MONISTAT 7(MICONAZOLE NITRATE) - 美国FDA药品数据库

药品名称	MONISTAT 7
申请号	017450	产品号	002
活性成分	MICONAZOLE NITRATE	市场状态	非处方药
剂型或给药途径	CREAM;VAGINAL	规格	2%
治疗等效代码		参比药物	是
批准日期	1991/02/15	申请机构	MEDTECH PRODUCTS INC
化学类型	New molecular entity (NME)	审评分类	Priority 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
017450	055	AP	Letter	2008/08/22	下载
017450	052	AP	Letter	2002/08/07	下载
017450	052	AP	Label	2002/08/07	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
017450	068	AP	2015/08/10	Manufacturing Change or Addition
017450	067	AP	2014/03/10	Manufacturing Change or Addition
017450	066	AP	2014/02/27	Manufacturing Change or Addition
017450	064	AP	2013/08/13	Manufacturing Change or Addition
017450	063	AP	2013/07/10	Manufacturing Change or Addition
017450	062	AP	2013/01/29	Manufacturing Change or Addition
017450	055	AP	2008/08/21	Manufacturing Change or Addition
017450	052	AP	2002/08/07	Package Change
017450	051	AP	2002/10/28	Control Supplement
017450	050	AP	2002/04/10	Package Change
017450	049	AP	2001/05/16	Manufacturing Change or Addition
017450	047	AP	1999/10/04	Manufacturing Change or Addition
017450	046	AP	1999/02/04	Package Change
017450	045	AP	1999/02/03	Package Change
017450	044	AP	1998/03/17	Manufacturing Change or Addition
017450	043	AP	1997/03/21	Formulation Revision
017450	042	AP	1995/03/06	Package Change
017450	041	AP	1993/09/03	Package Change
017450	040	AP	1995/02/09	Labeling Revision
017450	039	AP	1992/10/08	Labeling Revision
017450	038	AP	1993/04/26	New or Modified Indication
017450	037	AP	1992/06/03	Labeling Revision
017450	035	AP	1991/02/15	OTC Labeling
017450	034	AP	1990/03/09	Control Supplement
017450	032	AP	1986/08/26	Manufacturing Change or Addition
017450	031	AP	1986/07/22	Package Change
017450	030	AP	1986/07/22	Manufacturing Change or Addition
017450	029	AP	1985/07/05	Package Change
017450	028	AP	1985/06/27	Manufacturing Change or Addition
017450	027	AP	1984/06/12	Control Supplement
017450	026	AP	1984/05/29	Manufacturing Change or Addition
017450	025	AP	1983/06/02	Manufacturing Change or Addition
017450	024	AP	1982/09/17	Labeling Revision
017450	023	AP	1982/05/13	Manufacturing Change or Addition
017450	022	AP	1982/09/15	Labeling Revision
017450	021	AP	1982/04/19	Manufacturing Change or Addition
017450	020	AP	1982/09/17	Labeling Revision
017450	016	AP	1980/04/03	Manufacturing Change or Addition
017450	015	AP	1979/06/29	Manufacturing Change or Addition
017450	014	AP	1979/06/14	Manufacturing Change or Addition
017450	013	AP	1979/06/14	Manufacturing Change or Addition
017450	012	AP	1979/09/13	Manufacturing Change or Addition
017450	011	AP	1978/09/12	Labeling Revision
017450	010	AP	1979/03/23	Manufacturing Change or Addition
017450	009	AP	1978/04/25	Manufacturing Change or Addition
017450	007	AP	1977/12/22	Manufacturing Change or Addition
017450	006	AP	1977/08/02	Manufacturing Change or Addition
017450	005	AP	1977/08/02	Package Change
017450	003	AP	1977/07/28	Control Supplement
017450	002	AP	1976/04/21	Formulation Revision
017450	000	AP	1974/01/30	Approval

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