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
JXHL0600286	凡德他尼片	vandetanib	Tablet	Chemical Drugs(1.1)	Import Drug Application	2006-11-08	精鼎医药研究开发（上海）有限公司	Parexel China Co Ltd	Certificate Issued	2008-04-10	view
JXSL1500014	注射用重组人凝血因子VIII	Recombinant Coagulation Factor Ⅷ	Lyophilized	Biological Products	Import Drug Application	2015-04-17	精鼎医药研究开发（上海）有限公司	Parexel China Co Ltd	Certificate Issued	2017-12-06	view
JXHS1000084	酒石酸长春瑞滨软胶囊	vinorelbine tartrate	Soft capsules	Chemical Drugs	Import Drug Application	2010-11-17	精鼎医药研究开发（上海）有限公司	Parexel China Co Ltd	Certificate Issued	2014-09-10	view
JYHB2000407	异麦芽糖酐铁注射液		Injection	Chemical Drugs(5.1)	Supplementary Application	2020-04-07	精鼎医药研究开发（上海）有限公司	Parexel China Co Ltd	Filed	2020-04-17	view
JXHL1200336	HKI-272片剂	neratinib maleate	Tablet	Chemical Drugs	Import Drug Application	2012-11-08	精鼎医药研究开发（上海）有限公司	Parexel China Co Ltd	Certificate Issued	2013-04-23	view
JXSL1400025	注射用A型肉毒毒素(150 KD,不含复合蛋白)	Botulinum Toxin Type A	Lyophilized	Biological Products	Import Drug Application	2014-04-17	精鼎医药研究开发（上海）有限公司	Parexel China Co Ltd	Certificate Issued	2016-08-09	view
JXHL0800036	注射用坎格雷洛	cangrelor	Lyophilized	Chemical Drugs(1.1)	Import Drug Application	2008-01-25	精鼎医药研究开发（上海）有限公司	Parexel China Co Ltd	Certificate Issued	2009-04-08	view
JXSL1700060	利妥昔单抗注射液	rituximab	Injection	Biological Products	Import Drug Application	2017-10-23	精鼎医药研究开发（上海）有限公司	Parexel China Co Ltd	In Review	2017-10-20	view
JXHL1200337	HKI-272片剂	neratinib maleate	Tablet	Chemical Drugs	Import Drug Application	2012-10-23	精鼎医药研究开发（上海）有限公司	Parexel China Co Ltd	Certificate Issued	2013-04-23	view
JXFL1300014	白凡士林		Other	Other	Import Drug Application	2013-09-06	精鼎医药研究开发（上海）有限公司	Parexel China Co Ltd	Certificate Issued	2017-04-18	view
JXHL1000060	贝前列素钠缓释片	beraprost sodium	Tablet, extended release	Chemical Drugs	Import Drug Application	2010-03-05	精鼎医药研究开发（上海）有限公司	Parexel China Co Ltd	Certificate Issued	2011-02-21	view
JYHB2000406	异麦芽糖酐铁注射液		Injection	Chemical Drugs(5.1)	Supplementary Application	2020-04-07	精鼎医药研究开发（上海）有限公司	Parexel China Co Ltd	Filed	2020-04-17	view
JXHL1200338	HKI-272片剂	neratinib maleate	Tablet	Chemical Drugs	Import Drug Application	2012-11-08	精鼎医药研究开发（上海）有限公司	Parexel China Co Ltd	Certificate Issued	2013-04-23	view
JXSL1400026	注射用A型肉毒毒素(150 KD,不含复合蛋白)	Botulinum Toxin Type A	Lyophilized	Biological Products	Import Drug Application	2014-04-03	精鼎医药研究开发（上海）有限公司	Parexel China Co Ltd	Certificate Issued	2016-08-09	view
JXHL0700277	阿贝莫司钠注射液	abetimus	Injection	Chemical Drugs(1.1)	Import Drug Application	2007-09-25	精鼎医药研究开发（上海）有限公司	Parexel China Co Ltd	Certificate Issued	2008-07-16	view
JXSL1700061	利妥昔单抗注射液	rituximab	Injection	Biological Products	Import Drug Application	2017-10-23	精鼎医药研究开发（上海）有限公司	Parexel China Co Ltd	In Review	2017-10-20	view
JXFL1200029	粉状巴西棕榈蜡#120NF		Excipients	Other	Import Drug Application	2012-10-23	精鼎医药研究开发（上海）有限公司	Parexel China Co Ltd	Certificate Issued	2016-03-29	view
JXHL1300302	Sofosbuvir 片	Sofosbuvir	Tablet	Chemical Drugs	Import Drug Application	2013-08-19	精鼎医药研究开发（上海）有限公司	Parexel China Co Ltd	Certificate Issued	2015-01-29	view
JXSL1500013	注射用重组人凝血因子VIII	Recombinant Coagulation Factor Ⅷ	Lyophilized	Biological Products	Import Drug Application	2015-04-17	精鼎医药研究开发（上海）有限公司	Parexel China Co Ltd	Certificate Issued	2017-12-06	view
JXHL1900012	沙芬酰胺片	safinamide mesylate	Tablet	Chemical Drugs(5.1)	Import Drug Application	2019-01-28	精鼎医药研究开发（上海）有限公司	Parexel China Co Ltd	In Review	2019-01-25	view