药品名称ATIVAN
申请号018140产品号002
活性成分LORAZEPAM市场状态处方药
剂型或给药途径INJECTABLE;INJECTION规格4MG/ML
治疗等效代码AP参比药物
批准日期Approved Prior to Jan 1, 1982申请机构WEST-WARD PHARMACEUTICALS INTERNATIONAL LTD
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
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
018140040APLetter2016/05/31下载
018140028APLabel2006/12/04下载
018140028APLetter2006/12/28下载
018140027APReview2007/04/09下载
018140003APReview1997/10/05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
018140040AP2016/05/27Labeling Revision
018140039AP2015/10/02Manufacturing Change or Addition
018140038AP2016/04/18Manufacturing Change or Addition
018140028AP2006/11/29Labeling Revision
018140027AP2001/12/12Labeling Revision
018140026AP2000/09/26Labeling Revision
018140025AP1997/11/04Manufacturing Change or Addition
018140024AP1998/10/16Manufacturing Change or Addition
018140023AP1996/09/26Manufacturing Change or Addition
018140022AP1996/03/19Labeling Revision
018140021AP1995/03/08Expiration Date Change
018140020AP1995/01/06Control Supplement
018140019AP1993/09/29Package Change
018140018AP1993/09/29Package Change
018140017AP1993/06/03Control Supplement
018140016AP1992/08/18Package Change
018140015AP1991/06/26Manufacturing Change or Addition
018140014AP1991/01/02Manufacturing Change or Addition
018140013AP1989/11/03Manufacturing Change or Addition
018140012AP1996/03/19Labeling Revision
018140011AP1996/03/19Labeling Revision
018140010AP1989/06/13Manufacturing Change or Addition
018140009AP1996/03/19Labeling Revision
018140008AP1987/04/13Labeling Revision
018140007AP1987/04/24Manufacturing Change or Addition
018140006AP1984/02/14Manufacturing Change or Addition
018140005AP1984/02/14Control Supplement
018140004AP1983/06/14Package Change
018140003AP1997/09/05New or Modified Indication
018140002AP1981/02/02Expiration Date Change
018140001AP1980/09/09Labeling Revision
018140000AP1980/07/25Approval