药品名称COPEGUS
申请号021511产品号002
活性成分RIBAVIRIN市场状态停止上市
剂型或给药途径TABLET;ORAL规格400MG
治疗等效代码参比药物
批准日期2005/06/21申请机构HOFFMANN LA ROCHE INC
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
I-4472008/02/25
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
021511029APLetter2015/08/12下载
021511029APLabel2015/08/12下载
021511026APLetter2013/02/08下载
021511026APLabel2013/02/08下载
021511024APLetter2011/05/11下载
021511023APLabel2011/08/24下载
021511023APLetter2011/08/26下载
021511022APLetter2011/08/11下载
021511022APLabel2011/08/11下载
021511021APLabel2010/12/22下载
021511021APLetter2010/12/22下载
021511020APLabel2010/10/12下载
021511020APLetter2010/10/13下载
021511019APLetter2010/06/15下载
021511019APLabel2010/06/24下载
021511018APLabel2010/03/05下载
021511018APLetter2010/03/08下载
021511017APLetter2009/05/07下载
021511016APLetter2009/05/07下载
021511015APLetter2008/04/22下载
021511014APLabel2007/06/27下载
021511014APLetter2007/07/05下载
021511012APLabel2005/11/30下载
021511012APLetter2005/11/30下载
021511008APLetter2005/06/23下载
021511007APLetter2005/08/19下载
021511007APLabel2005/08/19下载
021511006APLabel2005/08/24下载
021511006APLetter2005/08/24下载
021511006APOther2005/09/22下载
021511006APOther2005/11/01下载
021511005APLetter2005/03/03下载
021511005APLabel2005/03/03下载
021511002APLabel2004/05/07下载
021511002APLetter2004/05/07下载
021511000APReview2004/08/10下载
021511000APLetter2002/12/03下载
021511000APLabel2002/12/03下载
021511000APMedication Guide2003/12/17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
021511029AP2015/08/11Labeling Revision
021511027AP2014/03/04Manufacturing Change or Addition
021511026AP2013/02/06Labeling Revision
021511024AP2011/05/09Labeling Revision
021511023AP2011/08/22Labeling Revision
021511022AP2011/08/09Efficacy Supplement with Clinical Data to Support
021511021AP2010/12/21Efficacy Supplement with Clinical Data to Support
021511020AP2010/10/08Labeling Revision
021511019AP2010/06/09Labeling Revision
021511018AP2010/03/03Labeling Revision
021511017AP2009/04/15Labeling Revision
021511016AP2009/04/15Labeling Revision
021511015AP2008/04/17Labeling Revision
021511014AP2007/06/19Labeling Revision
021511012AP2005/11/23Labeling Revision
021511008AP2005/06/21Formulation Revision
021511007AP2005/08/16Labeling Revision
021511006AP2005/08/22Labeling Revision
021511005AP2005/02/25New or Modified Indication
021511002AP2004/05/05Labeling Revision
021511000AP2002/12/03Approval