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
BOSUTINIB	209577	001	ANDA	BOSUTINIB MONOHYDRATE	TABLET;FILM COATED	400MG	No	No	2023/08/25 (TA)	--	SUN PHARM INDUSTRIES	None (Tentative Approval)
BOSUTINIB	209577	002	ANDA	BOSUTINIB MONOHYDRATE	TABLET;FILM COATED	EQ 100MG BASE	No	No	2023/08/25 (TA)	--	SUN PHARM INDUSTRIES	None (Tentative Approval)
BOSUTINIB	209577	003	ANDA	BOSUTINIB MONOHYDRATE	TABLET;FILM COATED	EQ 500MG BASE	No	No	2023/08/25 (TA)	--	SUN PHARM INDUSTRIES	None (Tentative Approval)
BOSUTINIB MONOHYDRATE	209543	001	ANDA	BOSUTINIB MONOHYDRATE	TABLET;ORAL	EQ 100MG BASE	No	No	2025/05/23	2025/05/23	ALEMBIC	Prescription
BOSUTINIB MONOHYDRATE	209543	002	ANDA	BOSUTINIB MONOHYDRATE	TABLET;ORAL	EQ 500MG BASE	No	No	2025/05/23	2025/05/23	ALEMBIC	Prescription
BOSUTINIB	209624	001	ANDA	BOSUTINIB MONOHYDRATE	TABLET;FILM COATED	400MG	No	No	2025/05/28 (TA)	--	MSN LABORATORIES PRIVATE LTD	None (Tentative Approval)
BOSUTINIB	209624	002	ANDA	BOSUTINIB MONOHYDRATE	TABLET;FILM COATED	EQ 100MG BASE	No	No	2025/05/28 (TA)	--	MSN LABORATORIES PRIVATE LTD	None (Tentative Approval)
BOSUTINIB	209624	003	ANDA	BOSUTINIB MONOHYDRATE	TABLET;FILM COATED	EQ 500MG BASE	No	No	2025/05/28 (TA)	--	MSN LABORATORIES PRIVATE LTD	None (Tentative Approval)