药品名称KADIAN
申请号020616产品号009
活性成分MORPHINE SULFATE市场状态处方药
剂型或给药途径CAPSULE, EXTENDED RELEASE;ORAL规格40MG
治疗等效代码AB参比药物
批准日期2012/07/09申请机构ALLERGAN SALES LLC
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
020616058APLetter2016/10/04下载
020616055APLetter2016/04/22下载
020616054APLetter2015/07/02下载
020616053APLetter2014/08/20下载
020616051APLabel2014/04/16下载
020616051APLetter2014/04/17下载
020616048APLetter2013/03/29下载
020616047APLetter2013/04/17下载
020616044APLabel2012/07/13下载
020616041APLetter2012/07/11下载
020616041APLabel2012/07/12下载
020616025APLabel2007/04/25下载
020616025APLetter2007/05/01下载
020616022APLabel2006/11/06下载
020616022APLetter2006/11/06下载
020616021APReview2007/11/19下载
020616021APLetter2007/03/07下载
020616021APLabel2007/03/07下载
020616017APLabel2007/03/07下载
020616017APReview2007/11/19下载
020616017APLetter2007/03/07下载
020616010APLabel2005/09/30下载
020616010APLetter2005/10/20下载
020616001APReview2011/02/04下载
020616000APMedication Guide2012/07/11下载
020616000APOther2012/07/11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
020616058AP2016/09/30Supplement
020616055AP2016/04/20Supplement
020616054AP2015/06/26Supplement
020616053AP2014/08/19Supplement
020616052AP2014/04/14Manufacturing Change or Addition
020616051AP2014/04/16Labeling Revision
020616048AP2013/03/27Labeling Revision
020616047AP2013/04/15Labeling Revision
020616046AP2013/01/14Manufacturing Change or Addition
020616044AP2012/07/09Manufacturing Change or Addition
020616041AP2012/07/09Labeling Revision
020616036AP2012/07/09Labeling Revision
020616025AP2007/04/20Formulation Revision
020616022AP2006/10/27Formulation Revision
020616021AP2007/02/27Labeling Revision
020616017AP2007/02/27Formulation Revision
020616010AP2005/09/28Package Change
020616009AP2002/03/28Control Supplement
020616008AP2001/12/18Control Supplement
020616007AP2001/12/21Control Supplement
020616006AP2001/02/08Manufacturing Change or Addition
020616005AP2000/02/28Formulation Revision
020616004AP2001/03/09Control Supplement
020616003AP1999/07/16Labeling Revision
020616002AP1998/04/08Package Change
020616001AP1997/07/29Labeling Revision
020616000AP1996/07/03Approval