药品名称NEGGRAM
申请号014214产品号002
活性成分NALIDIXIC ACID市场状态停止上市
剂型或给药途径TABLET;ORAL规格250MG
治疗等效代码参比药物
批准日期Approved Prior to Jan 1, 1982申请机构SANOFI AVENTIS US LLC
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
014214060APLetter2012/11/29下载
014214060APLabel2012/12/10下载
014214059APLabel2011/05/02下载
014214059APLetter2011/05/03下载
014214058APLetter2009/04/01下载
014214058APLabel2009/04/03下载
014214057APLetter2007/05/29下载
014214057APLabel2007/05/29下载
014214056APLetter2004/09/10下载
014214056APLabel2004/09/10下载
014214055APLabel2004/09/10下载
014214055APLetter2004/09/10下载
014214053APLetter2004/09/10下载
014214053APLabel2004/09/10下载
014214051APReview2004/08/10下载
014214050APReview2004/08/10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
014214060AP2012/11/28Labeling Revision
014214059AP2011/04/29Labeling Revision
014214058AP2009/03/28Labeling Revision
014214057AP2007/05/24Labeling Revision
014214056AP2004/09/07Labeling Revision
014214055AP2004/09/07Labeling Revision
014214053AP2004/09/07Labeling Revision
014214052AP2002/09/20Manufacturing Change or Addition
014214051AP1999/11/23Labeling Revision
014214050AP1999/11/23Labeling Revision
014214049AP1995/10/03Control Supplement
014214048AP1991/06/24Control Supplement
014214047AP1990/09/17Manufacturing Change or Addition
014214046AP1990/10/05Manufacturing Change or Addition
014214045AP1990/07/20Control Supplement
014214044AP1995/02/07Labeling Revision
014214043AP1986/03/21Package Change
014214042AP1986/04/28Labeling Revision
014214040AP1983/08/17Control Supplement
014214038AP1981/08/18Package Change
014214037AP1981/06/04Package Change
014214036AP1981/06/04Package Change
014214035AP1981/08/18Package Change
014214034AP1980/12/12Labeling Revision
014214033AP1980/04/09Package Change
014214032AP1979/02/13Control Supplement
014214031AP1978/07/11Manufacturing Change or Addition
014214030AP1981/02/23Labeling Revision
014214029AP1978/05/03Labeling Revision
014214026AP1977/06/29Control Supplement
014214024AP1976/03/31Labeling Revision
014214023AP1976/04/08Control Supplement
014214022AP1975/09/08Control Supplement
014214021AP1975/07/18Control Supplement
014214020AP1977/02/23Supplement
014214014AP1975/02/26Supplement
014214000AP1964/03/06Approval