PLATINOL(CISPLATIN) - 美国FDA药品数据库

药品名称	PLATINOL
申请号	018057	产品号	002
活性成分	CISPLATIN	市场状态	停止上市
剂型或给药途径	INJECTABLE;INJECTION	规格	50MG/VIAL
治疗等效代码		参比药物	否
批准日期	Approved Prior to Jan 1, 1982	申请机构	HQ SPECIALTY PHARMA CORP
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
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
018057	083	AP	Letter	2015/02/27	下载
018057	083	AP	Label	2015/03/02	下载
018057	081	AP	Letter	2012/01/03	下载
018057	081	AP	Label	2012/01/11	下载
018057	080	AP	Label	2011/08/30	下载
018057	080	AP	Letter	2011/08/31	下载
018057	079	AP	Letter	2010/09/07	下载
018057	079	AP	Label	2010/09/07	下载
018057	076	AP	Letter	2002/11/08	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
018057	085	AP	2015/10/06	Manufacturing Change or Addition
018057	084	AP	2015/03/03	Manufacturing Change or Addition
018057	083	AP	2015/02/26	Labeling Revision
018057	082	AP	2014/02/06	Manufacturing Change or Addition
018057	081	AP	2011/12/29	Labeling Revision
018057	080	AP	2011/08/26	Labeling Revision
018057	079	AP	2010/09/02	Labeling Revision
018057	076	AP	2002/11/08	Labeling Revision
018057	075	AP	2001/01/16	Manufacturing Change or Addition
018057	074	AP	2000/09/13	Package Change
018057	072	AP	1999/05/05	Labeling Revision
018057	066	AP	1996/04/18	Manufacturing Change or Addition
018057	065	AP	1995/08/09	Labeling Revision
018057	064	AP	1995/12/04	Manufacturing Change or Addition
018057	063	AP	1995/12/13	Manufacturing Change or Addition
018057	062	AP	1993/05/17	Labeling Revision
018057	061	AP	1993/04/22	New Dosage Regimen
018057	060	AP	1993/03/25	Labeling Revision
018057	059	AP	1991/11/01	Package Change
018057	058	AP	1990/05/29	Control Supplement
018057	057	AP	1991/07/11	Control Supplement
018057	056	AP	1992/07/27	Labeling Revision
018057	055	AP	1990/09/27	Control Supplement
018057	053	AP	1991/11/27	Control Supplement
018057	052	AP	1990/04/04	Manufacturing Change or Addition
018057	051	AP	1990/12/11	Labeling Revision
018057	050	AP	1988/01/12	Control Supplement
018057	049	AP	1989/03/02	Labeling Revision
018057	047	AP	1988/11/08	Control Supplement
018057	046	AP	1987/04/10	Labeling Revision
018057	045	AP	1988/01/13	Manufacturing Change or Addition
018057	044	AP	1988/05/05	Manufacturing Change or Addition
018057	043	AP	1987/03/23	Labeling Revision
018057	042	AP	1986/11/06	Labeling Revision
018057	041	AP	1986/08/19	Labeling Revision
018057	040	AP	1987/06/08	Manufacturing Change or Addition
018057	039	AP	1986/08/26	Labeling Revision
018057	038	AP	1986/01/22	Labeling Revision
018057	035	AP	1987/03/05	Package Change
018057	033	AP	1985/09/16	Manufacturing Change or Addition
018057	032	AP	1985/07/03	Labeling Revision
018057	029	AP	1985/03/05	Control Supplement
018057	028	AP	1985/03/05	Control Supplement
018057	027	AP	1988/02/11	Expiration Date Change
018057	026	AP	1983/10/31	Labeling Revision
018057	024	AP	1984/04/04	Control Supplement
018057	023	AP	1984/07/18	Control Supplement
018057	022	AP	1985/08/23	Labeling Revision
018057	021	AP	1986/05/02	Control Supplement
018057	020	AP	1984/02/27	Labeling Revision
018057	019	AP	1983/01/13	Control Supplement
018057	017	AP	1982/06/10	Manufacturing Change or Addition
018057	012	AP	1981/12/29	General Efficacy (MarkIV)
018057	011	AP	1981/03/12	Labeling Revision
018057	010	AP	1980/07/04	Package Change
018057	009	AP	1980/09/16	Labeling Revision
018057	007	AP	1981/01/22	Expiration Date Change
018057	006	AP	1980/02/26	Labeling Revision
018057	005	AP	1980/01/31	Labeling Revision
018057	004	AP	1980/01/31	Manufacturing Change or Addition
018057	003	AP	1979/12/05	Manufacturing Change or Addition
018057	002	AP	1979/12/18	Labeling Revision
018057	001	AP	1979/09/11	Manufacturing Change or Addition
018057	000	AP	1978/12/19	Approval

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