药品名称NORDETTE-21
申请号018668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;0.15MG
治疗等效代码参比药物
批准日期1982/05/10申请机构TEVA BRANDED PHARMACEUTICAL PRODUCTS R AND D 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
018668030APReview2003/02/05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
018668034AP2002/03/06Manufacturing Change or Addition
018668032AP1998/12/11Manufacturing Change or Addition
018668031AP1998/03/11Manufacturing Change or Addition
018668030AP2000/04/03Labeling Revision
018668029AP1996/05/17Manufacturing Change or Addition
018668028AP1995/10/11Control Supplement
018668027AP1994/04/08Manufacturing Change or Addition
018668026AP1994/11/29Labeling Revision
018668025AP1994/01/28Labeling Revision
018668024AP1992/06/10Control Supplement
018668023AP1991/05/03Manufacturing Change or Addition
018668022AP1991/05/20Manufacturing Change or Addition
018668021AP1989/05/19Manufacturing Change or Addition
018668020AP1988/09/09Control Supplement
018668019AP1988/04/27Expiration Date Change
018668018AP1990/08/08Labeling Revision
018668016AP1987/04/07Control Supplement
018668015AP1986/07/15Labeling Revision
018668014AP1986/04/18Labeling Revision
018668013AP1986/09/18Control Supplement
018668012AP1985/12/20Labeling Revision
018668011AP1986/02/19Control Supplement
018668010AP1985/09/06Labeling Revision
018668009AP1985/07/29Control Supplement
018668008AP1985/07/26Labeling Revision
018668007AP1984/06/25Labeling Revision
018668006AP1985/03/12Manufacturing Change or Addition
018668005AP1984/09/25Control Supplement
018668004AP1984/05/30Package Change
018668003AP1984/05/30Control Supplement
018668002AP1983/07/08Labeling Revision
018668001AP1982/07/06Control Supplement
018668000AP1982/05/10Approval