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	211489	001	ANDA	DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE	TABLET, EXTENDED RELEASE;ORAL	5MG;500MG	No	No	2026/04/06	2026/04/06	AUROBINDO PHARMA	Prescription
DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE	211489	002	ANDA	DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE	TABLET, EXTENDED RELEASE;ORAL	5MG;1GM	No	No	2026/04/06	2026/04/06	AUROBINDO PHARMA	Prescription
DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE	211489	003	ANDA	DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE	TABLET, EXTENDED RELEASE;ORAL	10MG;500MG	No	No	2026/04/06	2026/04/06	AUROBINDO PHARMA	Prescription
DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE	211489	004	ANDA	DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE	TABLET, EXTENDED RELEASE;ORAL	10MG;1GM	No	No	2026/04/06	2026/04/06	AUROBINDO PHARMA	Prescription
DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE	211489	005	ANDA	DAPAGLIFLOZIN, METFORMIN HYDROCHLORIDE	TABLET	2.5MG	No	No	2026/04/06	--	AUROBINDO PHARMA	None (Tentative Approval)
DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE	211491	001	ANDA	DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE	TABLET, EXTENDED RELEASE;ORAL	5MG;1GM	No	No	2026/04/06	2026/04/06	SUN PHARM	Prescription
DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE	211491	001	ANDA	DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE	TABLET, EXTENDED RELEASE;ORAL	5MG;1GM	No	No	2026/04/06 (TA)	2026/04/06	SUN PHARM	Prescription
DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE	211491	002	ANDA	DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE	TABLET, EXTENDED RELEASE;ORAL	10MG;500MG	No	No	2026/04/06	2026/04/06	SUN PHARM	Prescription
DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE	211491	002	ANDA	DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE	TABLET, EXTENDED RELEASE;ORAL	10MG;500MG	No	No	2026/04/06 (TA)	2026/04/06	SUN PHARM	Prescription
DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE	211491	003	ANDA	DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE	TABLET, EXTENDED RELEASE;ORAL	10MG;1GM	No	No	2026/04/06	2026/04/06	SUN PHARM	Prescription
DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE	211491	003	ANDA	DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE	TABLET, EXTENDED RELEASE;ORAL	10MG;1GM	No	No	2026/04/06 (TA)	2026/04/06	SUN PHARM	Prescription
DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE	211536	001	ANDA	DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE	TABLET, EXTENDED RELEASE;ORAL	5MG;500MG	No	No	2026/04/06	2026/04/06	CIPLA LTD	Prescription
DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE	211536	002	ANDA	DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE	TABLET, EXTENDED RELEASE;ORAL	10MG;500MG	No	No	2026/04/06	2026/04/06	CIPLA LTD	Prescription
DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE	211536	003	ANDA	DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE	TABLET, EXTENDED RELEASE;ORAL	10MG;1GM	No	No	2026/04/06	2026/04/06	CIPLA LTD	Prescription
DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE	211559	001	ANDA	DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE	TABLET, EXTENDED RELEASE;ORAL	5MG;500MG	No	No	2026/04/06	2026/04/06	MACLEODS PHARMS LTD	Prescription
DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE	211559	002	ANDA	DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE	TABLET, EXTENDED RELEASE;ORAL	5MG;1GM	No	No	2026/04/06	2026/04/06	MACLEODS PHARMS LTD	Prescription
DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE	211559	003	ANDA	DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE	TABLET, EXTENDED RELEASE;ORAL	10MG;500MG	No	No	2026/04/06	2026/04/06	MACLEODS PHARMS LTD	Prescription
DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE	211559	004	ANDA	DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE	TABLET, EXTENDED RELEASE;ORAL	10MG;1GM	No	No	2026/04/06	2026/04/06	MACLEODS PHARMS LTD	Prescription
DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE	211563	001	ANDA	DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE	TABLET, EXTENDED RELEASE;ORAL	5MG;500MG	No	No	2026/04/06	2026/04/06	ALKEM LABS LTD	Prescription
DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE	211563	001	ANDA	DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE	TABLET, EXTENDED RELEASE;ORAL	5MG;500MG	No	No	2026/04/06 (TA)	2026/04/06	ALKEM LABS LTD	Prescription