药品名称ARANESP
申请号103951产品号004
活性成分DARBEPOETIN ALFA市场状态处方药
剂型或给药途径VIAL; INTRAVENOUS规格100UG/ML
治疗等效代码参比药物
批准日期申请机构AMGEN
化学类型审评分类
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
1039515370APLetter2016/04/28下载
1039515363APLetter2015/07/24下载
1039515363APLabel2015/07/24下载
1039515353APLabel2014/04/18下载
1039515349APLabel2014/01/07下载
1039515349APLetter2014/01/02下载
1039515337APLetter2013/03/29下载
1039515325APLetter2014/01/02下载
1039515325APLabel2014/01/07下载
1039515285APLetter2012/06/04下载
1039515285APLabel2012/06/06下载
1039515258APLabel2011/06/24下载
1039515258APLetter2011/06/24下载
1039515248APLetter2011/06/24下载
1039515223APLabel2010/02/04下载
1039515211APLabel2010/02/04下载
1039515211APLetter2010/02/05下载
1039515197APLetter2010/02/16下载
1039515197APLabel2010/02/16下载
1039515195APLetter2011/04/28下载
1039515195APLabel2008/11/26下载
1039515173APSummary Review2012/05/25下载
1039515173APReview2012/07/16下载
1039515173APLetter2011/06/24下载
1039515173APLabel2011/06/24下载
1039515170APLabel2008/03/11下载
1039515170APPatient Package Insert2008/03/12下载
1039515170APLetter2008/03/13下载
1039515169APLabel2008/01/30下载
1039515169APLetter2008/01/31下载
1039515164APLetter2007/11/08下载
1039515164APLabel2007/11/08下载
1039515164APPatient Package Insert2007/11/08下载
1039515139APLabel2007/03/09下载
1039515139APLetter2007/03/15下载
1039515135APLetter2007/04/20下载
1039515135APLabel2007/04/20下载
1039515097APLetter2006/04/05下载
1039515097APLabel2006/04/05下载
1039515096APLetter2005/12/16下载
1039515096APLabel2005/12/16下载
1039515088APLabel2006/02/08下载
1039515088APLetter2006/02/08下载
1039515069APLetter2005/01/26下载
1039515069APLabel2005/01/26下载
1039515001APLetter2004/03/11下载
1039515001APLabel2004/03/11下载
1039515001APPatient Package Insert2004/09/22下载
1039515001APReview2011/12/02下载
1039510000APReview2004/01/21下载
1039510000APLetter2004/01/21下载
1039510000APLabel2004/01/21下载
1039510000APMedication Guide2010/02/05下载
1039510000APOther2010/02/16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
1039515370AP2016/04/27Labeling Revision
1039515363AP2015/07/23Efficacy Supplement with Clinical Data to Support
1039515353AP2014/04/17Labeling Revision
1039515349AP2013/12/31Labeling Revision
1039515337AP2013/03/27Labeling Revision
1039515325AP2013/12/31Labeling Revision
1039515285AP2012/05/31Supplement
1039515258AP2011/06/24Supplement
1039515248AP2011/06/24Supplement
1039515223AP2010/01/11Supplement
1039515211AP2009/10/13Supplement
1039515197AP2010/02/16Supplement
1039515195AP2008/11/19Supplement
1039515173AP2011/06/24Supplement
1039515170AP2008/03/07Supplement
1039515169AP2007/12/17Supplement
1039515164AP2007/11/08Supplement
1039515139AP2007/03/09Supplement
1039515135AP2007/04/10Supplement
1039515111AP2008/05/05Supplement
1039515097AP2006/03/23Supplement
1039515096AP2005/10/26Supplement
1039515088AP2005/12/15Supplement
1039515069AP2004/12/16Supplement
1039515001AP2002/07/19Supplement
1039510000AP2001/09/17Approval