药品名称AUGMENTIN '125'
申请号050575产品号001
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125MG/5ML;EQ 31.25MG BASE/5ML
治疗等效代码AB参比药物
批准日期1984/08/06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
050575042APLabel2013/01/23下载
050575042APLetter2013/01/24下载
050575040APLetter2013/01/24下载
050575040APLabel2013/01/23下载
050575039APLabel2011/09/30下载
050575039APLetter2011/10/04下载
050575038APLabel2008/03/27下载
050575038APLetter2008/04/02下载
050575037APLabel2008/12/08下载
050575037APLetter2008/12/11下载
050575036APLetter2004/08/12下载
050575035APLetter2004/06/07下载
050575032APLetter2003/06/08下载
050575025APLetter2004/05/27下载
050575016APReview1999/08/02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
050575044AP2014/09/30Manufacturing Change or Addition
050575042AP2013/01/22Labeling Revision
050575040AP2013/01/22Labeling Revision
050575039AP2011/09/29Labeling Revision
050575038AP2008/03/27Labeling Revision
050575037AP2008/12/04Labeling Revision
050575036AP2004/08/11Labeling Revision
050575035AP2004/06/03Labeling Revision
050575034AP2002/10/17Control Supplement
050575033AP2002/12/04Control Supplement
050575032AP2003/05/12Labeling Revision
050575030AP2001/04/17Control Supplement
050575028AP1999/11/19Control Supplement
050575027AP1999/09/23Control Supplement
050575026AP1999/02/01Control Supplement
050575025AP2002/04/10Labeling Revision
050575024AP1998/02/11Manufacturing Change or Addition
050575023AP1998/02/11Labeling Revision
050575022AP1997/03/19Labeling Revision
050575019AP1996/03/04Labeling Revision
050575018AP1994/07/06Labeling Revision
050575017AP1994/09/15Control Supplement
050575016AP1996/02/16Labeling Revision
050575015AP1992/07/21Labeling Revision
050575014AP1991/11/05Control Supplement
050575013AP1994/04/18Control Supplement
050575012AP1991/12/05Labeling Revision
050575011AP1991/05/22Manufacturing Change or Addition
050575000AP1984/08/06Approval