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
VORTIOXETINE HYDROBROMIDE	211146	001	ANDA	VORTIOXETINE HYDROBROMIDE	TABLET;ORAL	EQ 5MG BASE	No	No	2024/04/02 (TA)	--	ZYDUS PHARMS	Discontinued
VORTIOXETINE HYDROBROMIDE	211146	002	ANDA	VORTIOXETINE HYDROBROMIDE	TABLET;ORAL	EQ 10MG BASE	No	No	2024/04/02 (TA)	--	ZYDUS PHARMS	Discontinued
VORTIOXETINE HYDROBROMIDE	211146	003	ANDA	VORTIOXETINE HYDROBROMIDE	TABLET;ORAL	EQ 20MG BASE	No	No	2024/04/02 (TA)	--	ZYDUS PHARMS	Discontinued
VORTIOXETINE HYDROBROMIDE	211101	002	ANDA	VORTIOXETINE HYDROBROMIDE	TABLET;ORAL	10MG	No	No	2025/11/03 (TA)	--	MSN LABORATORIES PRIVATE LTD	None (Tentative Approval)
VORTIOXETINE HYDROBROMIDE	211101	003	ANDA	VORTIOXETINE HYDROBROMIDE	TABLET;ORAL	20MG	No	No	2025/11/03 (TA)	--	MSN LABORATORIES PRIVATE LTD	None (Tentative Approval)
VORTIOXETINE HYDROBROMIDE	211165	001	ANDA	VORTIOXETINE	TABLET:FILM COATED	20MG	No	No	2025/11/10 (TA)	--	MACLEODS PHARMACEUTICALS LTD	None (Tentative Approval)
VORTIOXETINE HYDROBROMIDE	211165	002	ANDA	VORTIOXETINE	TABLET:FILM COATED	10MG	No	No	2025/11/10 (TA)	--	MACLEODS PHARMACEUTICALS LTD	None (Tentative Approval)
VORTIOXETINE HYDROBROMIDE	211165	003	ANDA	VORTIOXETINE	TABLET:FILM COATED	15MG	No	No	2025/11/10 (TA)	--	MACLEODS PHARMACEUTICALS LTD	None (Tentative Approval)
VORTIOXETINE HYDROBROMIDE	211165	004	ANDA	VORTIOXETINE	TABLET:FILM COATED	5MG	No	No	2025/11/10 (TA)	--	MACLEODS PHARMACEUTICALS LTD	None (Tentative Approval)