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	203161	003	ANDA	IRBESARTAN	TABLET;ORAL	300MG	No	No	2012/09/27	2012/09/27	CHARTWELL RX	Discontinued
IRBESARTAN AND HYDROCHLOROTHIAZIDE	203500	001	ANDA	HYDROCHLOROTHIAZIDE; IRBESARTAN	TABLET;ORAL	12.5MG;150MG	No	No	2012/09/27	2012/09/27	DR REDDYS LABS LTD	Prescription
IRBESARTAN AND HYDROCHLOROTHIAZIDE	203500	002	ANDA	HYDROCHLOROTHIAZIDE; IRBESARTAN	TABLET;ORAL	12.5MG;300MG	No	No	2012/09/27	2012/09/27	DR REDDYS LABS LTD	Prescription
HYDROCHLOROTHIAZIDE; IRBESARTAN	201616	001	ANDA	HYDROCHLOROTHIAZIDE; IRBESARTAN	TABLET; ORAL	12.5MG; 150MG	No	No	2012/09/28 (TA)	--	CIPLA LIMITED	None (Tentative Approval)
HYDROCHLOROTHIAZIDE; IRBESARTAN	201616	002	ANDA	HYDROCHLOROTHIAZIDE; IRBESARTAN	TABLET; ORAL	12.5MG; 300MG	No	No	2012/09/28 (TA)	--	CIPLA LIMITED	None (Tentative Approval)
IRBESARTAN	202254	001	ANDA	IRBESARTAN	TABLET;ORAL	75MG	No	No	2012/10/03	2012/10/03	MACLEODS PHARMS LTD	Prescription
IRBESARTAN	202254	002	ANDA	IRBESARTAN	TABLET;ORAL	150MG	No	No	2012/10/03	2012/10/03	MACLEODS PHARMS LTD	Prescription
IRBESARTAN	202254	003	ANDA	IRBESARTAN	TABLET;ORAL	300MG	No	No	2012/10/03	2012/10/03	MACLEODS PHARMS LTD	Prescription
IRBESARTAN	090720	001	ANDA	IRBESARTAN	TABLET;ORAL	75MG	No	No	2012/10/12	2012/10/12	WATSON LABS INC	Discontinued
IRBESARTAN	090720	002	ANDA	IRBESARTAN	TABLET;ORAL	150MG	No	No	2012/10/12	2012/10/12	WATSON LABS INC	Discontinued
IRBESARTAN	090720	003	ANDA	IRBESARTAN	TABLET;ORAL	300MG	No	No	2012/10/12	2012/10/12	WATSON LABS INC	Discontinued
IRBESARTAN	090201	001	ANDA	IRBESARTAN	TABLET;ORAL	75MG	No	No	2012/10/15	2012/10/15	HIKMA	Discontinued
IRBESARTAN	090201	002	ANDA	IRBESARTAN	TABLET;ORAL	150MG	No	No	2012/10/15	2012/10/15	HIKMA	Discontinued
IRBESARTAN	090201	003	ANDA	IRBESARTAN	TABLET;ORAL	300MG	No	No	2012/10/15	2012/10/15	HIKMA	Discontinued
IRBESARTAN AND HYDROCHLOROTHIAZIDE	090351	001	ANDA	HYDROCHLOROTHIAZIDE; IRBESARTAN	TABLET;ORAL	12.5MG;150MG	No	No	2012/10/15	2012/10/15	HIKMA	Prescription
IRBESARTAN AND HYDROCHLOROTHIAZIDE	090351	002	ANDA	HYDROCHLOROTHIAZIDE; IRBESARTAN	TABLET;ORAL	12.5MG;300MG	No	No	2012/10/15	2012/10/15	HIKMA	Prescription
IRBESARTAN AND HYDROCHLOROTHIAZIDE	090351	003	ANDA	HYDROCHLOROTHIAZIDE; IRBESARTAN	TABLET;ORAL	25MG;300MG	No	No	2012/10/15	2017/06/08	HIKMA	Prescription
IRBESARTAN	091236	001	ANDA	IRBESARTAN	TABLET;ORAL	75MG	No	No	2012/10/15	2012/10/15	ALEMBIC PHARMS LTD	Prescription
IRBESARTAN	091236	002	ANDA	IRBESARTAN	TABLET;ORAL	150MG	No	No	2012/10/15	2012/10/15	ALEMBIC PHARMS LTD	Prescription
IRBESARTAN	091236	003	ANDA	IRBESARTAN	TABLET;ORAL	300MG	No	No	2012/10/15	2012/10/15	ALEMBIC PHARMS LTD	Prescription