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
EMPAGLIFLOZIN METFORMIN HYDROCHLORIDE	212362	003	ANDA	EMPAGLIFLOZIN;METFORMIN HYDROCHLORIDE	TABLET, EXTENDED RELEASE; ORAL	12.5MG/1000MG	No	No	2023/01/31 (TA)	--	MSN LABS PVT LTD	None (Tentative Approval)
EMPAGLIFLOZIN METFORMIN HYDROCHLORIDE	212362	004	ANDA	EMPAGLIFLOZIN;METFORMIN HYDROCHLORIDE	TABLET, EXTENDED RELEASE; ORAL	25MG/1000MG	No	No	2023/01/31 (TA)	--	MSN LABS PVT LTD	None (Tentative Approval)
CANAGLIFLOZIN; METFORMIN HYDROCHLORIDE	210542	001	ANDA	CANAGLIFLOZIN;METFORMIN HYDROCHLORIDE	TABLET;ORAL	50MG;500MG	No	No	2023/02/16 (TA)	--	ZYDUS PHARMS USA INC	None (Tentative Approval)
CANAGLIFLOZIN; METFORMIN HYDROCHLORIDE	210542	002	ANDA	CANAGLIFLOZIN;METFORMIN HYDROCHLORIDE	TABLET;ORAL	50MG;1000MG	No	No	2023/02/16 (TA)	--	ZYDUS PHARMS USA INC	None (Tentative Approval)
CANAGLIFLOZIN; METFORMIN HYDROCHLORIDE	210542	003	ANDA	CANAGLIFLOZIN;METFORMIN HYDROCHLORIDE	TABLET;ORAL	150MG;500MG	No	No	2023/02/16 (TA)	--	ZYDUS PHARMS USA INC	None (Tentative Approval)
CANAGLIFLOZIN; METFORMIN HYDROCHLORIDE	210542	004	ANDA	CANAGLIFLOZIN;METFORMIN HYDROCHLORIDE	TABLET;ORAL	150MG;1000MG	No	No	2023/02/16 (TA)	--	ZYDUS PHARMS USA INC	None (Tentative Approval)
LINAGLIPTIN AND METFORMIN HYDROCHLORIDE	208449	001	ANDA	LINAGLIPTIN; METFORMIN HYDROCHLORIDE	TABLET;ORAL	2.5MG;500MG	No	No	2023/03/30	2023/03/30	ZYDUS PHARMS	Discontinued
LINAGLIPTIN AND METFORMIN HYDROCHLORIDE	208449	002	ANDA	LINAGLIPTIN; METFORMIN HYDROCHLORIDE	TABLET;ORAL	2.5MG;850MG	No	No	2023/03/30	2023/03/30	ZYDUS PHARMS	Discontinued
LINAGLIPTIN AND METFORMIN HYDROCHLORIDE	208449	003	ANDA	LINAGLIPTIN; METFORMIN HYDROCHLORIDE	TABLET;ORAL	2.5MG;1GM	No	No	2023/03/30	2023/03/30	ZYDUS PHARMS	Discontinued
METFORMIN HYDROCHLORIDE	215629	001	ANDA	METFORMIN HYDROCHLORIDE	TABLET, EXTENDED RELEASE;ORAL	500MG	No	No	2023/06/20	2023/06/20	RK PHARMA	Prescription
METFORMIN HYDROCHLORIDE	215629	002	ANDA	METFORMIN HYDROCHLORIDE	TABLET, EXTENDED RELEASE;ORAL	1GM	No	No	2023/06/20	2023/06/20	RK PHARMA	Prescription
SAXAGLIPTIN AND METFORMIN HYDROCHLORIDE	205981	001	ANDA	METFORMIN HYDROCHLORIDE; SAXAGLIPTIN HYDROCHLORIDE	TABLET, EXTENDED RELEASE;ORAL	500MG;EQ 5MG BASE	No	No	2023/07/31	2023/07/31	MYLAN	Prescription
SAXAGLIPTIN AND METFORMIN HYDROCHLORIDE	205981	002	ANDA	METFORMIN HYDROCHLORIDE; SAXAGLIPTIN HYDROCHLORIDE	TABLET, EXTENDED RELEASE;ORAL	1GM;EQ 2.5MG BASE	No	No	2023/07/31	2023/07/31	MYLAN	Prescription
SAXAGLIPTIN AND METFORMIN HYDROCHLORIDE	205981	003	ANDA	METFORMIN HYDROCHLORIDE; SAXAGLIPTIN HYDROCHLORIDE	TABLET, EXTENDED RELEASE;ORAL	1GM;EQ 5MG BASE	No	No	2023/07/31	2023/07/31	MYLAN	Prescription
SAXAGLIPTIN AND METFORMIN HYDROCHLORIDE	206081	001	ANDA	METFORMIN HYDROCHLORIDE; SAXAGLIPTIN HYDROCHLORIDE	TABLET, EXTENDED RELEASE;ORAL	500MG;EQ 5MG BASE	No	No	2023/07/31	2023/07/31	SUN PHARM	Prescription
SAXAGLIPTIN AND METFORMIN HYDROCHLORIDE	206081	002	ANDA	METFORMIN HYDROCHLORIDE; SAXAGLIPTIN HYDROCHLORIDE	TABLET, EXTENDED RELEASE;ORAL	1GM;EQ 2.5MG BASE	No	No	2023/07/31	2023/07/31	SUN PHARM	Prescription
SAXAGLIPTIN AND METFORMIN HYDROCHLORIDE	206081	003	ANDA	METFORMIN HYDROCHLORIDE; SAXAGLIPTIN HYDROCHLORIDE	TABLET, EXTENDED RELEASE;ORAL	1GM;EQ 5MG BASE	No	No	2023/07/31	2023/07/31	SUN PHARM	Prescription
METFORMIN HYDROCHLORIDE; SAXAGLIPTIN HYDROCHLORIDE	207678	001	ANDA	METFORMIN HYDROCHLORIDE; SAXAGLIPTIN HYDROCHLORIDE	TABLET, EXTENDED RELEASE;ORAL	500MG;EQ 5MG BASE	No	No	2023/08/09	2023/08/09	DR REDDYS LABS SA	Prescription
METFORMIN HYDROCHLORIDE; SAXAGLIPTIN HYDROCHLORIDE	207678	002	ANDA	METFORMIN HYDROCHLORIDE; SAXAGLIPTIN HYDROCHLORIDE	TABLET, EXTENDED RELEASE;ORAL	1GM;EQ 2.5MG BASE	No	No	2023/08/09	2023/08/09	DR REDDYS LABS SA	Prescription
METFORMIN HYDROCHLORIDE; SAXAGLIPTIN HYDROCHLORIDE	207678	003	ANDA	METFORMIN HYDROCHLORIDE; SAXAGLIPTIN HYDROCHLORIDE	TABLET, EXTENDED RELEASE;ORAL	1GM;EQ 5MG BASE	No	Yes	2023/08/09	2023/08/09	DR REDDYS LABS SA	Prescription