药品名称AMBIEN
申请号019908产品号001
活性成分ZOLPIDEM TARTRATE市场状态处方药
剂型或给药途径TABLET;ORAL规格5MG
治疗等效代码AB参比药物
批准日期1992/12/16申请机构SANOFI AVENTIS US LLC
化学类型New molecular entity (NME)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
43829382006/10/21U-74PDF格式
4382938*PED2007/04/21PDF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
M-542010/03/29
PED2010/09/29
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
019908036APLetter2016/08/12下载
019908036APLabel2016/08/12下载
019908035APLetter2014/10/09下载
019908035APLabel2014/10/09下载
019908034APLetter2013/04/24下载
019908034APReview2013/09/30下载
019908034APLabel2013/04/23下载
019908032APLetter2013/04/24下载
019908032APReview2013/09/30下载
019908032APLabel2013/04/23下载
019908029APLetter2010/04/19下载
019908029APLabel2010/04/19下载
019908027APLetter2008/05/09下载
019908027APLabel2008/05/28下载
019908027APMedication Guide2008/05/28下载
019908025APMedication Guide2007/10/22下载
019908025APLetter2007/10/22下载
019908022APLabel2007/03/31下载
019908022APLetter2007/04/09下载
019908002APReview2007/07/09下载
019908000APReview2005/07/13下载
019908000APOther Important Information from FDA2007/03/16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
019908036AP2016/08/11Labeling Revision
019908035AP2014/10/07Labeling Revision
019908034AP2013/04/19Labeling Revision
019908033AP2013/06/05Manufacturing Change or Addition
019908032AP2013/04/19Labeling Revision
019908029AP2010/04/14Labeling Revision
019908027AP2008/05/07Labeling Revision
019908025AP2007/10/04Labeling Revision
019908022AP2007/03/28Patient Population Altered
019908020AP2007/10/04Labeling Revision
019908015AP2002/09/25Manufacturing Change or Addition
019908014AP2002/05/21Manufacturing Change or Addition
019908013AP2002/01/15Manufacturing Change or Addition
019908012AP2001/11/15Manufacturing Change or Addition
019908011AP2001/05/04Manufacturing Change or Addition
019908010AP2001/04/13Manufacturing Change or Addition
019908009AP1999/12/01Labeling Revision
019908005AP1996/04/18Manufacturing Change or Addition
019908004AP1995/10/04Control Supplement
019908003AP1995/01/09Package Change
019908002AP1995/07/14Labeling Revision
019908001AP1995/07/14Labeling Revision
019908000AP1992/12/16Approval