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Acceptance No. Drug Name Active Ingredient Dosage Form Classification Submission Acceptance Date Manufacturers Manufacturers Review Status Status Date View
CXSL1500109 CMAB806 tocilizumab Injection Biological Products(2) New Drug Application 2016-02-16 泰州迈博太科药业有限公司 Taizhou Maibotaike Pharmaceutical Co Ltd Certificate Issued 2016-11-09 view
CXSL1700217 QX003S注射液 tocilizumab Injection Biological Products(2) New Drug Application 2018-02-06 江苏荃信生物医药有限公司 Jiangsu Quan Xin Biomedical Co Ltd Certificate Issued 2018-06-28 view
CXSL2100074 托珠单抗注射液 tocilizumab Injection Biological Products(3.4) New Drug Application 2021-02-27 百奥泰生物制药股份有限公司 Bio-Thera Solutions Ltd In Review 2021-02-26 view
CXSS2101047 托珠单抗注射液 tocilizumab Injection Biological Products(3.3) New Drug Application 2021-11-08 Bio-Thera Solutions Ltd view
CXSS2101048 托珠单抗注射液 tocilizumab Injection Biological Products(3.3) New Drug Application 2021-11-08 Bio-Thera Solutions Ltd view
CXSS2101049 托珠单抗注射液 tocilizumab Injection Biological Products(3.3) New Drug Application 2021-11-08 Bio-Thera Solutions Ltd view
CXSS2101056 托珠单抗注射液 tocilizumab Injection Biological Products(3.3) New Drug Application 2021-12-22 Livzon Mabpharm INC view
CXSS2300001 托珠单抗注射液 tocilizumab Injection Biological Products(3.3) New Drug Application 2023-01-07 view
CXSS2300005 托珠单抗注射液 tocilizumab Injection Biological Products(3.3) New Drug Application 2023-02-07 Hisun Biopharmaceutical Co Ltd view
CYSB2300048 托珠单抗注射液 tocilizumab Injection Biological Products(3.3) Supplementary Application 2023-02-22 Livzon Mabpharm INC view
CYSB2300049 托珠单抗注射液 tocilizumab Injection Biological Products(3.3) Supplementary Application 2023-02-22 Livzon Mabpharm INC view
CYSB2400108 托珠单抗注射液 tocilizumab Injection Biological Products(3.3) Supplementary Application 2024-05-09 Bio-Thera Solutions Ltd view
CYSB2400109 托珠单抗注射液 tocilizumab Injection Biological Products(3.3) Supplementary Application 2024-05-09 Bio-Thera Solutions Ltd view
CYSB2400110 托珠单抗注射液 tocilizumab Injection Biological Products(3.3) Supplementary Application 2024-05-09 Bio-Thera Solutions Ltd view
CYSB2400220 托珠单抗注射液 tocilizumab Injection Biological Products(3.3) Supplementary Application 2024-08-21 Bio-Thera Solutions Ltd view
CYSB2400221 托珠单抗注射液 tocilizumab Injection Biological Products(3.3) Supplementary Application 2024-08-21 Bio-Thera Solutions Ltd view
J0402200 Tocilizumab注射剂 tocilizumab Injection Biological Products(1) Import Drug Application 2004-11-17 中外制药株式会社 Chugai Pharma Co Ltd Certificate Issued 2005-11-01 view
JXSL0500030 Tocilizumab注射剂 tocilizumab Injection Biological Products(1) Import Drug Application 2006-01-04 中外制药株式会社 Chugai Pharma Co Ltd Certificate Issued 2006-11-23 view
JXSL0800039 托珠单抗注射液 tocilizumab Injection Biological Products Import Drug Application 2008-12-12 Roche Pharma (Schweiz) Ltd Roche Pharma (Schweiz) Ltd Certificate Issued 2010-05-26 view
JXSL0800041 托珠单抗注射液 tocilizumab Injection Biological Products Import Drug Application 2008-12-02 Roche Pharma (Schweiz) Ltd Roche Pharma (Schweiz) Ltd Certificate Issued 2010-05-26 view