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
JXHL1100470	Dexpramipexole dihydrochloride tablets	dexpramipexole	Tablet	Chemical Drugs	Import Drug Application	2011-12-30	百健艾迪医药咨询（上海）有限公司	Baijian Aidi Medical Consulting (Shanghai) Co Ltd;Biogen Idec Research Ltd	Certificate Issued	2013-03-28	view
JXHB2500049	Dexpramipexole片	dexpramipexole	Tablet	Chemical Drugs(1)	Supplementary Application	2025-04-16		Catalent Pharma Solutions LLC;Areteia Therapeutics Inc			view
JXHB2500048	Dexpramipexole片	dexpramipexole	Tablet	Chemical Drugs(1)	Supplementary Application	2025-04-16		Catalent Pharma Solutions LLC;Areteia Therapeutics Inc			view
JXHL2400155	Dexpramipexole片	dexpramipexole	Tablet	Chemical Drugs(1)	Import Drug Application	2024-07-04		Parexel China Co Ltd;Areteia Therapeutics Inc			view
JXHL2400156	Dexpramipexole片	dexpramipexole	Tablet	Chemical Drugs(1)	Import Drug Application	2024-07-04		Parexel China Co Ltd;Areteia Therapeutics Inc			view