药品名称DERMOTIC
申请号019452产品号003
活性成分FLUOCINOLONE ACETONIDE市场状态处方药
剂型或给药途径OIL/DROPS;OTIC规格0.01%
治疗等效代码AT参比药物
批准日期2005/11/09申请机构HILL DERMACEUTICALS INC
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
019452020APLabel2005/11/17下载
019452020APLetter2005/11/18下载
019452019APLabel2005/11/17下载
019452019APLetter2005/11/18下载
019452018APLabel2003/05/29下载
019452018APLetter2003/05/29下载
019452017APLetter2001/10/10下载
019452017APLabel2001/10/10下载
019452017APReview2001/10/10下载
019452016APLabel2005/11/17下载
019452016APLetter2005/11/18下载
019452015APLetter1999/08/18下载
019452015APReview1999/08/18下载
019452015APLabel1999/08/18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
019452024AP2007/12/12Patient Population Altered
019452020AP2005/11/09Efficacy Supplement with Clinical Data to Support
019452019AP2005/11/09Efficacy Supplement with Clinical Data to Support
019452018AP2003/04/21Package Change
019452017AP2001/10/10Patient Population Altered
019452016AP2005/11/09Efficacy Supplement with Clinical Data to Support
019452015AP1999/08/18New or Modified Indication
019452014AP1997/02/04Manufacturing Change or Addition
019452013AP1996/04/26Manufacturing Change or Addition
019452012AP1996/01/30Manufacturing Change or Addition
019452010AP1995/02/16New or Modified Indication
019452009AP1995/02/16Labeling Revision
019452008AP1992/06/25Package Change
019452007AP1996/08/27Control Supplement
019452005AP1990/10/16Manufacturing Change or Addition
019452004AP1990/01/10Manufacturing Change or Addition
019452003AP1989/06/27Manufacturing Change or Addition
019452002AP1989/03/15Manufacturing Change or Addition
019452001AP1988/09/08Manufacturing Change or Addition
019452000AP1988/02/03Approval