药品名称SUBOXONE
申请号022410产品号004
活性成分BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE市场状态处方药
剂型或给药途径FILM;BUCCAL, SUBLINGUAL规格EQ 12MG BASE;EQ 3MG BASE
治疗等效代码参比药物
批准日期2012/08/10申请机构INDIVIOR INC
化学类型New combination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
84758322030/03/26YU-1411PDF格式
86035142024/04/03YU-1464PDF格式
80171502023/02/13YPDF格式
历史专利信息
86035142024/04/03YPDF格式
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
NDF2013/08/30
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
022410025APLetter2016/07/12下载
022410022APLetter2015/09/24下载
022410022APLabel2015/10/06下载
022410020APLetter2015/09/24下载
022410020APLabel2015/10/06下载
022410018APLabel2014/04/29下载
022410018APLetter2014/04/29下载
022410017APLetter2014/04/29下载
022410017APLabel2014/04/29下载
022410016APReview2014/08/05下载
022410015APLetter2013/11/25下载
022410015APLabel2013/11/26下载
022410014APReview2014/08/05下载
022410011APReview2014/08/05下载
022410007APReview2013/02/25下载
022410007APMedication Guide2012/08/15下载
022410007APLabel2012/08/15下载
022410006APReview2013/02/25下载
022410006APLabel2012/08/15下载
022410006APMedication Guide2012/08/15下载
022410004APLetter2014/04/29下载
022410004APLabel2014/04/29下载
022410000APLetter2010/09/02下载
022410000APLabel2010/09/10下载
022410000APMedication Guide2010/09/15下载
022410000APOther2010/10/01下载
022410000APReview2011/08/12下载
022410000APSummary Review2011/08/12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
022410025AP2016/07/07Supplement
022410024AP2016/04/15Manufacturing Change or Addition
022410022AP2015/09/22Supplement
022410021AP2015/06/23Manufacturing Change or Addition
022410020AP2015/09/22Efficacy Supplement with Clinical Data to Support
022410019AP2014/08/12Manufacturing Change or Addition
022410018AP2014/04/28Efficacy Supplement with Clinical Data to Support
022410017AP2014/04/28Labeling Revision
022410016AP2014/06/05Manufacturing Change or Addition
022410015AP2013/11/22Labeling Revision
022410014AP2014/03/12Manufacturing Change or Addition
022410011AP2013/08/08Manufacturing Change or Addition
022410007AP2012/08/10Manufacturing Change or Addition
022410006AP2012/08/10Manufacturing Change or Addition
022410004AP2014/04/28Efficacy Supplement with Clinical Data to Support
022410000AP2010/08/30Approval