药品名称INDOCIN
申请号016059产品号002
活性成分INDOMETHACIN市场状态停止上市
剂型或给药途径CAPSULE;ORAL规格50MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
治疗等效代码参比药物
批准日期Approved Prior to Jan 1, 1982申请机构IROKO PHARMACEUTICALS LLC
化学类型New molecular entity (NME)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
016059099APLetter2016/05/11下载
016059099APLabel2016/05/11下载
016059098APLetter2016/05/11下载
016059098APLabel2016/05/11下载
016059097APLabel2007/02/02下载
016059097APLetter2007/02/02下载
016059096APLabel2006/01/27下载
016059095APLetter2005/03/29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
016059099AP2016/05/09Labeling Revision
016059098AP2016/05/09Labeling Revision
016059097AP2007/01/30Labeling Revision
016059096AP2006/01/26Labeling Revision
016059095AP2005/03/24Labeling Revision
016059090AP1997/12/01Control Supplement
016059089AP1996/03/01Manufacturing Change or Addition
016059088AP2001/10/31Labeling Revision
016059087AP1994/10/24Labeling Revision
016059086AP1994/09/13Labeling Revision
016059085AP1994/08/18Control Supplement
016059084AP1994/12/30Control Supplement
016059083AP1994/09/14Labeling Revision
016059082AP1994/09/26Labeling Revision
016059079AP1991/04/04Manufacturing Change or Addition
016059078AP1989/05/25Labeling Revision
016059077AP1989/01/06Labeling Revision
016059075AP1989/01/09Labeling Revision
016059074AP1988/05/03Manufacturing Change or Addition
016059073AP1989/01/06Labeling Revision
016059071AP1988/06/03Labeling Revision
016059068AP1986/09/22Labeling Revision
016059067AP1986/08/15Labeling Revision
016059065AP1986/06/04Labeling Revision
016059062AP1986/08/15Labeling Revision
016059061AP1985/07/23Labeling Revision
016059060AP1984/11/27Labeling Revision
016059059AP1984/12/06Labeling Revision
016059058AP1984/06/25Manufacturing Change or Addition
016059054AP1983/05/11Manufacturing Change or Addition
016059052AP1983/01/19Package Change
016059051AP1983/11/18Labeling Revision
016059050AP1983/01/31Control Supplement
016059047AP1984/08/13Package Change
016059046AP1982/03/03Manufacturing Change or Addition
016059045AP1986/01/06General Efficacy (MarkIV)
016059044AP1981/04/09Control Supplement
016059043AP1980/09/27Labeling Revision
016059042AP1983/07/29Package Change
016059041AP1981/05/28Labeling Revision
016059040AP1979/10/26Labeling Revision
016059039AP1979/08/08Labeling Revision
016059038AP1979/09/24Manufacturing Change or Addition
016059036AP1979/01/29Control Supplement
016059035AP1978/02/23Control Supplement
016059034AP1979/10/26Package Change
016059033AP1978/10/11Control Supplement
016059031AP1977/12/22Labeling Revision
016059030AP1976/06/29Labeling Revision
016059029AP1981/10/07Labeling Revision
016059028AP1976/08/27Control Supplement
016059000AP1965/06/10Approval