药品名称VENOFER
申请号021135产品号004
活性成分IRON SUCROSE市场状态处方药
剂型或给药途径INJECTABLE;INTRAVENOUS规格EQ 200MG BASE/10ML (EQ 20MG BASE/ML)
治疗等效代码参比药物
批准日期2007/02/09申请机构LUITPOLD PHARMACEUTICALS INC
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
I-4592008/06/17
I-4742008/10/17
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
021135024APLetter2012/09/24下载
021135024APLabel2012/09/25下载
021135023APLabel2013/04/01下载
021135020APLetter2011/06/28下载
021135020APLabel2011/06/29下载
021135017APLabel2007/12/14下载
021135017APLetter2008/01/09下载
021135015APLabel2007/02/21下载
021135013APLetter2005/10/19下载
021135013APLabel2005/10/19下载
021135010APLetter2005/03/31下载
021135008APLetter2005/06/21下载
021135008APLabel2005/06/21下载
021135008APReview2008/07/30下载
021135006APLetter2003/07/24下载
021135005APLetter2003/06/08下载
021135005APLabel2003/06/08下载
021135000APLabel2004/06/29下载
021135000APReview2004/06/29下载
021135000APLetter2000/11/13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
021135031AP2016/05/27Manufacturing Change or Addition
021135029AP2016/06/13Manufacturing Change or Addition
021135028AP2015/05/13Manufacturing Change or Addition
021135027AP2014/06/13Manufacturing Change or Addition
021135026AP2016/03/02Manufacturing Change or Addition
021135024AP2012/09/21Supplement
021135023AP2013/03/29Manufacturing Change or Addition
021135020AP2011/06/22Labeling Revision
021135017AP2007/12/03Labeling Revision
021135015AP2007/02/09Package Change
021135013AP2005/10/17New or Modified Indication
021135010AP2005/03/29Package Change
021135008AP2005/06/17New or Modified Indication
021135008AP2005/06/17Supplement
021135006AP2003/06/02New Dosage Regimen
021135005AP2002/07/26Control Supplement
021135003AP2002/12/05Control Supplement
021135002AP2002/01/22Control Supplement
021135001AP2001/02/13Labeling Revision
021135000AP2000/11/06Approval