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
APRESOLINE-ESIDRIX	012026	002	NDA	HYDRALAZINE HYDROCHLORIDE; HYDROCHLOROTHIAZIDE	TABLET;ORAL	25MG;15MG	No	No	--	Approved Prior to Jan 1, 1982	NOVARTIS	Discontinued
APRESOLINE	008303	001	NDA	HYDRALAZINE HYDROCHLORIDE	TABLET;ORAL	25MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	Yes	No	1953/01/15	Approved Prior to Jan 1, 1982	NOVARTIS	Discontinued
APRESOLINE	008303	002	NDA	HYDRALAZINE HYDROCHLORIDE	TABLET;ORAL	50MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	Yes	No	1953/01/15	Approved Prior to Jan 1, 1982	NOVARTIS	Discontinued
APRESOLINE	008303	003	NDA	HYDRALAZINE HYDROCHLORIDE	INJECTABLE;INJECTION	20MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	Yes	No	1953/01/15	Approved Prior to Jan 1, 1982	NOVARTIS	Discontinued
APRESOLINE	008303	004	NDA	HYDRALAZINE HYDROCHLORIDE	TABLET;ORAL	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	Yes	No	1953/01/15	Approved Prior to Jan 1, 1982	NOVARTIS	Discontinued
APRESOLINE	008303	005	NDA	HYDRALAZINE HYDROCHLORIDE	TABLET;ORAL	100MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	Yes	No	1953/01/15	Approved Prior to Jan 1, 1982	NOVARTIS	Discontinued
SERPASIL-APRESOLINE	009296	002	NDA	HYDRALAZINE HYDROCHLORIDE; RESERPINE	TABLET;ORAL	50MG;0.2MG	No	No	1954/04/01	Approved Prior to Jan 1, 1982	NOVARTIS	Discontinued
SERPASIL-APRESOLINE	009296	004	NDA	HYDRALAZINE HYDROCHLORIDE; RESERPINE	TABLET;ORAL	25MG;0.1MG	No	No	1954/04/01	Approved Prior to Jan 1, 1982	NOVARTIS	Discontinued