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
DAPAGLIFLOZIN;METFORMIN HYDROCHLORIDE	211583	001	ANDA	DAPAGLIFLOZIN;METFORMIN HYDROCHLORIDE	TABLET, EXTENDED RELEASE;ORAL	2.5MG/1000MG	No	No	2022/08/03 (TA)	--	TEVA PHARMS USA INC	None (Tentative Approval)
DAPAGLIFLOZIN;METFORMIN HYDROCHLORIDE	211583	002	ANDA	DAPAGLIFLOZIN;METFORMIN HYDROCHLORIDE	TABLET, EXTENDED RELEASE;ORAL	5MG/500MG	No	No	2022/08/03 (TA)	--	TEVA PHARMS USA INC	None (Tentative Approval)
DAPAGLIFLOZIN;METFORMIN HYDROCHLORIDE	211583	003	ANDA	DAPAGLIFLOZIN;METFORMIN HYDROCHLORIDE	TABLET, EXTENDED RELEASE;ORAL	5MG/1000MG	No	No	2022/08/03 (TA)	--	TEVA PHARMS USA INC	None (Tentative Approval)
DAPAGLIFLOZIN;METFORMIN HYDROCHLORIDE	211583	004	ANDA	DAPAGLIFLOZIN;METFORMIN HYDROCHLORIDE	TABLET, EXTENDED RELEASE;ORAL	10MG/500MG	No	No	2022/08/03 (TA)	--	TEVA PHARMS USA INC	None (Tentative Approval)
DAPAGLIFLOZIN;METFORMIN HYDROCHLORIDE	211583	005	ANDA	DAPAGLIFLOZIN;METFORMIN HYDROCHLORIDE	TABLET, EXTENDED RELEASE;ORAL	10MG/1000MG	No	No	2022/08/03 (TA)	--	TEVA PHARMS USA INC	None (Tentative Approval)