药品名称DESOGEN
申请号020071产品号001
活性成分DESOGESTREL; ETHINYL ESTRADIOL市场状态停止上市
剂型或给药途径TABLET;ORAL-21规格0.15MG;0.03MG
治疗等效代码参比药物
批准日期1992/12/10申请机构ORGANON USA INC
化学类型审评分类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
020071017APLabel2007/06/12下载
020071017APLetter2007/06/14下载
020071014APLetter2004/08/11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
020071022AP2015/11/30Manufacturing Change or Addition
020071021AP2015/01/12Manufacturing Change or Addition
020071020AP2016/02/11Manufacturing Change or Addition
020071017AP2007/06/07Labeling Revision
020071015AP2002/03/08Control Supplement
020071014AP2004/08/11Labeling Revision
020071013AP2000/11/27Manufacturing Change or Addition
020071012AP1998/11/19Manufacturing Change or Addition
020071011AP1998/02/24Formulation Revision
020071010AP1997/11/20Control Supplement
020071009AP1997/11/20Control Supplement
020071008AP1998/03/05Labeling Revision
020071007AP1996/07/26Labeling Revision
020071006AP1995/04/25Manufacturing Change or Addition
020071005AP1994/02/18Manufacturing Change or Addition
020071004AP1995/02/03Labeling Revision
020071002AP1995/04/28Labeling Revision
020071001AP1993/03/09Labeling Revision
020071000AP1992/12/10Approval