药品名称CAPEX
申请号020001产品号001
活性成分FLUOCINOLONE ACETONIDE市场状态处方药
剂型或给药途径SHAMPOO;TOPICAL规格0.01%
治疗等效代码参比药物
批准日期1990/08/27申请机构GALDERMA LABORATORIES LP
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
020001012APLetter2015/12/18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
020001014AP2016/03/18Manufacturing Change or Addition
020001013AP2016/04/22Manufacturing Change or Addition
020001012AP2015/12/17Labeling Revision
020001011AP2015/07/06Manufacturing Change or Addition
020001010AP2001/01/12Control Supplement
020001009AP1997/02/04Manufacturing Change or Addition
020001008AP1996/04/26Manufacturing Change or Addition
020001007AP1996/01/30Manufacturing Change or Addition
020001005AP1995/02/16Labeling Revision
020001003AP1991/11/19Expiration Date Change
020001002AP1991/06/24Manufacturing Change or Addition
020001001AP1990/11/19Manufacturing Change or Addition
020001000AP1990/08/27Approval