美国FDA药品数据库-药物在线

商品名	申请号	产品号	申请类型	活性成分	剂型/给药途径	规格/剂量	RLD	RS	申请号原始批准/暂定批准日期	产品号批准日期	申请人	市场状态
MONISTAT-DERM	017739	001	NDA	MICONAZOLE NITRATE	LOTION;TOPICAL	2%	No	No	--	Approved Prior to Jan 1, 1982	INSIGHT PHARMS	Discontinued
MONISTAT-DERM	017494	001	NDA	MICONAZOLE NITRATE	CREAM;TOPICAL	2%	No	No	1974/01/08	Approved Prior to Jan 1, 1982	INSIGHT PHARMS	Discontinued
MONISTAT 7	017450	002	NDA	MICONAZOLE NITRATE	CREAM;VAGINAL	2%	Yes	Yes	1974/01/30	1991/02/15	MEDTECH PRODUCTS	Over-the-counter
MONISTAT	018040	001	NDA	MICONAZOLE	INJECTABLE;INJECTION	10MG/ML	No	No	1978/10/04	Approved Prior to Jan 1, 1982	JANSSEN PHARMA	Discontinued
MONISTAT 7	018520	002	NDA	MICONAZOLE NITRATE	SUPPOSITORY;VAGINAL	100MG	Yes	Yes	1982/03/15	1991/02/15	MEDTECH PRODUCTS	Over-the-counter
MONISTAT 3	018888	001	NDA	MICONAZOLE NITRATE	SUPPOSITORY;VAGINAL	200MG	Yes	Yes	1984/08/15	1984/08/15	MEDTECH PRODUCTS	Prescription
MONISTAT 5	018592	001	NDA	MICONAZOLE NITRATE	TAMPON;VAGINAL	100MG	No	No	1989/10/27	1989/10/27	PERSONAL PRODS	Discontinued
MONISTAT 7 COMBINATION PACK	020288	002	NDA	MICONAZOLE NITRATE	CREAM, SUPPOSITORY;TOPICAL, VAGINAL	2%,100MG	Yes	Yes	1993/04/26	1993/04/26	MEDTECH PRODUCTS	Over-the-counter
MONISTAT 3 COMBINATION PACK	020670	002	NDA	MICONAZOLE NITRATE	CREAM, SUPPOSITORY;TOPICAL, VAGINAL	2%,200MG	Yes	Yes	1996/04/16	1996/04/16	MEDTECH PRODUCTS	Over-the-counter
MONISTAT 3	020827	001	NDA	MICONAZOLE NITRATE	CREAM;VAGINAL	4%	Yes	Yes	1998/03/30	1998/03/30	MEDTECH PRODUCTS	Over-the-counter
MONISTAT DUAL- PAK	020968	001	NDA	MICONAZOLE NITRATE	CREAM, SUPPOSITORY;TOPICAL, VAGINAL	1.2GM;2%	No	No	1999/06/30	--	PERSONAL PRODS	Discontinued
MONISTAT 3 COMBINATION PACK (PREFILLED)	021261	001	NDA	MICONAZOLE NITRATE	CREAM;TOPICAL, VAGINAL	2%,4%	Yes	Yes	2001/02/02	2001/02/02	MEDTECH PRODUCTS	Over-the-counter
MONISTAT 3 COMBINATION PACK	021261	003	NDA	MICONAZOLE NITRATE	CREAM;TOPICAL, VAGINAL	2%,4%	Yes	No	2001/02/02	2003/06/17	MEDTECH PRODUCTS	Over-the-counter
MONISTAT 1 COMBINATION PACK	021308	001	NDA	MICONAZOLE NITRATE	CREAM, INSERT;TOPICAL, VAGINAL	2%,1.2GM	Yes	Yes	2001/06/29	2001/06/29	MEDTECH PRODUCTS	Over-the-counter