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Acceptance No. Drug Name Active Ingredient Dosage Form Classification Submission Acceptance Date Manufacturers Manufacturers Review Status Status Date View
CXSL2200462 达雷妥尤单抗注射液 daratumumab Injection Biological Products(3.3) New Drug Application 2022-09-16 Nanjing Shunxin Pharmaceuticals Co LTDof Chiatai Tianqing Pharmaceutical Group view
CXSL2200463 达雷妥尤单抗注射液 daratumumab Injection Biological Products(3.3) New Drug Application 2022-09-16 Nanjing Shunxin Pharmaceuticals Co LTDof Chiatai Tianqing Pharmaceutical Group view
CXSL2200528 达雷妥尤单抗注射液 daratumumab Injection Biological Products(3.3) New Drug Application 2022-10-20 Nanjing Shunxin Pharmaceuticals Co LTDof Chiatai Tianqing Pharmaceutical Group view
CXSL2200529 达雷妥尤单抗注射液 daratumumab Injection Biological Products(3.3) New Drug Application 2022-10-20 Nanjing Shunxin Pharmaceuticals Co LTDof Chiatai Tianqing Pharmaceutical Group view
CXSL2300108 达雷妥尤单抗注射液 daratumumab Injection Biological Products(3.3) New Drug Application 2023-02-09 Hangzhou Jiuyuan Genetic Biopharmaceutical Co Ltd view
CXSL2300110 达雷妥尤单抗注射液 daratumumab Injection Biological Products(3.3) New Drug Application 2023-02-09 Hangzhou Jiuyuan Genetic Biopharmaceutical Co Ltd view
CXSL2400135 达雷妥尤单抗注射液 daratumumab Injection Biological Products(3.3) New Drug Application 2024-02-21 Nanjing Shunxin Pharmaceuticals Co LTDof Chiatai Tianqing Pharmaceutical Group view
CXSL2400136 达雷妥尤单抗注射液 daratumumab Injection Biological Products(3.3) New Drug Application 2024-02-21 Nanjing Shunxin Pharmaceuticals Co LTDof Chiatai Tianqing Pharmaceutical Group view
CXSL2400635 达雷妥尤单抗注射液 daratumumab Injection Biological Products(3.3) New Drug Application 2024-09-21 CSPC Megalith Biopharmaceutical Co Ltd view
JXSB2300033 达雷妥尤单抗注射液(皮下注射) daratumumab Injection Biological Products(3.4) Supplementary Application 2023-03-28 Cilag AG;Janssen Research & Development LLC view
JXSL2200010 达雷妥尤单抗注射液(皮下注射) daratumumab Injection Biological Products(3.4) Import Drug Application 2022-01-19 Janssen Research & Development LLC;Johnson & Johnson (CHINA) Investment Ltd view
JXSL2300040 达雷妥尤单抗注射液(皮下注射) daratumumab Injection Biological Products(3.1) Import Drug Application 2023-02-23 Janssen-Cilag International NV;Johnson & Johnson (CHINA) Investment Ltd view
JXSL2300072 达雷妥尤单抗注射液 daratumumab Injection Biological Products(3.4) Import Drug Application 2023-04-21 Janssen-Cilag AG;Johnson & Johnson (CHINA) Investment Ltd view
JXSS2000019 达雷妥尤单抗注射液 daratumumab Injection Biological Products Import Drug Application 2020-07-03 Janssen-Cilag International NV Janssen-Cilag International NV;Cilag AG In Review 2020-07-02 view
JXSS2000020 达雷妥尤单抗注射液 daratumumab Injection Biological Products Import Drug Application 2020-07-03 Janssen-Cilag International NV Janssen-Cilag International NV;Cilag AG In Review 2020-07-02 view
JXSS2000050 达雷妥尤单抗注射液(皮下注射) daratumumab Injection Biological Products(2.2) Import Drug Application 2020-11-06 西安杨森制药有限公司 Xian Janssen Pharmaceutical Ltd;Cilag AG;Janssen-Cilag International NV Certificate Issued 2021-10-11 view
JXSS2100015 达雷妥尤单抗注射液 daratumumab Injection Biological Products(3.1) Import Drug Application 2021-02-19 西安杨森制药有限公司 Xian Janssen Pharmaceutical Ltd;Cilag AG;Janssen-Cilag International NV Certificate Issued 2021-11-12 view
JXSS2100016 达雷妥尤单抗注射液 daratumumab Injection Biological Products(3.1) Import Drug Application 2021-02-19 西安杨森制药有限公司 Xian Janssen Pharmaceutical Ltd;Cilag AG;Janssen-Cilag International NV Certificate Issued 2021-11-12 view
JXSS2200013 达雷妥尤单抗注射液(皮下注射) daratumumab Injection Biological Products(3.1) Import Drug Application 2022-04-15 Cilag AG;Xian Janssen Pharmaceutical Ltd;Janssen-Cilag International NV view
JXSS2500061 达雷妥尤单抗注射液(皮下注射) daratumumab Injection Biological Products(3.1) Import Drug Application 2025-05-14 Johnson & Johnson;Cilag AG;Janssen-Cilag International NV view