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
RAZADYNE	021169	001	NDA	GALANTAMINE HYDROBROMIDE	TABLET;ORAL	EQ 4MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	Yes	No	2001/02/28	2001/02/28	JANSSEN PHARMS	Discontinued
RAZADYNE	021169	002	NDA	GALANTAMINE HYDROBROMIDE	TABLET;ORAL	EQ 8MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	Yes	No	2001/02/28	2001/02/28	JANSSEN PHARMS	Discontinued
RAZADYNE	021169	003	NDA	GALANTAMINE HYDROBROMIDE	TABLET;ORAL	EQ 12MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	Yes	No	2001/02/28	2001/02/28	JANSSEN PHARMS	Discontinued
RAZADYNE	021224	001	NDA	GALANTAMINE HYDROBROMIDE	SOLUTION;ORAL	4MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	No	No	2001/06/22	2001/06/22	JANSSEN PHARMS	Discontinued
RAZADYNE ER	021615	001	NDA	GALANTAMINE HYDROBROMIDE	CAPSULE, EXTENDED RELEASE;ORAL	EQ 8MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	Yes	No	2005/04/01	2005/04/01	JANSSEN PHARMS	Discontinued
RAZADYNE ER	021615	002	NDA	GALANTAMINE HYDROBROMIDE	CAPSULE, EXTENDED RELEASE;ORAL	EQ 16MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	Yes	No	2005/04/01	2005/04/01	JANSSEN PHARMS	Discontinued
RAZADYNE ER	021615	003	NDA	GALANTAMINE HYDROBROMIDE	CAPSULE, EXTENDED RELEASE;ORAL	EQ 24MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	Yes	No	2005/04/01	2005/04/01	JANSSEN PHARMS	Discontinued