药品名称OMNIPAQUE 300
申请号018956产品号003
活性成分IOHEXOL市场状态处方药
剂型或给药途径SOLUTION;INJECTION, ORAL, RECTAL规格64.7%
治疗等效代码参比药物
批准日期1985/12/26申请机构GE HEALTHCARE
化学类型New molecular entity (NME)审评分类Standard 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
018956095APLabel2015/07/09下载
018956095APLetter2015/07/10下载
018956076APLetter2007/10/04下载
018956065APLetter2005/03/30下载
018956062APLetter2004/12/29下载
018956058APLetter2004/03/10下载
018956049APLetter2002/12/23下载
018956043APReview1998/05/11下载
018956039APLetter2002/12/23下载
018956028APReview2003/08/05下载
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
018956096AP2015/10/21Manufacturing Change or Addition
018956095AP2015/07/06Labeling Revision
018956094AP2015/03/03Manufacturing Change or Addition
018956093AP2014/06/19Manufacturing Change or Addition
018956092AP2013/11/20Manufacturing Change or Addition
018956091AP2014/02/10Manufacturing Change or Addition
018956089AP2013/08/21Manufacturing Change or Addition
018956076AP2007/10/01Labeling Revision
018956065AP2005/03/25Manufacturing Change or Addition
018956062AP2004/12/27Labeling Revision
018956058AP2004/03/05Labeling Revision
018956054AP2002/11/20Manufacturing Change or Addition
018956053AP2002/08/05Manufacturing Change or Addition
018956052AP2000/12/19Control Supplement
018956051AP1998/09/08Control Supplement
018956049AP2002/12/23Labeling Revision
018956046AP1995/08/18Manufacturing Change or Addition
018956045AP1994/11/04Manufacturing Change or Addition
018956044AP1995/08/18Control Supplement
018956043AP1995/06/15Labeling Revision
018956042AP1995/11/28Control Supplement
018956041AP1994/09/30Package Change
018956040AP1992/10/20Control Supplement
018956039AP2002/12/23Labeling Revision
018956038AP1992/09/30Manufacturing Change or Addition
018956037AP1992/12/11Package Change
018956036AP1994/06/01Labeling Revision
018956035AP1994/06/01Package Change
018956034AP1993/03/01Package Change
018956033AP1993/03/01Labeling Revision
018956032AP1993/03/01Control Supplement
018956031AP1993/03/01Manufacturing Change or Addition
018956030AP1995/12/04Control Supplement
018956029AP1990/08/24Package Change
018956028AP1993/07/13New Route of Administration
018956027AP1992/03/26Control Supplement
018956026AP1989/11/30Patient Population Altered
018956024AP1989/05/03Labeling Revision
018956023AP1989/07/28New or Modified Indication
018956022AP1989/07/28Patient Population Altered
018956021AP1989/06/30New or Modified Indication
018956020AP1989/06/30New or Modified Indication
018956019AP1989/01/04Control Supplement
018956018AP1989/03/31New or Modified Indication
018956017AP1988/11/30New or Modified Indication
018956016AP1988/04/18Manufacturing Change or Addition
018956015AP1988/05/24New or Modified Indication
018956014AP1988/07/29New or Modified Indication
018956013AP1988/01/27Control Supplement
018956012AP1988/02/01Patient Population Altered
018956010AP1989/05/22Manufacturing Change or Addition
018956009AP1987/05/12New or Modified Indication
018956008AP1993/12/23Manufacturing Change or Addition
018956007AP1987/06/04Package Change
018956006AP1987/05/27Labeling Revision
018956004AP1987/04/21Labeling Revision
018956003AP1986/11/20Labeling Revision
018956002AP1987/02/05Manufacturing Change or Addition
018956001AP1986/11/26New or Modified Indication
018956000AP1985/12/26Approval