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Acceptance No. Drug Name Active Ingredient Dosage Form Classification Submission Acceptance Date Manufacturers Manufacturers Review Status Status Date View
JYSB2100053 依洛硫酸酯酶α注射液 elosulfase alfa Injection Biological Products Supplementary Application 2021-02-23 百傲万里(上海) 生物医药技术咨询有限公司 Baiao Wanli (Shanghai) Biomedical Technology Consulting Co Ltd;Vetter Pharma-Fertigung Gmbh & Co KG;Biomarin International Ltd In Review 2021-02-22 view
JYSB2100014 依洛硫酸酯酶α注射液 elosulfase alfa Injection Biological Products Supplementary Application 2021-01-20 百傲万里(上海) 生物医药技术咨询有限公司 Baiao Wanli (Shanghai) Biomedical Technology Consulting Co Ltd;Vetter Pharma-Fertigung Gmbh & Co KG;Biomarin International Ltd Filed 2021-01-22 view
JYSB1900044 Elosulfase alfa注射用浓溶液 elosulfase alfa Injection Biological Products Supplementary Application 2019-02-11 百傲万里(上海) 生物医药技术咨询有限公司 Baiao Wanli (Shanghai) Biomedical Technology Consulting Co Ltd;Vetter Pharma-Fertigung Gmbh & Co KG;Biomarin International Ltd Certificate Issued 2019-05-28 view
JXSL1700009 Elosulfase alfa注射用浓溶液 elosulfase alfa Injection Biological Products Import Drug Application 2017-02-13 百傲万里(上海) 生物医药技术咨询有限公司 Baiao Wanli (Shanghai) Biomedical Technology Consulting Co Ltd;BioMarin Europe Ltd Certificate Issued 2019-05-28 view