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
JTH2400190	Pexidartinib胶囊 (PLX3397)	pexidartinib hydrochloride	Capsule	Chemical Drugs	Disposable Import Drug Application	2024-11-12		Catalent Cts LLC;Daiichi Sankyo Korea Co Ltd;Daiichi Sankyo (CHINA) HOLDINGS Co Ltd			view
JXHL1600071	PLX3397 HCl胶囊	pexidartinib hydrochloride	Capsule	Chemical Drugs	Import Drug Application	2016-07-15	昆泰企业管理（上海）有限公司	Aikunwei Medical Technology (Shanghai) Co Ltd;Daiichi Sankyo Co Ltd	Certificate Issued	2017-03-14	view
JXHS2500004	盐酸吡昔替尼胶囊	pexidartinib hydrochloride	Capsule	Chemical Drugs(5.1)	Import Drug Application	2025-01-15		Catalent Cts LLC;Daiichi Sankyo Korea Co Ltd			view
JYHB1901623	PLX3397 HCl胶囊	pexidartinib hydrochloride	Capsule	Chemical Drugs(5.1)	Supplementary Application	2020-01-01	第一三共（中国）投资有限公司	Daiichi Sankyo (CHINA) HOLDINGS Co Ltd;Catalent Cts LLC;Daiichi Sankyo Co Ltd	In Review	2019-12-31	view