PARAGARD T 380A(COPPER) - 美国FDA药品数据库

药品名称	PARAGARD T 380A
申请号	018680	产品号	001
活性成分	COPPER	市场状态	处方药
剂型或给药途径	INTRAUTERINE DEVICE;INTRAUTERINE	规格	309MG/COPPER
治疗等效代码		参比药物	是
批准日期	1984/11/15	申请机构	TEVA WOMENS HEALTH INC
化学类型	New dosage form	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
018680	066	AP	Letter	2013/06/13	下载
018680	066	AP	Label	2013/06/18	下载
018680	060	AP	Label	2005/09/08	下载
018680	060	AP	Letter	2005/09/08	下载
018680	057	AP	Letter	2003/05/29	下载
018680	055	AP	Label	2003/04/30	下载
018680	000	AP	Review	2011/02/15	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
018680	068	AP	2014/02/20	Manufacturing Change or Addition
018680	066	AP	2013/06/11	Labeling Revision
018680	060	AP	2005/09/01	Efficacy Supplement with Clinical Data to Support
018680	057	AP	2003/04/22	Labeling Revision
018680	056	AP	2001/09/27	Manufacturing Change or Addition
018680	055	AP	2001/08/24	Labeling Revision
018680	054	AP	2000/09/20	Manufacturing Change or Addition
018680	053	AP	2000/04/25	Control Supplement
018680	052	AP	2000/03/27	Manufacturing Change or Addition
018680	051	AP	1999/12/14	Control Supplement
018680	050	AP	1999/07/23	Manufacturing Change or Addition
018680	049	AP	1999/07/23	Manufacturing Change or Addition
018680	048	AP	1999/02/02	Control Supplement
018680	047	AP	1999/02/02	Control Supplement
018680	046	AP	1998/05/29	Manufacturing Change or Addition
018680	045	AP	1998/05/29	Control Supplement
018680	044	AP	1998/07/07	Control Supplement
018680	043	AP	1998/07/07	Control Supplement
018680	042	AP	1998/02/10	Control Supplement
018680	041	AP	1997/11/03	Control Supplement
018680	040	AP	1997/10/09	Control Supplement
018680	039	AP	1997/06/04	Control Supplement
018680	038	AP	1997/03/13	Control Supplement
018680	037	AP	1997/02/14	Control Supplement
018680	036	AP	1996/05/17	Control Supplement
018680	035	AP	1996/04/12	Control Supplement
018680	034	AP	1996/04/12	Control Supplement
018680	033	AP	1996/01/18	Package Change
018680	032	AP	1996/01/24	Control Supplement
018680	030	AP	1995/07/24	Manufacturing Change or Addition
018680	026	AP	1994/05/19	New Dosage Regimen
018680	025	AP	1993/06/17	Expiration Date Change
018680	023	AP	1991/11/25	Labeling Revision
018680	021	AP	1991/11/20	Labeling Revision
018680	020	AP	1991/11/25	Package Change
018680	019	AP	1991/11/25	Control Supplement
018680	017	AP	1991/07/17	Manufacturing Change or Addition
018680	016	AP	1991/08/13	New Dosage Regimen
018680	015	AP	1991/05/03	Labeling Revision
018680	014	AP	1991/11/25	Control Supplement
018680	013	AP	1991/03/22	Control Supplement
018680	012	AP	1990/09/24	Labeling Revision
018680	011	AP	1989/07/24	Labeling Revision
018680	010	AP	1989/07/24	Labeling Revision
018680	009	AP	1989/03/01	Labeling Revision
018680	008	AP	1989/07/17	New Dosage Regimen
018680	006	AP	1988/10/17	Labeling Revision
018680	005	AP	1988/11/18	Control Supplement
018680	003	AP	1988/04/29	Labeling Revision
018680	000	AP	1984/11/15	Approval

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