药品名称LOPID
申请号018422产品号002
活性成分GEMFIBROZIL市场状态停止上市
剂型或给药途径CAPSULE;ORAL规格300MG
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 PHARMACEUTICALS LTD
化学类型New molecular entity (NME)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
018422055APLabel2016/04/07下载
018422055APLetter2016/04/08下载
018422054APLetter2014/11/07下载
018422054APLabel2014/11/07下载
018422053APLabel2013/11/01下载
018422053APLetter2013/11/06下载
018422050APLabel2010/09/27下载
018422050APLetter2010/09/29下载
018422048APLetter2009/07/17下载
018422048APLabel2009/07/17下载
018422045APLetter2004/04/07下载
018422043APLetter2003/01/15下载
018422041APLabel2003/04/14下载
018422041APLetter2004/06/08下载
018422040APLabel2003/04/14下载
018422040APLetter2004/06/08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
018422055AP2016/04/06Labeling Revision
018422054AP2014/11/05Labeling Revision
018422053AP2013/10/31Labeling Revision
018422050AP2010/09/27Labeling Revision
018422048AP2009/07/14Labeling Revision
018422045AP2004/03/30Labeling Revision
018422043AP2003/01/15Labeling Revision
018422042AP2002/09/26Control Supplement
018422041AP2001/08/07Labeling Revision
018422040AP2001/08/07Labeling Revision
018422039AP1997/07/18Manufacturing Change or Addition
018422037AP1995/03/24Labeling Revision
018422035AP1995/03/24Labeling Revision
018422034AP1998/12/03Labeling Revision
018422033AP1995/03/24Labeling Revision
018422032AP1992/12/02Labeling Revision
018422031AP1992/03/16Labeling Revision
018422030AP1990/01/29Manufacturing Change or Addition
018422029AP1990/01/03Manufacturing Change or Addition
018422028AP1989/05/30Manufacturing Change or Addition
018422027AP1989/05/30Manufacturing Change or Addition
018422026AP1990/06/04Labeling Revision
018422024AP1988/11/15Manufacturing Change or Addition
018422023AP1988/12/01Manufacturing Change or Addition
018422022AP1989/01/17New or Modified Indication
018422021AP1988/05/25Control Supplement
018422020AP1988/02/03Manufacturing Change or Addition
018422019AP1988/02/03Control Supplement
018422018AP1987/11/03Manufacturing Change or Addition
018422017AP1988/01/28Manufacturing Change or Addition
018422016AP1987/11/03Control Supplement
018422014AP1987/08/26Package Change
018422012AP1986/04/04Labeling Revision
018422011AP1985/12/10Manufacturing Change or Addition
018422010AP1985/12/20Control Supplement
018422008AP1986/11/20Control Supplement
018422005AP1984/08/22Control Supplement
018422004AP1983/09/26Manufacturing Change or Addition
018422002AP1982/06/01Labeling Revision
018422001AP1982/05/05Control Supplement
018422000AP1981/12/21Approval