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	211579	002	ANDA	DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE	TABLET, EXTENDED RELEASE;ORAL	5MG;1GM	No	No	2026/04/06	2026/04/06	LUPIN	Prescription
DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE	211579	002	ANDA	DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE	TABLET, EXTENDED RELEASE;ORAL	5MG;1GM	No	No	2026/04/06 (TA)	2026/04/06	LUPIN	Prescription
DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE	211579	003	ANDA	DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE	TABLET, EXTENDED RELEASE;ORAL	10MG;500MG	No	No	2026/04/06	2026/04/06	LUPIN	Prescription
DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE	211579	003	ANDA	DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE	TABLET, EXTENDED RELEASE;ORAL	10MG;500MG	No	No	2026/04/06 (TA)	2026/04/06	LUPIN	Prescription
DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE	211579	004	ANDA	DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE	TABLET, EXTENDED RELEASE;ORAL	10MG;1GM	No	No	2026/04/06	2026/04/06	LUPIN	Prescription
DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE	211579	004	ANDA	DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE	TABLET, EXTENDED RELEASE;ORAL	10MG;1GM	No	No	2026/04/06 (TA)	2026/04/06	LUPIN	Prescription
DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE	211583	001	ANDA	DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE	TABLET, EXTENDED RELEASE;ORAL	2.5MG;1GM	No	No	2026/04/06	2026/04/06	TEVA PHARMS USA INC	Prescription
DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE	211583	002	ANDA	DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE	TABLET, EXTENDED RELEASE;ORAL	5MG;500MG	No	No	2026/04/06	2026/04/06	TEVA PHARMS USA INC	Prescription
DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE	211583	003	ANDA	DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE	TABLET, EXTENDED RELEASE;ORAL	5MG;1GM	No	No	2026/04/06	2026/04/06	TEVA PHARMS USA INC	Prescription
DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE	211583	004	ANDA	DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE	TABLET, EXTENDED RELEASE;ORAL	10MG;500MG	No	No	2026/04/06	2026/04/06	TEVA PHARMS USA INC	Prescription
DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE	211583	005	ANDA	DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE	TABLET, EXTENDED RELEASE;ORAL	10MG;1GM	No	No	2026/04/06	2026/04/06	TEVA PHARMS USA INC	Prescription
DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE	211595	001	ANDA	DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE	TABLET, EXTENDED RELEASE;ORAL	5MG;1GM	No	No	2026/04/06	2026/04/06	CIPLA	Prescription
DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE	219755	002	ANDA	DAPAGLIFLOZIN, METFORMIN HYDROCHLORIDE	TABLET, EXTENDED RELEASE	10MG	No	No	2026/04/09 (TA)	--	INVENTIA HEALTHCARE LIMITED	None (Tentative Approval)
DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE	219755	003	ANDA	DAPAGLIFLOZIN, METFORMIN HYDROCHLORIDE	TABLET, EXTENDED RELEASE	5MG	No	No	2026/04/09 (TA)	--	INVENTIA HEALTHCARE LIMITED	None (Tentative Approval)
DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE	219755	004	ANDA	DAPAGLIFLOZIN, METFORMIN HYDROCHLORIDE	TABLET, EXTENDED RELEASE	500MG	No	No	2026/04/09 (TA)	--	INVENTIA HEALTHCARE LIMITED	None (Tentative Approval)
DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE	219755	005	ANDA	DAPAGLIFLOZIN, METFORMIN HYDROCHLORIDE	TABLET, EXTENDED RELEASE	2.5MG	No	No	2026/04/09 (TA)	--	INVENTIA HEALTHCARE LIMITED	None (Tentative Approval)
SITAGLIPTIN AND METFORMIN HYDROCHLORIDE	202426	001	ANDA	METFORMIN HYDROCHLORIDE; SITAGLIPTIN PHOSPHATE	TABLET;ORAL	500MG;EQ 50MG BASE	No	No	2026/04/30	2026/04/30	APOTEX	Prescription
SITAGLIPTIN AND METFORMIN HYDROCHLORIDE	202426	002	ANDA	METFORMIN HYDROCHLORIDE; SITAGLIPTIN PHOSPHATE	TABLET;ORAL	1GM;EQ 50MG BASE	No	No	2026/04/30	2026/04/30	APOTEX	Prescription
SITAGLIPTIN AND METFORMIN HYDROCHLORIDE	215411	002	ANDA	SITAGLIPTIN, METFORMIN HYDROCHLORIDE	TABLET	50MG	No	No	2026/05/07 (TA)	--	INVENTIA HEALTHCARE LIMITED	None (Tentative Approval)
SITAGLIPTIN AND METFORMIN HYDROCHLORIDE	215411	003	ANDA	SITAGLIPTIN, METFORMIN HYDROCHLORIDE	TABLET	500MG	No	No	2026/05/07 (TA)	--	INVENTIA HEALTHCARE LIMITED	None (Tentative Approval)