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
SAXAGLIPTIN AND METFORMIN HYDROCHLORIDE	206081	001	ANDA	METFORMIN HYDROCHLORIDE; SAXAGLIPTIN HYDROCHLORIDE	TABLET, EXTENDED RELEASE;ORAL	500MG;EQ 5MG BASE	No	No	2023/07/31	2023/07/31	SUN PHARM	Prescription
SAXAGLIPTIN AND METFORMIN HYDROCHLORIDE	206081	002	ANDA	METFORMIN HYDROCHLORIDE; SAXAGLIPTIN HYDROCHLORIDE	TABLET, EXTENDED RELEASE;ORAL	1GM;EQ 2.5MG BASE	No	No	2023/07/31	2023/07/31	SUN PHARM	Prescription
SAXAGLIPTIN AND METFORMIN HYDROCHLORIDE	206081	003	ANDA	METFORMIN HYDROCHLORIDE; SAXAGLIPTIN HYDROCHLORIDE	TABLET, EXTENDED RELEASE;ORAL	1GM;EQ 5MG BASE	No	No	2023/07/31	2023/07/31	SUN PHARM	Prescription
METFORMIN HYDROCHLORIDE; SAXAGLIPTIN HYDROCHLORIDE	207678	001	ANDA	METFORMIN HYDROCHLORIDE; SAXAGLIPTIN HYDROCHLORIDE	TABLET, EXTENDED RELEASE;ORAL	500MG;EQ 5MG BASE	No	No	2023/08/09	2023/08/09	DR REDDYS LABS SA	Prescription
METFORMIN HYDROCHLORIDE; SAXAGLIPTIN HYDROCHLORIDE	207678	002	ANDA	METFORMIN HYDROCHLORIDE; SAXAGLIPTIN HYDROCHLORIDE	TABLET, EXTENDED RELEASE;ORAL	1GM;EQ 2.5MG BASE	No	No	2023/08/09	2023/08/09	DR REDDYS LABS SA	Prescription
METFORMIN HYDROCHLORIDE; SAXAGLIPTIN HYDROCHLORIDE	207678	003	ANDA	METFORMIN HYDROCHLORIDE; SAXAGLIPTIN HYDROCHLORIDE	TABLET, EXTENDED RELEASE;ORAL	1GM;EQ 5MG BASE	No	Yes	2023/08/09	2023/08/09	DR REDDYS LABS SA	Prescription
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)