药品名称ORTHO-NOVUM 7/14-28
申请号019004产品号002
活性成分ETHINYL ESTRADIOL; NORETHINDRONE市场状态停止上市
剂型或给药途径TABLET;ORAL-28规格0.035MG;0.5MG;1MG
治疗等效代码参比药物
批准日期1984/04/04申请机构ORTHO MCNEIL PHARMACEUTICAL INC
化学类型New dosage form审评分类Standard review drug
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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
019004028AP2002/06/03Control Supplement
019004027AP2002/02/21Manufacturing Change or Addition
019004026AP2001/07/09Control Supplement
019004025AP1998/04/28Manufacturing Change or Addition
019004024AP1998/04/13Manufacturing Change or Addition
019004023AP1997/01/29Manufacturing Change or Addition
019004022AP1997/02/24Control Supplement
019004021AP1996/05/10Control Supplement
019004020AP1995/11/30Manufacturing Change or Addition
019004019AP1995/09/07Control Supplement
019004018AP1995/02/16Control Supplement
019004017AP1994/06/29Labeling Revision
019004016AP1993/11/04Manufacturing Change or Addition
019004015AP1993/05/18Control Supplement
019004014AP1994/03/07Formulation Revision
019004012AP1991/03/18Control Supplement
019004011AP1991/09/23Labeling Revision
019004010AP1991/09/16Labeling Revision
019004009AP1990/01/16Package Change
019004008AP1990/01/18Control Supplement
019004005AP1989/02/14Control Supplement
019004004AP1989/02/14Package Change
019004003AP1989/02/14Package Change
019004002AP1989/07/17Labeling Revision
019004000AP1984/04/04Approval