药品名称LOESTRIN 21 1/20
申请号017876产品号001
活性成分ETHINYL ESTRADIOL; NORETHINDRONE ACETATE市场状态处方药
剂型或给药途径TABLET;ORAL-21规格0.02MG;1MG
治疗等效代码AB参比药物
批准日期Approved Prior to Jan 1, 1982申请机构ALLERGAN PHARMACEUTICALS INTERNATIONAL LTD
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
017876031APLetter2003/05/30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
017876033AP2014/09/26Manufacturing Change or Addition
017876031AP2003/04/29Labeling Revision
017876030AP1999/03/31Labeling Revision
017876029AP1999/11/24Labeling Revision
017876028AP1999/01/08Labeling Revision
017876027AP1998/01/16Labeling Revision
017876026AP1997/11/20Manufacturing Change or Addition
017876025AP1997/07/28Manufacturing Change or Addition
017876024AP1997/07/28Control Supplement
017876023AP1995/07/07Expiration Date Change
017876022AP1994/06/02Package Change
017876021AP1994/06/27Control Supplement
017876020AP1996/03/08Labeling Revision
017876019AP1994/03/07Manufacturing Change or Addition
017876018AP1993/07/09Control Supplement
017876017AP1996/03/08Labeling Revision
017876016AP1991/04/22Labeling Revision
017876015AP1989/05/17Package Change
017876014AP1988/03/16Package Change
017876013AP1988/09/13Labeling Revision
017876012AP1986/06/04Labeling Revision
017876011AP1984/10/22Labeling Revision
017876010AP1985/09/17Control Supplement
017876009AP1982/11/18Control Supplement
017876005AP1977/11/10Labeling Revision
017876004AP1978/06/14Control Supplement
017876002AP1977/02/09Control Supplement
017876001AP1977/02/09Control Supplement
017876000AP1976/10/01Approval