药品名称LOESTRIN 21 1.5/30
申请号017875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0.03MG;1.5MG
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
017875032APLetter2003/05/30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
017875034AP2014/09/26Manufacturing Change or Addition
017875032AP2003/04/29Labeling Revision
017875031AP1999/03/31Labeling Revision
017875030AP1999/11/24Labeling Revision
017875029AP1999/01/08Labeling Revision
017875028AP1998/01/16Labeling Revision
017875027AP1997/11/20Manufacturing Change or Addition
017875026AP1997/07/28Manufacturing Change or Addition
017875025AP1997/07/28Control Supplement
017875024AP1995/07/07Expiration Date Change
017875023AP1994/06/02Package Change
017875022AP1994/06/27Control Supplement
017875021AP1994/03/07Manufacturing Change or Addition
017875020AP1996/03/08Labeling Revision
017875019AP1993/07/09Control Supplement
017875018AP1996/03/08Labeling Revision
017875017AP1991/04/22Labeling Revision
017875016AP1989/05/17Package Change
017875015AP1988/03/16Package Change
017875014AP1988/09/13Labeling Revision
017875013AP1986/06/04Labeling Revision
017875012AP1984/10/22Labeling Revision
017875011AP1985/09/17Control Supplement
017875010AP1982/11/18Control Supplement
017875008AP1981/11/09Formulation Revision
017875007AP1981/04/08Labeling Revision
017875005AP1977/11/10Labeling Revision
017875004AP1978/06/14Control Supplement
017875002AP1977/02/08Control Supplement
017875001AP1977/02/08Control Supplement
017875000AP1976/10/01Approval