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	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)
DAPAGLIFLOZIN	211523	001	ANDA	DAPAGLIFLOZIN	TABLET; ORAL	5MG	No	No	2023/03/03 (TA)	--	AIZANT	None (Tentative Approval)
DAPAGLIFLOZIN	211523	002	ANDA	DAPAGLIFLOZIN	TABLET; ORAL	10MG	No	No	2023/03/03 (TA)	--	AIZANT	None (Tentative Approval)
DAPAGLIFLOZIN AND SAXAGLIPTIN MONOHYDRATE	211532	001	ANDA	DAPAGLIFLOZIN, SAXAGLIPTIN MONOHYDRATE	TABLET; ORAL	5MG	No	No	2024/01/03 (TA)	--	LUPIN LTD	None (Tentative Approval)
DAPAGLIFLOZIN AND SAXAGLIPTIN MONOHYDRATE	211532	002	ANDA	DAPAGLIFLOZIN, SAXAGLIPTIN MONOHYDRATE	TABLET; ORAL	10MG	No	No	2024/01/03 (TA)	--	LUPIN LTD	None (Tentative Approval)
DAPAGLIFLOZIN	211582	001	ANDA	DAPAGLIFLOZIN	TABLET;ORAL	5MG	No	No	2024/02/28 (TA)	--	ZYDUS PHARMS	None (Tentative Approval)
DAPAGLIFLOZIN	211582	002	ANDA	DAPAGLIFLOZIN	TABLET;ORAL	10MG	No	No	2024/02/28 (TA)	--	ZYDUS PHARMS	None (Tentative Approval)