药品名称TRIPHASIL-28
申请号019190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-28规格0.03MG;0.04MG;0.05MG;0.075MG;0.125MG
治疗等效代码参比药物
批准日期1984/11/01申请机构WYETH 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
019190036APLabel2016/04/07下载
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
019190038AP2002/03/06Manufacturing Change or Addition
019190036AP2000/03/23Labeling Revision
019190035AP1998/12/11Manufacturing Change or Addition
019190034AP2000/02/02Labeling Revision
019190033AP1998/03/11Manufacturing Change or Addition
019190032AP1997/08/25Manufacturing Change or Addition
019190031AP1996/05/17Manufacturing Change or Addition
019190030AP1995/10/11Control Supplement
019190029AP1995/05/03Labeling Revision
019190028AP1995/05/03Labeling Revision
019190027AP1994/05/27Control Supplement
019190026AP1994/04/08Manufacturing Change or Addition
019190025AP1993/10/04Labeling Revision
019190024AP1993/03/09Package Change
019190023AP1993/04/29Labeling Revision
019190022AP1992/06/10Control Supplement
019190021AP1991/05/20Manufacturing Change or Addition
019190020AP1991/05/03Manufacturing Change or Addition
019190019AP1990/05/30Labeling Revision
019190018AP1990/05/15Package Change
019190017AP1990/01/18Manufacturing Change or Addition
019190016AP1989/05/19Manufacturing Change or Addition
019190014AP1991/08/15Control Supplement
019190013AP1988/04/27Expiration Date Change
019190012AP1990/08/08Labeling Revision
019190011AP1987/10/27Package Change
019190009AP1987/05/15Control Supplement
019190008AP1986/09/25Manufacturing Change or Addition
019190007AP1986/07/15Labeling Revision
019190006AP1991/10/07Control Supplement
019190005AP1986/05/12Control Supplement
019190004AP1986/05/28Control Supplement
019190003AP1985/12/20Labeling Revision
019190002AP1985/09/06Labeling Revision
019190001AP1985/07/29Control Supplement
019190000AP1984/11/01Approval