药品名称AVANDIA
申请号021071产品号003
活性成分ROSIGLITAZONE MALEATE市场状态处方药
剂型或给药途径TABLET;ORAL规格EQ 4MG BASE
治疗等效代码AB参比药物
批准日期1999/05/25申请机构SB PHARMCO PUERTO RICO INC
化学类型New molecular entity (NME)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
62880952017/02/11U-420PDF格式
73583662020/04/19YPDF格式
6288095*PED2017/08/11PDF格式
7358366*PED2020/10/19PDF格式
历史专利信息
50029532011/09/17YYU-329PDF格式
50029532011/09/17YYU-628PDF格式
50029532011/09/17YYU-840PDF格式
5002953*PED2012/03/17PDF格式
57418032015/04/21YYU-329PDF格式
57418032015/04/21YYU-628PDF格式
5741803*PED2015/10/21PDF格式
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
I-4532008/02/28
PED2006/08/27
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
021071051APLetter2016/09/21下载
021071051APLabel2016/09/21下载
021071050APLetter2015/12/17下载
021071049APLetter2014/05/08下载
021071049APLabel2014/05/12下载
021071048APLabel2014/05/12下载
021071048APReview2016/08/04下载
021071048APLetter2014/05/08下载
021071047APLetter2014/05/08下载
021071047APLabel2014/05/12下载
021071045APLetter2013/09/19下载
021071044APLetter2013/01/30下载
021071041APLetter2012/06/04下载
021071041APLabel2012/06/06下载
021071040APLabel2011/11/16下载
021071040APMedication Guide2011/11/16下载
021071040APLetter2011/11/21下载
021071039APLabel2011/05/17下载
021071039APMedication Guide2011/05/17下载
021071039APLetter2011/05/24下载
021071038APLetter2011/02/03下载
021071038APLabel2011/02/04下载
021071034APLetter2008/10/21下载
021071034APLabel2008/10/31下载
021071032APLetter2008/02/25下载
021071032APLabel2008/02/25下载
021071031APLabel2007/11/19下载
021071031APLetter2007/11/19下载
021071029APLabel2008/01/18下载
021071029APLetter2008/01/18下载
021071028APLabel2007/08/15下载
021071028APLetter2007/08/17下载
021071027APLetter2007/09/25下载
021071027APLabel2007/09/26下载
021071026APLabel2008/07/14下载
021071026APLetter2008/07/14下载
021071023APLabel2007/04/25下载
021071023APLetter2007/05/01下载
021071021APLabel2006/06/20下载
021071021APLetter2006/06/20下载
021071019APLabel2006/06/20下载
021071019APLetter2006/06/20下载
021071016APLabel2006/04/25下载
021071016APLetter2006/04/25下载
021071015APLetter2005/08/03下载
021071015APLabel2005/08/03下载
021071014APLetter2005/01/11下载
021071014APLabel2005/01/11下载
021071014APReview2009/09/14下载
021071012APLetter2005/03/03下载
021071012APLabel2005/03/03下载
021071010APLetter2005/05/17下载
021071010APLabel2005/05/17下载
021071009APLetter2004/05/26下载
021071008APLetter2002/12/03下载
021071004APLabel2003/02/27下载
021071004APLetter2003/03/10下载
021071004APReview2007/07/27下载
021071001APLetter2000/04/04下载
021071001APLabel2000/04/04下载
021071001APReview2004/05/27下载
021071000APReview2004/05/27下载
021071000APLetter1999/05/25下载
021071000APLabel1999/05/25下载
021071000APMedication Guide2008/02/25下载
021071000APOther Important Information from FDA2008/02/21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
021071051AP2016/09/19Labeling Revision
021071050AP2015/12/16Supplement
021071049AP2014/05/07Labeling Revision
021071048AP2014/05/07Labeling Revision
021071047AP2014/05/07Labeling Revision
021071045AP2013/09/16Labeling Revision
021071044AP2013/01/25Labeling Revision
021071041AP2012/05/30Labeling Revision
021071040AP2011/11/13Labeling Revision
021071039AP2011/05/18Labeling Revision
021071038AP2011/02/03Labeling Revision
021071034AP2008/10/20Labeling Revision
021071032AP2008/02/22Labeling Revision
021071031AP2007/11/14Labeling Revision
021071029AP2008/01/16Labeling Revision
021071028AP2007/08/14Labeling Revision
021071027AP2007/09/20Labeling Revision
021071026AP2008/07/10Efficacy Supplement with Clinical Data to Support
021071024AP2007/06/25Labeling Revision
021071023AP2007/04/23Labeling Revision
021071021AP2006/06/16Labeling Revision
021071019AP2006/06/16Labeling Revision
021071016AP2006/04/21Efficacy Supplement with Clinical Data to Support
021071015AP2005/07/29Patient Population Altered
021071014AP2005/01/04Labeling Revision
021071012AP2005/02/28New or Modified Indication
021071010AP2005/05/12Labeling Revision
021071009AP2004/05/19Labeling Revision
021071008AP2002/12/03Labeling Revision
021071007AP2000/12/13Control Supplement
021071006AP2001/02/08Labeling Revision
021071005AP2000/12/05Labeling Revision
021071004AP2003/02/27New or Modified Indication
021071003AP2000/07/03Manufacturing Change or Addition
021071002AP2000/07/11Labeling Revision
021071001AP2000/04/03New or Modified Indication
021071000AP1999/05/25Approval