HEPARIN SODIUM PRESERVATIVE FREE(HEPARIN SODIUM)

药品名称	HEPARIN SODIUM PRESERVATIVE FREE
申请号	017029	产品号	019
活性成分	HEPARIN SODIUM	市场状态	处方药
剂型或给药途径	INJECTABLE;INJECTION	规格	10,000 UNITS/ML
治疗等效代码		参比药物	是
批准日期	2010/11/22	申请机构	FRESENIUS KABI USA LLC
化学类型	New formulation or new manufacturer	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
017029	135	AP	Letter	2014/04/07	下载
017029	131	AP	Label	2011/12/23	下载
017029	131	AP	Letter	2011/12/29	下载
017029	128	AP	Letter	2011/07/05	下载
017029	120	AP	Letter	2010/06/14	下载
017029	120	AP	Label	2010/06/24	下载
017029	108	AP	Letter	2008/09/26	下载
017029	108	AP	Label	2008/10/03	下载
017029	099	AP	Letter	2002/03/22	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
017029	139	AP	2016/06/09	Manufacturing Change or Addition
017029	137	AP	2015/07/21	Manufacturing Change or Addition
017029	136	AP	2013/09/24	Manufacturing Change or Addition
017029	135	AP	2014/03/21	Labeling Revision
017029	134	AP	2015/03/09	Manufacturing Change or Addition
017029	131	AP	2011/12/23	Labeling Revision
017029	129	AP	2015/12/23	Manufacturing Change or Addition
017029	128	AP	2011/06/24	Labeling Revision
017029	120	AP	2010/06/11	Labeling Revision
017029	108	AP	2008/09/23	Labeling Revision
017029	099	AP	2002/03/22	Labeling Revision
017029	098	AP	1999/12/13	Manufacturing Change or Addition
017029	097	AP	2000/03/08	Package Change
017029	096	AP	1997/11/04	Control Supplement
017029	095	AP	1997/06/24	Control Supplement
017029	094	AP	1998/08/06	Manufacturing Change or Addition
017029	084	AP	1995/05/17	Manufacturing Change or Addition
017029	078	AP	1994/10/27	Manufacturing Change or Addition
017029	073	AP	1996/07/26	Control Supplement
017029	069	AP	1993/08/25	Labeling Revision
017029	063	AP	1998/08/06	Manufacturing Change or Addition
017029	062	AP	1998/08/06	Manufacturing Change or Addition
017029	061	AP	1989/06/08	Package Change
017029	060	AP	1988/09/22	Labeling Revision
017029	058	AP	1988/02/16	Control Supplement
017029	057	AP	1989/12/01	Package Change
017029	056	AP	1992/06/26	Labeling Revision
017029	054	AP	1986/04/28	Control Supplement
017029	053	AP	1986/04/07	Labeling Revision
017029	051	AP	1987/09/22	Package Change
017029	050	AP	1987/09/22	Package Change
017029	049	AP	1985/07/29	General Efficacy (MarkIV)
017029	048	AP	1984/11/06	Package Change
017029	047	AP	1985/12/05	Package Change
017029	046	AP	1985/12/05	Package Change
017029	045	AP	1985/12/05	Package Change
017029	044	AP	1985/12/05	Package Change
017029	043	AP	1985/12/05	Package Change
017029	042	AP	1985/12/05	Package Change
017029	041	AP	1983/11/02	Formulation Revision
017029	040	AP	1983/11/02	Formulation Revision
017029	039	AP	1983/11/02	Formulation Revision
017029	038	AP	1983/11/02	Formulation Revision
017029	037	AP	1985/05/16	Formulation Revision
017029	036	AP	1983/11/02	Formulation Revision
017029	034	AP	1983/11/02	Expiration Date Change
017029	033	AP	1983/01/04	Expiration Date Change
017029	032	AP	1982/09/21	Manufacturing Change or Addition
017029	031	AP	1982/09/21	Manufacturing Change or Addition
017029	030	AP	1982/05/06	Labeling Revision
017029	029	AP	1982/09/17	Control Supplement
017029	027	AP	1981/02/24	Labeling Revision
017029	026	AP	1981/03/24	Manufacturing Change or Addition
017029	025	AP	1979/10/31	Control Supplement
017029	024	AP	1979/10/31	Manufacturing Change or Addition
017029	023	AP	1978/11/21	Control Supplement
017029	022	AP	1978/11/21	Control Supplement
017029	021	AP	1978/05/23	Labeling Revision
017029	020	AP	1977/12/14	Control Supplement
017029	019	AP	1976/12/03	Control Supplement
017029	017	AP	1976/12/03	Formulation Revision
017029	016	AP	1977/01/26	Formulation Revision
017029	015	AP	1977/12/04	Labeling Revision
017029	014	AP	1976/06/16	Manufacturing Change or Addition
017029	012	AP	1976/02/09	Labeling Revision
017029	011	AP	1976/01/09	Control Supplement
017029	010	AP	1976/01/09	Formulation Revision
017029	009	AP	1976/03/17	Control Supplement
017029	008	AP	1976/02/09	Control Supplement
017029	007	AP	1975/08/29	Control Supplement
017029	000	AP	1972/02/22	Approval

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