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
BALANCED SALT	075503	001	ANDA	CALCIUM CHLORIDE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM ACETATE; SODIUM CHLORIDE; SODIUM CITRATE	SOLUTION;IRRIGATION	0.48MG/ML;0.3MG/ML;0.75MG/ML;3.9MG/ML;6.4MG/ML;1.7MG/ML	No	No	2006/09/27	2006/09/27	EPIC PHARMA LLC	Discontinued
BALSALAZIDE DISODIUM	077806	001	ANDA	BALSALAZIDE DISODIUM	CAPSULE;ORAL	750MG	No	No	2007/12/28	2007/12/28	HIKMA	Prescription
BALSALAZIDE DISODIUM	077807	001	ANDA	BALSALAZIDE DISODIUM	CAPSULE;ORAL	750MG	No	No	2007/12/28	2007/12/28	NOVITIUM PHARMA	Prescription
BALSALAZIDE DISODIUM	077883	001	ANDA	BALSALAZIDE DISODIUM	CAPSULE;ORAL	750MG	No	No	2007/12/28	2007/12/28	APOTEX	Prescription
CYMBALTA	022148	001	NDA	DULOXETINE HYDROCHLORIDE	CAPSULE, DELAYED REL PELLETS; ORAL	EQ 20MG BASE	No	No	2008/06/13	--	LILLY	Prescription
CYMBALTA	022148	002	NDA	DULOXETINE HYDROCHLORIDE	CAPSULE, DELAYED REL PELLETS; ORAL	EQ 30MG BASE	No	No	2008/06/13	--	LILLY	Prescription
CYMBALTA	022148	003	NDA	DULOXETINE HYDROCHLORIDE	CAPSULE, DELAYED REL PELLETS; ORAL	EQ 60MG BASE	No	No	2008/06/13	--	LILLY	Prescription
BALANCED SALT	091387	001	ANDA	CALCIUM CHLORIDE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM ACETATE; SODIUM CHLORIDE; SODIUM CITRATE	SOLUTION;IRRIGATION	0.48MG/ML;0.3MG/ML;0.75MG/ML;3.9MG/ML;6.4MG/ML;1.7MG/ML	No	No	2010/02/03	2010/02/03	B BRAUN	Prescription
CYMBALTA	022516	001	NDA	DULOXETINE HYDROCHLORIDE	CAPSULE, DELAYED REL PELLETS; ORAL	EQ 20MG BASE	No	No	2010/11/04	--	LILLY	Prescription
CYMBALTA	022516	002	NDA	DULOXETINE HYDROCHLORIDE	CAPSULE, DELAYED REL PELLETS; ORAL	EQ 30MG BASE	No	No	2010/11/04	--	LILLY	Prescription
CYMBALTA	022516	003	NDA	DULOXETINE HYDROCHLORIDE	CAPSULE, DELAYED REL PELLETS; ORAL	EQ 60MG BASE	No	No	2010/11/04	--	LILLY	Prescription
PREGABALIN	091229	001	ANDA	PREGABALIN	CAPSULE; ORAL	25MG	No	No	2012/12/31 (TA)	--	SANDOZ INC	None (Tentative Approval)
PREGABALIN	091229	002	ANDA	PREGABALIN	CAPSULE; ORAL	50MG	No	No	2012/12/31 (TA)	--	SANDOZ INC	None (Tentative Approval)
PREGABALIN	091229	003	ANDA	PREGABALIN	CAPSULE; ORAL	75MG	No	No	2012/12/31 (TA)	--	SANDOZ INC	None (Tentative Approval)
PREGABALIN	091229	004	ANDA	PREGABALIN	CAPSULE; ORAL	100MG	No	No	2012/12/31 (TA)	--	SANDOZ INC	None (Tentative Approval)
PREGABALIN	091229	005	ANDA	PREGABALIN	CAPSULE; ORAL	150MG	No	No	2012/12/31 (TA)	--	SANDOZ INC	None (Tentative Approval)
PREGABALIN	091229	006	ANDA	PREGABALIN	CAPSULE; ORAL	200MG	No	No	2012/12/31 (TA)	--	SANDOZ INC	None (Tentative Approval)
PREGABALIN	091229	007	ANDA	PREGABALIN	CAPSULE; ORAL	225MG	No	No	2012/12/31 (TA)	--	SANDOZ INC	None (Tentative Approval)
PREGABALIN	091229	008	ANDA	PREGABALIN	CAPSULE; ORAL	300MG	No	No	2012/12/31 (TA)	--	SANDOZ INC	None (Tentative Approval)
PREGABALIN	201989	001	ANDA	PREGABALIN	SOLUTION; ORAL	20MG/ML	No	No	2013/06/04 (TA)	--	LUPIN LTD	None (Tentative Approval)