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Acceptance No. Drug Name Active Ingredient Dosage Form Classification Submission Acceptance Date Manufacturers Manufacturers Review Status Status Date View
CXHB2400252 注射用右旋兰索拉唑 dexlansoprazole Lyophilized Chemical Drugs(原2) Supplementary Application 2024-11-19 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
CXHB2200167 注射用右兰索拉唑 dexlansoprazole Lyophilized Chemical Drugs(2.2) Supplementary Application 2022-10-10 Hunan Sailong Pharmaceutical Co Ltd view
CYHB2400833 注射用右兰索拉唑 dexlansoprazole Lyophilized Chemical Drugs(2.2) Supplementary Application 2024-06-18 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
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
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
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
CXHL1401195 右兰索拉唑 dexlansoprazole Active ingredient Chemical Drugs(3.1) New Drug Application 2014-11-15 上海汇伦江苏药业有限公司 Shanghai Huilun (Jiangsu) Pharmaceutical Co Ltd Certificate Issued 2016-04-07 view
CXHL1401681 注射用右兰索拉唑 dexlansoprazole Lyophilized Chemical Drugs(2) New Drug Application 2015-04-17 上海汇伦江苏药业有限公司 Shanghai Huilun (Jiangsu) Pharmaceutical Co Ltd Certificate Issued 2016-04-18 view
CXHL1401196 右兰索拉唑缓释胶囊 dexlansoprazole Capsules, extended release Chemical Drugs(3.1) New Drug Application 2014-11-17 上海汇伦江苏药业有限公司 Shanghai Huilun (Jiangsu) Pharmaceutical Co Ltd Certificate Issued 2016-08-12 view
CXHL1401904 右旋兰索拉唑 dexlansoprazole Active ingredient Chemical Drugs(3.1) New Drug Application 2015-02-13 中美华世通生物医药科技(武汉)有限公司 Waterstone Pharmaceuticals (WUHAN) Co Ltd Certificate Issued 2016-05-19 view
CXHB1500126 注射用右旋兰索拉唑 dexlansoprazole Lyophilized Chemical Drugs Supplementary Application 2015-11-16 南京优科制药有限公司 Nanjing YOKO Pharmaceutical Co Ltd Certificate Issued 2016-09-04 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
CXHL1401043 右兰索拉唑缓释胶囊 dexlansoprazole Capsules, extended release Chemical Drugs(3.1) New Drug Application 2014-09-25 南京优科制药有限公司 Nanjing YOKO Pharmaceutical Co Ltd Certificate Issued 2016-03-17 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