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
APIXABAN	209845	001	ANDA	APIXABAN	TABLET;ORAL	2.5MG	No	No	2021/07/26	2021/07/26	BRECKENRIDGE	Discontinued
APIXABAN	209845	002	ANDA	APIXABAN	TABLET;ORAL	5MG	No	No	2021/07/26	2021/07/26	BRECKENRIDGE	Discontinued
APIXABAN	210053	001	ANDA	APIXABAN	TABLET; ORAL	2.5MG	No	No	2022/02/01 (TA)	--	SIGMAPHARM LABS LLC	None (Tentative Approval)
APIXABAN	210053	002	ANDA	APIXABAN	TABLET; ORAL	5MG	No	No	2022/02/01 (TA)	--	SIGMAPHARM LABS LLC	None (Tentative Approval)
APIXABAN	210133	002	ANDA	APIXABAN	TABLET; ORAL	5mg	No	No	2022/04/12 (TA)	--	PRINSTON PHARMA INC	None (Tentative Approval)
APIXABAN	213903	001	ANDA	APIXABAN	TABLET;ORAL	2.5MG	No	No	2022/06/21 (TA)	--	ZHEJIANG YONGNING PHARMACEUTICAL CO LTD	None (Tentative Approval)
APIXABAN	210185	001	ANDA	APIXABAN	TABLET;ORAL	2.5MG	No	No	2023/02/27	2023/02/27	ZYDUS PHARMS	Discontinued
APIXABAN	210185	002	ANDA	APIXABAN	TABLET;ORAL	5MG	No	No	2023/02/27	2023/02/27	ZYDUS PHARMS	Discontinued
APIXABAN	210026	001	ANDA	APIXABAN	TABLET;ORAL	2.5MG	No	No	2023/05/26	2023/05/26	AUROBINDO PHARMA LTD	Discontinued
APIXABAN	210026	002	ANDA	APIXABAN	TABLET;ORAL	5MG	No	No	2023/05/26	2023/05/26	AUROBINDO PHARMA LTD	Discontinued
APIXABAN	210066	001	ANDA	APIXABAN	TABLET;ORAL	2.5MG	No	No	2023/11/21	2023/11/21	HETERO LABS LTD V	Prescription
APIXABAN	210066	002	ANDA	APIXABAN	TABLET;ORAL	5MG	No	No	2023/11/21	2023/11/21	HETERO LABS LTD V	Prescription
APIXABAN	210091	001	ANDA	APIXABAN	TABLET;ORAL	2.5MG	No	No	2024/02/16	2024/02/16	APOTEX	Discontinued
APIXABAN	210091	002	ANDA	APIXABAN	TABLET;ORAL	5MG	No	No	2024/02/16	2024/02/16	APOTEX	Discontinued