药品名称NIZORAL
申请号019927产品号001
活性成分KETOCONAZOLE市场状态处方药
剂型或给药途径SHAMPOO;TOPICAL规格2%
治疗等效代码AB参比药物
批准日期1990/08/31申请机构JANSSEN PHARMACEUTICALS 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
019927032APLetter2013/10/30下载
019927032APLabel2013/10/31下载
019927031APLabel2012/12/05下载
019927031APLetter2012/12/05下载
019927028APLabel2009/09/17下载
019927000APOther Important Information from FDA2014/02/07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
019927034AP2014/01/08Manufacturing Change or Addition
019927033AP2013/06/05Manufacturing Change or Addition
019927032AP2013/10/29Labeling Revision
019927031AP2012/12/04Labeling Revision
019927028AP2009/08/07Labeling Revision
019927022AP2002/10/02Package Change
019927021AP2002/05/06Control Supplement
019927020AP2002/02/28Control Supplement
019927019AP1999/02/01Package Change
019927018AP1998/05/26Package Change
019927016AP1998/05/26Control Supplement
019927015AP1998/02/09Control Supplement
019927014AP1997/10/10Labeling Revision
019927013AP1996/07/09Control Supplement
019927012AP1997/05/30New or Modified Indication
019927011AP1996/04/25Labeling Revision
019927010AP1995/11/02Manufacturing Change or Addition
019927009AP1996/02/08Manufacturing Change or Addition
019927008AP1995/11/02Manufacturing Change or Addition
019927007AP1995/10/26Manufacturing Change or Addition
019927006AP1995/11/02Control Supplement
019927005AP1993/10/07Manufacturing Change or Addition
019927004AP1993/07/02Control Supplement
019927003AP1992/09/11Manufacturing Change or Addition
019927002AP1995/03/06Labeling Revision
019927001AP1990/10/05Formulation Revision
019927000AP1990/08/31Approval