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Acceptance No. Drug Name Active Ingredient Dosage Form Classification Submission Acceptance Date Manufacturers Manufacturers Review Status Status Date 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
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
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
JXSL2300177 AMG 509 AMG-509 Injection Biological Products(1) Import Drug Application 2023-10-11 view
JXSB2400107 AMG 509 AMG-509 Injection Biological Products(1) Supplementary Application 2024-07-31 Amgen Inc view
JXSL2300063 AMG 509 AMG-509 Injection Biological Products(1) Import Drug Application 2023-03-31 view
JXSB2400004 AMG 509 AMG-509 Injection Biological Products(1) Supplementary Application 2024-01-17 Amgen Inc 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
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
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
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
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
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
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
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
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
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
JXHL2300194 BI685509片 Avenciguat Tablet Chemical Drugs(1) Import Drug Application 2023-08-22 view
JXHB2400006 BI685509片 Avenciguat Tablet Chemical Drugs(1) Supplementary Application 2024-01-04 Boehringer Ingelheim International GmbH view
JXHL2101224 BI685509片 Avenciguat Tablet Chemical Drugs(1) Import Drug Application 2021-10-27 view