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	212243	001	ANDA	EMPAGLIFLOZIN;METFORMIN HYDROCHLORIDE	TABLET, EXTENDED RELEASE;ORAL	5MG;1000MG	No	No	2024/12/26 (TA)	--	CIPLA LTD	None (Tentative Approval)
METFORMIN HYDROCHLORIDE AND SITAGLIPTIN PHOSPHATE	212338	001	ANDA	METFORMIN HYDROCHLORIDE \|\| SITAGLIPTIN	TABLET:FILM COATED	50MG	No	No	2025/01/07 (TA)	--	MACLEODS PHARMS LTD	None (Tentative Approval)
METFORMIN HYDROCHLORIDE AND SITAGLIPTIN PHOSPHATE	212338	002	ANDA	METFORMIN HYDROCHLORIDE \|\| SITAGLIPTIN	TABLET;FILM COATED	500MG	No	No	2025/01/07 (TA)	--	MACLEODS PHARMS LTD	None (Tentative Approval)
METFORMIN HYDROCHLORIDE AND SITAGLIPTIN PHOSPHATE	212338	003	ANDA	METFORMIN HYDROCHLORIDE \|\| SITAGLIPTIN	TABLET;FILM COATED	1000MG	No	No	2025/01/07 (TA)	--	MACLEODS PHARMS LTD	None (Tentative Approval)
METFORMIN HYDROCHLORIDE	215008	001	ANDA	METFORMIN HYDROCHLORIDE	SOLUTION;ORAL	500MG/5ML	No	No	2025/03/13	2025/03/13	ANNORA PHARMA	Prescription
SITAGLIPTIN PHOSPHATE AND METFORMIN HYDROCHLORIDE	216885	001	ANDA	METFORMIN HYDROCHLORIDE, SITAGLIPTIN PHOSPHATE	TABLET;FILM COATED	1000MG	No	No	2025/03/13 (TA)	--	PRINSTON PHARMACEUTICAL INC	None (Tentative Approval)
SITAGLIPTIN PHOSPHATE AND METFORMIN HYDROCHLORIDE	216885	002	ANDA	METFORMIN HYDROCHLORIDE, SITAGLIPTIN PHOSPHATE	TABLET;FILM COATED	50MG	No	No	2025/03/13 (TA)	--	PRINSTON PHARMACEUTICAL INC	None (Tentative Approval)
SITAGLIPTIN PHOSPHATE AND METFORMIN HYDROCHLORIDE	216885	003	ANDA	METFORMIN HYDROCHLORIDE, SITAGLIPTIN PHOSPHATE	TABLET;FILM COATED	500MG	No	No	2025/03/13 (TA)	--	PRINSTON PHARMACEUTICAL INC	None (Tentative Approval)
METFORMIN HYDROCHLORIDE	219151	001	ANDA	METFORMIN HYDROCHLORIDE	SOLUTION;ORAL	500MG/5ML	No	No	2025/04/14	2025/04/14	BIONPHARMA	Prescription
SITAGLIPTIN AND METFORMIN HYDROCHLORIDE	218069	002	ANDA	METFORMIN HYDROCHLORIDE, SITAGLIPTIN	TABLET, EXTENDED RELEASE	EQ 100MG BASE TABLET	No	No	2025/05/28 (TA)	--	NOVAST LABS LTD	None (Tentative Approval)
SITAGLIPTIN AND METFORMIN HYDROCHLORIDE	218069	003	ANDA	METFORMIN HYDROCHLORIDE, SITAGLIPTIN	TABLET, EXTENDED RELEASE	500MG	No	No	2025/05/28 (TA)	--	NOVAST LABS LTD	None (Tentative Approval)
SITAGLIPTIN AND METFORMIN HYDROCHLORIDE	218069	004	ANDA	METFORMIN HYDROCHLORIDE, SITAGLIPTIN	TABLET, EXTENDED RELEASE	50MG	No	No	2025/05/28 (TA)	--	NOVAST LABS LTD	None (Tentative Approval)
SITAGLIPTIN AND METFORMIN HYDROCHLORIDE	218069	005	ANDA	METFORMIN HYDROCHLORIDE, SITAGLIPTIN	TABLET, EXTENDED RELEASE	1000MG	No	No	2025/05/28 (TA)	--	NOVAST LABS LTD	None (Tentative Approval)
SITAGLIPTIN AND METFORMIN HYDROCHLORIDE	204144	001	ANDA	METFORMIN HYDROCHLORIDE; SITAGLIPTIN PHOSPHATE	TABLET, EXTENDED RELEASE;ORAL	500MG;EQ 50MG BASE	No	No	2025/06/04	2025/06/04	PH HEALTH	Discontinued
SITAGLIPTIN AND METFORMIN HYDROCHLORIDE	204144	002	ANDA	METFORMIN HYDROCHLORIDE; SITAGLIPTIN PHOSPHATE	TABLET, EXTENDED RELEASE;ORAL	1GM;EQ 50MG BASE	No	No	2025/06/04	2025/06/04	PH HEALTH	Discontinued
SITAGLIPTIN AND METFORMIN HYDROCHLORIDE	204144	003	ANDA	METFORMIN HYDROCHLORIDE; SITAGLIPTIN PHOSPHATE	TABLET, EXTENDED RELEASE;ORAL	1GM;EQ 100MG BASE	No	No	2025/06/04	2025/06/04	PH HEALTH	Discontinued
SITAGLIPTIN AND METFORMIN HYDROCHLORIDE	216288	002	ANDA	METFORMIN HYDROCHLORIDE, SITAGLIPTIN	TABLET, COATED	50MG	No	No	2025/07/14 (TA)	--	MSN LABORATORIES PRIVATE LTD	None (Tentative Approval)
SITAGLIPTIN AND METFORMIN HYDROCHLORIDE	216288	003	ANDA	METFORMIN HYDROCHLORIDE, SITAGLIPTIN	TABLET, COATED	500MG	No	No	2025/07/14 (TA)	--	MSN LABORATORIES PRIVATE LTD	None (Tentative Approval)
EMPAGLIFLOZIN; METFORMIN HYDROCHLORIDE	212373	001	ANDA	EMPAGLIFLOZIN;METFORMIN HYDROCHLORIDE	TABLET;ORAL	5MG;500MG	No	No	2025/07/16 (TA)	--	MACLEODS PHARMS LTD	None (Tentative Approval)
EMPAGLIFLOZIN; METFORMIN HYDROCHLORIDE	212373	002	ANDA	EMPAGLIFLOZIN;METFORMIN HYDROCHLORIDE	TABLET;ORAL	5MG;1000MG	No	No	2025/07/16 (TA)	--	MACLEODS PHARMS LTD	None (Tentative Approval)