药品名称ORTHO-CEPT
申请号020301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1992/12/14申请机构JANSSEN PHARMACEUTICALS INC
化学类型New formulation or new manufacturer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
020301036APLetter2015/12/02下载
020301036APLabel2015/12/02下载
020301034APLetter2013/10/04下载
020301030APLetter2013/10/04下载
020301028APLetter2013/10/04下载
020301027APLetter2012/06/20下载
020301027APLabel2012/07/13下载
020301025APLabel2013/10/04下载
020301025APLetter2013/10/04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
020301036AP2015/12/01Labeling Revision
020301034AP2013/10/02Labeling Revision
020301033AP2014/04/08Manufacturing Change or Addition
020301030AP2013/10/02Labeling Revision
020301028AP2013/10/02Labeling Revision
020301027AP2012/06/18Labeling Revision
020301025AP2013/10/02Labeling Revision
020301018AP2002/02/21Manufacturing Change or Addition
020301016AP2001/06/07Manufacturing Change or Addition
020301015AP2001/06/19Labeling Revision
020301014AP2000/01/05Control Supplement
020301012AP1999/03/03Manufacturing Change or Addition
020301011AP1998/11/19Manufacturing Change or Addition
020301010AP1998/11/19Control Supplement
020301009AP1997/02/04Labeling Revision
020301008AP1996/02/14Labeling Revision
020301007AP1996/03/04Manufacturing Change or Addition
020301006AP1996/02/21Manufacturing Change or Addition
020301005AP1996/12/04Control Supplement
020301004AP1995/06/02Labeling Revision
020301003AP1993/11/04Manufacturing Change or Addition
020301002AP1994/01/05Manufacturing Change or Addition
020301000AP1992/12/14Approval