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
CSL20020064	重组甘精胰岛素注射液	insulin glargine	Injection	Biological Products(2)	New Drug Application	2002-09-16	北京甘李生物技术有限公司	Gan & Lee Pharmaceuticals	Certificate Issued	2003-05-09	view
X0405013	重组甘精胰岛素注射液	insulin glargine	Injection	Biological Products(7)	New Drug Application	2004-09-05	北京甘李生物技术有限公司	Gan & Lee Pharmaceuticals	Certificate Issued	2005-05-27	view
X0405012	重组甘精胰岛素注射液	insulin glargine	Injection	Biological Products(7)	New Drug Application	2004-09-05	北京甘李生物技术有限公司	Gan & Lee Pharmaceuticals	Certificate Issued	2005-05-27	view
Y0412676	重组甘精胰岛素注射液	insulin glargine	Injection	Biological Products(15)	Generic Drug	2004-10-28	重庆富进生物医药有限公司	Chongqing Fujin Biological Medicine Co Ltd	Certificate Issued	2006-05-29	view
Y0412675	重组甘精胰岛素注射液	insulin glargine	Injection	Biological Products(15)	Generic Drug	2004-10-28	重庆富进生物医药有限公司	Chongqing Fujin Biological Medicine Co Ltd	Certificate Completed-Pending Issued	2006-05-17	view
CXSB0500150	重组甘精胰岛素注射液	insulin glargine	Injection	Biological Products	Supplementary Application	2005-11-23	山东新时代药业有限公司	Shandong New Time Pharmaceutical Co Ltd	In Approval	2011-08-04	view
CXSB0500151	重组甘精胰岛素注射液	insulin glargine	Injection	Biological Products	Supplementary Application	2005-11-23	山东新时代药业有限公司	Shandong New Time Pharmaceutical Co Ltd	In Approval	2011-08-04	view
CXSB0700035	重组甘精胰岛素注射液	insulin glargine	Injection	Biological Products	Supplementary Application	2007-09-12	甘李药业有限公司	Gan & Lee Pharmaceuticals	Certificate Issued	2008-04-18	view
CXSL0900030	重组甘精胰岛素注射液	insulin glargine	Injection	Biological Products(15)	New Drug Application	2010-02-08	珠海联邦制药股份有限公司中山分公司	Zhuhai United Laboratories Co Ltd	Certificate Issued	2011-09-29	view
CYSB1100044	重组甘精胰岛素注射液	insulin glargine	Injection	Biological Products	Supplementary Application	2011-06-07	甘李药业有限公司	Gan & Lee Pharmaceuticals	Certificate Issued	2014-06-05	view
CXSS1100016	重组甘精胰岛素注射液	insulin glargine	Injection	Biological Products(15)	New Drug Application	2011-08-31	山东新时代药业有限公司	Shandong New Time Pharmaceutical Co Ltd	Certificate Issued	2016-03-10	view
JXSL1200009	重组甘精胰岛素注射液	insulin glargine	Injection	Biological Products	Import Drug Application	2012-02-14	杭州泰格医药科技股份有限公司	Hangzhou Tigermed Consulting Co Ltd	Certificate Issued	2014-01-30	view
CXSL1300007	重组甘精胰岛素注射液	insulin glargine	Injection	Biological Products(15)	New Drug Application	2013-07-01	江苏万邦生化医药股份有限公司	Wanbang Biopharmaceuticals	Certificate Issued	2016-01-13	view
CXSL1300053	重组甘精胰岛素注射液	insulin glargine	Injection	Biological Products(15)	New Drug Application	2013-10-28	浙江海正药业股份有限公司	Zhejiang Hisun Pharmaceutical Co Ltd	Certificate Issued	2015-07-13	view
CYSB1500535	重组甘精胰岛素注射液	insulin glargine	Injection	Biological Products	Supplementary Application	2016-09-18	甘李药业股份有限公司	Gan & Lee Pharmaceuticals	Certificate Issued	2017-09-14	view
CXSL1700016	重组甘精胰岛素注射液	insulin glargine	Injection	Biological Products(15)	New Drug Application	2017-03-30	合肥天麦生物科技发展有限公司	Hefei Tianmai BIOTECHNOLOGY Development Co Ltd	Certificate Issued	2018-04-10	view
CYSB1700181	重组甘精胰岛素注射液	insulin glargine	Injection	Biological Products	Supplementary Application	2017-11-16	甘李药业股份有限公司	Gan & Lee Pharmaceuticals	In Review	2017-11-14	view
CYSB1700216	重组甘精胰岛素注射液	insulin glargine	Injection	Biological Products	Supplementary Application	2018-06-15	甘李药业股份有限公司	Gan & Lee Pharmaceuticals	Certificate Issued	2019-06-26	view
CYSB2000016	重组甘精胰岛素注射液	insulin glargine	Injection	Biological Products	Supplementary Application	2020-02-14	甘李药业股份有限公司	Gan & Lee Pharmaceuticals	Certificate Issued	2020-03-26	view
CXSS2000009	重组甘精胰岛素注射液	insulin glargine	Injection	Biological Products(15)	New Drug Application	2020-03-19	江苏万邦生化医药集团有限责任公司	Wanbang Biopharmaceuticals	In Review	2020-03-17	view