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Acceptance No. Drug Name Active Ingredient Dosage Form Classification Submission Acceptance Date Manufacturers Manufacturers Review Status Status Date View
CXSL1100046 冻干静注乙型肝炎人免疫球蛋白(pH4) human hepatitis B immunoglobulin(pH4) Lyophilized Biological Products(15) New Drug Application 2011-09-21 同路生物制药股份有限公司 Tonrol Bio-Pharmaceutical Co Limited Certificate Issued 2013-04-11 view
CXSS1900045 冻干静注乙型肝炎人免疫球蛋白(pH4) human hepatitis B immunoglobulin(pH4) Lyophilized Biological Products(15) New Drug Application 2019-12-11 同路生物制药有限公司 Tonrol Bio-Pharmaceutical Co Limited Certificate Issued 2021-08-04 view
CXSB2100004 冻干静注乙型肝炎人免疫球蛋白(pH4) human hepatitis B immunoglobulin(pH4) Lyophilized Biological Products Supplementary Application 2021-01-11 成都蓉生药业有限责任公司 Chengdu Rongsheng Pharmaceuticals Co Ltd Certificate Issued 2021-10-08 view