药品名称LOZOL
申请号018538产品号001
活性成分INDAPAMIDE市场状态停止上市
剂型或给药途径TABLET;ORAL规格2.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
治疗等效代码参比药物
批准日期1983/07/06申请机构SANOFI AVENTIS US LLC
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
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
018538028APLabel2009/10/08下载
018538028APLetter2009/11/09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
018538028AP2009/09/03Labeling Revision
018538027AP2000/03/07Manufacturing Change or Addition
018538026AP2000/10/10Labeling Revision
018538025AP1998/12/11Manufacturing Change or Addition
018538024AP1998/01/27Control Supplement
018538023AP1996/02/26Control Supplement
018538022AP1996/05/16Manufacturing Change or Addition
018538021AP1996/10/29Labeling Revision
018538020AP1996/10/29Labeling Revision
018538019AP1993/03/31Labeling Revision
018538018AP1993/08/19Control Supplement
018538017AP1993/04/29New Dosage Regimen
018538016AP1992/06/24Labeling Revision
018538015AP1992/04/01Manufacturing Change or Addition
018538014AP1991/09/25Labeling Revision
018538013AP1992/06/23Manufacturing Change or Addition
018538012AP1990/03/08Formulation Revision
018538011AP1989/10/13Formulation Revision
018538010AP1989/07/10Package Change
018538009AP1990/01/03Control Supplement
018538008AP1989/02/23Control Supplement
018538007AP1988/11/29Control Supplement
018538006AP1988/11/09Labeling Revision
018538005AP1988/07/08Expiration Date Change
018538004AP1987/06/30Control Supplement
018538003AP1984/04/10Manufacturing Change or Addition
018538002AP1983/10/12Package Change
018538001AP1983/11/29Control Supplement
018538000AP1983/07/06Approval