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Acceptance No. Drug Name Active Ingredient Dosage Form Classification Submission Acceptance Date Manufacturers Manufacturers Review Status Status Date View
CXHB1000409 艾塞那肽 Exenatide Active ingredient Chemical Drugs Supplementary Application 2010-11-03 长春百克生物科技股份公司 Changchun BCHT Biotechnology Co Certificate Issued 2011-02-12 view
CXHB1000410 注射用艾塞那肽 Exenatide Lyophilized Chemical Drugs Supplementary Application 2010-11-03 长春百克生物科技股份公司 Changchun BCHT Biotechnology Co Certificate Issued 2011-02-12 view
CXHB1700048 聚乙二醇化艾塞那肽 PEGylated exenatide Active ingredient Chemical Drugs Supplementary Application 2017-06-08 派格生物医药(苏州)有限公司 Peg BIO Co Ltd Certificate Issued 2017-10-17 view
CXHB1700049 聚乙二醇化艾塞那肽注射液 PB-119 Injection Chemical Drugs Supplementary Application 2017-06-08 派格生物医药(苏州)有限公司 Peg BIO Co Ltd Certificate Issued 2017-10-17 view
CXHB2000061 聚乙二醇化艾塞那肽注射液 PB-119 Injection Chemical Drugs Supplementary Application 2020-06-29 派格生物医药(苏州)有限公司 Peg BIO Co Ltd In Review 2020-06-28 view
CXHB2400043 聚乙二醇化艾塞那肽注射液 PB-119 Injection Chemical Drugs(1) Supplementary Application 2024-02-19 Peg BIO Co Ltd view
CXHL0600185 艾塞那肽 Exenatide Active ingredient Chemical Drugs(3.1) New Drug Application 2006-03-21 海南双成药业有限公司 Hainan Shuangcheng Pharmaceuticals Co Ltd Certificate Issued 2009-10-10 view
CXHL0600186 注射用艾塞那肽 Exenatide Lyophilized Chemical Drugs(3.1) New Drug Application 2006-03-21 海南双成药业有限公司 Hainan Shuangcheng Pharmaceuticals Co Ltd Certificate Issued 2009-09-29 view
CXHL0600921 艾塞那肽 Exenatide Active ingredient Chemical Drugs(3.1) New Drug Application 2006-07-11 长春高新百克药物研究院有限公司 Cchn Bcht Pharmaceutical Research Institute Co Ltd Certificate Issued 2008-08-07 view
CXHL0600922 注射用艾塞那肽 Exenatide Lyophilized Chemical Drugs(3.1) New Drug Application 2006-07-11 长春高新百克药物研究院有限公司 Cchn Bcht Pharmaceutical Research Institute Co Ltd Certificate Issued 2008-08-07 view
CXHL0601123 艾塞那肽 Exenatide Active ingredient Chemical Drugs(3.1) New Drug Application 2006-11-06 内蒙古科诺医药开发有限公司 Inner Mongolia Kenuo Pharmaceutical Development Co Ltd In Review 2013-02-25 view
CXHL0601124 艾塞那肽注射液 Exenatide Injection Chemical Drugs(3.1) New Drug Application 2006-11-06 内蒙古科诺医药开发有限公司 Inner Mongolia Kenuo Pharmaceutical Development Co Ltd Certificate Issued 2008-10-21 view
CXHL0700199 艾塞那肽 Exenatide Active ingredient Chemical Drugs(3.1) New Drug Application 2007-08-22 江苏豪森药业股份有限公司 Jiangsu Hansoh Pharmaceutical Group Co Ltd Certificate Issued 2008-09-12 view
CXHL0700200 艾塞那肽注射液 Exenatide Injection Chemical Drugs(3.1) New Drug Application 2007-08-22 江苏豪森药业股份有限公司 Jiangsu Hansoh Pharmaceutical Group Co Ltd Certificate Issued 2008-09-19 view
CXHL0700298 艾塞那肽 Exenatide Active ingredient Chemical Drugs(3.1) New Drug Application 2007-10-15 杭州九源基因工程有限公司 Hangzhou Jiuyuan Gene Engineering Co Ltd Certificate Issued 2010-01-14 view
CXHL0700299 艾塞那肽注射液 Exenatide Injection Chemical Drugs(3.1) New Drug Application 2007-10-15 杭州九源基因工程有限公司 Hangzhou Jiuyuan Gene Engineering Co Ltd Certificate Issued 2010-01-14 view
CXHL1200114 聚乙二醇化艾塞那肽 PEGylated exenatide Active ingredient Chemical Drugs(1.1) New Drug Application 2012-04-28 派格生物医药(苏州)有限公司 Peg BIO Co Ltd Certificate Issued 2013-09-13 view
CXHL1200115 聚乙二醇化艾塞那肽注射液 PB-119 Injection Chemical Drugs(1.1) New Drug Application 2012-04-28 派格生物医药(苏州)有限公司 Peg BIO Co Ltd Certificate Issued 2013-09-13 view
CXHL1300448 注射用艾塞那肽缓释微球 Exenatide Lyophilized Chemical Drugs(2) New Drug Application 2013-05-30 山东绿叶制药有限公司 Shandong Luye Pharmaceutical Co Ltd Certificate Issued 2016-11-09 view
CXHL1301447 艾塞那肽 Exenatide Active ingredient Chemical Drugs(3.1) New Drug Application 2014-02-17 齐鲁制药有限公司 QILU Pharmaceutical Co Ltd Certificate Issued 2016-02-03 view