药品名称OMNISCAN
申请号020123产品号001
活性成分GADODIAMIDE市场状态处方药
剂型或给药途径INJECTABLE;INJECTION规格287MG/ML
治疗等效代码参比药物
批准日期1993/01/08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
46876592007/05/04U-76PDF格式
53624752011/11/08YPDF格式
55609032013/10/01YPDF格式
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
020123043APLetter2014/11/18下载
020123043APLabel2014/11/20下载
020123039APLabel2013/08/28下载
020123039APLetter2013/08/29下载
020123037APLabel2010/12/20下载
020123037APLetter2010/12/22下载
020123035APLabel2007/12/27下载
020123035APLetter2008/01/09下载
020123034APLabel2007/09/06下载
020123034APLetter2007/09/07下载
020123023APLetter2003/07/31下载
020123022APLetter2002/06/28下载
020123021APLetter2002/05/17下载
020123018APLetter2002/07/08下载
020123015APReview1997/10/03下载
020123000APOther Important Information from FDA2006/06/09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
020123044AP2016/06/06Manufacturing Change or Addition
020123043AP2014/11/14Labeling Revision
020123042AP2014/06/23Manufacturing Change or Addition
020123041AP2014/04/03Manufacturing Change or Addition
020123040AP2014/05/14Manufacturing Change or Addition
020123039AP2013/08/27Labeling Revision
020123037AP2010/12/20Labeling Revision
020123035AP2007/12/14Labeling Revision
020123034AP2007/09/05Labeling Revision
020123024AP2002/08/12Control Supplement
020123023AP2002/11/15Manufacturing Change or Addition
020123022AP2002/06/28Labeling Revision
020123021AP2002/05/20Manufacturing Change or Addition
020123020AP2002/03/15Manufacturing Change or Addition
020123019AP2001/07/30Control Supplement
020123018AP2002/07/08Labeling Revision
020123017AP2001/03/13Manufacturing Change or Addition
020123016AP2001/01/17Expiration Date Change
020123015AP1997/10/03Labeling Revision
020123014AP1997/03/19Control Supplement
020123013AP1997/03/27Manufacturing Change or Addition
020123009AP1995/02/17Control Supplement
020123007AP1996/02/05New Dosage Regimen
020123005AP1996/02/05New or Modified Indication
020123004AP1996/02/05New Dosage Regimen
020123003AP1994/06/06Manufacturing Change or Addition
020123002AP1994/11/04Manufacturing Change or Addition
020123001AP1993/04/26Control Supplement
020123000AP1993/01/08Approval