药品名称VYVANSE
申请号021977产品号004
活性成分LISDEXAMFETAMINE DIMESYLATE市场状态处方药
剂型或给药途径CAPSULE;ORAL规格20MG
治疗等效代码参比药物
批准日期2007/12/10申请机构SHIRE DEVELOPMENT 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
76592532023/02/24YYU-727PDF格式
76592542023/02/24U-1034PDF格式
76627882023/02/24U-727PDF格式
76710302023/02/24YU-727PDF格式
77139362023/02/24U-727PDF格式
77186192023/02/24YU-842PDF格式
77233052023/02/24YU-842PDF格式
71054862023/02/24U-727PDF格式
71054862023/02/24U-842PDF格式
76710312023/02/24U-727PDF格式
76874672023/02/24YU-842PDF格式
76787712023/02/24YU-842PDF格式
76747742023/02/24YU-842PDF格式
76787702023/02/24U-842PDF格式
77005612023/02/24YPDF格式
76874662023/02/24YPDF格式
72237352023/02/24YPDF格式
76627872023/02/24YPDF格式
76556302023/02/24YPDF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
I-7032018/01/30
M-1882019/10/14
历史市场独占权保护信息
I-6452015/01/31
NCE2012/02/23
NPP2011/04/23
NPP2013/11/10
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
021977042APLabel2016/10/17下载
021977042APLetter2016/10/19下载
021977041APLabel2016/10/17下载
021977041APLetter2016/10/19下载
021977039APLetter2015/04/20下载
021977039APLabel2015/04/21下载
021977037APReview2015/05/14下载
021977037APLetter2015/02/02下载
021977037APLabel2015/02/03下载
021977036APLetter2015/02/02下载
021977036APLabel2015/02/03下载
021977036APReview2015/05/14下载
021977033APLetter2014/11/17下载
021977033APLabel2014/11/20下载
021977032APLabel2014/07/30下载
021977032APLetter2014/07/23下载
021977031APLabel2014/07/30下载
021977031APLetter2014/07/23下载
021977030APLetter2013/12/10下载
021977030APLabel2013/12/12下载
021977028APLabel2013/06/18下载
021977028APLetter2013/06/18下载
021977027APLabel2013/04/29下载
021977027APLetter2013/04/30下载
021977026APLetter2012/11/21下载
021977026APMedication Guide2012/11/26下载
021977026APLabel2012/11/26下载
021977025APLabel2012/11/26下载
021977025APLetter2012/11/21下载
021977025APMedication Guide2012/11/26下载
021977024APMedication Guide2012/11/26下载
021977024APLabel2012/11/26下载
021977024APLetter2012/11/21下载
021977023APLabel2011/09/02下载
021977023APLetter2011/09/06下载
021977022APLabel2012/02/01下载
021977022APLetter2012/02/03下载
021977021APLetter2010/11/15下载
021977021APLabel2010/11/12下载
021977019APLabel2010/11/12下载
021977019APLetter2010/11/15下载
021977018APLetter2010/11/15下载
021977018APLabel2010/11/12下载
021977016APLabel2010/11/12下载
021977016APLetter2010/11/15下载
021977015APLetter2010/04/08下载
021977015APLabel2010/04/05下载
021977013APLabel2009/12/11下载
021977013APLetter2010/01/28下载
021977012APLetter2011/03/21下载
021977012APLabel2011/03/21下载
021977010APLabel2010/04/05下载
021977010APLetter2010/04/08下载
021977008APLetter2008/11/13下载
021977007APLabel2009/05/25下载
021977007APLetter2009/05/29下载
021977006APLabel2009/05/25下载
021977006APLetter2009/05/29下载
021977002APLabel2007/12/14下载
021977002APLetter2008/01/09下载
021977001APLetter2008/04/25下载
021977001APLabel2008/06/05下载
021977000APLabel2007/02/26下载
021977000APMedication Guide2007/02/26下载
021977000APLetter2007/03/06下载
021977000APReview2007/04/05下载
021977000APOther 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
021977042AP2016/10/14Labeling Revision
021977041AP2016/10/14Efficacy Supplement with Clinical Data to Support
021977040AP2015/12/04Manufacturing Change or Addition
021977039AP2015/04/17Labeling Revision
021977037AP2015/01/30Efficacy Supplement with Clinical Data to Support
021977036AP2015/01/30Labeling Revision
021977035AP2014/10/30Manufacturing Change or Addition
021977033AP2014/11/14Labeling Revision
021977032AP2014/07/18Labeling Revision
021977031AP2014/07/18Labeling Revision
021977030AP2013/12/06Labeling Revision
021977029AP2014/05/14Manufacturing Change or Addition
021977028AP2013/06/14Labeling Revision
021977027AP2013/04/26New or Modified Indication
021977026AP2012/11/19Labeling Revision
021977025AP2012/11/19Labeling Revision
021977024AP2012/11/19Labeling Revision
021977023AP2011/09/01Supplement
021977022AP2012/01/31Patient Population Altered
021977021AP2010/11/10Labeling Revision
021977020AP2016/04/15Manufacturing Change or Addition
021977019AP2010/11/10Labeling Revision
021977018AP2010/11/10Labeling Revision
021977016AP2010/11/10Patient Population Altered
021977015AP2010/04/05Labeling Revision
021977013AP2009/12/02Labeling Revision
021977012AP2011/03/16Labeling Revision
021977010AP2010/04/05Efficacy Supplement with Clinical Data to Support
021977008AP2008/11/12Labeling Revision
021977007AP2009/05/22Efficacy Supplement with Clinical Data to Support
021977006AP2009/05/22Labeling Revision
021977002AP2007/12/10Manufacturing Change or Addition
021977001AP2008/04/23Patient Population Altered
021977000AP2007/02/23Approval