药品名称NAFTIN
申请号019599产品号002
活性成分NAFTIFINE HYDROCHLORIDE市场状态处方药
剂型或给药途径CREAM;TOPICAL规格2%
治疗等效代码AB参比药物
批准日期2012/01/13申请机构MERZ PHARMACEUTICALS 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
NS2015/01/13
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
019599012APLetter2014/10/14下载
019599012APLabel2014/10/15下载
019599011APLetter2012/01/18下载
019599011APLabel2012/01/23下载
019599010APLetter2009/01/30下载
019599007APReview2015/11/05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
019599012AP2014/10/10Efficacy Supplement with Clinical Data to Support
019599011AP2012/01/13New Dosage Regimen
019599010AP2009/01/26Package Change
019599007AP2002/06/04Manufacturing Change or Addition
019599006AP1998/11/30Manufacturing Change or Addition
019599005AP1997/09/24Control Supplement
019599004AP1995/06/15Package Change
019599003AP1990/01/30Control Supplement
019599002AP1990/07/05New Dosage Regimen
019599001AP1989/04/05New or Modified Indication
019599000AP1988/02/29Approval