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

药品名称	MONISTAT-DERM
申请号	017494	产品号	001
活性成分	MICONAZOLE NITRATE	市场状态	停止上市
剂型或给药途径	CREAM;TOPICAL	规格	2%
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	INSIGHT PHARMACEUTICALS CORP
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

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
017494	065	AP	2014/02/11	Manufacturing Change or Addition
017494	040	AP	2014/02/11	Manufacturing Change or Addition
017494	039	AP	2014/01/27	Manufacturing Change or Addition
017494	037	AP	2014/01/02	Manufacturing Change or Addition
017494	032	AP	2001/03/20	Package Change
017494	031	AP	2001/06/22	Control Supplement
017494	030	AP	1999/12/21	Manufacturing Change or Addition
017494	029	AP	1998/11/12	Package Change
017494	026	AP	1990/03/09	Control Supplement
017494	024	AP	1988/10/17	Labeling Revision
017494	023	AP	1986/09/17	Manufacturing Change or Addition
017494	022	AP	1986/04/25	Labeling Revision
017494	021	AP	1985/06/24	Control Supplement
017494	020	AP	1985/07/05	Package Change
017494	019	AP	1984/05/29	Manufacturing Change or Addition
017494	018	AP	1983/06/02	Manufacturing Change or Addition
017494	017	AP	1982/05/13	Manufacturing Change or Addition
017494	016	AP	1982/04/19	Manufacturing Change or Addition
017494	014	AP	1981/03/13	Labeling Revision
017494	013	AP	1980/04/28	Distributor
017494	009	AP	1976/12/16	Distributor
017494	008	AP	1977/04/21	Manufacturing Change or Addition
017494	005	AP	1975/12/30	Control Supplement
017494	000	AP	1974/01/08	Approval