药品名称MS CONTIN
申请号019516产品号001
活性成分MORPHINE SULFATE市场状态处方药
剂型或给药途径TABLET, EXTENDED RELEASE;ORAL规格30MG
治疗等效代码AB参比药物
批准日期1987/05/29申请机构PURDUE PHARMA LP
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
019516050APLetter2016/10/04下载
019516047APLetter2016/04/22下载
019516046APLetter2015/06/29下载
019516044APLetter2014/08/20下载
019516043APLetter2014/10/30下载
019516043APLabel2014/10/30下载
019516042APLabel2014/04/16下载
019516042APLetter2014/04/17下载
019516038APLetter2013/04/16下载
019516037APLabel2012/07/13下载
019516037APLetter2012/07/11下载
019516036APLabel2012/07/12下载
019516036APLetter2012/07/11下载
019516034APLetter2010/05/14下载
019516034APLabel2010/05/17下载
019516030APLetter2007/05/29下载
019516021APLetter2003/08/14下载
019516019APLetter2004/06/09下载
019516000APMedication Guide2012/07/11下载
019516000APOther2012/07/11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
019516050AP2016/09/30Supplement
019516048AP2016/09/21Manufacturing Change or Addition
019516047AP2016/04/20Supplement
019516046AP2015/06/26Supplement
019516044AP2014/08/19Supplement
019516043AP2014/10/22Labeling Revision
019516042AP2014/04/16Labeling Revision
019516040AP2014/06/02Manufacturing Change or Addition
019516038AP2013/04/15Labeling Revision
019516037AP2012/07/09Labeling Revision
019516036AP2012/07/09Labeling Revision
019516034AP2010/05/11Labeling Revision
019516030AP2007/05/11Supplement
019516021AP2003/08/06Labeling Revision
019516019AP2003/02/21Package Change
019516016AP2001/12/18Labeling Revision
019516015AP2001/02/12Labeling Revision
019516014AP2000/05/02Manufacturing Change or Addition
019516013AP2000/06/27Manufacturing Change or Addition
019516012AP2000/05/02Manufacturing Change or Addition
019516011AP2000/05/02Manufacturing Change or Addition
019516010AP2000/05/02Manufacturing Change or Addition
019516009AP2000/05/02Manufacturing Change or Addition
019516008AP2000/05/12Control Supplement
019516007AP1997/04/29Manufacturing Change or Addition
019516006AP1990/04/12Formulation Revision
019516005AP1988/05/02Control Supplement
019516004AP1993/11/08Control Supplement
019516003AP1990/01/16Control Supplement
019516002AP1989/09/12Control Supplement
019516001AP1988/04/08Control Supplement
019516000AP1987/05/29Approval