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Acceptance No. Drug Name Active Ingredient Dosage Form Classification Submission Acceptance Date Manufacturers Manufacturers Review Status Status Date View
CSL20020059 重组AAV-2/人凝血因子IX注射液 Injection Biological Products(1) New Drug Application 2002-09-02 本元正阳基因技术股份有限公司 Vgtc Gene Technology Company Ltd Approval Completed-Pending Certificated 2003-02-24 view
CXSL1600003 人凝血因子Ⅸ Human Coagulation Factor Ⅸ Lyophilized Biological Products(7) New Drug Application 2016-02-16 山东泰邦生物制品有限公司 Shandong Taibang Biological Products Co Ltd Certificate Issued 2016-09-04 view
CXSL1600041 人凝血因子IX Human Coagulation Factor Ⅸ Lyophilized Biological Products(7) New Drug Application 2016-07-11 四川远大蜀阳药业股份有限公司 Sichuan Yuanda Shuyang Pharmaceutical Co Ltd Certificate Issued 2016-12-08 view
CXSL2300259 注射用培重组人凝血因子IX-Fc融合蛋白 Lyophilized Biological Products(1) New Drug Application 2023-04-14 Zhengzhou Shengsi Biotechnology Co Ltd view
CXSL2300260 注射用培重组人凝血因子IX-Fc融合蛋白 Lyophilized Biological Products(1) New Drug Application 2023-04-14 Zhengzhou Shengsi Biotechnology Co Ltd view
CXSL2300529 人凝血因子IX Human Coagulation Factor Ⅸ Lyophilized Biological Products(3.4) New Drug Application 2023-08-01 Guangdong Shuanglin Bio-Pharmacy Co Ltd view
CXSL2300595 人凝血因子IX Human Coagulation Factor Ⅸ Lyophilized Biological Products(3.4) New Drug Application 2023-09-02 Hualan Biological Engineering Inc view
CXSL2400072 人凝血因子IX Human Coagulation Factor Ⅸ Lyophilized Biological Products(3.4) New Drug Application 2024-01-31 Chengdu Rongsheng Pharmaceuticals Co Ltd view
CXSS1800007 人凝血因子Ⅸ Human Coagulation Factor Ⅸ Lyophilized Biological Products(7) New Drug Application 2018-04-16 山东泰邦生物制品有限公司 Shandong Taibang Biological Products Co Ltd Certificate Issued 2020-07-16 view
CXSS1900050 人凝血因子IX Human Coagulation Factor Ⅸ Lyophilized Biological Products(7) New Drug Application 2019-12-26 四川远大蜀阳药业有限责任公司 Sichuan Yuanda Shuyang Pharmaceutical Co Ltd In Review 2019-12-25 view
CYSB2100054 人凝血因子Ⅸ Human Coagulation Factor Ⅸ Lyophilized Biological Products(原7) Supplementary Application 2021-02-05 山东泰邦生物制品有限公司 Shandong Taibang Biological Products Co Ltd In Review 2022-01-25 view
CYSB2300115 人凝血因子Ⅸ Human Coagulation Factor Ⅸ Lyophilized Biological Products(原7) Supplementary Application 2023-06-14 Shandong Taibang Biological Products Co Ltd view
CYSB2300147 人凝血因子Ⅸ Human Coagulation Factor Ⅸ Lyophilized Biological Products Supplementary Application 2023-07-28 Shandong Taibang Biological Products Co Ltd view
CYSB2400043 人凝血因子Ⅸ Human Coagulation Factor Ⅸ Lyophilized Biological Products(原7) Supplementary Application 2024-02-20 Shandong Taibang Biological Products Co Ltd view
CYSB2400105 人凝血因子Ⅸ Human Coagulation Factor Ⅸ Lyophilized Biological Products Supplementary Application 2024-05-08 Sichuan Yuanda Shuyang Pharmaceutical Co Ltd view
JXSL0900022 注射用重组人凝血因子IX Recombinant Coagulation Factor Ⅸ Lyophilized Biological Products Import Drug Application 2009-05-18 Wyeth Europa Ltd Certificate Issued 2010-05-13 view
JXSL0900023 注射用重组人凝血因子IX Recombinant Coagulation Factor Ⅸ Lyophilized Biological Products Import Drug Application 2009-05-06 Wyeth Europa Ltd Certificate Issued 2010-05-13 view
JXSL0900024 注射用重组人凝血因子IX Recombinant Coagulation Factor Ⅸ Lyophilized Biological Products Import Drug Application 2009-05-06 Wyeth Europa Ltd Certificate Issued 2010-07-06 view
JXSL0900025 注射用重组人凝血因子IX Recombinant Coagulation Factor Ⅸ Lyophilized Biological Products Import Drug Application 2009-05-06 Wyeth Europa Ltd Certificate Issued 2010-05-13 view
JXSL0900061 重组人凝血因子IX融合蛋白 Recombinant Coagulation Factor Ⅸ Fusion Protein Other Biological Products Import Drug Application 2009-08-17 杭州泰格医药科技有限公司 Hangzhou Tigermed Consulting Co Ltd Certificate Issued 2011-08-02 view