药品名称BREVIBLOC IN PLASTIC CONTAINER
申请号019386产品号004
活性成分ESMOLOL HYDROCHLORIDE市场状态处方药
剂型或给药途径INJECTABLE;INJECTION规格1GM/100ML
治疗等效代码参比药物
批准日期2001/02/16申请机构BAXTER HEALTHCARE CORP
化学类型New molecular entity (NME)审评分类Priority 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
65285402021/01/12PDF格式
63100942021/01/12PDF格式
6310094*PED2021/07/12PDF格式
6528540*PED2021/07/12PDF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
019386043APLabel2012/12/13下载
019386043APLetter2012/12/13下载
019386039APLabel2007/11/07下载
019386039APLetter2007/11/08下载
019386024APLetter2003/08/26下载
019386022APReview2007/07/06下载
019386022APLetter2003/05/30下载
019386021APReview2003/07/08下载
019386021APLetter2003/03/10下载
019386020APLetter2003/01/27下载
019386019APLetter2003/01/27下载
019386018APReview2007/09/14下载
019386017APReview2007/09/14下载
019386015APReview2007/09/14下载
019386012APReview2008/02/19下载
019386011APReview2008/02/19下载
019386010APReview2008/02/19下载
019386009APReview2008/02/19下载
019386007APReview2007/12/06下载
019386006APReview2007/12/06下载
019386005APReview2007/12/06下载
019386004APReview2007/12/06下载
019386002APReview2007/12/06下载
019386001APReview2007/12/06下载
019386000APReview2004/10/04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
019386048AP2015/08/14Manufacturing Change or Addition
019386047AP2015/01/26Manufacturing Change or Addition
019386046AP2014/03/20Manufacturing Change or Addition
019386043AP2012/12/11Labeling Revision
019386041AP2013/08/13Manufacturing Change or Addition
019386039AP2007/11/06Labeling Revision
019386024AP2003/08/18Formulation Revision
019386022AP2003/05/28Manufacturing Change or Addition
019386021AP2003/02/25Formulation Revision
019386020AP2003/01/27Formulation Revision
019386019AP2003/01/27Formulation Revision
019386018AP2001/02/16Package Change
019386017AP2001/01/26Control Supplement
019386016AP2000/01/19Labeling Revision
019386015AP2000/02/23Manufacturing Change or Addition
019386013AP1995/10/04Labeling Revision
019386012AP1994/01/13Control Supplement
019386011AP1993/11/24Control Supplement
019386010AP1993/07/01Labeling Revision
019386009AP1991/10/21Labeling Revision
019386008AP1992/12/18New Dosage Regimen
019386007AP1989/05/11Labeling Revision
019386006AP1988/08/15Labeling Revision
019386005AP1989/05/26Manufacturing Change or Addition
019386004AP1988/08/15Control Supplement
019386003AP1992/12/18New or Modified Indication
019386002AP1988/08/15Labeling Revision
019386001AP1988/08/15Package Change
019386000AP1986/12/31Approval