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
TOFACITINIB CITRATE	212943	001	ANDA	TOFACITINIB CITRATE	TABLET;ORAL	EQ 10MG BASE	No	No	2021/06/01	2021/06/01	AJANTA PHARMA LTD	Discontinued
TOFACITINIB CITRATE	212943	001	ANDA	TOFACITINIB CITRATE	TABLET;ORAL	EQ 10MG BASE	No	No	2021/06/01 (TA)	2021/06/01	AJANTA PHARMA LTD	Discontinued
TOFACITINIB	209633	001	ANDA	TOFACITINIB	TABLET;ORAL	5MG	No	No	2021/06/10 (TA)	--	BRECKENRIDGE PHARMS	None (Tentative Approval)
TOFACITINIB	214264	001	ANDA	TOFACITINIB CITRATE	TABLET, EXTENDED RELEASE;ORAL	EQ 11MG BASE	No	No	2021/08/19	2021/08/19	ZYDUS PHARMS	Discontinued
TOFACITINIB	214264	002	ANDA	TOFACITINIB CITRATE	TABLET, EXTENDED RELEASE;ORAL	EQ 22MG BASE	No	No	2021/08/19	2021/08/19	ZYDUS PHARMS	Discontinued
Tofacitinib	215552	001	ANDA	Tofacitinib	TABLET;ORAL	5MG	No	No	2022/10/04 (TA)	--	YAOPHARMA CO LTD	None (Tentative Approval)
Tofacitinib	215552	002	ANDA	Tofacitinib	TABLET;ORAL	10MG	No	No	2022/10/04 (TA)	--	YAOPHARMA CO LTD	None (Tentative Approval)
TOFACITINIB	217299	001	ANDA	TOFACITINIB CITRATE	TABLET;ORAL	5MG	No	No	2023/01/06 (TA)	--	MSN PHARMS INC	None (Tentative Approval)
TOFACITINIB	217299	002	ANDA	TOFACITINIB CITRATE	TABLET;ORAL	10MG	No	No	2023/01/06 (TA)	--	MSN PHARMS INC	None (Tentative Approval)
TOFACITINIB CITRATE	209738	001	ANDA	TOFACITINIB CITRATE	TABLET;ORAL	EQ 5MG BASE	No	No	2023/03/13	2023/03/13	MICRO LABS	Discontinued
TOFACITINIB CITRATE	209738	001	ANDA	TOFACITINIB CITRATE	TABLET;ORAL	EQ 5MG BASE	No	No	2023/03/13 (TA)	2023/03/13	MICRO LABS	Discontinued
TOFACITINIB CITRATE	209829	001	ANDA	TOFACITINIB CITRATE	TABLET;ORAL	EQ 5MG BASE	No	No	2023/03/14	2023/03/13	ZYDUS PHARMS	Discontinued
TOFACITINIB CITRATE	216878	001	ANDA	TOFACITINIB CITRATE	SOLUTION;ORAL	EQ 1MG BASE/ML	No	No	2023/09/25	2023/09/25	SLAYBACK PHARMA LLC	Prescription
TOFACITINIB	209923	001	ANDA	TOFACITINIB	TABLET;ORAL	5MG	No	No	2024/04/09 (TA)	--	PRINSTON PHARMA INC	None (Tentative Approval)