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Acceptance No. Drug Name Active Ingredient Dosage Form Classification Submission Acceptance Date Manufacturers Manufacturers Review Status Status Date View
CXSB2100005 静注人免疫球蛋白(pH4) Human Immunoglobulin(pH4) Injection Biological Products(原15) Supplementary Application 2021-01-11 新疆德源生物工程有限公司 Xinjiang Deyuan Biological Engineering Co Ltd Certificate Issued 2021-07-13 view
CXSL1200036 静注人免疫球蛋白(pH4) Human Immunoglobulin(pH4) Injection Biological Products(15) New Drug Application 2012-06-27 新疆德源生物工程有限公司 Xinjiang Deyuan Biological Engineering Co Ltd Certificate Issued 2014-07-24 view
CXSL1300123 静注人免疫球蛋白(pH4) Human Immunoglobulin(pH4) Injection Biological Products(15) New Drug Application 2014-01-27 河北大安制药有限公司 Bohui Biopharmaceutical (Hebei) Co Ltd Certificate Issued 2015-05-13 view
CXSL1400048 静注人免疫球蛋白(pH4) Human Immunoglobulin(pH4) Injection Biological Products(15) New Drug Application 2014-05-29 山东泰邦生物制品有限公司 Shandong Taibang Biological Products Co Ltd Certificate Issued 2015-10-20 view
CXSL1400052 10%静注人免疫球蛋白 Human Immunoglobulin(pH4) Injection Biological Products(7) New Drug Application 2014-06-13 武汉生物制品研究所有限责任公司 Wuhan Institute of Biological Products Co Ltd Certificate Issued 2015-12-10 view
CXSL1700099 静注人免疫球蛋白(pH4) Human Immunoglobulin(pH4) Injection Biological Products(15) New Drug Application 2017-11-03 四川远大蜀阳药业股份有限公司 Sichuan Yuanda Shuyang Pharmaceutical Co Ltd In Review 2017-11-01 view
CXSL1700123 静注人免疫球蛋白(10%) Human Immunoglobulin(pH4) Injection Biological Products(7) New Drug Application 2017-12-07 贵州泰邦生物制品有限公司 Guizhou Taibang Biological Products Co Ltd Certificate Issued 2018-11-09 view
CXSL1900155 静注人免疫球蛋白 Human Immunoglobulin(pH4) Injection Biological Products(7) New Drug Application 2020-01-20 华兰生物工程股份有限公司 Hualan Biological Engineering Inc In Review 2020-01-19 view
CXSL1900156 静注人免疫球蛋白 Human Immunoglobulin(pH4) Injection Biological Products(7) New Drug Application 2020-01-20 华兰生物工程股份有限公司 Hualan Biological Engineering Inc In Review 2020-01-19 view
CXSL1900157 静注人免疫球蛋白 Human Immunoglobulin(pH4) Injection Biological Products(7) New Drug Application 2020-01-20 华兰生物工程股份有限公司 Hualan Biological Engineering Inc In Review 2020-01-19 view
CXSL2101366 静注人免疫球蛋白(10%) Human Immunoglobulin(pH4) Injection Biological Products(3.2) New Drug Application 2021-10-14 China Resources Boya Bio-pharmaceutical Group Co Ltd view
CXSL2200012 静注人免疫球蛋白(pH4) Human Immunoglobulin(pH4) Injection Biological Products(3.4) New Drug Application 2022-01-12 Guangdong Danxia Biology Pharmcy Co Ltd view
CXSL2200013 静注人免疫球蛋白(pH4) Human Immunoglobulin(pH4) Injection Biological Products(3.4) New Drug Application 2022-01-12 Guangdong Danxia Biology Pharmcy Co Ltd view
CXSL2200229 静注人免疫球蛋白 Human Immunoglobulin(pH4) Injection Biological Products(3.2) New Drug Application 2022-05-27 Shenzhen Weiguang Biological Products Co Ltd view
CXSL2200230 静注人免疫球蛋白 Human Immunoglobulin(pH4) Injection Biological Products(3.2) New Drug Application 2022-05-27 Shenzhen Weiguang Biological Products Co Ltd view
CXSL2200603 静注人免疫球蛋白(pH4) Human Immunoglobulin(pH4) Injection Biological Products(3.4) New Drug Application 2022-12-16 Guangdong Danxia Biology Pharmcy Co Ltd view
CXSL2200604 静注人免疫球蛋白(pH4) Human Immunoglobulin(pH4) Injection Biological Products(3.4) New Drug Application 2022-12-16 Guangdong Danxia Biology Pharmcy Co Ltd view
CXSL2400234 静注人免疫球蛋白(pH4) Human Immunoglobulin(pH4) Injection Biological Products(3.4) New Drug Application 2024-04-16 Sichuan Yuanda Shuyang Pharmaceutical Co Ltd view
CXSL2400412 静注人免疫球蛋白(pH4) Human Immunoglobulin(pH4) Injection Biological Products(3.2) New Drug Application 2024-06-26 Chengdu Rongsheng Pharmaceuticals Co Ltd view
CXSS0500158 静注人免疫球蛋白(pH4) Human Immunoglobulin(pH4) Injection Biological Products(13) New Drug Application 2006-01-10 武汉生物制品研究所 Wuhan Institute of Biological Products Co Ltd Certificate Issued 2007-11-26 view