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Acceptance No. Drug Name Active Ingredient Dosage Form Classification Submission Acceptance Date Manufacturers Manufacturers Review Status Status Date View
JXSB2400107 AMG 509 AMG-509 Injection Biological Products(1) Supplementary Application 2024-07-31 Amgen Inc view
JXSB2400004 AMG 509 AMG-509 Injection Biological Products(1) Supplementary Application 2024-01-17 Amgen Inc view
JXHB2400004 BI685509片 Avenciguat Tablet Chemical Drugs(1) Supplementary Application 2024-01-04 Boehringer Ingelheim International GmbH view
JXHB2400006 BI685509片 Avenciguat Tablet Chemical Drugs(1) Supplementary Application 2024-01-04 Boehringer Ingelheim International GmbH view
JXHB2400005 BI685509片 Avenciguat Tablet Chemical Drugs(1) Supplementary Application 2024-01-04 Boehringer Ingelheim International GmbH view
CXHL2301244 HS-10509片 HS-10509 Tablet Chemical Drugs(1) New Drug Application 2023-11-08 view
CXHL2301243 HS-10509片 HS-10509 Tablet Chemical Drugs(1) New Drug Application 2023-11-08 view
CXHL2301242 HS-10509片 HS-10509 Tablet Chemical Drugs(1) New Drug Application 2023-11-08 view
JXSL2300177 AMG 509 AMG-509 Injection Biological Products(1) Import Drug Application 2023-10-11 view
JXHL2300193 BI685509片 Avenciguat Tablet Chemical Drugs(1) Import Drug Application 2023-08-22 view
JXHL2300194 BI685509片 Avenciguat Tablet Chemical Drugs(1) Import Drug Application 2023-08-22 view
JXHL2300195 BI685509片 Avenciguat Tablet Chemical Drugs(1) Import Drug Application 2023-08-22 view
JXSL2300063 AMG 509 AMG-509 Injection Biological Products(1) Import Drug Application 2023-03-31 view
JXHB2200167 BI685509片 Avenciguat Tablet Chemical Drugs(1) Supplementary Application 2022-11-03 Boehringer Ingelheim International GmbH view
JXHB2200169 BI685509片 Avenciguat Tablet Chemical Drugs(1) Supplementary Application 2022-11-03 Boehringer Ingelheim International GmbH view
JXHB2200168 BI685509片 Avenciguat Tablet Chemical Drugs(1) Supplementary Application 2022-11-03 Boehringer Ingelheim International GmbH view
JXHL2200205 BI685509片 Avenciguat Tablet Chemical Drugs(1) Import Drug Application 2022-07-20 view
JXHL2200206 BI685509片 Avenciguat Tablet Chemical Drugs(1) Import Drug Application 2022-07-20 view
JXHL2200207 BI685509片 Avenciguat Tablet Chemical Drugs(1) Import Drug Application 2022-07-20 view
JXHB2200081 GH509 GH509 Active ingredient Chemical Drugs(1) Supplementary Application 2022-06-23 view