药品名称MAGNEVIST
申请号019596产品号001
活性成分GADOPENTETATE DIMEGLUMINE市场状态处方药
剂型或给药途径INJECTABLE;INJECTION规格469.01MG/ML
治疗等效代码参比药物
批准日期1988/06/02申请机构BAYER HEALTHCARE PHARMACEUTICALS INC
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
53624752011/11/08PDF格式
55609032013/10/01PDF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
019596057APLetter2014/06/12下载
019596056APLetter2013/10/18下载
019596056APLabel2013/10/22下载
019596051APLabel2012/03/29下载
019596051APLetter2012/04/02下载
019596049APLabel2010/12/20下载
019596049APLetter2010/12/22下载
019596045APLabel2009/05/25下载
019596045APLetter2009/05/29下载
019596043APLabel2007/09/06下载
019596043APLetter2007/09/06下载
019596039APLetter2006/09/15下载
019596034APLetter2010/08/31下载
019596034APLabel2010/09/07下载
019596033APLetter2005/01/26下载
019596033APLabel2005/01/26下载
019596009APReview2011/02/04下载
019596008APReview2011/02/04下载
019596000APOther 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
019596058AP2015/12/07Manufacturing Change or Addition
019596057AP2014/06/11Labeling Revision
019596056AP2013/10/17Labeling Revision
019596055AP2013/09/06Manufacturing Change or Addition
019596054AP2012/11/30Manufacturing Change or Addition
019596051AP2012/03/29Labeling Revision
019596049AP2010/12/20Labeling Revision
019596045AP2009/05/22Control Supplement
019596043AP2007/09/04Labeling Revision
019596039AP2006/09/13Labeling Revision
019596034AP2010/08/19Labeling Revision
019596033AP2005/01/21Labeling Revision
019596027AP2002/10/29Manufacturing Change or Addition
019596025AP2001/11/05Manufacturing Change or Addition
019596023AP2001/04/18Manufacturing Change or Addition
019596022AP2000/11/14Control Supplement
019596021AP2000/10/24Manufacturing Change or Addition
019596020AP1999/11/10Manufacturing Change or Addition
019596019AP1999/02/05Manufacturing Change or Addition
019596018AP2000/03/10Labeling Revision
019596016AP1998/10/26Package Change
019596015AP1997/09/25Control Supplement
019596013AP1996/03/14Control Supplement
019596012AP1996/03/14Control Supplement
019596011AP1995/11/16Control Supplement
019596010AP1995/03/03Control Supplement
019596009AP1996/02/28Patient Population Altered
019596008AP1993/08/17New or Modified Indication
019596007AP1990/08/22Labeling Revision
019596006AP1992/02/12Formulation Revision
019596005AP1989/08/10Patient Population Altered
019596004AP1989/02/02Labeling Revision
019596003AP1989/03/23Control Supplement
019596001AP1989/04/28New or Modified Indication
019596000AP1988/06/02Approval