药品名称AUGMENTIN '400'
申请号050725产品号002
活性成分AMOXICILLIN; CLAVULANATE POTASSIUM市场状态处方药
剂型或给药途径FOR SUSPENSION;ORAL规格400MG/5ML;EQ 57MG BASE/5ML
治疗等效代码AB参比药物
批准日期1996/05/31申请机构DR REDDYS LABORATORIES 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
050725030APLabel2013/01/23下载
050725030APLetter2013/01/24下载
050725028APLetter2013/01/24下载
050725028APLabel2013/01/23下载
050725027APLabel2011/09/30下载
050725027APLetter2011/10/04下载
050725026APLabel2008/03/27下载
050725026APLetter2008/04/02下载
050725025APLabel2008/12/08下载
050725025APLetter2008/12/11下载
050725024APLetter2004/08/12下载
050725023APLetter2004/06/07下载
050725022APReview2006/10/25下载
050725021APReview2006/10/25下载
050725017APLetter2003/06/08下载
050725017APReview2006/10/25下载
050725014APReview2006/10/25下载
050725013APReview2006/10/25下载
050725011APReview2006/10/25下载
050725010APReview2006/10/25下载
050725008APReview2006/10/25下载
050725007APReview2006/10/25下载
050725006APReview2006/10/25下载
050725005APReview2006/10/25下载
050725004APReview2006/10/25下载
050725004APLetter2004/05/27下载
050725003APReview2006/10/25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
050725034AP2015/04/17Manufacturing Change or Addition
050725032AP2014/09/30Manufacturing Change or Addition
050725030AP2013/01/22Labeling Revision
050725028AP2013/01/22Labeling Revision
050725027AP2011/09/29Labeling Revision
050725026AP2008/03/27Labeling Revision
050725025AP2008/12/04Labeling Revision
050725024AP2004/08/11Labeling Revision
050725023AP2004/06/03Labeling Revision
050725022AP2003/12/23Supplement
050725021AP2003/06/13Supplement
050725020AP2002/10/17Control Supplement
050725019AP2002/10/07Formulation Revision
050725018AP2002/12/04Control Supplement
050725017AP2003/05/12Labeling Revision
050725015AP2002/11/27Formulation Revision
050725014AP2001/12/07Expiration Date Change
050725013AP2001/04/17Control Supplement
050725012AP2001/03/07Expiration Date Change
050725011AP2000/11/27Control Supplement
050725010AP2001/05/03Manufacturing Change or Addition
050725008AP2000/06/08Control Supplement
050725007AP1999/11/19Control Supplement
050725006AP1999/09/23Control Supplement
050725005AP1999/02/01Control Supplement
050725004AP2002/04/10Labeling Revision
050725003AP1998/02/19Manufacturing Change or Addition
050725002AP1998/02/11Labeling Revision
050725001AP1997/03/19Labeling Revision
050725000AP1996/05/31Approval