药品名称LAC-HYDRIN
申请号019155产品号001
活性成分AMMONIUM LACTATE市场状态停止上市
剂型或给药途径LOTION;TOPICAL规格EQ 12% BASE
治疗等效代码参比药物
批准日期1985/04/24申请机构RANBAXY LABORATORIES INC
化学类型New active ingredient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
019155022APLabel2007/11/19下载
019155022APLetter2007/11/19下载
019155020APLetter2004/05/03下载
019155020APReview2007/07/06下载
019155019APLetter2004/05/03下载
019155019APReview2007/07/06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
019155030AP2013/04/02Manufacturing Change or Addition
019155022AP2007/11/09Labeling Revision
019155020AP2004/04/29Labeling Revision
019155019AP2004/04/29Labeling Revision
019155018AP1998/05/20Manufacturing Change or Addition
019155017AP1997/12/08Control Supplement
019155016AP1997/12/08Control Supplement
019155013AP1995/05/08Control Supplement
019155012AP1995/05/05Control Supplement
019155011AP1995/01/04Formulation Revision
019155010AP1993/02/19Package Change
019155009AP1992/07/16Control Supplement
019155008AP1992/03/26Manufacturing Change or Addition
019155007AP1990/11/19Control Supplement
019155006AP1989/09/15Control Supplement
019155005AP1988/02/19Control Supplement
019155004AP1987/06/18Package Change
019155003AP1986/03/27Labeling Revision
019155002AP1985/08/09Control Supplement
019155001AP1985/08/09Manufacturing Change or Addition
019155000AP1985/04/24Approval