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
NINTEDANIB	212732	001	ANDA	NINTEDANIB	CAPSULE;ORAL	EQ 100MG BASE	No	No	2020/08/04 (TA)	--	ACCORD HLTHCARE INC	None (Tentative Approval)
NINTEDANIB	212732	002	ANDA	NINTEDANIB	CAPSULE;ORAL	EQ 150MG BASE	No	No	2020/08/04 (TA)	--	ACCORD HLTHCARE INC	None (Tentative Approval)
NINTEDANIB	212555	002	ANDA	NINTEDANIB ESYLATE	CAPSULE;ORAL	EQ 150MG BASE	No	No	2021/06/22 (TA)	--	GLENMARK PHARMS LTD	None (Tentative Approval)
NINTEDANIB	215123	002	ANDA	NINTEDANIB	CAPSULE;ORAL	EQ 150MG BASE	No	No	2022/05/12 (TA)	--	EUGIA PHARMA SPECLTS	None (Tentative Approval)
NINTEDANIB	216915	001	ANDA	NINTEDANIB	CAPSULE;ORAL	100MG	No	No	2023/01/12 (TA)	--	LOTUS PHARM CO LTD	None (Tentative Approval)
NINTEDANIB	216915	002	ANDA	NINTEDANIB	CAPSULE;ORAL	150MG	No	No	2023/01/12 (TA)	--	LOTUS PHARM CO LTD	None (Tentative Approval)