Drug Registration and Acceptance

Drug Name

Exact

Active Ingredient

Acceptance No.

Manufacturers

Acceptance Date

Status Date

Classification

Review Status

Drug Type

Submission

Evaluation Conclusion

ATC Category

Special Approval Varieties

Task Type

Major Special Varieties

Sequence No.

Stock Code

Visualized Analysis Export Evaluation Conclusion Evaluation Progress

Acceptance No.	Drug Name	Active Ingredient	Dosage Form	Classification	Submission	Acceptance Date	Manufacturers	Manufacturers	Review Status	Status Date	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
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
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
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