药品名称ORTHO-NOVUM 1/50 28
申请号016709产品号001
活性成分MESTRANOL; NORETHINDRONE市场状态停止上市
剂型或给药途径TABLET;ORAL-28规格0.05MG;1MG
治疗等效代码参比药物
批准日期Approved Prior to Jan 1, 1982申请机构ORTHO MCNEIL 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
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
016709128AP2002/06/03Control Supplement
016709126AP2000/06/05Labeling Revision
016709125AP2000/01/05Package Change
016709124AP1998/04/28Manufacturing Change or Addition
016709123AP1998/07/10Labeling Revision
016709122AP1997/11/28Labeling Revision
016709121AP1997/01/29Control Supplement
016709120AP1996/04/09Control Supplement
016709118AP1995/11/30Manufacturing Change or Addition
016709117AP1995/09/07Control Supplement
016709116AP1994/12/07Control Supplement
016709115AP1994/07/06Labeling Revision
016709114AP1993/11/04Manufacturing Change or Addition
016709113AP1993/05/18Control Supplement
016709112AP1994/03/07Formulation Revision
016709110AP1991/03/18Control Supplement
016709109AP1991/09/16Labeling Revision
016709108AP1990/01/18Control Supplement
016709107AP1996/12/27Control Supplement
016709106AP1989/10/23Labeling Revision
016709105AP1989/07/19Labeling Revision
016709104AP1988/10/28Control Supplement
016709103AP1988/06/08Manufacturing Change or Addition
016709102AP1988/09/09Labeling Revision
016709101AP1987/02/26Labeling Revision
016709100AP1987/11/23Control Supplement
016709098AP1985/10/21Labeling Revision
016709097AP1985/04/05Labeling Revision
016709096AP1984/06/21Labeling Revision
016709095AP1984/01/30Labeling Revision
016709094AP1983/09/29Labeling Revision
016709084AP1979/11/08Control Supplement
016709081AP1979/11/13Labeling Revision
016709080AP1979/10/19Package Change
016709077AP1978/07/25Control Supplement
016709076AP1978/06/26Labeling Revision
016709066AP1978/02/28Control Supplement
016709065AP1978/02/28Control Supplement
016709064AP1978/02/28Control Supplement
016709063AP1978/04/17Control Supplement
016709060AP1978/05/25Control Supplement
016709056AP1978/03/19Control Supplement
016709055AP1978/01/18Package Change
016709054AP1978/01/18Labeling Revision
016709053AP1978/07/25Control Supplement
016709052AP1977/07/01Labeling Revision
016709049AP1979/04/10Labeling Revision
016709038AP1976/08/09Control Supplement
016709034AP1976/08/09Control Supplement
016709032AP1975/08/07Control Supplement
016709031AP1975/08/07Control Supplement
016709030AP1975/08/07Control Supplement
016709029AP1975/08/07Control Supplement
016709028AP1975/08/07Control Supplement
016709027AP1975/08/07Control Supplement
016709026AP1975/05/21Control Supplement
016709025AP1975/05/21Control Supplement
016709023AP1975/05/21Control Supplement
016709022AP1975/05/21Control Supplement
016709021AP1975/03/06Other Amendment
016709000AP1968/08/21Approval