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, EMTRICITABINE and TENOFOVIR ALAFENAMIDE	215448	001	NDA	DOLUTEGRAVIR, EMTRICITABINE and TENOFOVIR ALAFENAMIDE	TABLET; ORAL	50MG/200MG/25MG	No	No	2023/05/26 (TA)	--	AUROBINDO PHARMA USA	None (Tentative Approval)
EMTRICITABINE AND TENOFOVIR ALAFENAMIDE	211148	001	ANDA	EMTRICITABINE, TENOFOVIR ALAFENAMIDE	TABLET; ORAL	10MG	No	No	2024/01/02 (TA)	--	MYLAN LABS LTD	None (Tentative Approval)
EMTRICITABINE AND TENOFOVIR ALAFENAMIDE	211148	002	ANDA	EMTRICITABINE, TENOFOVIR ALAFENAMIDE	TABLET; ORAL	15MG	No	No	2024/01/02 (TA)	--	MYLAN LABS LTD	None (Tentative Approval)
EMTRICITABINE AND TENOFOVIR ALAFENAMIDE	211148	003	ANDA	EMTRICITABINE, TENOFOVIR ALAFENAMIDE	TABLET; ORAL	25MG	No	No	2024/01/02 (TA)	--	MYLAN LABS LTD	None (Tentative Approval)
EMTRICITABINE AND TENOFOVIR ALAFENAMIDE	211148	004	ANDA	EMTRICITABINE, TENOFOVIR ALAFENAMIDE	TABLET; ORAL	120MG	No	No	2024/01/02 (TA)	--	MYLAN LABS LTD	None (Tentative Approval)
EMTRICITABINE AND TENOFOVIR ALAFENAMIDE	211148	005	ANDA	EMTRICITABINE, TENOFOVIR ALAFENAMIDE	TABLET; ORAL	200MG	No	No	2024/01/02 (TA)	--	MYLAN LABS LTD	None (Tentative Approval)
EFAVIRENZ, EMTRICITABINE AND TENOFOVIR ALAFENAMIDE	213509	001	NDA	EFAVIRENZ, EMTRICITABINE AND TENOFOVIR ALAFENAMIDE	TABLET; ORAL	400MG; 200MG; 25MG	No	No	2024/03/22 (TA)	--	MYLAN	None (Tentative Approval)
EMTRICITABINE AND TENOFOVIR ALAFENAMIDE FUMARATE	214053	001	ANDA	EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE	TABLET;ORAL	120MG;EQ 15MG BASE	No	No	2024/05/17	2024/05/17	APOTEX	Discontinued
EMTRICITABINE AND TENOFOVIR ALAFENAMIDE FUMARATE	214053	002	ANDA	EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE	TABLET;ORAL	200MG;EQ 25MG BASE	No	No	2024/05/17	2024/05/17	APOTEX	Discontinued
EMTRICITABINE AND TENOFOVIR ALAFENAMIDE FUMARATE	213926	001	ANDA	EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE	TABLET;ORAL	200MG;EQ 25MG BASE	No	No	2024/12/13	--	LUPIN LTD	Prescription