药品名称KLARON
申请号019931产品号001
活性成分SULFACETAMIDE SODIUM市场状态处方药
剂型或给药途径LOTION;TOPICAL规格10%
治疗等效代码AB参比药物
批准日期1996/12/23申请机构VALEANT PHARMACEUTICALS NORTH AMERICA 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
019931019APLabel2010/07/06下载
019931019APLetter2010/07/08下载
019931008APLetter2004/06/07下载
019931008APLabel2004/06/07下载
019931000APReview1997/11/17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
019931024AP2016/02/16Manufacturing Change or Addition
019931023AP2015/10/27Manufacturing Change or Addition
019931022AP2014/12/05Manufacturing Change or Addition
019931019AP2010/07/02Labeling Revision
019931008AP2003/02/21Control Supplement
019931007AP2002/10/09Manufacturing Change or Addition
019931006AP2002/10/09Manufacturing Change or Addition
019931005AP2002/09/12Manufacturing Change or Addition
019931004AP2002/09/12Manufacturing Change or Addition
019931003AP2002/03/26Manufacturing Change or Addition
019931001AP1999/06/15Manufacturing Change or Addition
019931000AP1996/12/23Approval