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
CXHL1100215	阿维莫泮	alvimopan	Active ingredient	Chemical Drugs(3.1)	New Drug Application	2011-06-22	信泰制药（苏州）有限公司	BrightGene Pharmaceutical Co Ltd	Certificate Issued	2015-01-15	view
CXHL1100216	阿维莫泮胶囊	alvimopan	Capsule	Chemical Drugs(3.1)	New Drug Application	2011-06-22	信泰制药（苏州）有限公司	BrightGene Pharmaceutical Co Ltd	Certificate Issued	2015-01-15	view
CXHL1400627	磺达肝癸钠	fondaparinux sodium	Active ingredient	Chemical Drugs(3.1)	New Drug Application	2014-07-14	信泰制药（苏州）有限公司	BrightGene Pharmaceutical Co Ltd	In Review	2014-07-11	view
CXHS1300292	醋酸卡泊芬净	caspofungin acetate	Active ingredient	Chemical Drugs(3.1)	New Drug Application	2014-01-29	信泰制药（苏州）有限公司	BrightGene Pharmaceutical Co Ltd	In Review	2014-06-20	view
CXHS1400129	米卡芬净钠	micafungin sodium	Active ingredient	Chemical Drugs(3.1)	New Drug Application	2014-07-14	信泰制药（苏州）有限公司	BrightGene Pharmaceutical Co Ltd	In Review	2014-07-11	view
CYHB1902032	恩替卡韦片	entecavir	Tablet	Chemical Drugs	Supplementary Application	2019-04-24	信泰制药（苏州）有限公司	BrightGene Pharmaceutical Co Ltd	Certificate Issued	2019-07-02	view
CYHB2040019	注射用米卡芬净钠	micafungin sodium	Lyophilized	Chemical Drugs	Supplementary Application	2020-05-10	信泰制药（苏州）有限公司	BrightGene Pharmaceutical Co Ltd	In Review	2020-05-09	view
CYHB2050415	磺达肝癸钠注射液	fondaparinux sodium	Injection	Chemical Drugs	Supplementary Application	2020-07-15	扬子江药业集团江苏紫龙药业有限公司,信泰制药（苏州）有限公司		Certificate Issued	2021-11-19	view
CYHS1200463	卡培他滨	capecitabine	Active ingredient	Chemical Drugs(6)	Generic Drug	2012-12-06	信泰制药（苏州）有限公司	BrightGene Pharmaceutical Co Ltd	In Review	2012-12-04	view
CYHS1200816	阿加曲班	argatroban	Active ingredient	Chemical Drugs(6)	Generic Drug	2012-12-06	信泰制药（苏州）有限公司	BrightGene Pharmaceutical Co Ltd	In Review	2012-12-04	view
CYHS1201134	培美曲塞二钠	pemetrexed disodium	Active ingredient	Chemical Drugs(6)	Generic Drug	2013-03-07	信泰制药（苏州）有限公司	BrightGene Pharmaceutical Co Ltd	In Review	2013-03-06	view
CYHS1300657	阿卡波糖片	acarbose	Tablet	Chemical Drugs(6)	Generic Drug	2013-10-08	信泰制药（苏州）有限公司	BrightGene Pharmaceutical Co Ltd	Certificate Issued	2015-12-30	view
CYHS1300925	奥拉西坦	oxiracetam	Active ingredient	Chemical Drugs(6)	Generic Drug	2014-01-17	信泰制药（苏州）有限公司	BrightGene Pharmaceutical Co Ltd	In Review	2014-01-15	view
CYHS1300926	奥拉西坦注射液	oxiracetam	Injection	Chemical Drugs(6)	Generic Drug	2014-01-17	信泰制药（苏州）有限公司	BrightGene Pharmaceutical Co Ltd	Certificate Issued	2021-03-16	view
CYHS1301195	埃索美拉唑钠	esomeprazole sodium	Active ingredient	Chemical Drugs(6)	Generic Drug	2014-04-30	信泰制药（苏州）有限公司	BrightGene Pharmaceutical Co Ltd	In Review	2014-04-29	view
CYHS1301196	注射用埃索美拉唑钠	esomeprazole sodium	Lyophilized	Chemical Drugs(6)	Generic Drug	2014-04-30	信泰制药（苏州）有限公司	BrightGene Pharmaceutical Co Ltd	Certificate Issued	2019-12-02	view
CYHS1301631	注射用醋酸卡泊芬净	caspofungin acetate	Lyophilized	Chemical Drugs(6)	Generic Drug	2014-03-06	信泰制药（苏州）有限公司	BrightGene Pharmaceutical Co Ltd	Certificate Issued	2020-01-14	view
CYHS1301632	注射用醋酸卡泊芬净	caspofungin acetate	Lyophilized	Chemical Drugs(6)	Generic Drug	2014-03-06	信泰制药（苏州）有限公司	BrightGene Pharmaceutical Co Ltd	Certificate Issued	2020-01-14	view
CYHS1400362	盐酸帕罗西汀	paroxetine hydrochloride	Active ingredient	Chemical Drugs(6)	Generic Drug	2014-11-27	信泰制药（苏州）有限公司	BrightGene Pharmaceutical Co Ltd	In Review	2014-11-25	view
CYHS1400363	盐酸帕罗西汀肠溶缓释片	paroxetine hydrochloride	Tablet, extended release	Chemical Drugs(6)	Generic Drug	2014-11-27	信泰制药（苏州）有限公司	BrightGene Pharmaceutical Co Ltd	Certificate Issued	2016-09-11	view