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Acceptance No. Drug Name Active Ingredient Dosage Form Classification Submission Acceptance Date Manufacturers Manufacturers Review Status Status Date View
CXHL1000599 右兰索拉唑 dexlansoprazole Active ingredient Chemical Drugs(3.1) New Drug Application 2011-01-05 江苏豪森药业股份有限公司 Jiangsu Hansoh Pharmaceutical Group Co Ltd Certificate Issued 2014-05-16 view
CXHL1000601 右兰索拉唑缓释胶囊 dexlansoprazole Capsules, extended release Chemical Drugs(3.1) New Drug Application 2011-01-05 江苏豪森药业股份有限公司 Jiangsu Hansoh Pharmaceutical Group Co Ltd Certificate Issued 2014-05-16 view
CXHL1000600 右兰索拉唑缓释胶囊 dexlansoprazole Capsules, extended release Chemical Drugs(3.1) New Drug Application 2011-01-05 江苏豪森药业股份有限公司 Jiangsu Hansoh Pharmaceutical Group Co Ltd Certificate Issued 2014-05-16 view
JXHL1100317 右兰索拉唑缓释胶囊 dexlansoprazole Capsules, extended release Chemical Drugs Import Drug Application 2011-09-05 Takeda Pharmaceuticals North America, Inc. Takeda Pharmaceuticals North America Inc Certificate Issued 2014-11-24 view
CXHL1000716 右旋兰索拉唑缓释胶囊 dexlansoprazole Capsules, extended release Chemical Drugs(3.1) New Drug Application 2011-09-21 江苏正大天晴药业股份有限公司 Jiangsu Chia Tai-Tianqing Pharmaceutical Co Ltd Certificate Issued 2015-05-27 view
CXHL1000715 右旋兰索拉唑 dexlansoprazole Active ingredient Chemical Drugs(3.1) New Drug Application 2011-09-21 江苏正大天晴药业股份有限公司 Jiangsu Chia Tai-Tianqing Pharmaceutical Co Ltd Certificate Issued 2015-05-27 view
JXHL1100318 右兰索拉唑缓释胶囊 dexlansoprazole Capsules, extended release Chemical Drugs Import Drug Application 2011-09-21 Takeda Pharmaceuticals North America, Inc. Takeda Pharmaceuticals North America Inc Certificate Issued 2014-11-24 view
CXHL1200429 右兰索拉唑 dexlansoprazole Active ingredient Chemical Drugs(3.1) New Drug Application 2012-09-26 河南新帅克制药股份有限公司 Germany Pharmaceutical Co Ltd Certificate Issued 2015-11-19 view
CXHL1200431 右兰索拉唑 dexlansoprazole Active ingredient Chemical Drugs(3.1) New Drug Application 2012-09-26 河南圣凡制药有限公司 Henan Shengfan Medicine Co Ltd Certificate Issued 2015-11-19 view
CXHL1200430 右兰索拉唑迟释胶囊 dexlansoprazole Capsule Chemical Drugs(3.1) New Drug Application 2012-09-26 河南新帅克制药股份有限公司 Germany Pharmaceutical Co Ltd Certificate Issued 2015-11-05 view
CXHL1200432 右兰索拉唑缓释胶囊 dexlansoprazole Capsules, extended release Chemical Drugs(3.1) New Drug Application 2012-10-10 河南圣凡制药有限公司 Henan Shengfan Medicine Co Ltd Certificate Issued 2015-11-05 view
JYHB1201365 右兰索拉唑缓释胶囊 dexlansoprazole Capsules, extended release Chemical Drugs Supplementary Application 2012-12-25 Takeda Canada Inc. Takeda Canada Inc Approval Completed-Pending Certificated 2014-09-17 view
JYHB1201364 右兰索拉唑缓释胶囊 dexlansoprazole Capsules, extended release Chemical Drugs Supplementary Application 2012-12-25 Takeda Canada Inc. Takeda Canada Inc Approval Completed-Pending Certificated 2014-09-17 view
CXHL1300074 右旋兰索拉唑 dexlansoprazole Active ingredient Chemical Drugs(3.1) New Drug Application 2013-03-21 南京优科制药有限公司 Nanjing YOKO Pharmaceutical Co Ltd Certificate Issued 2013-10-17 view
CXHL1300075 注射用右旋兰索拉唑 dexlansoprazole Lyophilized Chemical Drugs(2) New Drug Application 2013-03-21 南京优科制药有限公司 Nanjing YOKO Pharmaceutical Co Ltd Certificate Issued 2013-09-27 view
CXHL1300885 右兰索拉唑 dexlansoprazole Active ingredient Chemical Drugs(3.1) New Drug Application 2013-10-28 南京海纳医药科技有限公司 Nanjing Healthnice Pharmaceutical Technology Co Ltd Certificate Issued 2016-01-21 view
CXHL1300887 右兰索拉唑缓释胶囊 dexlansoprazole Capsules, extended release Chemical Drugs(3.1) New Drug Application 2013-10-28 南京海纳医药科技有限公司 Nanjing Healthnice Pharmaceutical Technology Co Ltd Certificate Issued 2016-01-21 view
CXHL1300886 右兰索拉唑缓释胶囊 dexlansoprazole Capsules, extended release Chemical Drugs(3.1) New Drug Application 2013-10-28 南京海纳医药科技有限公司 Nanjing Healthnice Pharmaceutical Technology Co Ltd Certificate Issued 2016-01-21 view
JYHB1301731 右兰索拉唑缓释胶囊 dexlansoprazole Capsules, extended release Chemical Drugs Supplementary Application 2014-01-17 Takeda (Thailand), Ltd. Takeda (Thailand) Ltd Approval Completed-Pending Certificated 2014-09-17 view
JYHB1301730 右兰索拉唑缓释胶囊 dexlansoprazole Capsules, extended release Chemical Drugs Supplementary Application 2014-01-17 Takeda (Thailand), Ltd. Takeda (Thailand) Ltd Approval Completed-Pending Certificated 2014-09-17 view