药品名称ZOMETA
申请号021223产品号001
活性成分ZOLEDRONIC ACID市场状态停止上市
剂型或给药途径INJECTABLE;IV (INFUSION)规格EQ 4MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
治疗等效代码参比药物
批准日期2001/08/20申请机构NOVARTIS PHARMACEUTICALS CORP
化学类型New molecular entity (NME)审评分类Priority review drug
罕用药/孤儿药
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
47771632007/07/24PDF格式
49391302012/09/02YYU-53PDF格式
4939130*PED2013/03/02PDF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
NCE2006/08/20
ODE2008/08/20
PED2009/02/20
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
021223034APLabel2016/03/31下载
021223034APLetter2016/04/04下载
021223032APLetter2015/06/10下载
021223032APLabel2015/06/11下载
021223031APLetter2015/01/07下载
021223031APLabel2015/01/08下载
021223028APLetter2014/04/08下载
021223028APLabel2014/04/08下载
021223027APLetter2013/10/01下载
021223027APLabel2013/10/01下载
021223023APLetter2012/11/14下载
021223023APLabel2012/11/15下载
021223022APLetter2012/03/16下载
021223022APLabel2012/03/16下载
021223018APLabel2009/11/17下载
021223018APLetter2010/01/25下载
021223016APLetter2008/03/21下载
021223016APLabel2008/03/24下载
021223015APLetter2007/11/08下载
021223014APLabel2007/11/07下载
021223014APLetter2007/11/08下载
021223012APLabel2006/05/26下载
021223012APLetter2006/05/26下载
021223011APLetter2005/10/14下载
021223011APLabel2005/10/14下载
021223010APLabel2005/02/03下载
021223010APLetter2005/02/03下载
021223009APLabel2005/02/03下载
021223009APLetter2005/02/03下载
021223008APLetter2004/03/28下载
021223008APLabel2004/04/05下载
021223006APLetter2004/03/02下载
021223006APLabel2004/03/25下载
021223004APLabel2003/03/26下载
021223004APLetter2003/03/26下载
021223004APReview2008/08/01下载
021223003APLetter2002/02/22下载
021223003APLabel2002/02/22下载
021223003APReview2002/02/22下载
021223000APLetter2001/08/20下载
021223000APLabel2001/08/20下载
021223000APReview2001/08/20下载
021223000APOther Important Information from FDA2003/12/12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
021223034AP2016/03/29Labeling Revision
021223033AP2016/04/22Manufacturing Change or Addition
021223032AP2015/06/09Labeling Revision
021223031AP2015/01/05Labeling Revision
021223030AP2014/06/17Manufacturing Change or Addition
021223028AP2014/04/07Labeling Revision
021223027AP2013/09/27Labeling Revision
021223025AP2013/03/06Manufacturing Change or Addition
021223023AP2012/11/09Labeling Revision
021223022AP2012/03/14Labeling Revision
021223018AP2009/11/09Labeling Revision
021223016AP2008/03/20Patient Population Altered
021223015AP2007/11/02Supplement
021223014AP2007/11/02Labeling Revision
021223012AP2006/05/25Labeling Revision
021223011AP2005/10/11Labeling Revision
021223010AP2005/01/31Labeling Revision
021223009AP2005/01/31Labeling Revision
021223008AP2004/03/24Labeling Revision
021223006AP2004/02/27Labeling Revision
021223004AP2003/03/07Formulation Revision
021223003AP2002/02/22Labeling Revision
021223002AP2002/05/13Manufacturing Change or Addition
021223001AP2002/02/12Manufacturing Change or Addition
021223000AP2001/08/20Approval