药品名称LOESTRIN FE 1/20
申请号017354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-28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Priority 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
017354044APLetter2003/05/30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
017354048AP2016/01/14Manufacturing Change or Addition
017354047AP2014/09/26Manufacturing Change or Addition
017354046AP2014/08/01Manufacturing Change or Addition
017354045AP2014/07/31Manufacturing Change or Addition
017354044AP2003/04/29Labeling Revision
017354043AP1999/03/31Labeling Revision
017354042AP1999/11/24Labeling Revision
017354041AP1999/01/08Labeling Revision
017354040AP1998/01/16Labeling Revision
017354039AP1997/11/20Manufacturing Change or Addition
017354038AP1997/07/28Manufacturing Change or Addition
017354037AP1997/07/28Control Supplement
017354036AP1995/07/07Expiration Date Change
017354035AP1994/06/02Package Change
017354034AP1994/06/27Control Supplement
017354033AP1996/03/08Labeling Revision
017354032AP1994/03/07Manufacturing Change or Addition
017354031AP1993/07/09Control Supplement
017354030AP1996/03/08Labeling Revision
017354029AP1991/04/22Labeling Revision
017354028AP1989/05/17Package Change
017354027AP1988/03/16Package Change
017354026AP1988/09/13Labeling Revision
017354025AP1986/10/22Package Change
017354024AP1986/06/04Labeling Revision
017354023AP1984/10/22Labeling Revision
017354022AP1985/09/17Control Supplement
017354021AP1982/11/18Control Supplement
017354019AP1981/04/09Labeling Revision
017354017AP1977/11/22Labeling Revision
017354016AP1978/06/14Control Supplement
017354014AP1977/02/08Control Supplement
017354013AP1977/02/08Control Supplement
017354010AP1975/11/11Labeling Revision
017354000AP1973/04/30Approval