药品名称RESTORIL
申请号018163产品号004
活性成分TEMAZEPAM市场状态处方药
剂型或给药途径CAPSULE;ORAL规格22.5MG
治疗等效代码AB参比药物
批准日期2004/11/02申请机构MALLINCKRODT INC
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
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
018163059APLabel2008/02/26下载
018163059APLetter2008/02/27下载
018163058APLetter2008/02/27下载
018163058APLabel2008/02/26下载
018163057APLetter2004/11/08下载
018163054APLetter2010/11/12下载
018163054APLabel2010/11/12下载
018163053APLetter2002/06/03下载
018163000APOther 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
018163059AP2008/02/25Labeling Revision
018163058AP2008/02/25Labeling Revision
018163057AP2004/11/02Manufacturing Change or Addition
018163054AP2010/11/08Labeling Revision
018163053AP2002/05/31Labeling Revision
018163052AP1999/10/27Manufacturing Change or Addition
018163051AP1999/04/15Package Change
018163050AP1995/12/07Manufacturing Change or Addition
018163049AP1995/12/18Control Supplement
018163048AP2000/04/11Labeling Revision
018163047AP1994/12/13Control Supplement
018163046AP1995/02/27Control Supplement
018163045AP1993/06/15Package Change
018163044AP1993/02/02Labeling Revision
018163043AP1994/07/15Control Supplement
018163042AP1992/11/25Labeling Revision
018163041AP1993/07/23Package Change
018163040AP1992/08/10Labeling Revision
018163039AP1994/07/13Package Change
018163038AP1994/07/13Package Change
018163037AP1992/04/16Labeling Revision
018163036AP1992/04/15Control Supplement
018163035AP1994/03/17Control Supplement
018163034AP1993/04/21Package Change
018163032AP2000/04/11Labeling Revision
018163031AP1994/03/29Labeling Revision
018163030AP1994/02/28Control Supplement
018163029AP1994/07/19Labeling Revision
018163028AP1990/03/14Control Supplement
018163027AP1990/02/16Package Change
018163026AP1989/06/28Manufacturing Change or Addition
018163025AP1990/01/22Labeling Revision
018163024AP1990/02/16Package Change
018163023AP1990/01/22Labeling Revision
018163022AP1991/10/25New or Modified Indication
018163021AP1987/09/02Package Change
018163020AP1987/04/10Labeling Revision
018163019AP1987/04/09Manufacturing Change or Addition
018163018AP1986/04/22Package Change
018163017AP1986/05/16Control Supplement
018163015AP1985/07/22Manufacturing Change or Addition
018163014AP1985/08/22Control Supplement
018163013AP1984/12/11Package Change
018163011AP1991/10/25New or Modified Indication
018163007AP1982/10/25Manufacturing Change or Addition
018163005AP1982/03/25Package Change
018163003AP1981/06/26Manufacturing Change or Addition
018163002AP1981/05/12Formulation Revision
018163001AP1981/05/12Package Change
018163000AP1981/02/27Approval