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
JXSL1700067	人源抗CD38单克隆抗体（Daratumumab）皮下注射液	daratumumab	Injection	Biological Products	Import Drug Application	2017-10-23	Janssen Research & Development, LLC	Janssen Research & Development LLC	Certificate Issued	2018-08-09	view
JXSL1700081	人源抗CD38单克隆抗体（Daratumumab）皮下注射液	daratumumab	Injection	Biological Products	Import Drug Application	2017-11-29	Janssen Research & Development, LLC	Janssen Research & Development LLC	Certificate Issued	2018-09-04	view
JXSL1700082	人源抗CD38单克隆抗体（Daratumumab）皮下注射液	daratumumab	Injection	Biological Products	Import Drug Application	2017-11-29	Janssen Research & Development, LLC	Janssen Research & Development LLC	Certificate Issued	2018-08-27	view
JYSB1800241	人源抗CD38单克隆抗体（Daratumumab）皮下注射液	daratumumab	Injection	Biological Products	Supplementary Application	2018-11-12	Janssen Research & Development, LLC	Janssen Research & Development LLC;Cilag AG	In Review	2018-11-10	view
JYSB1800240	人源抗CD38单克隆抗体（Daratumumab）皮下注射液	daratumumab	Injection	Biological Products	Supplementary Application	2018-11-12	Janssen Research & Development, LLC	Janssen Research & Development LLC;Cilag AG	In Review	2018-11-10	view
JXSL1900053	人源抗CD38单克隆抗体（Daratumumab）皮下注射液	daratumumab	Injection	Biological Products	Import Drug Application	2019-06-06	西安杨森制药有限公司	Xian Janssen Pharmaceutical Ltd;Janssen Research & Development LLC	In Review	2019-06-05	view
JYSB1900146	人源抗CD38单克隆抗体（Daratumumab）皮下注射液	daratumumab	Injection	Biological Products	Supplementary Application	2019-07-17	Janssen Research & Development, LLC	Janssen Research & Development LLC;Cilag AG	Certificate Issued	2019-08-05	view