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
LINAGLIPTIN AND METFORMIN HYDROCHLORIDE	208427	003	ANDA	LINAGLIPTIN; METFORMIN HYDROCHLORIDE	TABLET;ORAL	2.5MG;1GM	No	No	2025/11/03	2025/11/03	DR REDDYS	Prescription
LINAGLIPTIN AND METFORMIN HYDROCHLORIDE	208459	001	ANDA	LINAGLIPTIN; METFORMIN HYDROCHLORIDE	TABLET;ORAL	2.5MG;500MG	No	No	2025/11/03	2025/11/03	MSN	Prescription
LINAGLIPTIN AND METFORMIN HYDROCHLORIDE	208459	002	ANDA	LINAGLIPTIN; METFORMIN HYDROCHLORIDE	TABLET;ORAL	2.5MG;850MG	No	No	2025/11/03	2025/11/03	MSN	Prescription
LINAGLIPTIN AND METFORMIN HYDROCHLORIDE	208459	003	ANDA	LINAGLIPTIN; METFORMIN HYDROCHLORIDE	TABLET;ORAL	2.5MG;1GM	No	No	2025/11/03	2025/11/03	MSN	Prescription
SITAGLIPTIN AND METFORMIN HYDROCHLORIDE	217395	002	ANDA	SITAGLIPTIN PHOSPHATE ANHYDROUS, METFORMIN HYDROCHLORIDE	TABLET	100MG	No	No	2025/11/17 (TA)	--	MSN LABORATORIES PRIVATE LTD	None (Tentative Approval)
SITAGLIPTIN AND METFORMIN HYDROCHLORIDE	217395	003	ANDA	SITAGLIPTIN PHOSPHATE ANHYDROUS, METFORMIN HYDROCHLORIDE	TABLET	500MG	No	No	2025/11/17 (TA)	--	MSN LABORATORIES PRIVATE LTD	None (Tentative Approval)
SITAGLIPTIN AND METFORMIN HYDROCHLORIDE	217395	004	ANDA	SITAGLIPTIN PHOSPHATE ANHYDROUS, METFORMIN HYDROCHLORIDE	TABLET	50MG	No	No	2025/11/17 (TA)	--	MSN LABORATORIES PRIVATE LTD	None (Tentative Approval)
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
DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE	211489	002	ANDA	DAPAGLIFLOZIN, METFORMIN HYDROCHLORIDE	TABLET	10MG	No	No	2025/12/10 (TA)	--	AUROBINDO PHARMA LIMITED	None (Tentative Approval)
DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE	211489	003	ANDA	DAPAGLIFLOZIN, METFORMIN HYDROCHLORIDE	TABLET	5MG	No	No	2025/12/10 (TA)	--	AUROBINDO PHARMA LIMITED	None (Tentative Approval)
DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE	211489	004	ANDA	DAPAGLIFLOZIN, METFORMIN HYDROCHLORIDE	TABLET	500MG	No	No	2025/12/10 (TA)	--	AUROBINDO PHARMA LIMITED	None (Tentative Approval)
DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE	211489	005	ANDA	DAPAGLIFLOZIN, METFORMIN HYDROCHLORIDE	TABLET	2.5MG	No	No	2025/12/10 (TA)	--	AUROBINDO PHARMA LIMITED	None (Tentative Approval)