫法) Diagnostic reagent Biological Products New Drug Application 2008-06-26 北京万泰生物药业股份有限公司 Beijing Wantai Biological Pharmacy Enterprise Co Ltd Certificate Issued 2009-04-07 view
CXSS1100007 丙型肝炎病毒抗体诊断试剂盒(双抗原夹心酶联免疫法) Diagnostic reagent IVD New Drug Application 2011-11-08 北京万泰生物药业股份有限公司 Beijing Wantai Biological Pharmacy Enterprise Co Ltd Certificate Issued 2013-01-30 view
CXSS1200002 乙型肝炎病毒/丙型肝炎病毒/人类免疫缺陷病毒1型核酸联合检测试剂盒(PCR-荧光探针法) Diagnostic reagent IVD 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 2015-04-22 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
CYFB0900056 乙型肝炎病毒表面抗原诊断试剂盒(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
CYFB0900057 人类免疫缺陷病毒HIV(1+2型)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
CYFB0900058 丙型肝炎病毒抗体诊断试剂盒(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
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
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
CYFB0900061 乙型肝炎病毒表面抗原诊断试剂盒(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 2011-05-11 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
CYFB1000082 丙型肝炎病毒抗体诊断试剂盒(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