药品名称ORTHO-NOVUM 2-21
申请号012728产品号005
活性成分MESTRANOL; NORETHINDRONE市场状态停止上市
剂型或给药途径TABLET;ORAL-21规格0.1MG;2MG
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 PHARMACEUTICAL INC
化学类型New combination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
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与本品相关的市场独占权保护信息
独占权代码失效日期
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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
012728190AP2000/01/05Package Change
012728189AP1998/04/28Manufacturing Change or Addition
012728188AP1998/07/10Labeling Revision
012728186AP1997/01/29Control Supplement
012728185AP1996/04/09Control Supplement
012728183AP1995/11/30Manufacturing Change or Addition
012728182AP1995/09/07Control Supplement
012728181AP1994/12/07Control Supplement
012728180AP1994/06/28Labeling Revision
012728179AP1993/11/04Manufacturing Change or Addition
012728178AP1993/05/18Control Supplement
012728177AP1994/03/07Formulation Revision
012728175AP1991/03/18Control Supplement
012728174AP1991/09/16Labeling Revision
012728173AP1996/12/27Control Supplement
012728172AP1989/10/23Labeling Revision
012728171AP1989/07/19Labeling Revision
012728170AP1988/10/28Control Supplement
012728169AP1988/06/08Manufacturing Change or Addition
012728166AP1988/09/09Labeling Revision
012728165AP1987/02/26Labeling Revision
012728164AP1987/11/23Control Supplement
012728162AP1985/10/21Labeling Revision
012728161AP1985/04/05Labeling Revision
012728160AP1984/06/21Labeling Revision
012728159AP1984/01/30Labeling Revision
012728158AP1983/09/29Labeling Revision
012728105AP1978/09/14Labeling Revision
012728087AP1978/03/29Other Amendment
012728086AP1978/07/25Control Supplement
012728085AP1977/10/20Labeling Revision
012728084AP1977/07/01Labeling Revision
012728073AP1976/08/06Control Supplement
012728072AP1976/08/06Control Supplement
012728064AP1975/08/07Control Supplement
012728063AP1975/08/07Control Supplement
012728062AP1975/08/07Control Supplement
012728061AP1975/08/07Control Supplement
012728060AP1975/08/07Control Supplement
012728059AP1975/08/07Control Supplement
012728056AP1975/05/21Other Amendment
012728055AP1975/05/21Control Supplement
012728052AP1975/05/21Control Supplement
012728051AP1975/05/21Control Supplement
012728050AP1975/03/03Other Amendment
012728000AP1962/05/21Approval