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
DABIGATRAN ETEXILATE MESYLATE	213879	001	ANDA	DABIGATRAN ETEXILATE MESYLATE	CAPSULE;ORAL	EQ 75MG BASE	No	No	2022/03/21 (TA)	--	MSN LABORATORIES PRIVATE LTD	None (Tentative Approval)
DABIGATRAN ETEXILATE MESYLATE	213879	002	ANDA	DABIGATRAN ETEXILATE MESYLATE	CAPSULE;ORAL	EQ 110MG BASE	No	No	2022/03/21 (TA)	--	MSN LABORATORIES PRIVATE LTD	None (Tentative Approval)
DABIGATRAN ETEXILATE MESYLATE	213879	003	ANDA	DABIGATRAN ETEXILATE MESYLATE	CAPSULE;ORAL	EQ 150MG BASE	No	No	2022/03/21 (TA)	--	MSN LABORATORIES PRIVATE LTD	None (Tentative Approval)
DABIGATRAN ETEXILATE MESYLATE	208046	001	ANDA	DABIGATRAN ETEXILATE MESYLATE	CAPSULE;ORAL	EQ 150MG BASE	No	No	2022/04/04 (TA)	--	ALEMBIC PHARMS LTD	None (Tentative Approval)
DABIGATRAN ETEXILATE MESYLATE	215233	002	ANDA	DABIGATRAN ETEXILATE MESYLATE	CAPSULE;ORAL	EQ 110MG BASE	No	No	2022/04/06 (TA)	--	ALEMBIC PHARMS LTD	None (Tentative Approval)
DABIGATRAN ETEXILATE MESYLATE	215233	003	ANDA	DABIGATRAN ETEXILATE MESYLATE	CAPSULE;ORAL	EQ 150MG BASE	No	No	2022/04/06 (TA)	--	ALEMBIC PHARMS LTD	None (Tentative Approval)
DABIGATRAN ETEXILATE MESYLATE	208070	001	ANDA	DABIGATRAN ETEXILATE MESYLATE	CAPSULE;ORAL	EQ 75MG BASE	No	No	2023/12/15	2023/12/15	APOTEX	Prescription
DABIGATRAN ETEXILATE MESYLATE	208070	002	ANDA	DABIGATRAN ETEXILATE MESYLATE	CAPSULE;ORAL	EQ 110MG BASE	No	No	2023/12/15	2023/12/15	APOTEX	Prescription
DABIGATRAN ETEXILATE MESYLATE	208070	003	ANDA	DABIGATRAN ETEXILATE MESYLATE	CAPSULE;ORAL	EQ 150MG BASE	No	No	2023/12/15	2023/12/15	APOTEX	Prescription