药品名称MEGACE
申请号016979产品号002
活性成分MEGESTROL ACETATE市场状态停止上市
剂型或给药途径TABLET;ORAL规格40MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
治疗等效代码参比药物
批准日期Approved Prior to Jan 1, 1982申请机构BRISTOL MYERS SQUIBB
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
016979052APLetter2002/01/06下载
016979051APLetter2002/08/27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
016979052AP2003/01/06Labeling Revision
016979051AP2002/08/27Labeling Revision
016979050AP2001/06/15Manufacturing Change or Addition
016979049AP2001/01/31Labeling Revision
016979048AP1999/11/15Labeling Revision
016979047AP1997/09/04Labeling Revision
016979046AP1994/06/27Labeling Revision
016979045AP1993/08/11Manufacturing Change or Addition
016979044AP1991/03/14Manufacturing Change or Addition
016979042AP1991/03/04Control Supplement
016979041AP1989/08/11Package Change
016979040AP1989/08/08Labeling Revision
016979039AP1989/01/26Package Change
016979038AP1988/04/12Manufacturing Change or Addition
016979037AP1988/03/07Control Supplement
016979036AP1988/06/20Control Supplement
016979033AP1985/11/25Labeling Revision
016979031AP1987/11/13Labeling Revision
016979030AP1990/09/06Manufacturing Change or Addition
016979029AP1985/07/23Control Supplement
016979028AP1984/12/11Control Supplement
016979026AP1984/10/16Control Supplement
016979025AP1990/12/11Practioner Draft Labeling
016979024AP1982/11/19Formulation Revision
016979023AP1984/05/24Control Supplement
016979022AP1984/07/10Control Supplement
016979020AP1982/02/10Control Supplement
016979019AP1983/02/22Formulation Revision
016979018AP1981/03/11Labeling Revision
016979017AP1979/03/29Control Supplement
016979016AP1980/02/26Labeling Revision
016979015AP1979/06/20Manufacturing Change or Addition
016979014AP1977/06/15Labeling Revision
016979013AP1976/11/23Control Supplement
016979012AP1976/11/23Control Supplement
016979011AP1976/09/21Control Supplement
016979010AP1976/07/16Labeling Revision
016979009AP1976/07/07Control Supplement
016979008AP1975/06/03Other Amendment
016979000AP1971/08/18Approval