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Acceptance No. Drug Name Active Ingredient Dosage Form Classification Submission Acceptance Date Manufacturers Manufacturers Review Status Status Date 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
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
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
CXSL1400030 重组抗RANKL全人单克隆抗体注射液 denosumab Injection Biological Products(2) New Drug Application 2014-04-15 齐鲁制药有限公司 QILU Pharmaceutical Co Ltd Certificate Issued 2016-10-11 view
CXSL1400029 重组抗RANKL全人单克隆抗体注射液 denosumab Injection Biological Products(2) New Drug Application 2014-04-15 齐鲁制药有限公司 QILU Pharmaceutical Co Ltd Certificate Issued 2016-10-11 view
CXSL1400093 重组全人源抗RANKL单克隆抗体注射液 denosumab Injection Biological Products(2) New Drug Application 2014-12-11 江苏泰康生物医药有限公司 Jiangsu T-mab Bio-Pharmaceuticals Co Ltd Certificate Issued 2016-09-26 view
CXSL1500116 重组抗RANKL全人源单克隆抗体注射液 denosumab Injection Biological Products(2) New Drug Application 2016-01-15 浙江海正药业股份有限公司 Zhejiang Hisun Pharmaceutical Co Ltd Certificate Issued 2016-12-15 view
CXSL1600032 重组全人源抗RANKL单克隆抗体注射液 denosumab Injection Biological Products(2) New Drug Application 2016-05-18 江苏泰康生物医药有限公司 Jiangsu T-mab Bio-Pharmaceuticals Co Ltd Certificate Issued 2017-01-11 view
CXSL1600051 重组全人源抗RANKL单克隆抗体注射液 denosumab Injection Biological Products(1) New Drug Application 2016-08-11 上海津曼特生物科技有限公司 Shanghai GeneMab Biological Technology Co Ltd Certificate Issued 2017-07-06 view
CXSL1600053 重组全人源抗RANKL单克隆抗体注射液 denosumab Injection Biological Products(1) New Drug Application 2016-08-11 上海津曼特生物科技有限公司 Shanghai GeneMab Biological Technology Co Ltd Certificate Issued 2017-03-15 view
CXSL1600080 重组抗RANKL全人单克隆抗体注射液 denosumab Injection Biological Products(2) New Drug Application 2016-10-11 山东博安生物技术有限公司 Shandong BoAn Biotechnology Co Ltd Certificate Issued 2017-06-09 view
CXSL1600099 重组抗RANKL全人单克隆抗体注射液 denosumab Injection Biological Products(2) New Drug Application 2016-12-05 山东博安生物技术有限公司 Shandong BoAn Biotechnology Co Ltd Certificate Issued 2017-06-20 view
CXSL1600131 重组全人源抗RANKL单克隆抗体注射液 denosumab Injection Biological Products(2) New Drug Application 2017-02-13 菲洋生物科技(吉林)有限公司 Feiyang Biotechnology (Jilin) Co Ltd Certificate Issued 2017-12-21 view
CXSL1600096 CMAB807注射液 denosumab Injection Biological Products(2) New Drug Application 2017-05-04 上海百迈博制药有限公司 Shanghai Biomabs Pharmaceuticals Co Ltd Certificate Issued 2018-05-08 view
CXSL1700048 重组全人源抗RANKL单克隆抗体注射液 denosumab Injection Biological Products(1) New Drug Application 2017-07-17 珠海市丽珠单抗生物技术有限公司 Livzon Mabpharm INC Certificate Issued 2017-12-21 view
CXSL1700051 重组全人源抗RANKL单克隆抗体注射液 denosumab Injection Biological Products(1) New Drug Application 2017-07-25 珠海市丽珠单抗生物技术有限公司 Livzon Mabpharm INC Certificate Issued 2017-12-21 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 Certificate Issued 2018-08-13 view
CXSL1700110 重组抗RANKL全人源单克隆抗体注射液 denosumab Injection Biological Products(2) New Drug Application 2017-12-25 华兰基因工程有限公司 Hualan Genetic Engineering Co Ltd Certificate Issued 2018-10-08 view
CXSL1700211 重组全人源抗RANKL单克隆抗体注射液 denosumab Injection Biological Products(2) New Drug Application 2018-01-31 苏州信达生物科技有限公司 Suzhou Xinda Biotechnology Co Ltd Certificate Issued 2018-07-06 view
CXSL1800064 重组抗RANKL全人源单克隆抗体注射液 denosumab Injection Biological Products(2) New Drug Application 2018-06-13 浙江海正药业股份有限公司 Zhejiang Hisun Pharmaceutical Co Ltd Certificate Issued 2018-10-29 view