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
FAZACLO ODT	021590	001	NDA	CLOZAPINE	TABLET, ORALLY DISINTEGRATING;ORAL	25MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	Yes	No	2004/02/10	2004/02/10	JAZZ	Discontinued
FAZACLO ODT	021590	002	NDA	CLOZAPINE	TABLET, ORALLY DISINTEGRATING;ORAL	100MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	Yes	No	2004/02/10	2004/02/10	JAZZ	Discontinued
FAZACLO ODT	021590	003	NDA	CLOZAPINE	TABLET, ORALLY DISINTEGRATING;ORAL	50MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	No	No	2004/02/10	2005/06/03	JAZZ	Discontinued
FAZACLO ODT	021590	004	NDA	CLOZAPINE	TABLET, ORALLY DISINTEGRATING;ORAL	12.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	Yes	No	2004/02/10	2007/05/30	JAZZ	Discontinued
FAZACLO ODT	021590	005	NDA	CLOZAPINE	TABLET, ORALLY DISINTEGRATING;ORAL	150MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	Yes	No	2004/02/10	2010/07/09	JAZZ	Discontinued
FAZACLO ODT	021590	006	NDA	CLOZAPINE	TABLET, ORALLY DISINTEGRATING;ORAL	200MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	Yes	No	2004/02/10	2010/07/09	JAZZ	Discontinued