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Acceptance No. Drug Name Active Ingredient Dosage Form Classification Submission Acceptance Date Manufacturers Manufacturers Review Status Status Date View
JYHB2500149 马昔腾坦片 macitentan Tablet Chemical Drugs Supplementary Application 2025-03-12 Excella GmbH;Actelion Pharmaceuticals Ltd view
JYHZ2500048 马昔腾坦片 macitentan Tablet Chemical Drugs License Renew 2025-03-08 Johnson & Johnson;Excella GmbH;Actelion Pharmaceuticals Ltd 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
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
JTH2400126 马昔腾坦分散片 macitentan Tablet Chemical Drugs Disposable Import Drug Application 2024-08-02 Xian Janssen Pharmaceutical Ltd;Excella GmbH;Janssen-Cilag International NV view
JTH2400125 马昔腾坦分散片 macitentan Tablet Chemical Drugs Disposable Import Drug Application 2024-08-02 Xian Janssen Pharmaceutical Ltd;Excella GmbH;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
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
JYHB2400034 马昔腾坦片 macitentan Tablet Chemical Drugs Supplementary Application 2024-01-24 Excella GmbH;Actelion Pharmaceuticals Ltd view
CYHS2303558 马昔腾坦片 macitentan Tablet Chemical Drugs(4) Generic Drug 2023-12-22 Shandong Hubble Kisen Biological Technology Co Ltd;Anhui Taienkang Pharmaceutical Co 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
JXHB2300136 马昔腾坦片 macitentan Tablet Chemical Drugs(2.2) Supplementary Application 2023-08-29 Excella GmbH;Actelion Pharmaceuticals Ltd view
JXHB2300135 马昔腾坦片 macitentan Tablet Chemical Drugs(2.2) Supplementary Application 2023-08-29 Excella GmbH;Actelion Pharmaceuticals Ltd view
JXHB2300134 马昔腾坦片 macitentan Tablet Chemical Drugs Supplementary Application 2023-08-29 Actelion Pharmaceuticals Ltd;Patheon France view
JYHB2300447 马昔腾坦片 macitentan Tablet Chemical Drugs Supplementary Application 2023-08-15 Excella GmbH;Actelion Pharmaceuticals Ltd view
JXHB2300102 马昔腾坦片 macitentan Tablet Chemical Drugs(2.2) Supplementary Application 2023-06-14 Excella GmbH;Actelion Pharmaceuticals Ltd view
JXHB2300103 马昔腾坦片 macitentan Tablet Chemical Drugs(2.2) Supplementary Application 2023-06-14 Excella GmbH;Actelion Pharmaceuticals Ltd view
JXHB2300101 马昔腾坦片 macitentan Tablet Chemical Drugs Supplementary Application 2023-06-14 Actelion Pharmaceuticals Ltd;Patheon France view
JXHB2300035 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