药品名称DEXTROSTAT
申请号084051产品号001
活性成分DEXTROAMPHETAMINE SULFATE市场状态停止上市
剂型或给药途径TABLET;ORAL规格5MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**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Approved Prior to Jan 1, 1982申请机构SHIRE DEVELOPMENT INC
化学类型审评分类
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
084051000APOther Important Information from FDA2011/12/20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
084051024AP2002/11/20Control Supplement
084051023AP2002/01/17Facility Addition
084051022AP2000/02/28Manufacturing Revision
084051021AP2000/01/27Chemistry
084051020AP1998/10/26Labeling
084051019AP1998/04/15Chemistry
084051018AP1998/05/13Labeling
084051017AP1997/09/26Chemistry
084051016AP1997/09/26Chemistry
084051015AP1997/08/18Labeling
084051014AP1997/02/28Chemistry
084051013AP1997/08/18Labeling
084051012AP1998/01/09Chemistry
084051011AP1995/12/08Chemistry
084051010AP1995/12/08Chemistry
084051009AP1990/05/29Labeling
084051000AP1975/05/29Approval