药品名称MAXALT
申请号020864产品号002
活性成分RIZATRIPTAN BENZOATE市场状态处方药
剂型或给药途径TABLET;ORAL规格EQ 10MG BASE
治疗等效代码AB参比药物
批准日期1998/06/29申请机构MERCK AND CO 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
历史专利信息
52985202012/06/29U-240PDF格式
56021622014/02/11PDF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
NPP2014/12/16
PED2015/06/16
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
020864019APLabel2011/12/20下载
020864019APLetter2011/12/21下载
020864018APLetter2011/12/21下载
020864018APLabel2011/12/20下载
020864017APLabel2011/12/20下载
020864017APLetter2011/12/21下载
020864016APLetter2011/12/21下载
020864016APLabel2011/12/20下载
020864013APLetter2010/08/16下载
020864013APLabel2010/08/19下载
020864011APLabel2011/12/20下载
020864011APLetter2011/12/21下载
020864008APReview2008/08/01下载
020864008APLetter2002/04/22下载
020864007APReview2004/04/21下载
020864005APReview2004/04/21下载
020864004APReview2004/04/15下载
020864003APLetter1999/12/30下载
020864002APReview2004/04/15下载
020864000APOther Important Information from FDA2003/12/12下载
020864000APLetter1998/06/29下载
020864000APReview1999/04/08下载
020864000APLabel1998/06/29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
020864021AP2015/06/15Manufacturing Change or Addition
020864020AP2014/05/29Manufacturing Change or Addition
020864019AP2011/12/16Labeling Revision
020864018AP2011/12/16Labeling Revision
020864017AP2011/12/16Labeling Revision
020864016AP2011/12/16Labeling Revision
020864013AP2010/08/12Labeling Revision
020864011AP2011/12/16Labeling Revision
020864009AP2001/12/06Manufacturing Change or Addition
020864008AP2002/04/22Labeling Revision
020864007AP2000/12/11Labeling Revision
020864006AP2001/01/25Manufacturing Change or Addition
020864005AP2000/12/11Efficacy Supplement with Clinical Data to Support
020864004AP2000/12/11Labeling Revision
020864003AP1999/11/16Efficacy Supplement with Clinical Data to Support
020864002AP2000/06/21Efficacy Supplement with Clinical Data to Support
020864000AP1998/06/29Approval