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
JTH2100544	替勃龙杂质OM38		Active ingredient	Chemical Drugs	Disposable Import Drug Application	2021-06-15					view
JTH2100545	替勃龙杂质OM08	tibolone	Active ingredient	Chemical Drugs	Disposable Import Drug Application	2021-06-15					view
JYHZ2100509	替勃龙片	tibolone	Tablet	Chemical Drugs	License Renew	2021-03-29					view
CYHS2402072	替勃龙片	tibolone	Tablet	Chemical Drugs(4)	Generic Drug	2024-07-09					view
B19990140	替勃龙片	tibolone	Tablet	Chemical Drugs	Import Drug Application	2000-01-01	南京欧加农制药有限公司	Nanjing Organon Pharmaceutical Co Ltd	Approval Completed-Pending Certificated	1999-12-02	view
H20010142	替勃龙	tibolone	Active ingredient	Chemical Drugs	Import Drug Application	2001-06-11	南京欧加农公司北京办事处	Nanjing Organon Pharmaceutical Co Ltd	Approval Completed-Pending Certificated	2002-04-09	view
CXS01412	替勃龙片	tibolone	Tablet	Chemical Drugs(4)	New Drug Application	2001-08-28	北京紫竹药业有限公司	China Resources Zizhu Pharmaceutical Co Ltd	Certificate Issued	2002-06-19	view
CXS01411	替勃龙	tibolone	Active ingredient	Chemical Drugs(4)	New Drug Application	2001-08-28	北京紫竹药业有限公司	China Resources Zizhu Pharmaceutical Co Ltd	Certificate Issued	2002-06-19	view
H20010164	替勃龙	tibolone	Active ingredient	Chemical Drugs	Import Drug Application	2001-07-24	南京欧加农公司北京办事处	Nanjing Organon Pharmaceutical Co Ltd	Certificate Issued	2003-04-25	view
CXS20020563	替勃龙	tibolone	Active ingredient	Chemical Drugs(4)	New Drug Application	2002-07-08	北京集才医药技术开发有限公司天津药物研究院药业有限责任公司		Certificate Issued	2003-06-20	view
CXS20020564	替勃龙片	tibolone	Tablet	Chemical Drugs(4)	New Drug Application	2002-07-08	北京集才医药技术开发有限公司北京优华药业有限公司		Certificate Issued	2003-06-20	view
X0305970	替勃龙片	tibolone	Tablet	Chemical Drugs(4)	New Drug Application	2003-11-17	南京欧加农制药有限公司	Nanjing Organon Pharmaceutical Co Ltd	Certificate Issued	2004-09-10	view
CXHB0500303	替勃龙片	tibolone	Tablet	Chemical Drugs	Supplementary Application	2005-03-13	南京欧加农制药有限公司	Nanjing Organon Pharmaceutical Co Ltd	Certificate Issued	2005-06-08	view
CXHB0500934	替勃龙片	tibolone	Tablet	Chemical Drugs	Supplementary Application	2005-05-17	北京优华药业有限公司	Beijing Youhua Pharmaceutical Co Ltd	Certificate Issued	2005-11-23	view
JYHZ0500100	替勃龙片	tibolone	Tablet	Chemical Drugs	License Renew	2005-04-27	欧加农公司奥斯荷兰	N V Organon	Certificate Issued	2007-03-20	view
JYHB1100487	替勃龙片	tibolone	Tablet	Chemical Drugs	Supplementary Application	2011-06-03	百慕大先灵葆雅（中国）有限公司北京代表处		Certificate Issued	2011-11-18	view
CYHS1201158	替勃龙	tibolone	Active ingredient	Chemical Drugs(6)	Generic Drug	2012-12-26	湖北葛店人福药业有限责任公司	Hubei Gedian Humanwell Pharmaceutical Co Ltd	In Review	2012-12-25	view
JYHB1100148	替勃龙片	tibolone	Tablet	Chemical Drugs	Supplementary Application	2011-03-02	百慕大先灵葆雅（中国）有限公司北京代表处		Certificate Issued	2013-01-16	view
JYHB1200671	替勃龙颗粒	tibolone	Granule	Chemical Drugs	Supplementary Application	2012-06-29	默沙东（中国）有限公司北京办事处	Merck Sharp & Dohme (China) Ltd Beijing Representative Office	Certificate Issued	2014-11-14	view
CYHB1406955	替勃龙	tibolone	Active ingredient	Chemical Drugs	Supplementary Application	2014-10-27	秦皇岛紫竹药业有限公司	Qinhuangdao Zizhu Pharmaceutical Co Ltd	Certificate Issued	2017-06-20	view