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
ENDEP	083639	001	ANDA	AMITRIPTYLINE HYDROCHLORIDE	TABLET;ORAL	10MG	No	No	--	Approved Prior to Jan 1, 1982	ROCHE	Discontinued
ENDEP	083639	002	ANDA	AMITRIPTYLINE HYDROCHLORIDE	TABLET;ORAL	25MG	No	No	--	Approved Prior to Jan 1, 1982	ROCHE	Discontinued
ENDEP	083639	003	ANDA	AMITRIPTYLINE HYDROCHLORIDE	TABLET;ORAL	50MG	No	No	--	Approved Prior to Jan 1, 1982	ROCHE	Discontinued
ENDEP	083639	004	ANDA	AMITRIPTYLINE HYDROCHLORIDE	TABLET;ORAL	75MG	No	No	--	Approved Prior to Jan 1, 1982	ROCHE	Discontinued
ENDEP	083639	005	ANDA	AMITRIPTYLINE HYDROCHLORIDE	TABLET;ORAL	100MG	No	No	--	Approved Prior to Jan 1, 1982	ROCHE	Discontinued
ENDEP	085749	001	ANDA	AMITRIPTYLINE HYDROCHLORIDE	CONCENTRATE;ORAL	40MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	Yes	No	--	Approved Prior to Jan 1, 1982	ROCHE	Discontinued
ENDEP	085303	001	ANDA	AMITRIPTYLINE HYDROCHLORIDE	TABLET;ORAL	150MG	No	No	1976/12/27	Approved Prior to Jan 1, 1982	ROCHE	Discontinued