HEPARIN SODIUM(HEPARIN SODIUM) - 美国FDA药品数据库

药品名称	HEPARIN SODIUM
申请号	017037	产品号	001
活性成分	HEPARIN SODIUM	市场状态	处方药
剂型或给药途径	INJECTABLE;INJECTION	规格	1,000 UNITS/ML
治疗等效代码	AP	参比药物	是
批准日期	Approved Prior to Jan 1, 1982	申请机构	WEST-WARD PHARMACEUTICALS INTERNATIONAL LTD
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
017037	169	AP	Letter	2011/12/29	下载
017037	169	AP	Label	2012/01/26	下载
017037	168	AP	Letter	2011/02/28	下载
017037	168	AP	Label	2011/03/04	下载
017037	165	AP	Label	2009/10/16	下载
017037	165	AP	Letter	2009/11/09	下载
017037	162	AP	Letter	2009/02/19	下载
017037	161	AP	Label	2007/12/21	下载
017037	161	AP	Letter	2008/01/09	下载
017037	158	AP	Label	2006/10/05	下载
017037	158	AP	Letter	2006/10/13	下载
017037	156	AP	Label	2005/09/07	下载
017037	156	AP	Letter	2005/09/07	下载
017037	155	AP	Label	2005/09/07	下载
017037	155	AP	Letter	2005/09/07	下载
017037	154	AP	Label	2005/09/07	下载
017037	154	AP	Letter	2005/09/07	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
017037	176	AP	2015/10/30	Manufacturing Change or Addition
017037	175	AP	2015/12/23	Manufacturing Change or Addition
017037	174	AP	2015/12/02	Manufacturing Change or Addition
017037	173	AP	2015/01/05	Manufacturing Change or Addition
017037	172	AP	2014/01/15	Manufacturing Change or Addition
017037	171	AP	2014/01/09	Manufacturing Change or Addition
017037	170	AP	2013/08/27	Manufacturing Change or Addition
017037	169	AP	2011/12/23	Labeling Revision
017037	168	AP	2011/02/23	Labeling Revision
017037	165	AP	2009/10/01	Labeling Revision
017037	162	AP	2009/02/17	Labeling Revision
017037	161	AP	2007/12/14	Labeling Revision
017037	158	AP	2006/10/04	Labeling Revision
017037	156	AP	2005/09/02	Package Change
017037	155	AP	2005/09/02	Formulation Revision
017037	154	AP	2005/09/02	Control Supplement
017037	151	AP	2002/11/22	Expiration Date Change
017037	150	AP	2002/11/25	Expiration Date Change
017037	149	AP	2002/11/21	Package Change
017037	148	AP	2002/11/22	Package Change
017037	147	AP	2002/07/15	Expiration Date Change
017037	146	AP	2002/02/05	Labeling Revision
017037	145	AP	2001/08/31	Control Supplement
017037	144	AP	2000/11/16	Package Change
017037	143	AP	2000/05/31	Control Supplement
017037	142	AP	2000/05/26	Control Supplement
017037	141	AP	2000/05/26	Control Supplement
017037	140	AP	2000/05/01	Control Supplement
017037	139	AP	2000/02/15	Control Supplement
017037	138	AP	1999/05/13	Control Supplement
017037	136	AP	1999/09/30	Labeling Revision
017037	134	AP	1998/02/20	Control Supplement
017037	133	AP	1998/06/23	Labeling Revision
017037	132	AP	1997/04/24	Manufacturing Change or Addition
017037	131	AP	1996/03/05	Control Supplement
017037	130	AP	1993/02/09	Control Supplement
017037	128	AP	1991/04/23	Labeling Revision
017037	127	AP	1989/09/27	Expiration Date Change
017037	126	AP	1989/06/20	Labeling Revision
017037	125	AP	1989/06/20	Labeling Revision
017037	124	AP	1989/06/28	Labeling Revision
017037	123	AP	1987/10/14	Labeling Revision
017037	122	AP	1987/09/16	Labeling Revision
017037	121	AP	1987/07/02	Labeling Revision
017037	120	AP	1987/07/02	Labeling Revision
