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
JYSB2400152	奥法妥木单抗注射液	ofatumumab	Injection	Biological Products	Supplementary Application	2024-07-15		Novartis Pharmaceuticals Corporation;Novartis Pharma Stein AG			view
JYSB2400148	奥法妥木单抗注射液	ofatumumab	Injection	Biological Products	Supplementary Application	2024-07-10		Novartis Pharmaceuticals Corporation;Novartis Pharma Stein AG			view
JYSB2300101	奥法妥木单抗注射液	ofatumumab	Injection	Biological Products	Supplementary Application	2023-06-02		Novartis Pharmaceuticals Corporation;Novartis Pharma Stein AG			view
JYSB2300029	奥法妥木单抗注射液	ofatumumab	Injection	Biological Products	Supplementary Application	2023-02-17		Novartis Pharmaceuticals Corporation;Novartis Pharma Stein AG			view
JXSS2000049	奥法妥木单抗注射液	ofatumumab	Injection	Biological Products(3.1)	Import Drug Application	2020-11-05	北京诺华制药有限公司	Beijing Novartis Pharma Co Ltd;Novartis Pharmaceuticals Corporation;Novartis Pharma Stein AG	Approval Completed-Pending Certificated	2021-12-20	view
JXSL1600065	奥法妥木单抗注射液	ofatumumab	Injection	Biological Products	Import Drug Application	2016-11-07	北京诺华制药有限公司	Beijing Novartis Pharma Co Ltd;Novartis Pharma Schweiz AG	Certificate Issued	2018-06-14	view
JXSL1500011	奥法妥木单抗注射液	ofatumumab	Injection	Biological Products	Import Drug Application	2015-04-30	Glaxo Group Limited	Glaxo Group Ltd	Certificate Issued	2016-05-16	view
JXSL1100046	奥法妥木单抗注射液	ofatumumab	Injection	Biological Products	Import Drug Application	2011-10-20		Glaxo Group Ltd	Certificate Issued	2013-10-23	view
JXSL1100047	奥法妥木单抗注射液	ofatumumab	Injection	Biological Products	Import Drug Application	2011-09-22		Glaxo Group Ltd	Certificate Issued	2013-10-23	view
JXSL1000042	奥法妥木单抗注射液	ofatumumab	Injection	Biological Products	Import Drug Application	2010-09-09		Glaxo Group Ltd	Certificate Issued	2012-07-20	view