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 AND METFORMIN HYDROCHLORIDE	211559	002	ANDA	DAPAGLIFLOZIN, METFORMIN HYDROCHLORIDE	TABLET, EXTENDED RELEASE	10MG	No	No	2025/08/19 (TA)	--	MACLEODS PHARMACEUTICALS LTD	None (Tentative Approval)
DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE	211559	003	ANDA	DAPAGLIFLOZIN, METFORMIN HYDROCHLORIDE	TABLET, EXTENDED RELEASE	5MG	No	No	2025/08/19 (TA)	--	MACLEODS PHARMACEUTICALS LTD	None (Tentative Approval)
DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE	211559	004	ANDA	DAPAGLIFLOZIN, METFORMIN HYDROCHLORIDE	TABLET, EXTENDED RELEASE	500MG	No	No	2025/08/19 (TA)	--	MACLEODS PHARMACEUTICALS LTD	None (Tentative Approval)
DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE	211559	005	ANDA	DAPAGLIFLOZIN, METFORMIN HYDROCHLORIDE	TABLET, EXTENDED RELEASE	2.5MG	No	No	2025/08/19 (TA)	--	MACLEODS PHARMACEUTICALS LTD	None (Tentative Approval)
DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE	211489	002	ANDA	DAPAGLIFLOZIN, METFORMIN HYDROCHLORIDE	TABLET	10MG	No	No	2025/12/10 (TA)	--	AUROBINDO PHARMA LIMITED	None (Tentative Approval)
DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE	211489	003	ANDA	DAPAGLIFLOZIN, METFORMIN HYDROCHLORIDE	TABLET	5MG	No	No	2025/12/10 (TA)	--	AUROBINDO PHARMA LIMITED	None (Tentative Approval)
DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE	211489	004	ANDA	DAPAGLIFLOZIN, METFORMIN HYDROCHLORIDE	TABLET	500MG	No	No	2025/12/10 (TA)	--	AUROBINDO PHARMA LIMITED	None (Tentative Approval)
DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE	211489	005	ANDA	DAPAGLIFLOZIN, METFORMIN HYDROCHLORIDE	TABLET	2.5MG	No	No	2025/12/10 (TA)	--	AUROBINDO PHARMA LIMITED	None (Tentative Approval)