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
IRBESARTAN; HYDROCHLOROTHIAZIDE	090815	001	ANDA	IRBESARTAN; HYDROCHLOROTHIAZIDE	TABLET; ORAL	150MG; 12.5MG	No	No	2011/02/16 (TA)	--	ZYDUS PHARMS USA INC	None (Tentative Approval)
IRBESARTAN; HYDROCHLOROTHIAZIDE	090815	002	ANDA	IRBESARTAN; HYDROCHLOROTHIAZIDE	TABLET; ORAL	300MG; 12.5MG	No	No	2011/02/16 (TA)	--	ZYDUS PHARMS USA INC	None (Tentative Approval)
IRBESARTAN; HYDROCHLOROTHIAZIDE	090815	003	ANDA	IRBESARTAN; HYDROCHLOROTHIAZIDE	TABLET; ORAL	300MG; 25MG	No	No	2011/02/16 (TA)	--	ZYDUS PHARMS USA INC	None (Tentative Approval)
IRBESARTAN; HYDROCHLOROTHIAZIDE	202414	003	ANDA	IRBESARTAN: HYDROCHLOROTHIAZIDE	TABLET; ORAL	300MG; 25MG	No	No	2012/09/27	--	MACLEODS PHARMS LTD	None (Tentative Approval)
IRBESARTAN; HYDROCHLOROTHIAZIDE	202414	003	ANDA	IRBESARTAN: HYDROCHLOROTHIAZIDE	TABLET; ORAL	300MG; 25MG	No	No	2012/09/27 (TA)	--	MACLEODS PHARMS LTD	None (Tentative Approval)
IRBESARTAN; HYDROCHLOROTHIAZIDE	201524	003	ANDA	IRBESARTAN; HYDROCHLOROTHIAZIDE	TABLET; ORAL	300MG; 25MG	No	No	2013/02/27	--	LUPIN LTD	None (Tentative Approval)
IRBESARTAN; HYDROCHLOROTHIAZIDE	201524	003	ANDA	IRBESARTAN; HYDROCHLOROTHIAZIDE	TABLET; ORAL	300MG; 25MG	No	No	2013/02/27 (TA)	--	LUPIN LTD	None (Tentative Approval)