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
CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE	202884	001	ANDA	CANDESARTAN CILEXETIL; HYDROCHLOROTHIAZIDE	TABLET;ORAL	16MG;12.5MG	No	No	2012/12/04	2012/12/04	APOTEX INC	Discontinued
CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE	202884	002	ANDA	CANDESARTAN CILEXETIL; HYDROCHLOROTHIAZIDE	TABLET;ORAL	32MG;12.5MG	No	No	2012/12/04	2012/12/04	APOTEX INC	Discontinued
CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE	202884	003	ANDA	CANDESARTAN CILEXETIL; HYDROCHLOROTHIAZIDE	TABLET;ORAL	32MG;25MG	No	No	2012/12/04	2013/06/03	APOTEX INC	Discontinued
CANDESARTAN CILEXETIL; HYDROCHLOROTHIAZIDE	200887	001	ANDA	CANDESARTAN CILEXETIL; HYDROCHLOROTHIAZIDE	TABLET; ORAL	16MG; 12.5MG	No	No	2012/12/11 (TA)	--	TEVA PHARMS USA	None (Tentative Approval)
CANDESARTAN CILEXETIL; HYDROCHLOROTHIAZIDE	200887	002	ANDA	CANDESARTAN CILEXETIL; HYDROCHLOROTHIAZIDE	TABLET; ORAL	32MG; 12.5MG	No	No	2012/12/11 (TA)	--	TEVA PHARMS USA	None (Tentative Approval)
CANDESARTAN CILEXETIL; HYDROCHLOROTHIAZIDE	200887	003	ANDA	CANDESARTAN CILEXETIL; HYDROCHLOROTHIAZIDE	TABLET; ORAL	32MG; 25MG	No	No	2012/12/11 (TA)	--	TEVA PHARMS USA	None (Tentative Approval)
IRBESARTAN AND HYDROCHLOROTHIAZIDE	203630	001	ANDA	HYDROCHLOROTHIAZIDE; IRBESARTAN	TABLET;ORAL	12.5MG;150MG	No	No	2013/02/22	2013/02/22	AUROBINDO PHARMA LTD	Prescription
IRBESARTAN AND HYDROCHLOROTHIAZIDE	203630	002	ANDA	HYDROCHLOROTHIAZIDE; IRBESARTAN	TABLET;ORAL	12.5MG;300MG	No	No	2013/02/22	2013/02/22	AUROBINDO PHARMA LTD	Prescription
IRBESARTAN AND HYDROCHLOROTHIAZIDE	203630	003	ANDA	HYDROCHLOROTHIAZIDE; IRBESARTAN	TABLET;ORAL	25MG;300MG	No	No	2013/02/22	2016/03/31	AUROBINDO PHARMA LTD	Prescription
IRBESARTAN AND HYDROCHLOROTHIAZIDE	201524	001	ANDA	HYDROCHLOROTHIAZIDE; IRBESARTAN	TABLET;ORAL	12.5MG;150MG	No	No	2013/02/27	2013/02/27	LUPIN LTD	Prescription
IRBESARTAN AND HYDROCHLOROTHIAZIDE	201524	001	ANDA	HYDROCHLOROTHIAZIDE; IRBESARTAN	TABLET;ORAL	12.5MG;150MG	No	No	2013/02/27 (TA)	2013/02/27	LUPIN LTD	Prescription
IRBESARTAN AND HYDROCHLOROTHIAZIDE	201524	002	ANDA	HYDROCHLOROTHIAZIDE; IRBESARTAN	TABLET;ORAL	12.5MG;300MG	No	No	2013/02/27	2013/02/27	LUPIN LTD	Prescription
IRBESARTAN AND HYDROCHLOROTHIAZIDE	201524	002	ANDA	HYDROCHLOROTHIAZIDE; IRBESARTAN	TABLET;ORAL	12.5MG;300MG	No	No	2013/02/27 (TA)	2013/02/27	LUPIN LTD	Prescription
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)
LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE	201682	001	ANDA	HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM	TABLET;ORAL	12.5MG;50MG	No	No	2013/03/01	2013/03/01	IPCA LABS LTD	Prescription
LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE	201682	002	ANDA	HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM	TABLET;ORAL	12.5MG;100MG	No	No	2013/03/01	2013/03/01	IPCA LABS LTD	Prescription
LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE	201682	003	ANDA	HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM	TABLET;ORAL	25MG;100MG	No	No	2013/03/01	2013/03/01	IPCA LABS LTD	Prescription
QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE	091524	001	ANDA	HYDROCHLOROTHIAZIDE; QUINAPRIL HYDROCHLORIDE	TABLET;ORAL	12.5MG;EQ 10MG BASE	No	No	2013/03/12	2013/03/12	APOTEX	Prescription
QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE	091524	002	ANDA	HYDROCHLOROTHIAZIDE; QUINAPRIL HYDROCHLORIDE	TABLET;ORAL	12.5MG;EQ 20MG BASE	No	No	2013/03/12	2013/03/12	APOTEX	Prescription