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Acceptance No. Drug Name Active Ingredient Dosage Form Classification Submission Acceptance Date Manufacturers Manufacturers Review Status Status Date 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
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
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
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
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 Xian Janssen Pharmaceutical Ltd;Cilag AG;Janssen-Cilag International NV 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
JYSB2300140 达雷妥尤单抗注射液(皮下注射) daratumumab Injection Biological Products Supplementary Application 2023-08-18 Cilag AG;Janssen-Cilag International NV view
JYSB2500075 达雷妥尤单抗注射液(皮下注射) daratumumab Injection Biological Products Supplementary Application 2025-03-22 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
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
JYSB2500166 达雷妥尤单抗注射液(皮下注射) daratumumab Injection Biological Products Supplementary Application 2025-07-10 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
JYSB2500022 达雷妥尤单抗注射液(皮下注射) daratumumab Injection Biological Products Supplementary Application 2025-02-07 Cilag AG;Janssen-Cilag International NV view
JYSB2400094 达雷妥尤单抗注射液 daratumumab Injection Biological Products Supplementary Application 2024-04-25 Cilag AG;Janssen-Cilag AG view
JYSB2101145 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
JYSB2000285 达雷妥尤单抗注射液 daratumumab Injection Biological Products Supplementary Application 2020-06-19 Janssen-Cilag International NV Janssen-Cilag International NV;Cilag AG Filed 2020-06-23 view
JYSB2500168 达雷妥尤单抗注射液 daratumumab Injection Biological Products Supplementary Application 2025-07-10 Cilag AG;Janssen-Cilag AG 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
JYSZ2300047 达雷妥尤单抗注射液 daratumumab Injection Biological Products License Renew 2023-10-31 Xian Janssen Pharmaceutical Ltd;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