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Acceptance No. Drug Name Active Ingredient Dosage Form Classification Submission Acceptance Date Manufacturers Manufacturers Review Status Status Date 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
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
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
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
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
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
JYSB2400095 达雷妥尤单抗注射液 daratumumab Injection Biological Products Supplementary Application 2024-04-25 Cilag AG;Janssen-Cilag AG 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
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
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
JYSZ2300047 达雷妥尤单抗注射液 daratumumab Injection Biological Products License Renew 2023-10-31 Cilag AG;Xian Janssen Pharmaceutical Ltd;Janssen-Cilag AG view
JYSZ2300046 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
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
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
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
JYSB2300077 达雷妥尤单抗注射液 daratumumab Injection Biological Products Supplementary Application 2023-04-29 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
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
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