药品名称CORDARONE
申请号018972产品号001
活性成分AMIODARONE HYDROCHLORIDE市场状态处方药
剂型或给药途径TABLET;ORAL规格200MG
治疗等效代码AB参比药物
批准日期1985/12/24申请机构WYETH PHARMACEUTICALS 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
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
018972051APLetter2016/04/26下载
018972051APLabel2016/04/29下载
018972050APLetter2014/12/24下载
018972050APLabel2015/01/08下载
018972048APLetter2014/01/23下载
018972048APLabel2014/01/23下载
018972047APLetter2015/03/31下载
018972047APLabel2015/04/01下载
018972044APLabel2011/11/14下载
018972044APLetter2011/11/16下载
018972042APLabel2010/12/13下载
018972042APLetter2010/12/15下载
018972041APLabel2009/11/23下载
018972041APLetter2010/01/07下载
018972040APLetter2009/11/12下载
018972039APLetter2009/04/24下载
018972039APLabel2009/04/28下载
018972038APLabel2009/04/28下载
018972038APLetter2009/04/24下载
018972037APLetter2008/10/21下载
018972036APLetter2007/11/19下载
018972035APLetter2007/10/04下载
018972034APLetter2007/04/09下载
018972033APLetter2006/09/18下载
018972032APLetter2006/09/25下载
018972031APLetter2005/08/31下载
018972030APLabel2004/12/06下载
018972030APLetter2004/12/06下载
018972030APReview2005/04/27下载
018972029APLetter2004/11/08下载
018972028APLetter2004/09/03下载
018972027APLetter2004/05/27下载
018972026APLetter2003/05/30下载
018972025APLetter2004/06/01下载
018972023APLetter2003/05/29下载
018972022APLetter2004/05/27下载
018972020APReview1999/10/08下载
018972019APReview1999/10/08下载
018972018APReview1998/06/15下载
018972017APReview1999/01/05下载
018972017APLetter1999/01/05下载
018972016APReview1998/06/15下载
018972015APLetter1999/01/05下载
018972015APReview1999/01/05下载
018972014APReview1998/06/15下载
018972000APReview2004/08/26下载
018972000APOther Important Information from FDA2005/07/29下载
018972000APMedication Guide2009/11/16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
018972051AP2016/04/22Labeling Revision
018972050AP2014/12/22Labeling Revision
018972049AP2014/01/17Manufacturing Change or Addition
018972048AP2014/01/22Labeling Revision
018972047AP2015/03/27Labeling Revision
018972046AP2012/11/20Manufacturing Change or Addition
018972044AP2011/11/14Labeling Revision
018972042AP2010/12/13Labeling Revision
018972041AP2009/11/19Labeling Revision
018972040AP2009/09/28Labeling Revision
018972039AP2009/04/21Labeling Revision
018972038AP2009/04/21Labeling Revision
018972037AP2008/10/17Labeling Revision
018972036AP2007/11/13Labeling Revision
018972035AP2007/10/02Labeling Revision
018972034AP2007/03/30Labeling Revision
018972033AP2006/08/28Labeling Revision
018972032AP2006/09/21Labeling Revision
018972031AP2005/08/23Labeling Revision
018972030AP2004/12/03Labeling Revision
018972029AP2004/11/01Labeling Revision
018972028AP2004/09/02Labeling Revision
018972027AP2004/05/21Labeling Revision
018972026AP2003/05/06Labeling Revision
018972025AP2002/12/18Labeling Revision
018972024AP2002/09/20Control Supplement
018972023AP2003/04/30Labeling Revision
018972022AP2004/05/21Labeling Revision
018972021AP2001/12/18Labeling Revision
018972020AP1999/10/08Labeling Revision
018972019AP1999/10/08Labeling Revision
018972018AP1998/06/15Labeling Revision
018972017AP1999/01/05Labeling Revision
018972016AP1998/06/15Labeling Revision
018972015AP1999/01/05Labeling Revision
018972014AP1995/10/18Labeling Revision
018972012AP1994/04/14Labeling Revision
018972011AP1990/08/09Manufacturing Change or Addition
018972010AP1990/08/09Labeling Revision
018972009AP1989/02/10Labeling Revision
018972008AP1989/07/28Formulation Revision
018972007AP1988/06/29Labeling Revision
018972006AP1987/10/28Manufacturing Change or Addition
018972005AP1987/08/07Package Change
018972004AP1988/09/14Labeling Revision
018972003AP1987/05/15Labeling Revision
018972002AP1988/12/13Package Change
018972001AP1986/10/07Labeling Revision
018972000AP1985/12/24Approval