药品名称MODICON 28
申请号017735产品号001
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;0.5MG
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JANSSEN PHARMACEUTICALS INC
化学类型New formulation or new manufacturer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
017735117APLetter2015/11/04下载
017735117APLabel2015/11/04下载
017735114APLetter2013/10/04下载
017735110APLetter2013/10/04下载
017735108APLetter2013/10/04下载
017735107APLetter2012/06/20下载
017735107APLabel2012/07/13下载
017735104APLabel2013/10/04下载
017735104APLetter2013/10/04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
017735117AP2015/10/29Labeling Revision
017735116AP2014/09/11Manufacturing Change or Addition
017735114AP2013/10/02Labeling Revision
017735110AP2013/10/02Labeling Revision
017735108AP2013/10/02Labeling Revision
017735107AP2012/06/18Labeling Revision
017735104AP2013/10/02Labeling Revision
017735093AP2002/06/03Control Supplement
017735092AP2002/02/21Manufacturing Change or Addition
017735091AP2001/07/09Control Supplement
017735089AP2000/06/06Labeling Revision
017735088AP2000/01/05Package Change
017735087AP1999/08/27Labeling Revision
017735086AP1998/04/28Manufacturing Change or Addition
017735085AP1998/04/13Manufacturing Change or Addition
017735084AP1999/01/06Labeling Revision
017735083AP1999/08/27Labeling Revision
017735082AP1997/02/24Control Supplement
017735081AP1997/01/29Control Supplement
017735080AP1996/04/09Control Supplement
017735079AP1996/05/10Control Supplement
017735078AP1995/11/30Manufacturing Change or Addition
017735077AP1995/09/07Control Supplement
017735076AP1995/02/16Control Supplement
017735075AP1993/11/04Manufacturing Change or Addition
017735074AP1994/01/04Labeling Revision
017735073AP1993/05/18Control Supplement
017735072AP1994/03/07Formulation Revision
017735070AP1991/03/18Control Supplement
017735069AP1991/09/16Labeling Revision
017735068AP1990/01/18Control Supplement
017735066AP1989/10/23Labeling Revision
017735065AP1989/07/19Labeling Revision
017735064AP1988/10/28Control Supplement
017735063AP1988/06/08Manufacturing Change or Addition
017735062AP1988/09/08Labeling Revision
017735061AP1987/02/26Labeling Revision
017735060AP1987/11/23Control Supplement
017735058AP1985/10/21Labeling Revision
017735057AP1985/04/05Labeling Revision
017735056AP1984/06/21Labeling Revision
017735055AP1984/01/30Labeling Revision
017735054AP1983/09/29Labeling Revision
017735052AP1983/06/15Labeling Revision
017735051AP1983/06/09Control Supplement
017735049AP1982/09/29Labeling Revision
017735046AP1980/11/20Control Supplement
017735045AP1980/11/20Control Supplement
017735043AP1980/08/21Manufacturing Change or Addition
017735042AP1980/03/28Expiration Date Change
017735041AP1980/03/24Manufacturing Change or Addition
017735040AP1979/11/13Labeling Revision
017735039AP1979/11/08Control Supplement
017735038AP1979/05/07Expiration Date Change
017735037AP1979/08/15Labeling Revision
017735036AP1979/10/19Package Change
017735033AP1980/03/24Control Supplement
017735032AP1978/06/07Labeling Revision
017735023AP1979/06/19Formulation Revision
017735019AP1978/02/28Control Supplement
017735018AP1978/02/28Control Supplement
017735017AP1978/02/28Control Supplement
017735016AP1978/04/17Control Supplement
017735014AP1978/05/25Control Supplement
017735009AP1977/10/20Control Supplement
017735008AP1978/03/29Control Supplement
017735005AP1978/07/31Control Supplement
017735003AP1977/07/01Labeling Revision
017735002AP1977/07/15Manufacturing Change or Addition
017735001AP1976/12/30Control Supplement
017735000AP1976/05/14Approval