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Acceptance No. Drug Name Active Ingredient Dosage Form Classification Submission Acceptance Date Manufacturers Manufacturers Review Status Status Date View
JXHL1400081 ARN-509胶囊 apalutamide Capsule Chemical Drugs Import Drug Application 2014-03-25 Aragon Pharmaceuticals, Inc. Aragon Pharmaceuticals Inc Certificate Issued 2015-05-21 view
JXHL1500006 ARN-509片 apalutamide Tablet Chemical Drugs Import Drug Application 2015-03-27 Aragon Pharmaceuticals, Inc. Aragon Pharmaceuticals Inc Certificate Issued 2016-03-28 view
JXHL1400410 ARN-509片 apalutamide Tablet Chemical Drugs Import Drug Application 2015-03-27 Aragon Pharmaceuticals, Inc. Aragon Pharmaceuticals Inc Certificate Issued 2016-03-28 view
JXHL1500207 ARN-509片 apalutamide Tablet Chemical Drugs Import Drug Application 2015-08-24 Aragon Pharmaceuticals, Inc. Aragon Pharmaceuticals Inc Certificate Issued 2016-07-15 view
JXHL1500251 ARN-509片 apalutamide Tablet Chemical Drugs Import Drug Application 2015-10-12 Aragon Pharmaceuticals, Inc. Aragon Pharmaceuticals Inc Certificate Issued 2016-07-15 view
JYHB1601050 ARN-509片 apalutamide Tablet Chemical Drugs Supplementary Application 2016-08-19 Aragon Pharmaceuticals, Inc. Aragon Pharmaceuticals Inc Certificate Issued 2016-12-30 view
JYHB1800439 ARN-509片 apalutamide Tablet Chemical Drugs Supplementary Application 2018-04-20 Aragon Pharmaceuticals,Inc. Aragon Pharmaceuticals Inc Certificate Issued 2018-07-09 view
JYHB1800442 ARN-509片 apalutamide Tablet Chemical Drugs Supplementary Application 2018-04-20 Aragon Pharmaceuticals,Inc. Aragon Pharmaceuticals Inc Certificate Issued 2018-07-09 view
JYHB1800441 ARN-509片 apalutamide Tablet Chemical Drugs Supplementary Application 2018-04-20 Aragon Pharmaceuticals,Inc. Aragon Pharmaceuticals Inc Certificate Issued 2018-07-09 view
JYHB1800440 ARN-509片 apalutamide Tablet Chemical Drugs Supplementary Application 2018-04-20 Aragon Pharmaceuticals,Inc. Aragon Pharmaceuticals Inc Certificate Issued 2018-07-09 view
CXSL1800075 SYB509注射液 SYB509 Injection Biological Products(2) New Drug Application 2018-07-11 四川远大蜀阳药业股份有限公司 Sichuan Yuanda Shuyang Pharmaceutical Co Ltd In Review 2018-07-09 view
CXHL1800206 BPI-17509片 BPI-17509 Tablet Chemical Drugs(1) New Drug Application 2018-12-12 贝达药业股份有限公司 Betta Pharmaceuticals Co Ltd In Review 2018-12-11 view
CXHL1800205 BPI-17509片 BPI-17509 Tablet Chemical Drugs(1) New Drug Application 2018-12-12 贝达药业股份有限公司 Betta Pharmaceuticals Co Ltd In Review 2018-12-11 view
CXHL1800192 BPI-17509 BPI-17509 Active ingredient Chemical Drugs(1) New Drug Application 2018-12-12 贝达药业股份有限公司 Betta Pharmaceuticals Co Ltd In Review 2018-12-11 view
JXHL1900065 GH509 GH509 Active ingredient Chemical Drugs(1) Import Drug Application 2019-04-08 强新科技国际研究院 In Review 2019-04-04 view
CXHL1900215 509胶囊 509 Capsule Chemical Drugs(1) New Drug Application 2019-07-04 武汉恒信源药业有限公司 Wuhan Hengxinyuan Pharmaceutical Co Ltd In Review 2019-07-02 view
CXHL1900214 509 509 Active ingredient Chemical Drugs(1) New Drug Application 2019-07-04 武汉恒信源药业有限公司 Wuhan Hengxinyuan Pharmaceutical Co Ltd In Review 2019-07-02 view
CXHL1900216 509胶囊 509 Capsule Chemical Drugs(1) New Drug Application 2019-07-04 武汉恒信源药业有限公司 Wuhan Hengxinyuan Pharmaceutical Co Ltd In Review 2019-07-02 view
CXHL2000146 HRS5091片 HRS5091 Tablet Chemical Drugs(1) New Drug Application 2020-04-16 江苏恒瑞医药股份有限公司 Jiangsu Hengrui Pharmaceuticals Co Ltd In Review 2020-04-15 view
CXHL2000148 HRS5091片 HRS5091 Tablet Chemical Drugs(1) New Drug Application 2020-04-16 江苏恒瑞医药股份有限公司 Jiangsu Hengrui Pharmaceuticals Co Ltd In Review 2020-04-15 view