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	219542	001	ANDA	TOFACITINIB CITRATE	TABLET, EXTENDED RELEASE;ORAL	EQ 11MG BASE	No	No	2025/08/19	2025/08/19	AJANTA PHARMA LTD	Discontinued
TOFACITINIB CITRATE	219542	001	ANDA	TOFACITINIB CITRATE	TABLET, EXTENDED RELEASE;ORAL	EQ 11MG BASE	No	No	2025/08/19 (TA)	2025/08/19	AJANTA PHARMA LTD	Discontinued
TOFACITINIB	215356	002	ANDA	TOFACITINIB	TABLET	5MG	No	No	2025/09/17 (TA)	--	AUROBINDO PHARMA LIMITED	None (Tentative Approval)
TOFACITINIB CITRATE	216001	001	ANDA	TOFACITINIB CITRATE	TABLET, EXTENDED RELEASE;ORAL	EQ 11MG BASE	No	No	2025/09/30	2025/09/30	SINOTHERAPEUTICS INC	Prescription
TOFACITINIB CITRATE	216001	001	ANDA	TOFACITINIB CITRATE	TABLET, EXTENDED RELEASE;ORAL	EQ 11MG BASE	No	No	2025/09/30 (TA)	2025/09/30	SINOTHERAPEUTICS INC	Prescription
TOFACITINIB CITRATE	219442	001	ANDA	TOFACITINIB CITRATE	TABLET, EXTENDED RELEASE;ORAL	EQ 11MG BASE	No	No	2025/11/17	2025/11/17	BIOCON PHARMA	Prescription
TOFACITINIB CITRATE	219442	001	ANDA	TOFACITINIB CITRATE	TABLET, EXTENDED RELEASE;ORAL	EQ 11MG BASE	No	No	2025/11/17 (TA)	2025/11/17	BIOCON PHARMA	Prescription
TOFACITINIB CITRATE	219442	002	ANDA	TOFACITINIB CITRATE	TABLET, EXTENDED RELEASE;ORAL	EQ 22MG BASE	No	No	2025/11/17	--	BIOCON PHARMA	None (Tentative Approval)
TOFACITINIB CITRATE	219442	002	ANDA	TOFACITINIB CITRATE	TABLET, EXTENDED RELEASE;ORAL	EQ 22MG BASE	No	No	2025/11/17 (TA)	--	BIOCON PHARMA	None (Tentative Approval)
TOFACITINIB	209633	001	ANDA	TOFACITINIB	TABLET;ORAL	5MG	No	No	2026/02/19 (TA)	--	BRECKENRIDGE PHARMS	None (Tentative Approval)
TOFACITINIB	219395	002	ANDA	TOFACITINIB CITRATE	TABLET	5MG	No	No	2026/03/06 (TA)	--	SPECGX LLC	None (Tentative Approval)
TOFACITINIB CITRATE	212943	001	ANDA	TOFACITINIB CITRATE	TABLET;ORAL	EQ 10MG BASE	No	No	2026/03/20	2021/06/01	AJANTA PHARMA LTD	Discontinued