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 AND METFORMIN HYDROCHLORIDE	212198	001	ANDA	EMPAGLIFLOZIN; METFORMIN HYDROCHLORIDE	TABLET;ORAL	5MG;500MG	No	No	2022/07/07	2022/07/07	ZYDUS PHARMS	Discontinued
EMPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE	212198	002	ANDA	EMPAGLIFLOZIN; METFORMIN HYDROCHLORIDE	TABLET;ORAL	5MG;1GM	No	No	2022/07/07	2022/07/07	ZYDUS PHARMS	Discontinued
EMPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE	212198	003	ANDA	EMPAGLIFLOZIN; METFORMIN HYDROCHLORIDE	TABLET;ORAL	12.5MG;500MG	No	No	2022/07/07	2022/07/07	ZYDUS PHARMS	Discontinued
EMPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE	212198	004	ANDA	EMPAGLIFLOZIN; METFORMIN HYDROCHLORIDE	TABLET;ORAL	12.5MG;1GM	No	No	2022/07/07	2022/07/07	ZYDUS PHARMS	Discontinued
EMPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE	220511	002	ANDA	EMPAGLIFLOZIN, METFORMIN HYDROCHLORIDE	TABLET, EXTENDED RELEASE	10MG	No	No	2026/02/25 (TA)	--	AJANTA PHARMA LTD	None (Tentative Approval)
EMPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE	220511	003	ANDA	EMPAGLIFLOZIN, METFORMIN HYDROCHLORIDE	TABLET, EXTENDED RELEASE	12.5MG	No	No	2026/02/25 (TA)	--	AJANTA PHARMA LTD	None (Tentative Approval)
EMPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE	220511	004	ANDA	EMPAGLIFLOZIN, METFORMIN HYDROCHLORIDE	TABLET, EXTENDED RELEASE	25MG	No	No	2026/02/25 (TA)	--	AJANTA PHARMA LTD	None (Tentative Approval)