药品名称ORTHO CYCLEN-28
申请号019653产品号002
活性成分ETHINYL ESTRADIOL; NORGESTIMATE市场状态处方药
剂型或给药途径TABLET;ORAL-28规格0.035MG;0.25MG
治疗等效代码AB参比药物
批准日期1989/12/29申请机构JANSSEN PHARMACEUTICALS INC
化学类型审评分类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
M-412008/05/13
PED2008/11/13
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
019653056APLetter2015/05/04下载
019653056APLabel2015/05/04下载
019653054APLetter2013/10/04下载
019653051APLetter2013/10/04下载
019653049APLetter2013/10/04下载
019653048APLetter2012/06/20下载
019653048APLabel2012/07/13下载
019653046APLabel2013/10/04下载
019653046APLetter2013/10/04下载
019653045APLetter2008/06/03下载
019653037APLabel2007/05/07下载
019653037APLetter2007/05/09下载
019653035APReview2009/01/12下载
019653033APReview2009/01/12下载
019653032APReview2009/01/12下载
019653031APReview2009/01/12下载
019653030APReview2009/01/12下载
019653027APReview2009/01/12下载
019653024APReview2009/01/12下载
019653023APReview2009/01/12下载
019653022APReview2009/01/12下载
019653021APReview2009/01/12下载
019653020APReview2009/01/12下载
019653018APReview2009/01/12下载
019653017APReview2009/01/12下载
019653016APReview2009/01/12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
019653057AP2016/06/22Manufacturing Change or Addition
019653056AP2015/05/01Labeling Revision
019653054AP2013/10/02Labeling Revision
019653051AP2013/10/02Labeling Revision
019653049AP2013/10/02Labeling Revision
019653048AP2012/06/18Labeling Revision
019653046AP2013/10/02Labeling Revision
019653045AP2008/05/30Formulation Revision
019653037AP2007/05/03Labeling Revision
019653035AP2003/01/03Supplement
019653033AP2002/09/06Manufacturing Change or Addition
019653032AP2002/06/03Control Supplement
019653031AP2002/01/16Manufacturing Change or Addition
019653030AP2001/07/09Control Supplement
019653027AP2001/01/16Labeling Revision
019653025AP2000/06/05Labeling Revision
019653024AP2000/01/05Package Change
019653023AP1999/09/30Manufacturing Change or Addition
019653022AP1999/11/22Labeling Revision
019653021AP1999/11/02Manufacturing Change or Addition
019653020AP1999/10/20Control Supplement
019653018AP1996/08/21Control Supplement
019653017AP1998/04/20Labeling Revision
019653016AP1996/08/02Control Supplement
019653015AP1996/02/14Control Supplement
019653014AP1995/11/30Manufacturing Change or Addition
019653013AP1995/08/21Control Supplement
019653012AP1996/01/29Labeling Revision
019653011AP1994/06/28Labeling Revision
019653010AP1993/11/04Manufacturing Change or Addition
019653009AP1995/02/16Control Supplement
019653006AP1992/10/01Control Supplement
019653005AP1992/06/24Manufacturing Change or Addition
019653003AP1991/09/17Labeling Revision
019653002AP1991/05/23Control Supplement
019653001AP1993/09/30Labeling Revision
019653000AP1989/12/29Approval