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
HYDROCHLOROTHIAZIDE; VALSARTAN	205439	005	ANDA	HYDROCHLOROTHIAZIDE; VALSARTAN	TABLET;ORAL	25MG;320MG	No	No	2017/09/06 (TA)	--	HUAREN PHARMACEUTICAL CO LTD	None (Tentative Approval)
AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE	206180	001	ANDA	AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN	TABLET;ORAL	EQ 5MG BASE;12.5MG;160MG	No	No	2017/12/19	2017/12/19	AUROBINDO PHARMA	Prescription
AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE	206180	002	ANDA	AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN	TABLET;ORAL	EQ 5MG BASE;25MG;160MG	No	No	2017/12/19	2017/12/19	AUROBINDO PHARMA	Prescription
AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE	206180	003	ANDA	AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN	TABLET;ORAL	EQ 10MG BASE;12.5MG;160MG	No	No	2017/12/19	2017/12/19	AUROBINDO PHARMA	Prescription
AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE	206180	004	ANDA	AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN	TABLET;ORAL	EQ 10MG BASE;25MG;160MG	No	No	2017/12/19	2017/12/19	AUROBINDO PHARMA	Prescription
AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDE	206180	005	ANDA	AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN	TABLET;ORAL	EQ 10MG BASE;25MG;320MG	No	No	2017/12/19	2017/12/19	AUROBINDO PHARMA	Prescription
VALSARTAN	205347	001	ANDA	VALSARTAN	TABLET;ORAL	40MG	No	No	2018/04/09	2018/04/09	SQUARE PHARMS	Prescription
VALSARTAN	205347	002	ANDA	VALSARTAN	TABLET;ORAL	80MG	No	No	2018/04/09	2018/04/09	SQUARE PHARMS	Prescription
VALSARTAN	205347	003	ANDA	VALSARTAN	TABLET;ORAL	160MG	No	No	2018/04/09	2018/04/09	SQUARE PHARMS	Prescription
VALSARTAN	205347	004	ANDA	VALSARTAN	TABLET;ORAL	320MG	No	No	2018/04/09	2018/04/09	SQUARE PHARMS	Prescription
VALSARTAN	209261	001	ANDA	VALSARTAN	TABLET;ORAL	40MG	No	No	2018/05/04	2018/05/04	UNICHEM	Discontinued
VALSARTAN	209261	002	ANDA	VALSARTAN	TABLET;ORAL	80MG	No	No	2018/05/04	2018/05/04	UNICHEM	Discontinued
VALSARTAN	209261	003	ANDA	VALSARTAN	TABLET;ORAL	160MG	No	No	2018/05/04	2018/05/04	UNICHEM	Discontinued
VALSARTAN	209261	004	ANDA	VALSARTAN	TABLET;ORAL	320MG	No	No	2018/05/04	2018/05/04	UNICHEM	Discontinued
VALSARTAN	205536	001	ANDA	VALSARTAN	TABLET;ORAL	40MG	No	No	2019/03/12	2019/03/12	ALKEM LABS LTD	Prescription
VALSARTAN	205536	002	ANDA	VALSARTAN	TABLET;ORAL	80MG	No	No	2019/03/12	2019/03/12	ALKEM LABS LTD	Prescription
VALSARTAN	205536	003	ANDA	VALSARTAN	TABLET;ORAL	160MG	No	No	2019/03/12	2019/03/12	ALKEM LABS LTD	Prescription
VALSARTAN	205536	004	ANDA	VALSARTAN	TABLET;ORAL	320MG	No	No	2019/03/12	2019/03/12	ALKEM LABS LTD	Prescription
VALSARTAN AND HYDROCHLOROTHIAZIDE	203000	001	ANDA	HYDROCHLOROTHIAZIDE; VALSARTAN	TABLET;ORAL	12.5MG;80MG	No	No	2019/03/15	2019/03/15	ZYDUS LIFESCIENCES	Discontinued
VALSARTAN AND HYDROCHLOROTHIAZIDE	203000	002	ANDA	HYDROCHLOROTHIAZIDE; VALSARTAN	TABLET;ORAL	12.5MG;160MG	No	No	2019/03/15	2019/03/15	ZYDUS LIFESCIENCES	Discontinued