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
EMPAGLIFLOZIN; LINAGLIPTIN	212354	001	ANDA	EMPAGLIFLOZIN; LINAGLIPTIN	TABLET; ORAL	10MG/5MG	No	No	2020/08/26 (TA)	--	KINAPSE LIMITED	None (Tentative Approval)
EMPAGLIFLOZIN; LINAGLIPTIN	212354	002	ANDA	EMPAGLIFLOZIN; LINAGLIPTIN	TABLET;ORAL	25MG/5MG	No	No	2020/08/26 (TA)	--	KINAPSE LIMITED	None (Tentative Approval)
EMPAGLIFLOZIN; LINAGLIPTIN	212364	001	ANDA	EMPAGLIFLOZIN;LINAGLIPTIN	TABLET;ORAL	10MG; 5MG	No	No	2021/03/30 (TA)	--	ANNORA PHARMA	None (Tentative Approval)
EMPAGLIFLOZIN; LINAGLIPTIN	212364	002	ANDA	EMPAGLIFLOZIN;LINAGLIPTIN	TABLET;ORAL	25MG; 5MG	No	No	2021/03/30 (TA)	--	ANNORA PHARMA	None (Tentative Approval)
EMPAGLIFLOZIN; LINAGLIPTIN	212366	001	ANDA	EMPAGLIFLOZIN;LINAGLIPTIN	TABLET;ORAL	10MG/5MG	No	No	2022/08/09 (TA)	--	ALKEM LABS LTD	None (Tentative Approval)
EMPAGLIFLOZIN; LINAGLIPTIN	212366	002	ANDA	EMPAGLIFLOZIN;LINAGLIPTIN	TABLET;ORAL	25MG/5MG	No	No	2022/08/09 (TA)	--	ALKEM LABS LTD	None (Tentative Approval)
EMPAGLIFLOZIN; LINAGLIPTIN; METFORMIN HYDROCHLORIDE	217049	001	ANDA	EMPAGLIFLOZIN;LINAGLIPTIN;METFORMIN HYDROCHLORIDE	TABLET, EXTENDED RELEASE;ORAL	5MG;2.5MG;1000MG	No	No	2024/03/06 (TA)	--	ZYDUS PHARMS USA INC	None (Tentative Approval)
EMPAGLIFLOZIN; LINAGLIPTIN; METFORMIN HYDROCHLORIDE	217049	002	ANDA	EMPAGLIFLOZIN;LINAGLIPTIN;METFORMIN HYDROCHLORIDE	TABLET, EXTENDED RELEASE;ORAL	10MG;5MG;1000MG	No	No	2024/03/06 (TA)	--	ZYDUS PHARMS USA INC	None (Tentative Approval)
EMPAGLIFLOZIN; LINAGLIPTIN; METFORMIN HYDROCHLORIDE	217049	003	ANDA	EMPAGLIFLOZIN;LINAGLIPTIN;METFORMIN HYDROCHLORIDE	TABLET, EXTENDED RELEASE;ORAL	12.5MG;2.5MG;1000MG	No	No	2024/03/06 (TA)	--	ZYDUS PHARMS USA INC	None (Tentative Approval)
EMPAGLIFLOZIN; LINAGLIPTIN; METFORMIN HYDROCHLORIDE	217049	004	ANDA	EMPAGLIFLOZIN;LINAGLIPTIN;METFORMIN HYDROCHLORIDE	TABLET, EXTENDED RELEASE;ORAL	25MG;5MG;1000MG	No	No	2024/03/06 (TA)	--	ZYDUS PHARMS USA INC	None (Tentative Approval)