017037	119	AP	1987/04/24	Control Supplement
017037	118	AP	1987/03/10	Manufacturing Change or Addition
017037	117	AP	1987/04/29	Expiration Date Change
017037	116	AP	1986/09/23	Manufacturing Change or Addition
017037	115	AP	1987/04/29	Labeling Revision
017037	114	AP	1986/01/30	Labeling Revision
017037	113	AP	1985/10/10	Manufacturing Change or Addition
017037	112	AP	1986/04/07	Package Change
017037	111	AP	1985/08/29	Package Change
017037	110	AP	1985/08/29	Package Change
017037	109	AP	1985/05/13	Labeling Revision
017037	108	AP	1986/01/21	Formulation Revision
017037	107	AP	1984/10/11	Labeling Revision
017037	105	AP	1984/10/11	Labeling Revision
017037	104	AP	1984/08/02	Formulation Revision
017037	102	AP	1983/12/21	Labeling Revision
017037	101	AP	1983/09/05	Labeling Revision
017037	100	AP	1983/06/10	Control Supplement
017037	099	AP	1983/09/13	Control Supplement
017037	098	AP	1982/10/06	Manufacturing Change or Addition
017037	097	AP	1982/08/18	Package Change
017037	096	AP	1982/06/04	Manufacturing Change or Addition
017037	095	AP	1981/11/20	Labeling Revision
017037	094	AP	1981/05/22	Labeling Revision
017037	093	AP	1980/01/21	Control Supplement
017037	092	AP	1979/09/25	Formulation Revision
017037	091	AP	1979/03/06	Control Supplement
017037	090	AP	1979/01/16	Control Supplement
017037	089	AP	1979/01/16	Control Supplement
017037	088	AP	1979/01/16	Labeling Revision
017037	087	AP	1978/10/04	Labeling Revision
017037	086	AP	1978/08/04	Control Supplement
017037	085	AP	1978/07/31	Labeling Revision
017037	084	AP	1978/08/04	Manufacturing Change or Addition
017037	083	AP	1978/07/31	Manufacturing Change or Addition
017037	082	AP	1978/07/31	Labeling Revision
017037	081	AP	1977/12/14	Labeling Revision
017037	080	AP	1977/12/14	Manufacturing Change or Addition
017037	079	AP	1977/12/14	Labeling Revision
017037	078	AP	1978/04/27	Control Supplement
017037	077	AP	1978/04/27	Labeling Revision
017037	075	AP	1977/12/14	Labeling Revision
017037	074	AP	1977/12/14	Formulation Revision
017037	073	AP	1978/01/03	Manufacturing Change or Addition
017037	072	AP	1977/08/02	Distributor
017037	071	AP	1977/05/26	Control Supplement
017037	070	AP	1977/04/26	Package Change
017037	069	AP	1977/05/26	Package Change
017037	067	AP	1977/02/17	Control Supplement
017037	066	AP	1976/10/19	Distributor
017037	065	AP	1976/10/19	Labeling Revision
017037	063	AP	1976/09/08	Control Supplement
017037	059	AP	1976/09/08	Control Supplement
017037	058	AP	1976/09/08	Control Supplement
017037	057	AP	1976/09/08	Control Supplement
017037	055	AP	1976/05/28	Control Supplement
017037	048	AP	1976/01/09	Control Supplement
017037	047	AP	1975/09/04	Labeling Revision
017037	046	AP	1975/09/04	Labeling Revision
017037	045	AP	1975/09/04	Distributor
017037	044	AP	1975/09/04	Labeling Revision
017037	043	AP	1975/09/04	Labeling Revision
017037	042	AP	1975/09/04	Labeling Revision
017037	039	AP	1975/04/23	Control Supplement
017037	038	AP	1975/03/24	Labeling Revision
017037	013	AP	1984/03/05	Labeling Revision
017037	000	AP	1972/03/22	Approval

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