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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
JYHB2100019 盐酸沙丙蝶呤片 SAPROPTERIN HYDROCHLORIDE Tablet Chemical Drugs(5.1) Supplementary Application 2021-01-08 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 International Ltd;Excella GmbH Filed 2021-01-20 view
JYHB1900823 盐酸沙丙蝶呤片 SAPROPTERIN HYDROCHLORIDE Tablet Chemical Drugs Supplementary Application 2019-07-11 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;Biomarin International Ltd;Excella GmbH Certificate Issued 2019-09-26 view
JYHB1900641 盐酸沙丙蝶呤片 SAPROPTERIN HYDROCHLORIDE Tablet Chemical Drugs Supplementary Application 2019-06-06 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 International Ltd;Excella GmbH Certificate Issued 2019-09-26 view
JYHB1900640 盐酸沙丙蝶呤片 SAPROPTERIN HYDROCHLORIDE Tablet Chemical Drugs Supplementary Application 2019-05-27 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 International Ltd;Excella GmbH Filed 2019-05-31 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
JYHB1800812 盐酸沙丙蝶呤片 SAPROPTERIN HYDROCHLORIDE Tablet Chemical Drugs Supplementary Application 2018-07-20 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;Biomarin International Ltd;Excella GmbH Certificate Issued 2018-12-06 view
JYHZ1700309 盐酸沙丙蝶呤片 SAPROPTERIN HYDROCHLORIDE Tablet Chemical Drugs License Renew 2017-10-09 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 International Ltd;Excella GmbH Certificate Issued 2018-04-03 view
JYHB1700762 盐酸沙丙蝶呤片 SAPROPTERIN HYDROCHLORIDE Tablet Chemical Drugs Supplementary Application 2017-06-07 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 International Ltd;Excella GmbH Certificate Issued 2020-07-27 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
JYHB1601024 盐酸沙丙蝶呤片 SAPROPTERIN HYDROCHLORIDE Tablet Chemical Drugs Supplementary Application 2016-08-05 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 International Ltd;Excella GmbH Certificate Issued 2017-04-13 view
JYHB1601025 盐酸沙丙蝶呤片 SAPROPTERIN HYDROCHLORIDE Tablet Chemical Drugs Supplementary Application 2016-07-27 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 International Ltd;Excella GmbH Certificate Issued 2017-04-13 view