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
CXSS2000040	重组人源抗狂犬病毒单抗注射液	Ormutivimab	Injection	Biological Products(1)	New Drug Application	2020-07-04	华北制药金坦生物技术股份有限公司,华北制药集团新药研究开发有限责任公司		Certificate Issued	2021-08-13	view
CXSS2000039	重组人源抗狂犬病毒单抗注射液	Ormutivimab	Injection	Biological Products(1)	New Drug Application	2020-07-04	华北制药金坦生物技术股份有限公司	NCPC Genetech BIOTECHNOLOGY Co Ltd	In Review	2020-07-02	view
CYSB1800076	重组人源抗狂犬病毒单抗注射液	Ormutivimab	Injection	Biological Products	Supplementary Application	2018-04-27	华北制药集团新药研究开发有限责任公司	North China Pharmaceutical Group New Drug R&D Co Ltd	Certificate Issued	2018-07-13	view
CYSB1800075	重组人源抗狂犬病毒单抗注射液	Ormutivimab	Injection	Biological Products	Supplementary Application	2018-04-27	华北制药集团新药研究开发有限责任公司	North China Pharmaceutical Group New Drug R&D Co Ltd	Certificate Issued	2018-07-13	view
CXSL0700013	重组人源抗狂犬病毒单抗注射液	Ormutivimab	Injection	Biological Products(1)	New Drug Application	2007-11-11	华北制药集团新药研究开发有限责任公司	North China Pharmaceutical Group New Drug R&D Co Ltd	Certificate Issued	2009-07-09	view
CXSL0700014	重组人源抗狂犬病毒单抗注射液	Ormutivimab	Injection	Biological Products(1)	New Drug Application	2008-03-04	华北制药集团新药研究开发有限责任公司	North China Pharmaceutical Group New Drug R&D Co Ltd	Certificate Issued	2009-07-09	view
CYSB2300023	奥木替韦单抗注射液	Ormutivimab	Injection	Biological Products	Supplementary Application	2023-01-31					view
CYSB2300031	奥木替韦单抗注射液	Ormutivimab	Injection	Biological Products	Supplementary Application	2023-02-09					view