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
DEXEDRINE	083902	001	ANDA	DEXTROAMPHETAMINE SULFATE	ELIXIR;ORAL	5MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	No	No	1976/02/26	Approved Prior to Jan 1, 1982	GLAXOSMITHKLINE	Discontinued
DEXEDRINE	084935	001	ANDA	DEXTROAMPHETAMINE SULFATE	TABLET;ORAL	5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	Yes	No	1976/02/26	Approved Prior to Jan 1, 1982	GLAXOSMITHKLINE	Discontinued
DEXEDRINE SPANSULE	017078	001	NDA	DEXTROAMPHETAMINE SULFATE	CAPSULE, EXTENDED RELEASE;ORAL	5MG	Yes	No	1976/08/02	Approved Prior to Jan 1, 1982	IMPAX LABS INC	Prescription
DEXEDRINE SPANSULE	017078	002	NDA	DEXTROAMPHETAMINE SULFATE	CAPSULE, EXTENDED RELEASE;ORAL	10MG	Yes	No	1976/08/02	Approved Prior to Jan 1, 1982	IMPAX LABS INC	Prescription
DEXEDRINE SPANSULE	017078	003	NDA	DEXTROAMPHETAMINE SULFATE	CAPSULE, EXTENDED RELEASE;ORAL	15MG	Yes	Yes	1976/08/02	Approved Prior to Jan 1, 1982	IMPAX LABS INC	Prescription