药品名称FLAGYL I.V. RTU IN PLASTIC CONTAINER
申请号018657产品号001
活性成分METRONIDAZOLE市场状态处方药
剂型或给药途径INJECTABLE;INJECTION规格500MG/100ML
治疗等效代码AP参比药物
批准日期Approved Prior to Jan 1, 1982申请机构BAXTER HEALTHCARE CORP
化学类型New formulation or new manufacturer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
018657034APLetter2015/07/14下载
018657034APLabel2015/07/16下载
018657032APLetter2013/10/25下载
018657032APLabel2013/10/25下载
018657031APLetter2011/08/09下载
018657031APLabel2011/08/12下载
018657029APLabel2009/09/17下载
018657029APLetter2009/11/19下载
018657028APLetter2012/05/30下载
018657027APLetter2004/06/07下载
018657027APLabel2004/06/07下载
018657026APLetter2004/06/07下载
018657026APLabel2004/06/07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
018657035AP2016/01/13Manufacturing Change or Addition
018657034AP2015/07/13Labeling Revision
018657032AP2013/10/24Labeling Revision
018657031AP2011/08/05Labeling Revision
018657029AP2009/08/06Labeling Revision
018657028AP2012/05/25Labeling Revision
018657027AP2004/06/02Labeling Revision
018657026AP2004/06/02Labeling Revision
018657023AP1998/01/30Manufacturing Change or Addition
018657022AP1997/05/13Package Change
018657021AP1996/04/16Control Supplement
018657020AP1995/02/28Control Supplement
018657019AP1994/09/21Control Supplement
018657018AP1993/08/09Manufacturing Change or Addition
018657017AP1992/05/15Package Change
018657016AP1993/04/02Control Supplement
018657015AP1991/11/08Control Supplement
018657014AP1991/09/25Expiration Date Change
018657013AP1991/07/02Control Supplement
018657012AP1989/04/13Labeling Revision
018657011AP1987/12/28Labeling Revision
018657010AP1986/08/26Labeling Revision
018657009AP1988/02/17Labeling Revision
018657008AP1986/04/24Control Supplement
018657007AP1988/02/17Patient Population Altered
018657006AP1988/02/17Labeling Revision
018657005AP1984/11/13Control Supplement
018657004AP1987/08/21Labeling Revision
018657003AP1984/08/08Manufacturing Change or Addition
018657002AP1984/12/20Labeling Revision
018657001AP1982/06/30Labeling Revision
018657000AP1981/12/24Approval