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
DOLUTEGRAVIR SODIUM	208355	001	ANDA	DOLUTEGRAVIR SODIUM	TABLET;ORAL	50MG	No	No	2016/09/19 (TA)	--	AUROBINDO PHARMA LTD	None (Tentative Approval)
DOLUTEGRAVIR SODIUM	209658	001	ANDA	DOLUTEGRAVIR SODIUM	TABLET;ORAL	50MG	No	No	2018/03/05 (TA)	--	CIPLA LTD	None (Tentative Approval)
DOLUTEGRAVIR SODIUM	209602	001	ANDA	DOLUTEGRAVIR SODIUM	TABLET;ORAL	50MG	No	No	2018/07/06 (TA)	--	MYLAN LABS LTD	None (Tentative Approval)
DOLUTEGRAVIR SODIUM	210963	001	ANDA	DOLUTEGRAVIR SODIUM	TABLET; ORAL	50MG	No	No	2019/05/16 (TA)	--	LAURUS LABS LTD	None (Tentative Approval)
DOLUTEGRAVIR SODIUM	212179	001	ANDA	DOLUTEGRAVIR SODIUM	TABLET;ORAL	50MG	No	No	2019/09/13 (TA)	--	MICRO LABS LTD	None (Tentative Approval)
DOLUTEGRAVIR SODIUM	214566	001	NDA	DOLUTEGRAVIR SODIUM	TABLET; ORAL SUSPENSION	10MG	No	No	2021/03/16 (TA)	--	MACLEODS PHARMS LTD	None (Tentative Approval)
DOLUTEGRAVIR SODIUM	214397	001	ANDA	DOLUTEGRAVIR SODIUM	TABLET;ORAL	EQ 10MG BASE	No	No	2021/03/22 (TA)	--	MACLEODS PHARMS LTD	None (Tentative Approval)
DOLUTEGRAVIR SODIUM	214397	002	ANDA	DOLUTEGRAVIR SODIUM	TABLET;ORAL	EQ 25MG BASE	No	No	2021/03/22 (TA)	--	MACLEODS PHARMS LTD	None (Tentative Approval)
DOLUTEGRAVIR SODIUM	214397	003	ANDA	DOLUTEGRAVIR SODIUM	TABLET;ORAL	EQ 50MG BASE	No	No	2021/03/22 (TA)	--	MACLEODS PHARMS LTD	None (Tentative Approval)
DOLUTEGRAVIR SODIUM	210812	001	ANDA	DOLUTEGRAVIR SODIUM	TABLET;ORAL	50MG	No	No	2021/05/18 (TA)	--	CIPLA LTD	None (Tentative Approval)