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Acceptance No. Drug Name Active Ingredient Dosage Form Classification Submission Acceptance Date Manufacturers Manufacturers Review Status Status Date View
CXSL2500861 静注人免疫球蛋白 human immunoglobulin(PH4) Injection Biological Products(3.4) New Drug Application 2025-10-10 Guangdong Wellen Pharmaceutical Co Ltd view
JTS2500090 人免疫球蛋白 human immunoglobulin Injection Biological Products Disposable Import Drug Application 2025-09-23 Hunan Ziguang Huhan Nanyue Pharmaceutical Co Ltd;Biotest Pharma GmbH view
CYSB2500205 狂犬病人免疫球蛋白 human rabies immunoglobulin Injection Biological Products(3.4) Supplementary Application 2025-09-13 Hualan Biological Engineering Chongqing Co Ltd view
CYSB2500206 狂犬病人免疫球蛋白 human rabies immunoglobulin Injection Biological Products(3.4) Supplementary Application 2025-09-13 Hualan Biological Engineering Chongqing Co Ltd view
CYSB2500200 人免疫球蛋白 human immunoglobulin Injection Biological Products(3.4) Supplementary Application 2025-09-05 Guangdong Shuanglin Bio-Pharmacy Co Ltd view
CYSB2500201 人免疫球蛋白 human immunoglobulin Injection Biological Products(3.4) Supplementary Application 2025-09-05 Guangdong Shuanglin Bio-Pharmacy Co Ltd view
CYSB2500176 冻干静注乙型肝炎人免疫球蛋白 Injection Biological Products Supplementary Application 2025-08-06 Chengdu Rongsheng Pharmaceuticals Co Ltd view
CXSS2500078 破伤风人免疫球蛋白 human tetanus immunoglobulin Injection Biological Products(3.4) New Drug Application 2025-08-06 Guangdong Danxia Biology Pharmcy Co Ltd view
CYSB2500156 狂犬病人免疫球蛋白 human rabies immunoglobulin Injection Biological Products(原15) Supplementary Application 2025-07-10 Guizhou Taibang Biological Products Co Ltd view
CXSS2500038 破伤风人免疫球蛋白 human tetanus immunoglobulin Injection Biological Products(3.4) New Drug Application 2025-03-25 Zhejiang Haikang Biotech Products Co Ltd view
CXSL2500165 静注人免疫球蛋白 human immunoglobulin(PH4) Injection Biological Products(3.2) New Drug Application 2025-02-19 Shandong Taibang Biological Products Co Ltd view
CYSB2500038 静注人免疫球蛋白 human immunoglobulin(PH4) Injection Biological Products(3.4) Supplementary Application 2025-02-08 Hualan Biological Engineering Chongqing Co Ltd view
CYSB2500034 狂犬病人免疫球蛋白 human rabies immunoglobulin Injection Biological Products(原15) Supplementary Application 2025-01-27 Tonrol Bio-Pharmaceutical Co Limited view
CYSB2500035 狂犬病人免疫球蛋白 human rabies immunoglobulin Injection Biological Products(原15) Supplementary Application 2025-01-27 Tonrol Bio-Pharmaceutical Co Limited view
CYSB2500033 狂犬病人免疫球蛋白 human rabies immunoglobulin Injection Biological Products(原15) Supplementary Application 2025-01-27 Tonrol Bio-Pharmaceutical Co Limited view
CYSB2500020 静注人免疫球蛋白(pH4) human immunoglobulin(PH4) Injection Biological Products Supplementary Application 2025-01-17 Chengdu Rongsheng Pharmaceuticals Co Ltd view
CYSB2500019 静注人免疫球蛋白(pH4) human immunoglobulin(PH4) Injection Biological Products Supplementary Application 2025-01-17 Chengdu Rongsheng Pharmaceuticals Co Ltd view
CYSB2500018 静注人免疫球蛋白(pH4) human immunoglobulin(PH4) Injection Biological Products Supplementary Application 2025-01-17 Chengdu Rongsheng Pharmaceuticals Co Ltd view
CYSB2500012 静注人免疫球蛋白 human immunoglobulin(PH4) Injection Biological Products(原15) Supplementary Application 2025-01-11 Hualan Biological Engineering Inc view
CXSL2500031 皮下注射人免疫球蛋白 Lyophilized Biological Products(3.2) New Drug Application 2025-01-10 China Resources Boya Bio-pharmaceutical Group Co Ltd view