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
TEKTURNA	021985	001	NDA	ALISKIREN HEMIFUMARATE	TABLET;ORAL	EQ 150MG BASE	Yes	No	2007/03/05	2007/03/05	NODEN PHARMA	Prescription
TEKTURNA	021985	002	NDA	ALISKIREN HEMIFUMARATE	TABLET;ORAL	EQ 300MG BASE	Yes	Yes	2007/03/05	2007/03/05	NODEN PHARMA	Prescription
TEKTURNA HCT	022107	001	NDA	ALISKIREN HEMIFUMARATE; HYDROCHLOROTHIAZIDE	TABLET;ORAL	EQ 150MG BASE;12.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	Yes	No	2008/01/18	2008/01/18	NODEN PHARMA	Discontinued
TEKTURNA HCT	022107	002	NDA	ALISKIREN HEMIFUMARATE; HYDROCHLOROTHIAZIDE	TABLET;ORAL	EQ 150MG BASE;25MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	Yes	No	2008/01/18	2008/01/18	NODEN PHARMA	Discontinued
TEKTURNA HCT	022107	003	NDA	ALISKIREN HEMIFUMARATE; HYDROCHLOROTHIAZIDE	TABLET;ORAL	EQ 300MG BASE;12.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	Yes	No	2008/01/18	2008/01/18	NODEN PHARMA	Discontinued
TEKTURNA HCT	022107	004	NDA	ALISKIREN HEMIFUMARATE; HYDROCHLOROTHIAZIDE	TABLET;ORAL	EQ 300MG BASE;25MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	Yes	No	2008/01/18	2008/01/18	NODEN PHARMA	Discontinued
TEKTURNA	210709	001	NDA	ALISKIREN HEMIFUMARATE	CAPSULE, PELLET;ORAL	EQ 37.5MG BASE	Yes	No	2017/11/14	2017/11/14	NODEN PHARMA	Discontinued