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
METFORMIN HYDROCHLORIDE AND SITAGLIPTIN PHOSPHATE	208535	001	ANDA	METFORMIN HYDROCHLORIDE;SITAGLIPTIN PHOSPHATE	TABLET;ORAL	50MG/500MG;50MG/1000MG	No	No	2017/07/03 (TA)	--	ZYDUS PHARMS USA INC	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)