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Acceptance No. Drug Name Active Ingredient Dosage Form Classification Submission Acceptance Date Manufacturers Manufacturers Review Status Status Date 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
CXHL1402228 马昔腾坦片 macitentan Tablet 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
CYHS1900599 马昔腾坦片 macitentan Tablet Chemical Drugs(4) Generic Drug 2019-08-27 上海宣泰海门药业有限公司 Haimen PHARMA INC In Review 2019-08-26 view
CYHS1900608 马昔腾坦片 macitentan Tablet Chemical Drugs(4) Generic Drug 2019-09-05 南京正大天晴制药有限公司 Nanjing Zhengda Tianqing Pharmaceutical Co Ltd In Review 2020-10-10 view
CYHS2000952 马昔腾坦片 macitentan Tablet Chemical Drugs(4) Generic Drug 2020-12-29 杭州中美华东制药有限公司 Hangzhou Zhongmei Huadong Pharmaceutical Co Ltd In Review 2020-12-29 view
CYHS2201679 马昔腾坦片 macitentan Tablet Chemical Drugs(4) Generic Drug 2022-10-10 view
CYHS2202096 马昔腾坦片 macitentan Tablet Chemical Drugs(4) Generic Drug 2022-12-27 QILU Pharmaceutical Co Ltd view
CYHS2202176 马昔腾坦片 macitentan Tablet Chemical Drugs(4) Generic Drug 2023-01-01 Shanghai Xudong Haipu Pharmaceutical Co Ltd view
CYHS2300472 马昔腾坦片 macitentan Tablet Chemical Drugs(4) Generic Drug 2023-02-11 view
CYHS2303558 马昔腾坦片 macitentan Tablet Chemical Drugs(4) Generic Drug 2023-12-22 view
JTH2200103 马昔腾坦 macitentan Active ingredient Chemical Drugs Disposable Import Drug Application 2022-06-03 view
JTH2400079 马昔腾坦他达拉非片 macitentan;tadalafil Tablet Chemical Drugs Disposable Import Drug Application 2024-06-08 view
JTH2400080 马昔腾坦他达拉非片 macitentan;tadalafil Tablet Chemical Drugs Disposable Import Drug Application 2024-06-08 view
JTH2400125 马昔腾坦分散片 macitentan Tablet Chemical Drugs Disposable Import Drug Application 2024-08-02 view
JTH2400126 马昔腾坦分散片 macitentan Tablet Chemical Drugs Disposable Import Drug Application 2024-08-02 view
JXHB2101036 马昔腾坦分散片 macitentan Tablet Chemical Drugs(2.2) Supplementary Application 2021-07-05 view
JXHB2101037 马昔腾坦分散片 macitentan Tablet Chemical Drugs(2.2) Supplementary Application 2021-07-05 view
JXHB2101038 马昔腾坦分散片 macitentan Tablet Chemical Drugs(2.2) Supplementary Application 2021-07-05 view
JXHB2101042 马昔腾坦他达拉非片 macitentan;tadalafil Tablet Chemical Drugs(2.3) Supplementary Application 2021-07-26 view
JXHB2101066 马昔腾坦片 macitentan Tablet Chemical Drugs(2.4) Supplementary Application 2021-09-13 view