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 PHOSPHATE; METFORMIN HYDROCHLORIDE	204591	001	ANDA	SITAGLIPTIN PHOSPHATE;METFORMIN HYDROCHLORIDE	TABLET, EXTENDED RELEASE;ORAL	50MG;500MG	No	No	2015/09/29 (TA)	--	TEVA PHARMS USA INC	None (Tentative Approval)
SITAGLIPTIN PHOSPHATE; METFORMIN HYDROCHLORIDE	204591	002	ANDA	SITAGLIPTIN PHOSPHATE;METFORMIN HYDROCHLORIDE	TABLET, EXTENDED RELEASE;ORAL	50MG;1000MG	No	No	2015/09/29 (TA)	--	TEVA PHARMS USA INC	None (Tentative Approval)
SITAGLIPTIN PHOSPHATE; METFORMIN HYDROCHLORIDE	204591	003	ANDA	SITAGLIPTIN PHOSPHATE;METFORMIN HYDROCHLORIDE	TABLET, EXTENDED RELEASE;ORAL	100MG;1000MG	No	No	2015/09/29 (TA)	--	TEVA PHARMS USA INC	None (Tentative Approval)
SITAGLIPTIN PHOSPHATE; METFORMIN HYDROCHLORIDE	202365	001	ANDA	SITAGLIPTIN PHOSPHATE; METFORMIN HYDROCHLORIDE	TABLET;ORAL	50MG;500MG	No	No	2015/10/30 (TA)	--	WATSON LABS INC	None (Tentative Approval)
SITAGLIPTIN PHOSPHATE; METFORMIN HYDROCHLORIDE	202365	002	ANDA	SITAGLIPTIN PHOSPHATE; METFORMIN HYDROCHLORIDE	TABLET;ORAL	50MG;1000MG	No	No	2015/10/30 (TA)	--	WATSON LABS INC	None (Tentative Approval)