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Acceptance No. Drug Name Active Ingredient Dosage Form Classification Submission Acceptance Date Manufacturers Manufacturers Review Status Status Date View
CXSS0600006 高危型人乳头瘤病毒(HR-HPV)核酸扩增(PCR)荧光定量检测试剂盒 Diagnostic reagent IVD New Drug Application 2006-03-02 中山大学达安基因股份有限公司 Daan Gene Co Ltd Certificate Completed-Pending Issued view
CXSS0500154 解脲脲原体(UU)核酸扩增(PCR)荧光定量检测试剂盒 Diagnostic reagent IVD New Drug Application 2006-01-24 中山大学达安基因股份有限公司 Daan Gene Co Ltd Certificate Completed-Pending Issued view
CXSS0600008 解脲脲原体(UU)基因分型反向点杂交(RDB)检测试剂盒 Diagnostic reagent IVD New Drug Application 2006-05-16 中山大学达安基因股份有限公司 Daan Gene Co Ltd Approval Completed-Pending Certificated view
CXSS0800001 血源筛查HBV、HCV、HIV-1病毒核酸检测试剂盒(PCR-荧光探针法) Diagnostic reagent Biological Products New Drug Application 2008-05-19 中山大学达安基因股份有限公司 Daan Gene Co Ltd Certificate Issued 2010-12-07 view
X0400537 萘哌地尔缓释胶囊 naftopidil Capsules, extended release Chemical Drugs(5) New Drug Application 2004-02-09 中山大学中山医学院科技开发中心 Guangzhou Zhongda Zhongshan Medical Technology Development Co Ltd Certificate Issued 2005-07-29 view
X0400532 萘哌地尔缓释片 naftopidil Tablet, extended release Chemical Drugs(5) New Drug Application 2004-02-06 中山大学中山医学院科技发展有限公司 Guangzhou Zhongshan Medicine Technology Co Ltd Certificate Issued 2005-02-04 view
CXZL1200071 芩夷感冒颗粒 Granule Chinese Herbal Medicine(6.1) New Drug Application 2013-02-06 中山大学 Sun Yat-Sen University Certificate Issued 2014-01-16 view
X0407396 自体DC/肾癌融合细胞疫苗 Other Biological Products(3) New Drug Application 2004-12-09 中山大学肿瘤防治中心 Tumor Hospital Under Sun Yat-Sen University Certificate Issued 2008-08-07 view
CXFS0500061 肺炎支原体(MP)核酸扩增(PCR)荧光定量检测试剂盒 Diagnostic reagent IVD New Drug Application 2005-10-11 中山大学达安基因股份有限公司 Daan Gene Co Ltd Certificate Completed-Pending Issued view
CXSB0500078 结核分支杆菌核酸扩增(PCR)荧光检测试剂盒 Diagnostic reagent IVD Supplementary Application 2005-09-01 中山大学达安基因股份有限公司 Daan Gene Co Ltd Certificate Issued 2006-02-08 view
CXSS0600101 细胞角蛋白19片段定量测定试剂盒(时间分辨免疫荧光法) Diagnostic reagent IVD New Drug Application 2006-11-01 中山大学达安基因股份有限公司 Daan Gene Co Ltd In Approval 2008-07-29 view
X0305068 糖视明 滴丸 Pellet Chinese Herbal Medicine(6) New Drug Application 2004-12-22 中山大学中山医学院科技发展有限公司 Guangzhou Zhongshan Medicine Technology Co Ltd Certificate Issued 2005-05-09 view
CXZL0600123 糖脉交泰胶囊 Capsule Chinese Herbal Medicine(6) New Drug Application 2006-06-02 中山大学 Sun Yat-Sen University Certificate Issued 2008-02-28 view
CXSS0600102 神经元特异性烯醇化酶定量测定试剂盒(时间分辨免疫荧光法) Diagnostic reagent IVD New Drug Application 2006-11-01 中山大学达安基因股份有限公司 Daan Gene Co Ltd In Approval 2008-07-29 view
X0408320 癌胚抗原(CEA)定量检测试剂盒(时间分辨免疫荧光分析法) Diagnostic reagent IVD New Drug Application 2005-01-07 中山大学达安基因股份有限公司 Daan Gene Co Ltd Certificate Issued 2006-05-30 view
X0405546 甲胎蛋白(AFP)定量诊断试剂盒(时间分辨免疫荧光分析法) Diagnostic reagent IVD New Drug Application 2004-09-30 中山大学达安基因股份有限公司 Daan Gene Co Ltd Certificate Issued 2005-11-03 view
CXSS0600044 游离前列腺特异性抗原定量测定试剂盒(时间分辨免疫荧光法) Diagnostic reagent IVD New Drug Application 2006-04-19 中山大学达安基因股份有限公司 Daan Gene Co Ltd Approval Completed-Pending Certificated view
CXSS0500169 淋球菌(NGH)核酸扩增(PCR)荧光定量检测试剂盒 Diagnostic reagent IVD New Drug Application 2006-04-02 中山大学达安基因股份有限公司 Daan Gene Co Ltd In Approval 2008-07-29 view
CXL20022782 注射用尖吻蝮蛇凝血酶 haemocoagulase agkistrodon Lyophilized Chemical Drugs(1) New Drug Application 2002-10-29 中山大学 Sun Yat-Sen University In Approval view
CXHL1200557 柚皮苷片 Naringin Tablet Chemical Drugs(1.2) New Drug Application 2012-11-21 中山大学 Sun Yat-Sen University Certificate Issued 2013-07-29 view