药品名称LATUDA
申请号200603产品号005
活性成分LURASIDONE HYDROCHLORIDE市场状态处方药
剂型或给药途径TABLET;ORAL规格60MG
治疗等效代码参比药物
批准日期2013/07/12申请机构SUNOVION PHARMACEUTICALS 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
91749752026/06/25U-1770PDF格式
92594232031/05/23U-1822PDF格式
87290852026/05/26YPDF格式
55323722018/07/02YPDF格式
88837942026/05/26YPDF格式
RE455732025/06/23YPDF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
NCE2015/10/28
I-6742016/06/28
历史市场独占权保护信息
D-1342015/04/26
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
200603016APLetter2013/09/05下载
200603016APLabel2013/09/24下载
200603015APLabel2013/07/17下载
200603013APLetter2013/01/24下载
200603013APLabel2013/01/23下载
200603011APLetter2013/07/02下载
200603011APReview2015/11/17下载
200603011APLabel2013/07/09下载
200603010APReview2015/11/17下载
200603010APLabel2013/07/09下载
200603010APLetter2013/07/02下载
200603009APLetter2013/01/24下载
200603009APLabel2013/01/23下载
200603007APLabel2012/05/01下载
200603007APLetter2012/04/27下载
200603006APLetter2011/12/13下载
200603006APLabel2011/12/13下载
200603005APLabel2012/05/01下载
200603005APLetter2012/04/27下载
200603004APLetter2011/12/13下载
200603004APLabel2011/12/13下载
200603001APLabel2010/12/23下载
200603001APLetter2010/12/28下载
200603000APSummary Review2011/02/17下载
200603000APLabel2010/10/29下载
200603000APLetter2010/11/03下载
200603000APReview2010/12/03下载
200603000APOther Important Information from FDA2011/12/22下载
200603000APMedication Guide2013/07/24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
200603024AP2016/07/08Manufacturing Change or Addition
200603023AP2016/03/29Manufacturing Change or Addition
200603020AP2015/07/30Manufacturing Change or Addition
200603018AP2015/01/05Manufacturing Change or Addition
200603017AP2014/02/28Manufacturing Change or Addition
200603016AP2013/09/03Labeling Revision
200603015AP2013/07/12Manufacturing Change or Addition
200603014AP2014/05/21Manufacturing Change or Addition
200603013AP2013/01/22Labeling Revision
200603012AP2013/06/13Manufacturing Change or Addition
200603011AP2013/06/28Efficacy Supplement with Clinical Data to Support
200603010AP2013/06/28Efficacy Supplement with Clinical Data to Support
200603009AP2013/01/22Labeling Revision
200603007AP2012/04/26Labeling Revision
200603006AP2011/12/07Labeling Revision
200603005AP2012/04/26New Dosage Regimen
200603004AP2011/12/07Labeling Revision
200603001AP2010/12/10Labeling Revision
200603000AP2010/10/28Approval