药品名称DIDRONEL
申请号017831产品号001
活性成分ETIDRONATE DISODIUM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Approved Prior to Jan 1, 1982申请机构ALLERGAN PHARMACEUTICALS INTERNATIONAL LTD
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
017831058APLabel2015/04/10下载
017831058APLetter2015/04/13下载
017831057APLabel2015/03/19下载
017831057APLetter2015/03/19下载
017831056APLabel2013/04/23下载
017831056APLetter2013/04/24下载
017831055APLabel2010/01/04下载
017831055APLetter2010/01/06下载
017831054APLabel2006/01/10下载
017831054APLetter2006/01/20下载
017831053APReview2007/07/06下载
017831053APLetter2004/02/27下载
017831053APLabel2004/04/05下载
017831052APLetter2002/03/15下载
017831000APOther Important Information from FDA2008/01/07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
017831058AP2015/04/08Labeling Revision
017831057AP2015/03/18Labeling Revision
017831056AP2013/04/19Labeling Revision
017831055AP2009/12/31Labeling Revision
017831054AP2006/01/09Labeling Revision
017831053AP2004/02/25Labeling Revision
017831052AP2002/03/15Labeling Revision
017831050AP1997/06/16Labeling Revision
017831049AP1996/10/04Labeling Revision
017831048AP1996/02/29Labeling Revision
017831046AP1996/02/27Labeling Revision
017831044AP1994/05/05Labeling Revision
017831043AP1993/09/28Control Supplement
017831042AP1993/06/07Labeling Revision
017831038AP1989/07/05Labeling Revision
017831037AP1988/08/02Labeling Revision
017831036AP1988/09/23Labeling Revision
017831035AP1988/03/01Labeling Revision
017831034AP1986/07/10Control Supplement
017831033AP1986/03/24Labeling Revision
017831032AP1986/07/10Control Supplement
017831031AP1986/01/07Control Supplement
017831030AP1986/01/07Control Supplement
017831029AP1984/07/06Labeling Revision
017831028AP1984/07/06Control Supplement
017831021AP1983/01/08Control Supplement
017831019AP1983/01/11Control Supplement
017831018AP1983/01/11Labeling Revision
017831017AP1982/08/25Control Supplement
017831015AP1982/09/08Labeling Revision
017831013AP1981/08/04Labeling Revision
017831012AP1980/10/01Package Change
017831011AP1980/05/14Labeling Revision
017831010AP1979/12/13Manufacturing Change or Addition
017831009AP1980/08/25General Efficacy (MarkIV)
017831007AP1979/01/23Control Supplement
017831006AP1979/01/23Control Supplement
017831005AP1979/01/23Control Supplement
017831004AP1979/01/23General Efficacy (MarkIV)
017831001AP1978/01/11Labeling Revision
017831000AP1977/09/01Approval