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Acceptance No. Drug Name Active Ingredient Dosage Form Classification Submission Acceptance Date Manufacturers Manufacturers Review Status Status Date 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
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
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
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
CXSL2500022 静注人免疫球蛋白(10%) human immunoglobulin(PH4) Injection Biological Products(3.2) New Drug Application 2025-01-08 Guangdong Shuanglin Bio-Pharmacy Co Ltd view
CYSB2500005 静注人免疫球蛋白(pH4) human immunoglobulin(PH4) Injection Biological Products Supplementary Application 2025-01-04 Yunnan Bohui Innovative Biology Co Ltd view
CXSS2400135 静注人免疫球蛋白(pH4) human immunoglobulin(PH4) Injection Biological Products(3.4) New Drug Application 2024-12-04 Guangdong Danxia Biology Pharmcy Co Ltd view
CXSS2400136 静注人免疫球蛋白(pH4) human immunoglobulin(PH4) Injection Biological Products(3.4) New Drug Application 2024-12-04 Guangdong Danxia Biology Pharmcy Co Ltd view
CXSS2400133 皮下注射人免疫球蛋白 Lyophilized Biological Products(3.2) New Drug Application 2024-12-03 Chengdu Rongsheng Pharmaceuticals Co Ltd view
CYSB2400309 狂犬病人免疫球蛋白 human rabies immunoglobulin Injection Biological Products Supplementary Application 2024-12-03 Chengdu Rongsheng Pharmaceuticals Co Ltd view
CYSB2400305 静注人免疫球蛋白(pH4) human immunoglobulin(PH4) Injection Biological Products Supplementary Application 2024-11-21 Guangdong Shuanglin Bio-Pharmacy Co Ltd view
CYSB2400277 静注人免疫球蛋白 human immunoglobulin(PH4) Injection Biological Products(原15) Supplementary Application 2024-10-23 Hualan Biological Engineering Inc view
CYSB2400278 静注人免疫球蛋白 human immunoglobulin(PH4) Injection Biological Products(原15) Supplementary Application 2024-10-23 Hualan Biological Engineering Inc view