药品名称HALDOL
申请号018701产品号002
活性成分HALOPERIDOL DECANOATE市场状态处方药
剂型或给药途径INJECTABLE;INJECTION规格EQ 100MG BASE/ML
治疗等效代码AO参比药物
批准日期1997/01/31申请机构JANSSEN PHARMACEUTICALS INC
化学类型New active ingredient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
018701072APLetter2016/05/20下载
018701072APLabel2016/05/20下载
018701065APLetter2013/05/07下载
018701063APLabel2011/03/04下载
018701063APLetter2011/03/07下载
018701062APLabel2010/12/04下载
018701062APLetter2010/12/06下载
018701059APLabel2009/07/23下载
018701059APLetter2009/08/04下载
018701057APLetter2008/08/19下载
018701057APLabel2008/08/29下载
018701056APLetter2008/05/14下载
018701056APLabel2008/06/05下载
018701055APLetter2007/09/25下载
018701054APLetter2011/08/15下载
018701054APLabel2011/08/16下载
018701053APLabel2007/05/07下载
018701053APLetter2007/05/09下载
018701046APReview2007/07/06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
018701072AP2016/05/18Labeling Revision
018701069AP2013/12/19Manufacturing Change or Addition
018701068AP2013/06/05Manufacturing Change or Addition
018701067AP2013/05/24Manufacturing Change or Addition
018701065AP2013/05/06Labeling Revision
018701063AP2011/03/01Labeling Revision
018701062AP2010/12/01Labeling Revision
018701059AP2009/07/19Labeling Revision
018701057AP2008/08/14Labeling Revision
018701056AP2008/05/13Labeling Revision
018701055AP2007/09/19Labeling Revision
018701054AP2011/08/12Labeling Revision
018701053AP2007/05/04Labeling Revision
018701046AP2002/04/17Labeling Revision
018701045AP2000/04/13Manufacturing Change or Addition
018701043AP2000/05/02Labeling Revision
018701041AP1998/06/23Package Change
018701040AP1997/09/11Manufacturing Change or Addition
018701039AP1996/05/10Manufacturing Change or Addition
018701038AP1994/09/07Manufacturing Change or Addition
018701037AP1995/05/22Manufacturing Change or Addition
018701036AP1993/04/27Labeling Revision
018701035AP1994/06/29Control Supplement
018701034AP1993/04/21Labeling Revision
018701033AP1990/12/21Manufacturing Change or Addition
018701032AP1989/10/31Labeling Revision
018701031AP1989/05/10Manufacturing Change or Addition
018701030AP1989/02/16Package Change
018701029AP1997/01/31Labeling Revision
018701028AP1997/01/31Manufacturing Change or Addition
018701027AP1989/01/19Labeling Revision
018701025AP1988/10/20Labeling Revision
018701024AP1988/10/20Manufacturing Change or Addition
018701023AP1989/01/18Control Supplement
018701022AP1989/01/18Control Supplement
018701021AP1988/06/17Manufacturing Change or Addition
018701019AP1987/09/28Labeling Revision
018701018AP1988/08/24Manufacturing Change or Addition
018701015AP1988/08/24Manufacturing Change or Addition
018701012AP1986/11/18Labeling Revision
018701011AP1987/01/28Labeling Revision
018701010AP1987/01/28Manufacturing Change or Addition
018701009AP1987/01/28Labeling Revision
018701008AP1987/01/28Manufacturing Change or Addition
018701007AP1986/10/28Labeling Revision
018701006AP1987/06/15Labeling Revision
018701005AP1987/06/15Manufacturing Change or Addition
018701004AP1987/06/15Manufacturing Change or Addition
018701003AP1987/02/24Labeling Revision
018701002AP1986/06/10Control Supplement
018701000AP1986/01/14Approval