药品名称ADDERALL 15
申请号011522产品号013
活性成分AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE市场状态停止上市
剂型或给药途径TABLET;ORAL规格3.75MG;3.75MG;3.75MG;3.75MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**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2000/08/31申请机构TEVA WOMENS HEALTH INC
化学类型审评分类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
63840202020/07/06PDF格式
6384020*PED2021/01/06PDF格式
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
011522042APLetter2015/10/06下载
011522042APLabel2015/10/07下载
011522042APMedication Guide2015/10/23下载
011522041APLabel2015/04/19下载
011522041APLetter2015/04/20下载
011522040APLabel2007/06/12下载
011522040APLetter2007/06/14下载
011522037APLetter2006/07/27下载
011522037APLabel2006/07/27下载
011522034APLetter2006/07/27下载
011522034APLabel2006/07/27下载
011522033APLabel2005/08/04下载
011522033APLetter2005/08/04下载
011522032APLetter2005/08/04下载
011522032APLabel2005/08/04下载
011522030APReview2004/04/14下载
011522030APLetter2002/11/08下载
011522010APReview2000/06/12下载
011522000APOther Important Information from FDA2007/05/31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
011522042AP2015/10/01Labeling Revision
011522041AP2015/04/17Labeling Revision
011522040AP2007/06/07Labeling Revision
011522037AP2006/07/26Labeling Revision
011522034AP2006/07/26Labeling Revision
011522033AP2005/08/02Labeling Revision
011522032AP2005/08/02Labeling Revision
011522030AP2002/11/08Formulation Revision
011522029AP2002/04/11Manufacturing Change or Addition
011522028AP2001/12/10Control Supplement
011522027AP2000/07/24Control Supplement
011522026AP2000/08/31Manufacturing Change or Addition
011522025AP2000/02/15Manufacturing Change or Addition
011522024AP2000/01/26Manufacturing Change or Addition
011522023AP1999/09/20Control Supplement
011522022AP1999/11/12Control Supplement
011522021AP1999/05/21Manufacturing Change or Addition
011522020AP1999/02/23Manufacturing Change or Addition
011522019AP1998/03/16Control Supplement
011522018AP1998/01/08Control Supplement
011522017AP1997/07/25Labeling Revision
011522016AP1997/11/14Control Supplement
011522015AP1997/07/17Labeling Revision
011522014AP1997/06/13Control Supplement
011522013AP1997/05/12Manufacturing Change or Addition
011522012AP1997/01/29Control Supplement
011522011AP1997/07/17Labeling Revision
011522010AP1996/02/13Formulation Revision
011522009AP1996/02/13Labeling Revision
011522000AP1960/01/19Approval