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	200461	001	ANDA	IRBESARTAN	TABLET;ORAL	75MG	No	No	2012/09/27	2012/09/27	UPSHER SMITH LABS	Discontinued
IRBESARTAN	200461	002	ANDA	IRBESARTAN	TABLET;ORAL	150MG	No	No	2012/09/27	2012/09/27	UPSHER SMITH LABS	Discontinued
IRBESARTAN	200461	003	ANDA	IRBESARTAN	TABLET;ORAL	300MG	No	No	2012/09/27	2012/09/27	UPSHER SMITH LABS	Discontinued
IRBESARTAN AND HYDROCHLOROTHIAZIDE	202414	001	ANDA	HYDROCHLOROTHIAZIDE; IRBESARTAN	TABLET;ORAL	12.5MG;150MG	No	No	2012/09/27	2012/09/27	MACLEODS PHARMS LTD	Prescription
IRBESARTAN AND HYDROCHLOROTHIAZIDE	202414	001	ANDA	HYDROCHLOROTHIAZIDE; IRBESARTAN	TABLET;ORAL	12.5MG;150MG	No	No	2012/09/27 (TA)	2012/09/27	MACLEODS PHARMS LTD	Prescription
IRBESARTAN AND HYDROCHLOROTHIAZIDE	202414	002	ANDA	HYDROCHLOROTHIAZIDE; IRBESARTAN	TABLET;ORAL	12.5MG;300MG	No	No	2012/09/27	2012/09/27	MACLEODS PHARMS LTD	Prescription
IRBESARTAN AND HYDROCHLOROTHIAZIDE	202414	002	ANDA	HYDROCHLOROTHIAZIDE; IRBESARTAN	TABLET;ORAL	12.5MG;300MG	No	No	2012/09/27 (TA)	2012/09/27	MACLEODS PHARMS LTD	Prescription
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	202910	001	ANDA	IRBESARTAN	TABLET;ORAL	75MG	No	No	2012/09/27	2012/09/27	HETERO LABS LTD V	Prescription
IRBESARTAN	202910	002	ANDA	IRBESARTAN	TABLET;ORAL	150MG	No	No	2012/09/27	2012/09/27	HETERO LABS LTD V	Prescription
IRBESARTAN	202910	003	ANDA	IRBESARTAN	TABLET;ORAL	300MG	No	No	2012/09/27	2012/09/27	HETERO LABS LTD V	Prescription
IRBESARTAN	203071	001	ANDA	IRBESARTAN	TABLET;ORAL	75MG	No	No	2012/09/27	2012/09/27	PRINSTON INC	Prescription
IRBESARTAN	203071	002	ANDA	IRBESARTAN	TABLET;ORAL	150MG	No	No	2012/09/27	2012/09/27	PRINSTON INC	Prescription
IRBESARTAN	203071	003	ANDA	IRBESARTAN	TABLET;ORAL	300MG	No	No	2012/09/27	2012/09/27	PRINSTON INC	Prescription
IRBESARTAN	203081	001	ANDA	IRBESARTAN	TABLET;ORAL	75MG	No	No	2012/09/27	2012/09/27	AUROBINDO PHARMA LTD	Prescription
IRBESARTAN	203081	002	ANDA	IRBESARTAN	TABLET;ORAL	150MG	No	No	2012/09/27	2012/09/27	AUROBINDO PHARMA LTD	Prescription
IRBESARTAN	203081	003	ANDA	IRBESARTAN	TABLET;ORAL	300MG	No	No	2012/09/27	2012/09/27	AUROBINDO PHARMA LTD	Prescription
IRBESARTAN	203161	001	ANDA	IRBESARTAN	TABLET;ORAL	75MG	No	No	2012/09/27	2012/09/27	CHARTWELL RX	Discontinued
IRBESARTAN	203161	002	ANDA	IRBESARTAN	TABLET;ORAL	150MG	No	No	2012/09/27	2012/09/27	CHARTWELL RX	Discontinued