药品名称EXPAREL
申请号022496产品号001
活性成分BUPIVACAINE市场状态处方药
剂型或给药途径INJECTABLE, LIPOSOMAL;INJECTION规格133MG/10ML (13.3MG/ML)
治疗等效代码参比药物是
批准日期2011/10/28申请机构PACIRA PHARMACEUTICALS INC
化学类型New dosage form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
81828352018/09/18YU-1246PDF格式
88349212018/09/18YU-1587PDF格式
历史专利信息
61327662013/11/16YPDF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
无
历史市场独占权保护信息
NP2014/10/28
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
022496019APLetter2015/12/14下载
022496019APLabel2015/12/14下载
022496005APLetter2014/12/09下载
022496005APLabel2014/12/16下载
022496000APLetter2011/10/31下载
022496000APLabel2011/11/01下载
022496000APReview2012/06/04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
022496021AP2016/09/19Manufacturing Change or Addition
022496020AP2016/06/10Manufacturing Change or Addition
022496019AP2015/12/14Labeling Revision
022496018AP2016/04/15Manufacturing Change or Addition
022496017AP2016/04/05Manufacturing Change or Addition
022496016AP2015/10/08Manufacturing Change or Addition
022496015AP2015/09/11Manufacturing Change or Addition
022496014AP2015/07/27Manufacturing Change or Addition
022496012AP2015/05/27Manufacturing Change or Addition
022496010AP2014/12/15Manufacturing Change or Addition
022496008AP2014/08/13Manufacturing Change or Addition
022496007AP2014/06/05Manufacturing Change or Addition
022496006AP2014/03/28Manufacturing Change or Addition
022496005AP2014/12/05Labeling Revision
022496004AP2013/07/10Manufacturing Change or Addition
022496000AP2011/10/28Approval