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
CXSL1300083	地特胰岛素注射液	insulin detemir	Injection	Biological Products(15)	New Drug Application	2014-01-03	正大天晴药业集团股份有限公司	Jiangsu Chia Tai-Tianqing Pharmaceutical Co Ltd	Certificate Issued	2015-07-13	view
CXSL1300086	地特胰岛素注射液	insulin detemir	Injection	Biological Products(15)	New Drug Application	2013-12-17	珠海联邦制药股份有限公司	Zhuhai United Laboratories Co Ltd	Certificate Issued	2016-07-14	view
CXSL1500039	地特胰岛素注射液	insulin detemir	Injection	Biological Products(15)	New Drug Application	2015-09-28	通化东宝药业股份有限公司	Tonghua Dongbao Pharmaceutical Co Ltd	Certificate Issued	2017-10-17	view
CXSL1800007	地特胰岛素注射液	insulin detemir	Injection	Biological Products(15)	New Drug Application	2018-02-06	杭州中美华东制药有限公司	Hangzhou Zhongmei Huadong Pharmaceutical Co Ltd	Certificate Issued	2018-11-09	view
CXSL1900092	地特胰岛素注射液	insulin detemir	Injection	Biological Products(15)	New Drug Application	2019-08-28	华润昂德生物药业有限公司	Shandong E Hua Biology Medicine Co Ltd	In Review	2019-08-27	view
CYSB1900292	地特胰岛素注射液	insulin detemir	Injection	Biological Products	Supplementary Application	2019-08-15	诺和诺德（中国）制药有限公司	Novo Nordisk (China) Pharmaceuticals Co Ltd	In Review	2019-08-14	view
CYSB2000154	地特胰岛素注射液	insulin detemir	Injection	Biological Products	Supplementary Application	2020-06-19	诺和诺德（中国）制药有限公司	Novo Nordisk (China) Pharmaceuticals Co Ltd	Certificate Issued	2021-07-22	view
CYSB2101230	地特胰岛素注射液	insulin detemir	Injection	Biological Products	Supplementary Application	2021-10-19		Novo Nordisk (China) Pharmaceuticals Co Ltd			view
CYSB2101231	地特胰岛素注射液	insulin detemir	Injection	Biological Products	Supplementary Application	2021-10-19		Novo Nordisk (China) Pharmaceuticals Co Ltd			view
CYSB2200068	地特胰岛素注射液	insulin detemir	Injection	Biological Products	Supplementary Application	2022-03-07		Novo Nordisk (China) Pharmaceuticals Co Ltd			view
CYSB2200069	地特胰岛素注射液	insulin detemir	Injection	Biological Products	Supplementary Application	2022-03-07		Novo Nordisk (China) Pharmaceuticals Co Ltd			view
J0401804	地特胰岛素注射液	insulin detemir	Injection	Biological Products(7)	Import Drug Application	2004-09-24	丹麦诺和诺德公司	Novo Nordisk A/S	Certificate Issued	2005-12-06	view
J0401805	地特胰岛素注射液	insulin detemir	Injection	Biological Products(7)	Import Drug Application	2004-09-24	丹麦诺和诺德公司	Novo Nordisk A/S	Certificate Issued	2005-12-06	view
JTS1900026	地特胰岛素注射液	insulin detemir	Injection	Biological Products	Disposable Import Drug Application	2019-06-21	Novo Nordisk A/S	Novo Nordisk A/S	Certificate Issued	2019-07-05	view
JTS1900027	地特胰岛素注射液	insulin detemir	Injection	Biological Products	Disposable Import Drug Application	2019-06-21	Novo Nordisk A/S	Novo Nordisk A/S	Certificate Issued	2019-07-05	view
JXSS0800001	地特胰岛素注射液	insulin detemir	Injection	Biological Products(7)	Import Drug Application	2008-02-18	丹麦诺和诺德公司	Novo Nordisk A/S	Certificate Issued	2009-07-01	view
JXSS0800002	地特胰岛素注射液	insulin detemir	Injection	Biological Products(7)	Import Drug Application	2008-02-18	丹麦诺和诺德公司	Novo Nordisk A/S	Certificate Issued	2009-07-01	view
JYSB0700042	地特胰岛素注射液	insulin detemir	Injection	Biological Products	Supplementary Application	2007-03-12	丹麦诺和诺德公司	Novo Nordisk A/S	Certificate Issued	2007-12-21	view
JYSB0700043	地特胰岛素注射液	insulin detemir	Injection	Biological Products	Supplementary Application	2007-03-12	丹麦诺和诺德公司	Novo Nordisk A/S	Certificate Issued	2007-12-21	view
JYSB0900250	地特胰岛素注射液	insulin detemir	Injection	Biological Products	Supplementary Application	2009-12-18	丹麦诺和诺德公司	Novo Nordisk A/S	Certificate Issued	2011-10-09	view