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Acceptance No. Drug Name Active Ingredient Dosage Form Classification Submission Acceptance Date Manufacturers Manufacturers Review Status Status Date View
JYSZ2400053 地舒单抗注射液 denosumab Injection Biological Products License Renew 2024-09-30 Amgen Europe BV;Amgen Manufacturing Ltd;Amgen Biology Technology Consulting (Shanghai) Co Ltd view
JYSZ2300054 地舒单抗注射液 denosumab Injection Biological Products License Renew 2023-12-21 Amgen Inc;BeiGene (Beijing) Co Ltd;Amgen Manufacturing Ltd view
JYSB2300213 地舒单抗注射液 denosumab Injection Biological Products Supplementary Application 2023-12-14 Amgen Europe BV;Amgen Manufacturing Ltd view
JYSB2300112 地舒单抗注射液 denosumab Injection Biological Products Supplementary Application 2023-06-22 Amgen Inc;Amgen Manufacturing Ltd;Bushu Pharmaceuticals Ltd view
JYSB2200025 地舒单抗注射液 denosumab Injection Biological Products Supplementary Application 2022-02-25 Amgen Inc;Amgen Manufacturing Ltd;Bushu Pharmaceuticals Ltd view
JYSB2101087 地舒单抗注射液 denosumab Injection Biological Products Supplementary Application 2021-07-24 Amgen Europe BV;Amgen Manufacturing Ltd view
JYSB2101008 地舒单抗注射液 denosumab Injection Biological Products Supplementary Application 2021-04-10 Amgen Europe BV;Amgen Manufacturing Ltd view
JYSB2000222 地舒单抗注射液 denosumab Injection Biological Products Supplementary Application 2020-06-02 百济神州(北京)生物科技有限公司 BeiGene (Beijing) Co Ltd;Amgen Inc;Amgen Manufacturing Ltd Filed 2020-06-09 view
JXSS2300031 地舒单抗注射液 denosumab Injection Biological Products(3.1) Import Drug Application 2023-04-13 Amgen Europe BV;Amgen Manufacturing Ltd;Amgen Biology Technology Consulting (Shanghai) Co Ltd view
JXSS2200019 地舒单抗注射液 denosumab Injection Biological Products(3.1) Import Drug Application 2022-06-13 Amgen Europe BV;Amgen Manufacturing Ltd;Amgen Biology Technology Consulting (Shanghai) Co Ltd view
JXSS2000009 地舒单抗注射液 denosumab Injection Biological Products Import Drug Application 2020-04-23 安进生物技术咨询(上海)有限公司 Amgen Biology Technology Consulting (Shanghai) Co Ltd;Amgen Inc;Amgen Manufacturing Ltd Certificate Issued 2020-11-19 view
JXSS1900034 地舒单抗注射液 denosumab Injection Biological Products Import Drug Application 2019-06-22 安进生物技术咨询(上海)有限公司 Amgen Biology Technology Consulting (Shanghai) Co Ltd;Amgen Europe BV;Amgen Manufacturing Ltd Certificate Issued 2020-06-22 view
JXSS1800026 地舒单抗注射液 denosumab Injection Biological Products Import Drug Application 2018-10-26 安进生物技术咨询(上海)有限公司 Amgen Biology Technology Consulting (Shanghai) Co Ltd;Amgen Inc;Amgen Manufacturing Ltd Certificate Issued 2019-05-23 view
JXSL1900137 地舒单抗注射液 denosumab Injection Biological Products Import Drug Application 2019-12-06 安进生物技术咨询(上海)有限公司 Amgen Biology Technology Consulting (Shanghai) Co Ltd;Amgen Inc In Review 2019-12-05 view
JXSL1700064 地舒单抗注射液 denosumab Injection Biological Products Import Drug Application 2017-10-20 安进生物技术咨询(上海)有限公司 Amgen Biology Technology Consulting (Shanghai) Co Ltd;Amgen Inc Certificate Issued 2018-08-13 view
JXSL1000037 狄诺塞单抗注射液 denosumab Injection Biological Products Import Drug Application 2010-09-09 Amgen Europe BV Certificate Issued 2012-08-14 view
JXSL1000036 狄诺塞单抗注射液 denosumab Injection Biological Products Import Drug Application 2010-08-27 Amgen Europe BV Certificate Issued 2013-10-23 view
JXSL1000024 狄诺塞麦 denosumab Injection Biological Products Import Drug Application 2010-05-31 安进有限公司 Amgen Inc Certificate Issued 2012-05-25 view
JTS2100502 地舒单抗(狄诺塞麦)注射液 denosumab Injection Biological Products Disposable Import Drug Application 2021-05-21 Amgen Manufacturing Ltd;Shanghai Biomabs Pharmaceuticals Co Ltd view
JTS2000046 地舒单抗注射液 denosumab Injection Biological Products Disposable Import Drug Application 2020-10-19 Amgen Manufacturing Limited Amgen Manufacturing Ltd;Amgen Inc;KPC Pharmaceuticals Inc In Review 2020-10-14 view