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	219408	001	ANDA	DAPAGLIFLOZIN	TABLET	5MG	No	No	2026/01/08 (TA)	--	SCIEGEN PHARMACEUTICALS INC	None (Tentative Approval)
DAPAGLIFLOZIN	219408	002	ANDA	DAPAGLIFLOZIN	TABLET	10MG	No	No	2026/01/08 (TA)	--	SCIEGEN PHARMACEUTICALS INC	None (Tentative Approval)
DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE	219755	002	ANDA	DAPAGLIFLOZIN, METFORMIN HYDROCHLORIDE	TABLET, EXTENDED RELEASE	10MG	No	No	2026/01/29 (TA)	--	INVENTIA HEALTHCARE LIMITED	None (Tentative Approval)
DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE	219755	003	ANDA	DAPAGLIFLOZIN, METFORMIN HYDROCHLORIDE	TABLET, EXTENDED RELEASE	5MG	No	No	2026/01/29 (TA)	--	INVENTIA HEALTHCARE LIMITED	None (Tentative Approval)
DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE	219755	004	ANDA	DAPAGLIFLOZIN, METFORMIN HYDROCHLORIDE	TABLET, EXTENDED RELEASE	500MG	No	No	2026/01/29 (TA)	--	INVENTIA HEALTHCARE LIMITED	None (Tentative Approval)
DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE	219755	005	ANDA	DAPAGLIFLOZIN, METFORMIN HYDROCHLORIDE	TABLET, EXTENDED RELEASE	2.5MG	No	No	2026/01/29 (TA)	--	INVENTIA HEALTHCARE LIMITED	None (Tentative Approval)
DAPAGLIFLOZIN	211582	001	ANDA	DAPAGLIFLOZIN	TABLET;ORAL	5MG	No	No	2026/02/02 (TA)	--	ZYDUS PHARMS	None (Tentative Approval)
DAPAGLIFLOZIN	211582	002	ANDA	DAPAGLIFLOZIN	TABLET;ORAL	10MG	No	No	2026/02/02 (TA)	--	ZYDUS PHARMS	None (Tentative Approval)