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
ELTROMBOPAG	206788	001	ANDA	ELTROMBOPAG	TABLET;ORAL	12.5MG	No	No	2016/07/06 (TA)	--	HETERO LABS LTD V	None (Tentative Approval)
ELTROMBOPAG	206788	002	ANDA	ELTROMBOPAG	TABLET;ORAL	25MG	No	No	2016/07/06 (TA)	--	HETERO LABS LTD V	None (Tentative Approval)
ELTROMBOPAG	206788	003	ANDA	ELTROMBOPAG	TABLET;ORAL	50MG	No	No	2016/07/06 (TA)	--	HETERO LABS LTD V	None (Tentative Approval)
ELTROMBOPAG	206788	004	ANDA	ELTROMBOPAG	TABLET;ORAL	75MG	No	No	2016/07/06 (TA)	--	HETERO LABS LTD V	None (Tentative Approval)
ELTROMBOPAG	208815	001	ANDA	ELTROMBOPAG	TABLET;ORAL	50MG	No	No	2017/11/28 (TA)	--	ACTAVIS LABS FL INC	None (Tentative Approval)
ELTROMBOPAG	209938	001	ANDA	ELTROMBOPAG	TABLET;ORAL	12.5MG	No	No	2018/02/16 (TA)	--	TEVA PHARMS USA INC	None (Tentative Approval)
ELTROMBOPAG	209938	002	ANDA	ELTROMBOPAG	TABLET;ORAL	25MG	No	No	2018/02/16 (TA)	--	TEVA PHARMS USA INC	None (Tentative Approval)
ELTROMBOPAG	209938	003	ANDA	ELTROMBOPAG	TABLET;ORAL	75MG	No	No	2018/02/16 (TA)	--	TEVA PHARMS USA INC	None (Tentative Approval)
ELTROMBOPAG OLAMINE	216620	001	ANDA	ELTROMBOPAG OLAMINE	FOR SUSPENSION;ORAL	EQ 12.5MG ACID/PACKET	No	No	2024/04/18	2024/04/18	ANNORA PHARMA	Prescription
ELTROMBOPAG OLAMINE	216620	002	ANDA	ELTROMBOPAG OLAMINE	FOR SUSPENSION;ORAL	EQ 25MG ACID/PACKET	No	No	2024/04/18	2024/04/18	ANNORA PHARMA	Prescription
ELTROMBOPAG	212884	001	ANDA	ELTROMBOPAG	TABLET; ORAL	12.5MG	No	No	2024/04/30 (TA)	--	AMNEAL EU LTD	None (Tentative Approval)
ELTROMBOPAG	212884	002	ANDA	ELTROMBOPAG	TABLET; ORAL	25MG	No	No	2024/04/30 (TA)	--	AMNEAL EU LTD	None (Tentative Approval)
ELTROMBOPAG	212884	003	ANDA	ELTROMBOPAG	TABLET; ORAL	50MG	No	No	2024/04/30 (TA)	--	AMNEAL EU LTD	None (Tentative Approval)
ELTROMBOPAG	212884	004	ANDA	ELTROMBOPAG	TABLET; ORAL	75MG	No	No	2024/04/30 (TA)	--	AMNEAL EU LTD	None (Tentative Approval)