药品名称PROHANCE
申请号020131产品号001
活性成分GADOTERIDOL市场状态处方药
剂型或给药途径INJECTABLE;INJECTION规格279.3MG/ML
治疗等效代码参比药物
批准日期1992/11/16申请机构BRACCO DIAGNOSTICS INC
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
58465192015/12/08PDF格式
历史专利信息
48853632006/12/05PDF格式
54747562012/12/12U-480PDF格式
61432742012/12/12U-480PDF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
020131026APLabel2013/08/15下载
020131026APLetter2013/08/16下载
020131024APLabel2010/12/20下载
020131024APLetter2010/12/22下载
020131023APLabel2007/09/06下载
020131023APLetter2007/09/06下载
020131016APLetter2002/09/30下载
020131009APLetter2002/09/30下载
020131000APOther 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
020131026AP2013/08/13Labeling Revision
020131024AP2010/12/20Labeling Revision
020131023AP2007/09/04Labeling Revision
020131021AP2002/06/03Manufacturing Change or Addition
020131019AP2001/07/19Manufacturing Change or Addition
020131018AP2001/03/09Manufacturing Change or Addition
020131017AP2001/01/24Manufacturing Change or Addition
020131016AP2002/09/30Labeling Revision
020131015AP1998/04/02Manufacturing Change or Addition
020131014AP1997/06/13Manufacturing Change or Addition
020131013AP1997/06/13Manufacturing Change or Addition
020131012AP1997/01/29Manufacturing Change or Addition
020131011AP1997/04/08Control Supplement
020131010AP1996/02/01Control Supplement
020131009AP2002/09/30Labeling Revision
020131008AP1996/10/08Control Supplement
020131005AP1995/05/08Labeling Revision
020131004AP1993/10/26Control Supplement
020131002AP1994/11/21New or Modified Indication
020131001AP1994/11/21New or Modified Indication
020131000AP1992/11/16Approval