药品名称OVRETTE
申请号017031产品号001
活性成分NORGESTREL市场状态停止上市
剂型或给药途径TABLET;ORAL规格0.075MG
治疗等效代码参比药物
批准日期Approved Prior to Jan 1, 1982申请机构LABORATOIRE HRA PHARMA
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
017031034APLetter2004/07/21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
017031034AP2004/07/20Labeling Revision
017031031AP2002/03/06Manufacturing Change or Addition
017031030AP1998/07/08Manufacturing Change or Addition
017031027AP1996/01/18Labeling Revision
017031026AP1994/11/29Labeling Revision
017031025AP1993/01/21Control Supplement
017031024AP1992/08/19Labeling Revision
017031023AP1988/10/06Control Supplement
017031022AP1988/09/01Manufacturing Change or Addition
017031020AP1987/04/07Expiration Date Change
017031019AP1985/10/16Labeling Revision
017031018AP1984/05/03Labeling Revision
017031017AP1983/12/22Labeling Revision
017031015AP1982/06/03Formulation Revision
017031011AP1980/04/15Control Supplement
017031006AP1977/08/15Formulation Revision
017031004AP1977/12/08Labeling Revision
017031003AP1976/12/01Control Supplement
017031002AP1976/01/15Control Supplement
017031000AP1973/10/23Approval