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Acceptance No. Drug Name Active Ingredient Dosage Form Classification Submission Acceptance Date Manufacturers Manufacturers Review Status Status Date 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
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
JXHL1500304 无定形右兰索拉唑 dexlansoprazole Active ingredient Chemical Drugs Import Drug Application 2016-05-27 意大利蒂法马梵思股份有限公司北京代表处 In Review 2016-05-26 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
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
CYHS1700641 右旋兰索拉唑 dexlansoprazole Active ingredient Chemical Drugs(3) Generic Drug 2018-10-19 海南碧凯药业有限公司 Hainan Bikai Pharmaceutical Co Ltd In Review 2018-10-17 view
CYHL1700008 右旋兰索拉唑 dexlansoprazole Active ingredient Chemical Drugs(3) Generic Drug 2018-07-12 杭州华东医药集团新药研究院有限公司 Hangzhou Huadong MEDICINE Group Pharmaceutical Research Institute Co Ltd In Review 2018-07-10 view
CYHL1600017 右旋兰索拉唑 dexlansoprazole Active ingredient Chemical Drugs(3) Generic Drug 2017-01-20 湖南赛隆药业有限公司 Hunan Sailong Pharmaceutical Co Ltd In Review 2017-01-19 view
CYHB2400833 注射用右兰索拉唑 dexlansoprazole Lyophilized Chemical Drugs(2.2) Supplementary Application 2024-06-18 view
CYHB2400432 注射用右兰索拉唑 dexlansoprazole Lyophilized Chemical Drugs(2.2) Supplementary Application 2024-03-27 view
CYHB2300465 注射用右兰索拉唑 dexlansoprazole Lyophilized Chemical Drugs(2.2) Supplementary Application 2023-03-06 view
CYHB1704323 注射用右旋兰索拉唑 dexlansoprazole Lyophilized Chemical Drugs Supplementary Application 2017-08-30 南京优科制药有限公司 Nanjing YOKO Pharmaceutical Co Ltd Certificate Issued 2018-02-24 view
CXHS2200027 注射用右兰索拉唑 dexlansoprazole Lyophilized Chemical Drugs(2.2) New Drug Application 2022-05-25 Jiangsu Aosaikang Pharmaceutical Co Ltd view
CXHS2100001 注射用右兰索拉唑 dexlansoprazole Lyophilized Chemical Drugs(2.2) New Drug Application 2021-01-09 江苏奥赛康药业有限公司 Jiangsu Aosaikang Pharmaceutical Co Ltd Certificate Issued 2021-08-19 view
CXHS1900031 注射用右旋兰索拉唑 dexlansoprazole Lyophilized Chemical Drugs(2.2) New Drug Application 2019-09-19 盛禾(中国)生物制药有限公司 Shenghe (China) Biopharmaceutical Co Ltd In Review 2019-09-18 view
CXHL1700323 注射用右旋兰索拉唑 dexlansoprazole Lyophilized Chemical Drugs(2.2) New Drug Application 2018-10-17 海南碧凯药业有限公司 Hainan Bikai Pharmaceutical Co Ltd In Review 2018-10-16 view
CXHL1700309 注射用右旋兰索拉唑 dexlansoprazole Lyophilized Chemical Drugs(2.2) New Drug Application 2018-07-12 杭州中美华东制药有限公司 Hangzhou Zhongmei Huadong Pharmaceutical Co Ltd In Review 2018-07-10 view
CXHL1700308 注射用右旋兰索拉唑 dexlansoprazole Lyophilized Chemical Drugs(2.2) New Drug Application 2018-07-12 杭州中美华东制药有限公司 Hangzhou Zhongmei Huadong Pharmaceutical Co Ltd In Review 2018-07-10 view