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
AS20010013	注射用因福利美	infliximab	Lyophilized	Biological Products	New Drug Application	2003-09-19	西安杨森制药有限公司	Xian Janssen Pharmaceutical Ltd	Approval Completed-Pending Certificated	2003-12-17	view
J0402107	注射用英夫利西单抗	infliximab	Lyophilized	Biological Products(7)	Import Drug Application	2004-11-10	西安杨森制药有限公司	Xian Janssen Pharmaceutical Ltd	Certificate Completed-Pending Issued	2006-05-26	view
JYSB0600066	注射用英夫利西单抗	infliximab	Lyophilized	Biological Products	Supplementary Application	2006-06-23	西安杨森制药有限公司	Xian Janssen Pharmaceutical Ltd	Certificate Issued	2007-02-26	view
JXSL0700014	注射用英夫利西单抗	infliximab	Lyophilized	Biological Products(2)	Import Drug Application	2007-05-11	Centocor B.V.	Centocor BV	Certificate Issued	2008-06-20	view
JXSS1000018	注射用英夫利西单抗	infliximab	Lyophilized	Biological Products	Import Drug Application	2010-11-04	Centocor B.V.	Centocor BV	Certificate Issued	2013-08-22	view
JXSL1300082	注射用英夫利西单抗	infliximab	Lyophilized	Biological Products	Import Drug Application	2014-01-03	精鼎医药研究开发（上海）有限公司	Parexel China Co Ltd	Certificate Issued	2017-04-06	view
JXSS1400009	注射用英夫利西单抗	infliximab	Lyophilized	Biological Products	Import Drug Application	2014-11-17	西安杨森制药有限公司	Xian Janssen Pharmaceutical Ltd	Certificate Issued	2015-05-04	view
JYSB1400228	注射用英夫利西单抗	infliximab	Lyophilized	Biological Products	Supplementary Application	2014-11-24	西安杨森制药有限公司	Xian Janssen Pharmaceutical Ltd	Certificate Issued	2015-07-13	view
JYSB1500077	注射用英夫利西单抗	infliximab	Lyophilized	Biological Products	Supplementary Application	2015-04-10	西安杨森制药有限公司	Xian Janssen Pharmaceutical Ltd	Certificate Issued	2015-09-11	view
JXSS1500015	注射用英夫利西单抗	infliximab	Lyophilized	Biological Products	Import Drug Application	2015-11-23	西安杨森制药有限公司	Xian Janssen Pharmaceutical Ltd	Certificate Issued	2018-12-29	view
JYSB1600195	注射用英夫利西单抗	infliximab	Lyophilized	Biological Products	Supplementary Application	2016-09-28	Janssen Biologics B.V.	Janssen Biologics BV	Certificate Issued	2016-11-18	view
JYSB1700005	注射用英夫利西单抗	infliximab	Lyophilized	Biological Products	Supplementary Application	2017-01-22	Janssen Biologics B.V.	Janssen Biologics BV	Certificate Issued	2017-05-25	view
JYSB1700012	注射用英夫利西单抗	infliximab	Lyophilized	Biological Products	Supplementary Application	2017-02-17	Janssen Biologics B.V.	Janssen Biologics BV	Certificate Issued	2018-12-04	view
JYSB1700095	注射用英夫利西单抗	infliximab	Lyophilized	Biological Products	Supplementary Application	2017-05-15	Janssen Biologics B.V.	Janssen Biologics BV	Certificate Issued	2017-07-21	view
JYSB1800138	注射用英夫利西单抗	infliximab	Lyophilized	Biological Products	Supplementary Application	2018-07-09	Janssen Biologics B.V.	Janssen Biologics BV	Certificate Issued	2019-02-22	view
JYSB1900061	注射用英夫利西单抗	infliximab	Lyophilized	Biological Products	Supplementary Application	2019-03-11	Janssen Biologics B.V.	Janssen Biologics BV	Certificate Issued	2019-05-17	view
JYSB1900127	注射用英夫利西单抗	infliximab	Lyophilized	Biological Products	Supplementary Application	2019-06-24	Janssen Biologics B.V.	Janssen Biologics BV	Certificate Issued	2020-02-26	view
JYSB1900332	注射用英夫利西单抗	infliximab	Lyophilized	Biological Products	Supplementary Application	2019-11-29	Janssen Biologics B.V.	Janssen Biologics BV	Filed	2019-12-10	view
CXSS2000004	注射用英夫利西单抗	infliximab	Lyophilized	Biological Products(2)	New Drug Application	2020-02-14	泰州迈博太科药业有限公司	Taizhou Maibotaike Pharmaceutical Co Ltd	In Approval	2021-07-05	view
JYSB2000030	注射用英夫利西单抗	infliximab	Lyophilized	Biological Products	Supplementary Application	2020-02-19	Janssen Biologics B.V.	Janssen Biologics BV	Certificate Issued	2020-04-23	view