药品名称NORINYL 1+35 28-DAY
申请号017565产品号002
活性成分ETHINYL ESTRADIOL; NORETHINDRONE市场状态处方药
剂型或给药途径TABLET;ORAL-28规格0.035MG;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 SALES LLC
化学类型New formulation or new manufacturer审评分类Standard review drug
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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
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
017565071AP2001/08/15Manufacturing Change or Addition
017565070AP2000/01/24Labeling Revision
017565069AP1999/02/04Control Supplement
017565068AP1998/11/16Manufacturing Change or Addition
017565067AP1997/07/30Manufacturing Change or Addition
017565066AP1994/12/13Labeling Revision
017565065AP1994/12/13Labeling Revision
017565064AP1995/08/30Labeling Revision
017565063AP1992/07/31Manufacturing Change or Addition
017565062AP1994/02/04Labeling Revision
017565061AP1990/09/19Control Supplement
017565060AP1989/10/24Control Supplement
017565059AP1989/02/22Control Supplement
017565058AP1990/11/02Labeling Revision
017565055AP1986/07/17Labeling Revision
017565054AP1985/10/25Labeling Revision
017565053AP1985/04/16Labeling Revision
017565051AP1984/11/13Manufacturing Change or Addition
017565050AP1984/07/30Labeling Revision
017565049AP1984/06/12Labeling Revision
017565047AP1984/09/27Control Supplement
017565046AP1984/05/07Labeling Revision
017565045AP1983/07/26Control Supplement
017565044AP1984/03/06Labeling Revision
017565043AP1983/06/13Control Supplement
017565042AP1986/09/22Formulation Revision
017565041AP1984/05/16Control Supplement
017565038AP1982/07/29Control Supplement
017565035AP1982/01/11Control Supplement
017565031AP1980/12/18Control Supplement
017565030AP1980/12/18Control Supplement
017565029AP1980/07/31Package Change
017565028AP1980/08/26Labeling Revision
017565026AP1979/07/18Manufacturing Change or Addition
017565023AP1979/07/18Control Supplement
017565021AP1978/11/06Control Supplement
017565020AP1978/11/06Control Supplement
017565018AP1978/05/26Control Supplement
017565010AP1977/07/01Distributor
017565009AP1977/07/01Distributor
017565008AP1980/10/14Labeling Revision
017565006AP1975/05/16Labeling Revision
017565005AP1975/05/16Control Supplement
017565003AP1976/05/16Control Supplement
017565001AP1975/05/16Labeling Revision
017565000AP1974/12/27Approval