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
SITAGLIPTIN	216337	002	ANDA	SITAGLIPTIN	TABLET; FILM COATED	50MG	No	No	2025/03/06 (TA)	--	SCIEGEN PHARMACEUTICALS INC	None (Tentative Approval)
SITAGLIPTIN	216337	003	ANDA	SITAGLIPTIN	TABLET; FILM COATED	100MG	No	No	2025/03/06 (TA)	--	SCIEGEN PHARMACEUTICALS INC	None (Tentative Approval)
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)
SITAGLIPTIN PHOSPHATE	211073	001	ANDA	SITAGLIPTIN PHOSPHATE	TABLET; ORAL	25MG	TBD	No	2025/04/02 (TA)	--	MACLEODS PHARMS LTD	None (Tentative Approval)
SITAGLIPTIN PHOSPHATE	211073	002	ANDA	SITAGLIPTIN PHOSPHATE	TABLET; ORAL	50MG	TBD	No	2025/04/02 (TA)	--	MACLEODS PHARMS LTD	None (Tentative Approval)
SITAGLIPTIN PHOSPHATE	211073	003	ANDA	SITAGLIPTIN PHOSPHATE	TABLET; ORAL	100MG	TBD	No	2025/04/02 (TA)	--	MACLEODS PHARMS LTD	None (Tentative Approval)
SITAGLIPTIN PHOSPHATE	214700	001	ANDA	SITAGLIPTIN PHOSPHATE	TABLET;FILM COATED	25MG	No	No	2025/05/12 (TA)	--	DR REDDYS LABS LTD	None (Tentative Approval)
SITAGLIPTIN PHOSPHATE	214700	002	ANDA	SITAGLIPTIN PHOSPHATE	TABLET;FILM COATED	50MG	No	No	2025/05/12 (TA)	--	DR REDDYS LABS LTD	None (Tentative Approval)
SITAGLIPTIN PHOSPHATE	214700	003	ANDA	SITAGLIPTIN PHOSPHATE	TABLET;FILM COATED	100MG	No	No	2025/05/12 (TA)	--	DR REDDYS LABS LTD	None (Tentative Approval)
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)