HALDOL(HALOPERIDOL DECANOATE) - 美国FDA药品数据库

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	是
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
无
历史专利信息
无

与本品相关的市场独占权保护信息
独占权代码	失效日期
无
历史市场独占权保护信息
无

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
018701	072	AP	Letter	2016/05/20	下载
018701	072	AP	Label	2016/05/20	下载
018701	065	AP	Letter	2013/05/07	下载
018701	063	AP	Label	2011/03/04	下载
018701	063	AP	Letter	2011/03/07	下载
018701	062	AP	Label	2010/12/04	下载
018701	062	AP	Letter	2010/12/06	下载
018701	059	AP	Label	2009/07/23	下载
018701	059	AP	Letter	2009/08/04	下载
018701	057	AP	Letter	2008/08/19	下载
018701	057	AP	Label	2008/08/29	下载
018701	056	AP	Letter	2008/05/14	下载
018701	056	AP	Label	2008/06/05	下载
018701	055	AP	Letter	2007/09/25	下载
018701	054	AP	Letter	2011/08/15	下载
018701	054	AP	Label	2011/08/16	下载
018701	053	AP	Label	2007/05/07	下载
018701	053	AP	Letter	2007/05/09	下载
018701	046	AP	Review	2007/07/06	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
018701	072	AP	2016/05/18	Labeling Revision
018701	069	AP	2013/12/19	Manufacturing Change or Addition
018701	068	AP	2013/06/05	Manufacturing Change or Addition
018701	067	AP	2013/05/24	Manufacturing Change or Addition
018701	065	AP	2013/05/06	Labeling Revision
018701	063	AP	2011/03/01	Labeling Revision
018701	062	AP	2010/12/01	Labeling Revision
018701	059	AP	2009/07/19	Labeling Revision
018701	057	AP	2008/08/14	Labeling Revision
018701	056	AP	2008/05/13	Labeling Revision
018701	055	AP	2007/09/19	Labeling Revision
018701	054	AP	2011/08/12	Labeling Revision
018701	053	AP	2007/05/04	Labeling Revision
018701	046	AP	2002/04/17	Labeling Revision
018701	045	AP	2000/04/13	Manufacturing Change or Addition
018701	043	AP	2000/05/02	Labeling Revision
018701	041	AP	1998/06/23	Package Change
018701	040	AP	1997/09/11	Manufacturing Change or Addition
018701	039	AP	1996/05/10	Manufacturing Change or Addition
018701	038	AP	1994/09/07	Manufacturing Change or Addition
018701	037	AP	1995/05/22	Manufacturing Change or Addition
018701	036	AP	1993/04/27	Labeling Revision
018701	035	AP	1994/06/29	Control Supplement
018701	034	AP	1993/04/21	Labeling Revision
018701	033	AP	1990/12/21	Manufacturing Change or Addition
018701	032	AP	1989/10/31	Labeling Revision
018701	031	AP	1989/05/10	Manufacturing Change or Addition
018701	030	AP	1989/02/16	Package Change
018701	029	AP	1997/01/31	Labeling Revision
018701	028	AP	1997/01/31	Manufacturing Change or Addition
018701	027	AP	1989/01/19	Labeling Revision
018701	025	AP	1988/10/20	Labeling Revision
018701	024	AP	1988/10/20	Manufacturing Change or Addition
018701	023	AP	1989/01/18	Control Supplement
018701	022	AP	1989/01/18	Control Supplement
018701	021	AP	1988/06/17	Manufacturing Change or Addition
018701	019	AP	1987/09/28	Labeling Revision
018701	018	AP	1988/08/24	Manufacturing Change or Addition
018701	015	AP	1988/08/24	Manufacturing Change or Addition
018701	012	AP	1986/11/18	Labeling Revision
018701	011	AP	1987/01/28	Labeling Revision
018701	010	AP	1987/01/28	Manufacturing Change or Addition
018701	009	AP	1987/01/28	Labeling Revision
018701	008	AP	1987/01/28	Manufacturing Change or Addition
018701	007	AP	1986/10/28	Labeling Revision
018701	006	AP	1987/06/15	Labeling Revision
018701	005	AP	1987/06/15	Manufacturing Change or Addition
018701	004	AP	1987/06/15	Manufacturing Change or Addition
018701	003	AP	1987/02/24	Labeling Revision
018701	002	AP	1986/06/10	Control Supplement
018701	000	AP	1986/01/14	Approval

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