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
FOCALIN XR	021802	001	NDA	DEXMETHYLPHENIDATE HYDROCHLORIDE	CAPSULE, EXTENDED RELEASE;ORAL	5MG	Yes	No	2005/05/26	2005/05/26	SANDOZ	Prescription
FOCALIN XR	021802	002	NDA	DEXMETHYLPHENIDATE HYDROCHLORIDE	CAPSULE, EXTENDED RELEASE;ORAL	10MG	Yes	No	2005/05/26	2005/05/26	SANDOZ	Prescription
FOCALIN XR	021802	003	NDA	DEXMETHYLPHENIDATE HYDROCHLORIDE	CAPSULE, EXTENDED RELEASE;ORAL	20MG	Yes	No	2005/05/26	2005/05/26	SANDOZ	Prescription
FOCALIN XR	021802	004	NDA	DEXMETHYLPHENIDATE HYDROCHLORIDE	CAPSULE, EXTENDED RELEASE;ORAL	15MG	Yes	No	2005/05/26	2006/08/01	SANDOZ	Prescription
FOCALIN XR	021802	005	NDA	DEXMETHYLPHENIDATE HYDROCHLORIDE	CAPSULE, EXTENDED RELEASE;ORAL	30MG	Yes	No	2005/05/26	2009/10/23	SANDOZ	Prescription
FOCALIN XR	021802	006	NDA	DEXMETHYLPHENIDATE HYDROCHLORIDE	CAPSULE, EXTENDED RELEASE;ORAL	40MG	Yes	Yes	2005/05/26	2010/08/11	SANDOZ	Prescription
FOCALIN XR	021802	007	NDA	DEXMETHYLPHENIDATE HYDROCHLORIDE	CAPSULE, EXTENDED RELEASE;ORAL	35MG	Yes	No	2005/05/26	2011/04/21	SANDOZ	Prescription
FOCALIN XR	021802	008	NDA	DEXMETHYLPHENIDATE HYDROCHLORIDE	CAPSULE, EXTENDED RELEASE;ORAL	25MG	Yes	No	2005/05/26	2011/04/21	SANDOZ	Prescription