药品名称TRIPHASIL-21
申请号019192产品号001
活性成分ETHINYL ESTRADIOL; LEVONORGESTREL市场状态停止上市
剂型或给药途径TABLET;ORAL-21规格0.03MG;0.04MG;0.05MG;0.075MG;0.125MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
治疗等效代码参比药物
批准日期1984/11/01申请机构WYETH PHARMACEUTICALS INC SUB PFIZER 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
019192037AP2002/03/06Manufacturing Change or Addition
019192035AP2000/03/23Labeling Revision
019192034AP1998/12/11Manufacturing Change or Addition
019192033AP2000/02/02Labeling Revision
019192032AP1998/03/11Manufacturing Change or Addition
019192031AP1996/05/17Manufacturing Change or Addition
019192030AP1995/10/11Control Supplement
019192029AP1995/05/03Labeling Revision
019192028AP1995/05/03Labeling Revision
019192027AP1994/05/27Control Supplement
019192026AP1994/04/08Manufacturing Change or Addition
019192025AP1994/04/20Labeling Revision
019192024AP1993/03/09Package Change
019192023AP1993/04/29Labeling Revision
019192022AP1992/06/10Control Supplement
019192021AP1991/05/20Manufacturing Change or Addition
019192020AP1991/05/03Manufacturing Change or Addition
019192019AP1990/05/30Labeling Revision
019192018AP1990/05/15Package Change
019192017AP1990/01/18Manufacturing Change or Addition
019192016AP1989/05/19Manufacturing Change or Addition
019192014AP1991/08/15Control Supplement
019192013AP1988/04/27Expiration Date Change
019192012AP1990/08/08Labeling Revision
019192011AP1987/08/27Package Change
019192009AP1987/05/15Control Supplement
019192008AP1989/02/28Control Supplement
019192007AP1986/09/25Manufacturing Change or Addition
019192006AP1991/10/07Control Supplement
019192005AP1986/07/15Labeling Revision
019192004AP1986/05/28Control Supplement
019192003AP1985/12/20Labeling Revision
019192002AP1985/09/06Labeling Revision
019192001AP1985/07/29Control Supplement
019192000AP1984/11/01Approval