药品名称DEXEDRINE
申请号017078产品号002
活性成分DEXTROAMPHETAMINE SULFATE市场状态处方药
剂型或给药途径CAPSULE, EXTENDED RELEASE;ORAL规格10MG
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AMEDRA PHARMACEUTICALS LLC
化学类型New formulation or new manufacturer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
017078048APLabel2015/04/20下载
017078048APLetter2015/04/20下载
017078047APLetter2013/12/10下载
017078047APLabel2013/12/12下载
017078046APLetter2013/06/13下载
017078046APLabel2013/06/18下载
017078044APLetter2008/05/28下载
017078044APLabel2008/06/12下载
017078042APLetter2007/05/07下载
017078042APLabel2007/05/07下载
017078040APLabel2006/08/11下载
017078040APLetter2006/08/14下载
017078000APOther Important Information from FDA2007/05/18下载
017078000APMedication Guide2009/11/18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
017078048AP2015/04/17Labeling Revision
017078047AP2013/12/06Labeling Revision
017078046AP2013/06/11Labeling Revision
017078044AP2008/05/23Labeling Revision
017078042AP2007/05/01Labeling Revision
017078040AP2006/08/10Labeling Revision
017078038AP2000/10/20Control Supplement
017078037AP2000/04/13Manufacturing Change or Addition
017078036AP1999/10/07Formulation Revision
017078035AP1999/10/07Manufacturing Change or Addition
017078034AP1999/11/03Labeling Revision
017078033AP1998/12/03Manufacturing Change or Addition
017078032AP1998/06/12Control Supplement
017078031AP1998/04/06Manufacturing Change or Addition
017078030AP1998/04/06Formulation Revision
017078027AP1997/07/09Labeling Revision
017078025AP1994/09/12Labeling Revision
017078022AP1993/07/21Labeling Revision
017078021AP1987/12/16Labeling Revision
017078020AP1987/12/02Labeling Revision
017078019AP1982/08/25Labeling Revision
017078018AP1982/08/25Labeling Revision
017078017AP1983/02/22Labeling Revision
017078016AP1980/10/06Labeling Revision
017078015AP1980/09/19Labeling Revision
017078014AP1980/08/29Labeling Revision
017078013AP1980/08/29Labeling Revision
017078012AP1980/08/29Labeling Revision
017078011AP1980/04/16Labeling Revision
017078009AP1979/08/30Labeling Revision
017078008AP1979/06/27Labeling Revision
017078007AP1979/06/06Labeling Revision
017078005AP1979/03/30Labeling Revision
017078003AP1979/03/30Labeling Revision
017078000AP1976/08/02Approval