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Acceptance No. Drug Name Active Ingredient Dosage Form Classification Submission Acceptance Date Manufacturers Manufacturers Review Status Status Date View
JYSB2101129 达雷妥尤单抗注射液 daratumumab Injection Biological Products Supplementary Application 2021-09-13 Cilag AG;Janssen-Cilag International NV 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
JYSB2500003 达雷妥尤单抗注射液 daratumumab Injection Biological Products Supplementary Application 2025-01-03 Cilag AG;Janssen-Cilag AG view
JYSB2300076 达雷妥尤单抗注射液 daratumumab Injection Biological Products Supplementary Application 2023-04-29 Cilag AG;Janssen-Cilag AG view
JYSB2200057 达雷妥尤单抗注射液 daratumumab Injection Biological Products Supplementary Application 2022-03-28 Cilag AG;Janssen-Cilag AG view
JYSB2101146 达雷妥尤单抗注射液 daratumumab Injection Biological Products Supplementary Application 2021-10-11 Cilag AG;Janssen-Cilag International NV 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
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
JYSB2500002 达雷妥尤单抗注射液 daratumumab Injection Biological Products Supplementary Application 2025-01-03 Cilag AG;Janssen-Cilag AG 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
JYSB2300079 达雷妥尤单抗注射液 daratumumab Injection Biological Products Supplementary Application 2023-04-29 Cilag AG;Janssen-Cilag AG 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
JYSB2200015 达雷妥尤单抗注射液(皮下注射) daratumumab Injection Biological Products Supplementary Application 2022-01-30 Cilag AG;Janssen-Cilag International NV view
JYSB2300204 达雷妥尤单抗注射液(皮下注射) daratumumab Injection Biological Products Supplementary Application 2023-12-08 Cilag AG;Janssen-Cilag International NV view
JYSB2200040 达雷妥尤单抗注射液(皮下注射) daratumumab Injection Biological Products Supplementary Application 2022-03-10 Cilag AG;Janssen-Cilag International NV 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
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
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
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
JYSB2300078 达雷妥尤单抗注射液 daratumumab Injection Biological Products Supplementary Application 2023-04-29 Cilag AG;Janssen-Cilag AG view