药品名称LIDEX
申请号017373产品号001
活性成分FLUOCINONIDE市场状态停止上市
剂型或给药途径GEL;TOPICAL规格0.05% **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**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Approved Prior to Jan 1, 1982申请机构COUNTY LINE PHARMACEUTICALS LLC
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
017373038APLetter2006/01/19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
017373038AP2005/12/16Control Supplement
017373035AP2000/09/26Manufacturing Change or Addition
017373034AP1996/07/22Manufacturing Change or Addition
017373033AP1992/11/16Control Supplement
017373032AP1992/04/24Control Supplement
017373031AP1991/03/12Labeling Revision
017373030AP1990/02/13Control Supplement
017373029AP1989/12/06Control Supplement
017373028AP1989/02/10Control Supplement
017373027AP1985/04/10Labeling Revision
017373026AP1984/08/29Manufacturing Change or Addition
017373025AP1983/09/07Manufacturing Change or Addition
017373024AP1983/12/06Expiration Date Change
017373023AP1983/04/21Practioner Draft Labeling
017373021AP1982/11/19Manufacturing Change or Addition
017373020AP1981/11/20Manufacturing Change or Addition
017373019AP1981/11/10Control Supplement
017373018AP1981/11/03Control Supplement
017373017AP1981/01/19Package Change
017373016AP1981/01/19Package Change
017373015AP1981/01/19Package Change
017373014AP1980/08/07Package Change
017373013AP1979/10/23Manufacturing Change or Addition
017373012AP1979/08/13Manufacturing Change or Addition
017373011AP1978/11/29Control Supplement
017373010AP1978/09/12Labeling Revision
017373009AP1978/10/13Labeling Revision
017373008AP1978/07/05Control Supplement
017373007AP1977/12/14Control Supplement
017373006AP1977/06/04Manufacturing Change or Addition
017373005AP1977/01/04Labeling Revision
017373004AP1976/01/23Labeling Revision
017373000AP1973/05/15Approval