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
MAXIDEX	013422	001	NDA	DEXAMETHASONE	SUSPENSION/DROPS;OPHTHALMIC	0.1%	Yes	Yes	1962/06/20	Approved Prior to Jan 1, 1982	HARROW EYE	Prescription
MAXIDEX	083342	001	ANDA	DEXAMETHASONE SODIUM PHOSPHATE	OINTMENT;OPHTHALMIC	EQ 0.05% PHOSPHATE	No	No	1973/10/23	Approved Prior to Jan 1, 1982	ALCON	Discontinued
AXID	019508	001	NDA	NIZATIDINE	CAPSULE;ORAL	150MG	No	No	1988/04/12	1988/04/12	SMITHKLINE BEECHAM	Discontinued
AXID	019508	002	NDA	NIZATIDINE	CAPSULE;ORAL	300MG	No	No	1988/04/12	1988/04/12	SMITHKLINE BEECHAM	Discontinued
AXID AR	020555	001	NDA	NIZATIDINE	TABLET;ORAL	75MG	Yes	Yes	1996/05/09	1996/05/09	HALEON US HOLDINGS	Over-the-counter
AXID	021494	001	NDA	NIZATIDINE	SOLUTION;ORAL	15MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	Yes	No	2004/05/25	2004/05/25	BRAINTREE	Discontinued
ZYMAXID	022548	001	NDA	GATIFLOXACIN	SOLUTION/DROPS;OPHTHALMIC	0.5%	Yes	Yes	2010/05/18	2010/05/18	ABBVIE	Prescription