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
CSL01011	曲妥珠单抗	trastuzumab	Lyophilized	Biological Products(4)	New Drug Application	2001-03-13	上海罗氏制药有限公司	Shanghai Roche Pharmaceutical Co Ltd	Certificate Issued	2001-11-13	view
BS20020011	注射用曲妥珠单抗	trastuzumab	Lyophilized	Biological Products	Import Drug Application	2002-09-25	上海罗氏制药有限公司	Shanghai Roche Pharmaceutical Co Ltd	Approval Completed-Pending Certificated	2003-05-08	view
JXSL0500008	注射用曲妥珠单抗	trastuzumab	Lyophilized	Biological Products(1)	Import Drug Application	2005-04-01		Roche Pharma (Schweiz) Ltd	Certificate Issued	2005-11-16	view
JXSL0500007	注射用曲妥珠单抗	trastuzumab	Lyophilized	Biological Products(1)	Import Drug Application	2005-04-01		Roche Pharma (Schweiz) Ltd	Certificate Issued	2005-11-16	view
JXSL0500006	注射用曲妥珠单抗	trastuzumab	Lyophilized	Biological Products(1)	Import Drug Application	2005-04-01		Roche Pharma (Schweiz) Ltd	Certificate Issued	2005-11-16	view
JYSB0500021	注射用曲妥珠单抗	trastuzumab	Lyophilized	Biological Products	Supplementary Application	2005-05-12			Certificate Issued	2005-09-23	view
JYSB0600001	注射用曲妥珠单抗	trastuzumab	Lyophilized	Biological Products	Supplementary Application	2006-01-12	上海罗氏制药有限公司北京办事处	Shanghai Roche Pharmaceuticals Ltd Beijing	Certificate Completed-Pending Issued	2006-05-30	view
JYSB0600180	注射用曲妥珠单抗	trastuzumab	Lyophilized	Biological Products	Supplementary Application	2006-12-20	上海罗氏制药有限公司	Shanghai Roche Pharmaceutical Co Ltd	Certificate Issued	2007-07-17	view
JXSL0700006	注射用曲妥珠单抗	trastuzumab	Lyophilized	Biological Products(7)	Import Drug Application	2007-03-26	上海罗氏制药有限公司	Shanghai Roche Pharmaceutical Co Ltd	Certificate Issued	2009-01-08	view
JXSL0700010	注射用曲妥珠单抗	trastuzumab	Lyophilized	Biological Products(7)	Import Drug Application	2007-04-20	上海罗氏制药有限公司	Shanghai Roche Pharmaceutical Co Ltd	Certificate Issued	2009-01-08	view
JYSB0700072	注射用曲妥珠单抗	trastuzumab	Lyophilized	Biological Products	Supplementary Application	2007-05-24	上海罗氏制药有限公司	Shanghai Roche Pharmaceutical Co Ltd	Certificate Issued	2009-04-22	view
JYSB0700104	注射用曲妥珠单抗	trastuzumab	Lyophilized	Biological Products	Supplementary Application	2007-07-18	上海罗氏制药有限公司	Shanghai Roche Pharmaceutical Co Ltd	Certificate Issued	2010-03-22	view
JYSB0900088	注射用曲妥珠单抗	trastuzumab	Lyophilized	Biological Products	Supplementary Application	2009-06-02	上海罗氏制药有限公司	Shanghai Roche Pharmaceutical Co Ltd	Certificate Issued	2009-11-16	view
JYSB0900087	注射用曲妥珠单抗	trastuzumab	Lyophilized	Biological Products	Supplementary Application	2009-06-02	上海罗氏制药有限公司	Shanghai Roche Pharmaceutical Co Ltd	Certificate Issued	2009-11-16	view
JYSB0900102	注射用曲妥珠单抗	trastuzumab	Lyophilized	Biological Products	Supplementary Application	2009-06-25	上海罗氏制药有限公司	Shanghai Roche Pharmaceutical Co Ltd	Certificate Issued	2009-11-16	view
JYSB0900142	注射用曲妥珠单抗	trastuzumab	Lyophilized	Biological Products	Supplementary Application	2009-07-16	上海罗氏制药有限公司	Shanghai Roche Pharmaceutical Co Ltd	Certificate Issued	2011-02-18	view
JYSZ0900036	注射用曲妥珠单抗	trastuzumab	Lyophilized	Biological Products	License Renew	2009-08-26	上海罗氏制药有限公司	Shanghai Roche Pharmaceutical Co Ltd	Certificate Issued	2011-08-03	view
JYSB0900187	注射用曲妥珠单抗	trastuzumab	Lyophilized	Biological Products	Supplementary Application	2009-08-28	上海罗氏制药有限公司	Shanghai Roche Pharmaceutical Co Ltd	Certificate Issued	2010-12-30	view
JXSL0900083	注射用曲妥珠单抗	trastuzumab	Lyophilized	Biological Products	Import Drug Application	2009-12-04	深圳万乐药业有限公司	Shenzhen Main Luck Pharmaceuticals INC	Certificate Issued	2011-03-07	view
JYSZ1000005	注射用曲妥珠单抗	trastuzumab	Lyophilized	Biological Products	License Renew	2010-02-03	上海罗氏制药有限公司	Shanghai Roche Pharmaceutical Co Ltd	Certificate Issued	2011-02-12	view