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Acceptance No. Drug Name Active Ingredient Dosage Form Classification Submission Acceptance Date Manufacturers Manufacturers Review Status Status Date View
CXSL2300638 注射用重组人凝血因子Ⅷ-Fc融合蛋白 Recombinant Human Coagulation Factor VIII-Fc Fusion Protein Lyophilized Biological Products(2.4) New Drug Application 2023-09-21 Chengdu Rongsheng Pharmaceuticals Co Ltd view
CXSS2300044 注射用重组人凝血因子Ⅷ-Fc融合蛋白 Recombinant Human Coagulation Factor VIII-Fc Fusion Protein Lyophilized Biological Products(1) New Drug Application 2023-06-21 Jiangsu Shengsi Biopharmaceutical Co Ltd;Thousand Oaks Biopharmaceuticals Co Ltd view
CXSL1700162 注射用重组人凝血因子Ⅷ-Fc融合蛋白 Recombinant Human Coagulation Factor VIII-Fc Fusion Protein Lyophilized Biological Products(1) New Drug Application 2018-03-09 开封制药(集团)有限公司 Kaifeng Pharmaceutical (GROUP) Co Ltd Certificate Issued 2018-09-25 view
CXSS2101084 注射用重组人凝血因子Ⅷ-Fc融合蛋白 Recombinant Human Coagulation Factor VIII-Fc Fusion Protein Lyophilized Biological Products(1) New Drug Application 2021-12-23 Jiangsu Shengsi Biopharmaceutical Co Ltd;Thousand Oaks Biopharmaceuticals Co Ltd view
CXSS2300045 注射用重组人凝血因子Ⅷ-Fc融合蛋白 Recombinant Human Coagulation Factor VIII-Fc Fusion Protein Lyophilized Biological Products(1) New Drug Application 2023-06-21 Jiangsu Shengsi Biopharmaceutical Co Ltd;Thousand Oaks Biopharmaceuticals Co Ltd view
CXSS2101083 注射用重组人凝血因子Ⅷ-Fc融合蛋白 Recombinant Human Coagulation Factor VIII-Fc Fusion Protein Lyophilized Biological Products(1) New Drug Application 2021-12-23 Jiangsu Shengsi Biopharmaceutical Co Ltd;Thousand Oaks Biopharmaceuticals Co Ltd view
CXSL1700163 注射用重组人凝血因子Ⅷ-Fc融合蛋白 Recombinant Human Coagulation Factor VIII-Fc Fusion Protein Lyophilized Biological Products(1) New Drug Application 2018-03-09 开封制药(集团)有限公司 Kaifeng Pharmaceutical (GROUP) Co Ltd Certificate Issued 2018-09-25 view
CXSB2400122 注射用重组人凝血因子Ⅷ-Fc融合蛋白 Recombinant Human Coagulation Factor VIII-Fc Fusion Protein Lyophilized Biological Products(2.4) Supplementary Application 2024-10-13 Chengdu Rongsheng Pharmaceuticals Co Ltd view
CXSL2300639 注射用重组人凝血因子Ⅷ-Fc融合蛋白 Recombinant Human Coagulation Factor VIII-Fc Fusion Protein Lyophilized Biological Products(2.4) New Drug Application 2023-09-21 Chengdu Rongsheng Pharmaceuticals Co Ltd view
JYSB2000568 注射用重组人凝血因子Ⅷ Recombinant Coagulation Factor Ⅷ Lyophilized Biological Products Supplementary Application 2020-11-18 Baxter AG;Baxalta Manufacturing Sàrl Filed 2020-12-01 view
JYSB2300036 注射用重组人凝血因子Ⅷ Recombinant Coagulation Factor Ⅷ Lyophilized Biological Products Supplementary Application 2023-02-23 Bayer Healthcare LLC view
JYSB1800204 注射用重组人凝血因子Ⅷ Recombinant Coagulation Factor Ⅷ Lyophilized Biological Products Supplementary Application 2018-09-29 Wyeth Farma SA;Pfizer Ltd Certificate Issued 2019-06-04 view
JYSB2200145 注射用重组人凝血因子Ⅷ Recombinant Coagulation Factor Ⅷ Lyophilized Biological Products Supplementary Application 2022-08-08 Bayer Healthcare LLC view
JYSB2500025 注射用重组人凝血因子Ⅷ Recombinant Coagulation Factor Ⅷ Lyophilized Biological Products Supplementary Application 2025-02-08 Pfizer Europe Ma Eeig;Wyeth Farma SA view
JYSB1800058 注射用重组人凝血因子Ⅷ Recombinant Coagulation Factor Ⅷ Lyophilized Biological Products Supplementary Application 2018-03-28 Baxter AG;Baxalta Manufacturing Sàrl Filed 2018-04-13 view
CXSB2400019 注射用重组人凝血因子Ⅷ Recombinant Coagulation Factor Ⅷ Lyophilized Biological Products Supplementary Application 2024-03-09 Nanjing Shunxin Pharmaceuticals Co LTDof Chiatai Tianqing Pharmaceutical Group view
JYSZ1700006 注射用重组人凝血因子Ⅷ Recombinant Coagulation Factor Ⅷ Lyophilized Biological Products License Renew 2017-03-06 惠氏制药有限公司 Wyeth Pharmaceutical Co Ltd;Wyeth Farma SA;Pfizer Ltd Certificate Issued 2018-07-18 view
JYSB1900284 注射用重组人凝血因子Ⅷ Recombinant Coagulation Factor Ⅷ Lyophilized Biological Products Supplementary Application 2019-11-22 Baxter AG;Baxalta Manufacturing Sàrl Certificate Issued 2020-01-03 view
JXSS1900040 注射用重组人凝血因子Ⅷ Recombinant Coagulation Factor Ⅷ Lyophilized Biological Products Import Drug Application 2019-07-10 丹麦诺和诺德公司 Novo Nordisk A/S Certificate Issued 2021-01-05 view
JYSZ2200049 注射用重组人凝血因子Ⅷ Recombinant Coagulation Factor Ⅷ Lyophilized Biological Products License Renew 2022-09-14 Bayer Healthcare LLC;Bayer Healthcare Company Ltd view