药品名称FLAGYL I.V.
申请号018353产品号001
活性成分METRONIDAZOLE HYDROCHLORIDE市场状态停止上市
剂型或给药途径INJECTABLE;INJECTION规格EQ 500MG BASE/VIAL
治疗等效代码参比药物
批准日期Approved Prior to Jan 1, 1982申请机构PFIZER INC
化学类型New dosage form审评分类Priority 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
018353027APLetter2015/07/14下载
018353027APLabel2015/07/16下载
018353026APLetter2013/08/20下载
018353026APLabel2013/08/21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
018353027AP2015/07/13Labeling Revision
018353026AP2013/08/16Labeling Revision
018353025AP1993/03/05Manufacturing Change or Addition
018353024AP1992/11/30Labeling Revision
018353023AP1989/04/13Labeling Revision
018353022AP1988/02/17Labeling Revision
018353021AP1986/09/09Manufacturing Change or Addition
018353020AP1986/09/02Labeling Revision
018353018AP1986/04/24Package Change
018353017AP1986/06/20Manufacturing Change or Addition
018353016AP1988/02/17Labeling Revision
018353015AP1988/02/17Patient Population Altered
018353014AP1988/02/17Labeling Revision
018353013AP1987/10/29Package Change
018353011AP1987/08/21Manufacturing Change or Addition
018353010AP1983/12/14Labeling Revision
018353009AP1982/12/02Expiration Date Change
018353008AP1982/09/15Manufacturing Change or Addition
018353007AP1982/06/30Labeling Revision
018353006AP1982/01/11Control Supplement
018353005AP1981/11/02Manufacturing Change or Addition
018353003AP1981/11/25Manufacturing Change or Addition
018353002AP1984/12/20Labeling Revision
018353001AP1981/05/29Control Supplement
018353000AP1980/11/28Approval