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; LINAGLIPTIN; METFORMIN HYDROCHLORIDE	217049	001	ANDA	EMPAGLIFLOZIN;LINAGLIPTIN;METFORMIN HYDROCHLORIDE	TABLET, EXTENDED RELEASE;ORAL	5MG;2.5MG;1000MG	No	No	2025/11/25 (TA)	--	ZYDUS PHARMS USA INC	None (Tentative Approval)
EMPAGLIFLOZIN; LINAGLIPTIN; METFORMIN HYDROCHLORIDE	217049	002	ANDA	EMPAGLIFLOZIN;LINAGLIPTIN;METFORMIN HYDROCHLORIDE	TABLET, EXTENDED RELEASE;ORAL	10MG;5MG;1000MG	No	No	2025/11/25 (TA)	--	ZYDUS PHARMS USA INC	None (Tentative Approval)
EMPAGLIFLOZIN; LINAGLIPTIN; METFORMIN HYDROCHLORIDE	217049	003	ANDA	EMPAGLIFLOZIN;LINAGLIPTIN;METFORMIN HYDROCHLORIDE	TABLET, EXTENDED RELEASE;ORAL	12.5MG;2.5MG;1000MG	No	No	2025/11/25 (TA)	--	ZYDUS PHARMS USA INC	None (Tentative Approval)
EMPAGLIFLOZIN; LINAGLIPTIN; METFORMIN HYDROCHLORIDE	217049	004	ANDA	EMPAGLIFLOZIN;LINAGLIPTIN;METFORMIN HYDROCHLORIDE	TABLET, EXTENDED RELEASE;ORAL	25MG;5MG;1000MG	No	No	2025/11/25 (TA)	--	ZYDUS PHARMS USA INC	None (Tentative Approval)
SITAGLIPTIN AND METFORMIN HYDROCHLORIDE	217017	002	ANDA	METFORMIN HYDROCHLORIDE, SITAGLIPTIN PHOSPHATE	TABLET, EXTENDED RELEASE	100MG	No	No	2025/11/26 (TA)	--	ZHEJIANG JIUZHOU BIOPHARMA CO., LTD.	None (Tentative Approval)
SITAGLIPTIN AND METFORMIN HYDROCHLORIDE	217017	003	ANDA	METFORMIN HYDROCHLORIDE, SITAGLIPTIN PHOSPHATE	TABLET, EXTENDED RELEASE	500MG	No	No	2025/11/26 (TA)	--	ZHEJIANG JIUZHOU BIOPHARMA CO., LTD.	None (Tentative Approval)
SITAGLIPTIN AND METFORMIN HYDROCHLORIDE	217017	004	ANDA	METFORMIN HYDROCHLORIDE, SITAGLIPTIN PHOSPHATE	TABLET, EXTENDED RELEASE	50MG	No	No	2025/11/26 (TA)	--	ZHEJIANG JIUZHOU BIOPHARMA CO., LTD.	None (Tentative Approval)
SITAGLIPTIN AND METFORMIN HYDROCHLORIDE	202388	001	ANDA	METFORMIN HYDROCHLORIDE; SITAGLIPTIN PHOSPHATE	TABLET;ORAL	500MG;EQ 50MG BASE	No	No	2025/12/02	2025/12/02	SANDOZ	Prescription
SITAGLIPTIN AND METFORMIN HYDROCHLORIDE	202388	002	ANDA	METFORMIN HYDROCHLORIDE; SITAGLIPTIN PHOSPHATE	TABLET;ORAL	1GM;EQ 50MG BASE	No	No	2025/12/02	2025/12/02	SANDOZ	Prescription
SITAGLIPTIN AND METFORMIN HYDROCHLORIDE	215220	002	ANDA	SITAGLIPTIN; METFORMIN HYDROCHLORIDE	TABLET; ORAL	50MG/1000MG	No	No	2025/12/31 (TA)	--	AJANTA PHARMA LTD	None (Tentative Approval)
DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE	219755	002	ANDA	DAPAGLIFLOZIN, METFORMIN HYDROCHLORIDE	TABLET, EXTENDED RELEASE	10MG	No	No	2026/01/29 (TA)	--	INVENTIA HEALTHCARE LIMITED	None (Tentative Approval)
DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE	219755	003	ANDA	DAPAGLIFLOZIN, METFORMIN HYDROCHLORIDE	TABLET, EXTENDED RELEASE	5MG	No	No	2026/01/29 (TA)	--	INVENTIA HEALTHCARE LIMITED	None (Tentative Approval)
DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE	219755	004	ANDA	DAPAGLIFLOZIN, METFORMIN HYDROCHLORIDE	TABLET, EXTENDED RELEASE	500MG	No	No	2026/01/29 (TA)	--	INVENTIA HEALTHCARE LIMITED	None (Tentative Approval)
DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE	219755	005	ANDA	DAPAGLIFLOZIN, METFORMIN HYDROCHLORIDE	TABLET, EXTENDED RELEASE	2.5MG	No	No	2026/01/29 (TA)	--	INVENTIA HEALTHCARE LIMITED	None (Tentative Approval)
SITAGLIPTIN AND METFORMIN HYDROCHLORIDE	214859	002	ANDA	SITAGLIPTIN AND METFORMIN HYDROCHLORIDE	TABLET	500MG	No	No	2026/02/24 (TA)	--	AUROBINDO PHARMA LIMITED	None (Tentative Approval)
SITAGLIPTIN AND METFORMIN HYDROCHLORIDE	214859	003	ANDA	SITAGLIPTIN AND METFORMIN HYDROCHLORIDE	TABLET	1000MG	No	No	2026/02/24 (TA)	--	AUROBINDO PHARMA LIMITED	None (Tentative Approval)
EMPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE	220511	001	ANDA	EMPAGLIFLOZIN, METFORMIN HYDROCHLORIDE	TABLET, EXTENDED RELEASE	5MG/1000MG	No	No	2026/02/25 (TA)	--	AJANTA PHARMA LTD	None (Tentative Approval)
EMPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE	220511	002	ANDA	EMPAGLIFLOZIN, METFORMIN HYDROCHLORIDE	TABLET, EXTENDED RELEASE	10MG/1000MG	No	No	2026/02/25 (TA)	--	AJANTA PHARMA LTD	None (Tentative Approval)
EMPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE	220511	003	ANDA	EMPAGLIFLOZIN, METFORMIN HYDROCHLORIDE	TABLET, EXTENDED RELEASE	12.5MG/1000MG	No	No	2026/02/25 (TA)	--	AJANTA PHARMA LTD	None (Tentative Approval)
EMPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE	220511	004	ANDA	EMPAGLIFLOZIN, METFORMIN HYDROCHLORIDE	TABLET, EXTENDED RELEASE	25MG/1000MG	No	No	2026/02/25 (TA)	--	AJANTA PHARMA LTD	None (Tentative Approval)