药品名称ORTHO-NOVUM 1/35-28
申请号017919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JANSSEN PHARMACEUTICALS 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
017919099APLetter2015/11/04下载
017919099APLabel2015/11/04下载
017919096APLetter2013/10/04下载
017919092APLetter2013/10/04下载
017919090APLetter2013/10/04下载
017919089APLetter2012/06/20下载
017919089APLabel2012/07/13下载
017919086APLabel2013/10/04下载
017919086APLetter2013/10/04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
017919099AP2015/10/29Labeling Revision
017919098AP2014/09/11Manufacturing Change or Addition
017919096AP2013/10/02Labeling Revision
017919092AP2013/10/02Labeling Revision
017919090AP2013/10/02Labeling Revision
017919089AP2012/06/18Labeling Revision
017919086AP2013/10/02Labeling Revision
017919075AP2002/06/03Control Supplement
017919074AP2002/02/21Manufacturing Change or Addition
017919073AP2001/07/09Control Supplement
017919071AP2000/06/06Labeling Revision
017919070AP2000/01/05Package Change
017919069AP1999/08/27Labeling Revision
017919068AP1998/04/28Manufacturing Change or Addition
017919067AP1998/04/13Manufacturing Change or Addition
017919066AP1999/01/06Labeling Revision
017919065AP1999/08/27Labeling Revision
017919064AP1997/02/24Control Supplement
017919063AP1997/01/29Control Supplement
017919062AP1996/04/09Control Supplement
017919061AP1996/05/10Control Supplement
017919060AP1995/11/30Manufacturing Change or Addition
017919059AP1995/09/07Control Supplement
017919058AP1995/02/16Control Supplement
017919057AP1993/11/04Manufacturing Change or Addition
017919056AP1994/01/04Labeling Revision
017919055AP1993/05/18Control Supplement
017919052AP1994/03/07Formulation Revision
017919050AP1991/03/18Control Supplement
017919049AP1991/09/16Labeling Revision
017919048AP1990/01/18Control Supplement
017919046AP1989/10/23Labeling Revision
017919045AP1989/07/19Labeling Revision
017919044AP1988/10/28Control Supplement
017919043AP1988/06/08Manufacturing Change or Addition
017919042AP1988/09/09Labeling Revision
017919041AP1987/02/26Labeling Revision
017919040AP1987/11/23Control Supplement
017919038AP1985/10/21Labeling Revision
017919037AP1985/04/05Labeling Revision
017919036AP1984/06/21Labeling Revision
017919035AP1984/01/30Labeling Revision
017919034AP1983/09/29Labeling Revision
017919032AP1983/06/15Labeling Revision
017919031AP1983/06/09Control Supplement
017919029AP1982/09/29Labeling Revision
017919026AP1980/11/12Control Supplement
017919025AP1980/11/12Control Supplement
017919023AP1980/08/21Manufacturing Change or Addition
017919022AP1980/03/24Manufacturing Change or Addition
017919021AP1979/12/05Labeling Revision
017919020AP1979/12/05Labeling Revision
017919019AP1979/11/08Control Supplement
017919017AP1979/10/19Package Change
017919010AP1979/06/19Formulation Revision
017919009AP1978/02/28Control Supplement
017919008AP1978/02/28Control Supplement
017919007AP1978/02/28Control Supplement
017919006AP1978/04/17Control Supplement
017919005AP1978/05/25Control Supplement
017919003AP1978/07/31Control Supplement
017919002AP1977/10/20Control Supplement
017919001AP1978/03/29Control Supplement
017919000AP1977/06/23Approval