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	211089	001	ANDA	VORTIOXETINE	TABLET;ORAL	5MG	No	No	2019/08/21 (TA)	--	ALKEM LABS LTD	None (Tentative Approval)
VORTIOXETINE	211089	002	ANDA	VORTIOXETINE	TABLET;ORAL	10MG	No	No	2019/08/21 (TA)	--	ALKEM LABS LTD	None (Tentative Approval)
VORTIOXETINE	211089	003	ANDA	VORTIOXETINE	TABLET;ORAL	15MG	No	No	2019/08/21 (TA)	--	ALKEM LABS LTD	None (Tentative Approval)
VORTIOXETINE	211089	004	ANDA	VORTIOXETINE	TABLET;ORAL	20MG	No	No	2019/08/21 (TA)	--	ALKEM LABS LTD	None (Tentative Approval)
VORTIOXETINE	211085	001	ANDA	VORTIOXETINE	TABLET;ORAL	5MG	No	No	2019/08/23 (TA)	--	CIPLA LTD	None (Tentative Approval)
VORTIOXETINE HYDROBROMIDE	211101	002	ANDA	VORTIOXETINE HYDROBROMIDE	TABLET;ORAL	10MG	No	No	2021/12/03 (TA)	--	MSN LABORATORIES PRIVATE LTD	None (Tentative Approval)
VORTIOXETINE HYDROBROMIDE	211101	003	ANDA	VORTIOXETINE HYDROBROMIDE	TABLET;ORAL	20MG	No	No	2021/12/03 (TA)	--	MSN LABORATORIES PRIVATE LTD	None (Tentative Approval)
VORTIOXETINE	211024	001	ANDA	VORTIOXETINE	TABLET;ORAL	5MG	No	No	2022/07/28 (TA)	--	PRINSTON PHARMA INC	None (Tentative Approval)
VORTIOXETINE	211024	002	ANDA	VORTIOXETINE	TABLET;ORAL	10MG	No	No	2022/07/28 (TA)	--	PRINSTON PHARMA INC	None (Tentative Approval)
VORTIOXETINE	211024	003	ANDA	VORTIOXETINE	TABLET;ORAL	15MG	No	No	2022/07/28 (TA)	--	PRINSTON PHARMA INC	None (Tentative Approval)
VORTIOXETINE	211024	004	ANDA	VORTIOXETINE	TABLET;ORAL	20MG	No	No	2022/07/28 (TA)	--	PRINSTON PHARMA INC	None (Tentative Approval)
VORTIOXETINE HYDROBROMIDE	211146	001	ANDA	VORTIOXETINE HYDROBROMIDE	TABLET;ORAL	EQ 5MG BASE	No	No	2024/04/02 (TA)	2021/09/17	ZYDUS PHARMS	Discontinued
VORTIOXETINE HYDROBROMIDE	211146	002	ANDA	VORTIOXETINE HYDROBROMIDE	TABLET;ORAL	EQ 10MG BASE	No	No	2024/04/02 (TA)	2021/09/17	ZYDUS PHARMS	Discontinued
VORTIOXETINE HYDROBROMIDE	211146	003	ANDA	VORTIOXETINE HYDROBROMIDE	TABLET;ORAL	EQ 20MG BASE	No	No	2024/04/02 (TA)	2021/09/17	ZYDUS PHARMS	Discontinued