药品名称ORTHO-NOVUM 7/7/7-21
申请号018985产品号001
活性成分ETHINYL ESTRADIOL; NORETHINDRONE市场状态停止上市
剂型或给药途径TABLET;ORAL-21规格0.035MG;0.5MG;0.75MG;1MG
治疗等效代码参比药物
批准日期1984/04/04申请机构JANSSEN PHARMACEUTICALS INC
化学类型New dosage form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
018985063APLetter2015/11/04下载
018985063APLabel2015/11/04下载
018985060APLetter2013/10/04下载
018985056APLetter2013/10/04下载
018985054APLetter2013/10/04下载
018985053APLetter2012/06/20下载
018985053APLabel2012/07/13下载
018985050APLabel2013/10/04下载
018985050APLetter2013/10/04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
018985063AP2015/10/29Labeling Revision
018985062AP2014/09/11Manufacturing Change or Addition
018985060AP2013/10/02Labeling Revision
018985056AP2013/10/02Labeling Revision
018985054AP2013/10/02Labeling Revision
018985053AP2012/06/18Labeling Revision
018985050AP2013/10/02Labeling Revision
018985039AP2002/06/03Control Supplement
018985038AP2002/02/21Manufacturing Change or Addition
018985037AP2001/07/09Control Supplement
018985035AP2000/06/06Labeling Revision
018985034AP2000/01/05Package Change
018985033AP1999/08/27Labeling Revision
018985032AP1998/04/28Manufacturing Change or Addition
018985031AP1998/04/13Manufacturing Change or Addition
018985030AP1999/08/27Labeling Revision
018985029AP1999/08/27Labeling Revision
018985028AP1997/02/24Control Supplement
018985027AP1997/01/29Control Supplement
018985026AP1996/04/09Control Supplement
018985025AP1996/05/10Control Supplement
018985024AP1995/11/30Manufacturing Change or Addition
018985023AP1995/09/07Control Supplement
018985022AP1995/02/16Control Supplement
018985021AP1993/11/04Manufacturing Change or Addition
018985020AP1994/01/03Labeling Revision
018985019AP1993/05/18Control Supplement
018985017AP1994/03/07Formulation Revision
018985015AP1991/03/18Control Supplement
018985014AP1991/09/16Labeling Revision
018985013AP1990/01/18Control Supplement
018985011AP1989/10/23Labeling Revision
018985010AP1989/07/19Labeling Revision
018985009AP1988/10/28Control Supplement
018985008AP1988/06/08Manufacturing Change or Addition
018985007AP1988/09/09Labeling Revision
018985006AP1987/02/02Labeling Revision
018985005AP1987/11/23Control Supplement
018985003AP1985/10/21Labeling Revision
018985002AP1985/04/05Labeling Revision
018985001AP1984/06/21Labeling Revision
018985000AP1984/04/04Approval