药品名称HYPAQUE
申请号009561产品号003
活性成分DIATRIZOATE SODIUM市场状态停止上市
剂型或给药途径INJECTABLE;INJECTION规格25%
治疗等效代码参比药物
批准日期Approved Prior to Jan 1, 1982申请机构GE HEALTHCARE
化学类型New molecular entity (NME)审评分类Priority review drug
与本品相关的专利信息(来自橙皮书Orange Book)
专利号专利过期日是否化合物专利是否产品专利专利用途代码专利下载
历史专利信息
与本品相关的市场独占权保护信息
独占权代码失效日期
历史市场独占权保护信息
与药品注册相关的信息
申请号修订号审批结论公开文档类型文档创建时间获取文档
药品注册审批历史信息
申请号修订号审批结论审批日期审批内容
009561079AP2001/08/13Control Supplement
009561078AP1998/08/20Manufacturing Change or Addition
009561077AP1995/06/15Labeling Revision
009561076AP1996/08/23Control Supplement
009561075AP1993/10/05Manufacturing Change or Addition
009561073AP1991/10/03Labeling Revision
009561072AP1991/10/03Labeling Revision
009561071AP1991/10/03Labeling Revision
009561070AP1989/06/29Labeling Revision
009561069AP1989/05/26Labeling Revision
009561068AP1989/05/02Labeling Revision
009561067AP1989/04/11Manufacturing Change or Addition
009561066AP1988/02/22Labeling Revision
009561064AP1987/08/24Labeling Revision
009561063AP1986/11/07Labeling Revision
009561062AP1990/02/26Manufacturing Change or Addition
009561061AP1986/06/25Labeling Revision
009561060AP1986/03/17Labeling Revision
009561059AP1986/08/14Manufacturing Change or Addition
009561058AP1985/06/26Labeling Revision
009561057AP1985/04/19Labeling Revision
009561056AP1988/05/23Package Change
009561055AP1987/03/23Expiration Date Change
009561053AP1985/01/14Package Change
009561052AP1982/10/18Manufacturing Change or Addition
009561050AP1983/08/03Control Supplement
009561049AP1982/03/18Package Change
009561048AP1987/02/01Practioner Draft Labeling
009561047AP1982/02/24Labeling Revision
009561046AP1984/04/05Practioner Draft Labeling
009561045AP1984/02/29Practioner Draft Labeling
009561043AP1982/01/18Control Supplement
009561042AP1986/08/06Formulation Revision
009561041AP1981/04/11Manufacturing Change or Addition
009561040AP1982/06/30Labeling Revision
009561039AP1979/10/11Package Change
009561038AP1979/01/22Package Change
009561037AP1979/02/15Control Supplement
009561036AP1978/02/01Control Supplement
009561035AP1978/01/31Manufacturing Change or Addition
009561034AP1977/12/16Manufacturing Change or Addition
009561033AP1978/10/06Labeling Revision
009561031AP1977/02/23Labeling Revision
009561030AP1976/09/08Manufacturing Change or Addition
009561027AP1976/05/26Manufacturing Change or Addition
009561026AP1976/06/02Manufacturing Change or Addition
009561025AP1976/09/08Manufacturing Change or Addition
009561024AP1976/05/26Labeling Revision
009561023AP1976/06/02Labeling Revision
009561022AP1976/02/11Final Printed Labeling - MarkIV
009561000AP1954/11/26Approval