药品名称TRI-NORINYL 21-DAY
申请号018977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;1MG
治疗等效代码参比药物
批准日期1984/04/13申请机构MAYNE PHARMA LLC
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
018977028AP2001/08/15Manufacturing Change or Addition
018977027AP2000/01/24Labeling Revision
018977026AP2000/02/14Manufacturing Change or Addition
018977025AP1999/02/04Control Supplement
018977024AP1999/05/14Labeling Revision
018977023AP1997/07/30Manufacturing Change or Addition
018977022AP1996/02/22Labeling Revision
018977021AP1994/12/13Labeling Revision
018977020AP1994/12/13Labeling Revision
018977019AP1995/08/30Labeling Revision
018977018AP1992/07/31Manufacturing Change or Addition
018977017AP1994/02/04Labeling Revision
018977016AP1990/09/27Labeling Revision
018977015AP1990/09/19Control Supplement
018977014AP1989/10/23Control Supplement
018977013AP1989/10/23Control Supplement
018977012AP1989/02/03Formulation Revision
018977011AP1989/02/22Control Supplement
018977010AP1989/02/22Labeling Revision
018977008AP1986/07/17Labeling Revision
018977007AP1985/10/25Labeling Revision
018977006AP1985/04/16Labeling Revision
018977004AP1984/11/13Manufacturing Change or Addition
018977003AP1986/10/17Control Supplement
018977002AP1984/09/27Control Supplement
018977001AP1984/12/05Labeling Revision
018977000AP1984/04/11Approval