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Acceptance No. Drug Name Active Ingredient Dosage Form Classification Submission Acceptance Date Manufacturers Manufacturers Review Status Status Date View
JTH2200103 马昔腾坦 macitentan Active ingredient Chemical Drugs Disposable Import Drug Application 2022-06-03 Shandong Hubble Kisen Biological Technology Co Ltd view
CXHL1402227 马昔腾坦 macitentan Active ingredient Chemical Drugs(3.1) New Drug Application 2015-04-02 四川海思科制药有限公司 Sichuan Haisco Pharmaceutical Co Ltd Certificate Issued 2016-05-31 view
JXHS2400123 马昔腾坦他达拉非片 macitentan;tadalafil Tablet Chemical Drugs(5.1) Import Drug Application 2025-01-01 Johnson & Johnson;Penn Pharmaceutical Services Ltd;Janssen-Cilag International NV view
JTH2400080 马昔腾坦他达拉非片 macitentan;tadalafil Tablet Chemical Drugs Disposable Import Drug Application 2024-06-08 Johnson & Johnson Pharmaceutical Co Ltd;Janssen-Cilag AG;Penn Pharmaceutical Services Ltd view
JTH2400079 马昔腾坦他达拉非片 macitentan;tadalafil Tablet Chemical Drugs Disposable Import Drug Application 2024-06-08 Johnson & Johnson Pharmaceutical Co Ltd;Janssen-Cilag AG;Penn Pharmaceutical Services Ltd view
JXHL2300281 马昔腾坦他达拉非片 macitentan;tadalafil Tablet Chemical Drugs(2.3) Import Drug Application 2023-11-10 Actelion Pharmaceuticals Ltd;Johnson & Johnson (CHINA) Investment Ltd view
JXHL2000344 马昔腾坦他达拉非片 macitentan;tadalafil Tablet Chemical Drugs(2.3) Import Drug Application 2020-12-25 Actelion Pharmaceuticals Ltd Actelion Pharmaceuticals Ltd In Review 2020-12-23 view
JXHS2400122 马昔腾坦他达拉非片 macitentan;tadalafil Tablet Chemical Drugs(5.1) Import Drug Application 2025-01-01 Johnson & Johnson;Penn Pharmaceutical Services Ltd;Janssen-Cilag International NV view
JXHB2101042 马昔腾坦他达拉非片 macitentan;tadalafil Tablet Chemical Drugs(2.3) Supplementary Application 2021-07-26 Actelion Pharmaceuticals Ltd;Penn Pharmaceutical Services Ltd view
JXHB2300037 马昔腾坦分散片 macitentan Tablet Chemical Drugs(2.2) Supplementary Application 2023-02-18 Idorsia Pharmaceuticals Ltd;Actelion Pharmaceuticals Ltd view
JXHB2200072 马昔腾坦分散片 macitentan Tablet Chemical Drugs(2.2) Supplementary Application 2022-06-16 Idorsia Pharmaceuticals Ltd;Actelion Pharmaceuticals Ltd view
JXHB2101038 马昔腾坦分散片 macitentan Tablet Chemical Drugs(2.2) Supplementary Application 2021-07-05 Idorsia Pharmaceuticals Ltd;Actelion Pharmaceuticals Ltd view
JXHL2000008 马昔腾坦分散片 macitentan Tablet Chemical Drugs(2.2) Import Drug Application 2020-02-19 Actelion Pharmaceuticals Ltd Actelion Pharmaceuticals Ltd In Review 2020-02-18 view
JXHB2200075 马昔腾坦分散片 macitentan Tablet Chemical Drugs(2.2) Supplementary Application 2022-06-16 Idorsia Pharmaceuticals Ltd;Actelion Pharmaceuticals Ltd view
JXHL1700049 马昔腾坦分散片 macitentan Tablet Chemical Drugs(2.2) Import Drug Application 2017-03-27 北京法马苏提克咨询有限公司 Ppd Pharmaceutical Development (Beijing) Co Ltd;Actelion Pharmaceuticals Ltd Certificate Issued 2018-06-14 view
JXHB2300034 马昔腾坦分散片 macitentan Tablet Chemical Drugs(2.2) Supplementary Application 2023-02-18 Excella GmbH;Actelion Pharmaceuticals Ltd view
JXHB2200073 马昔腾坦分散片 macitentan Tablet Chemical Drugs(2.2) Supplementary Application 2022-06-16 Excella GmbH;Actelion Pharmaceuticals Ltd view
JXHB2101037 马昔腾坦分散片 macitentan Tablet Chemical Drugs(2.2) Supplementary Application 2021-07-05 Idorsia Pharmaceuticals Ltd;Actelion Pharmaceuticals Ltd view
JXHL2000007 马昔腾坦分散片 macitentan Tablet Chemical Drugs(2.2) Import Drug Application 2020-02-19 Actelion Pharmaceuticals Ltd Actelion Pharmaceuticals Ltd In Review 2020-02-18 view
JXHL2400107 马昔腾坦分散片 macitentan Tablet Chemical Drugs(2.2) Import Drug Application 2024-05-12 Actelion Pharmaceuticals Ltd;Johnson & Johnson (CHINA) Investment Ltd view