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
TENOFOVIR ALAFENAMIDE	213845	001	ANDA	TENOFOVIR ALAFENAMIDE	TABLET;ORAL	25MG	No	No	2021/07/08 (TA)	--	SUNSHINE LAKE	None (Tentative Approval)
DOLUTEGRAVIR LAMIVUDINE TENOFOVIR ALAFENAMIDE	212527	001	NDA	DOLUTEGRAVIR LAMIVUDINE TENOFOVIR ALAFENAMIDE	TABLET	EQ 50MG BASE; 300MG; 25MG	No	No	2022/03/30 (TA)	--	CIPLA USA INC.	None (Tentative Approval)
TENOFOVIR ALAFENAMIDE	214072	001	ANDA	TENOFOVIR ALAFENAMIDE	TABLET;ORAL	25MG	No	No	2022/09/15 (TA)	--	SHILPA MEDICARE LTD	None (Tentative Approval)
EMTRICITABINE; RILPIVIRINE; TENOFOVIR ALAFENAMIDE	214058	001	ANDA	EMTRICITABINE;RILPIVIRINE;TENOFOVIR ALAFENAMIDE	TABLET;ORAL	200MG;25MG;25MG	No	No	2022/09/27 (TA)	--	CIPLA LIMITED	None (Tentative Approval)
EMTRICITABINE; TENOFOVIR ALAFENAMIDE	216875	001	ANDA	EMTRICITABINE;TENOFOVIR ALAFENAMIDE	TABLET;ORAL	200MG/25MG	No	No	2022/12/19 (TA)	--	AUROBINDO PHARMA	None (Tentative Approval)
DOLUTEGRAVIR; EMTRICITABINE; TENOFOVIR ALAFENAMIDE	214544	001	NDA	DOLUTEGRAVIR;EMTRICITABINE;TENOFOVIR ALAFENAMIDE	TABLET;ORAL	50MG;200MG;25MG	No	No	2023/01/19 (TA)	--	LUPIN LTD	None (Tentative Approval)
TENOFOVIR ALAFENAMIDE	214226	001	ANDA	TENOFOVIR ALAFENAMIDE FUMARATE	TABLET;ORAL	EQ 25MG BASE	No	No	2023/03/30	2023/03/30	LUPIN LTD	Prescription
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)
DOLUTEGRAVIR;LAMIVUDINE;TENOFOVIR ALAFENAMIDE	215187	001	NDA	DOLUTEGRAVIR;LAMIVUDINE;TENOFOVIR ALAFENAMIDE	TABLET; ORAL	50MG;300MG;25MG	No	No	2023/07/18 (TA)	--	LUPIN PHARMS	None (Tentative Approval)
TENOFOVIR ALAFENAMIDE FUMARATE	214030	001	ANDA	TENOFOVIR ALAFENAMIDE FUMARATE	TABLET;ORAL	EQ 25MG BASE	No	No	2023/09/22 (TA)	--	LAURUS LABS LTD	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)
TENOFOVIR ALAFENAMIDE FUMARATE	213867	001	ANDA	TENOFOVIR ALAFENAMIDE FUMARATE	TABLET;ORAL	EQ 25MG BASE	No	No	2024/03/21	2024/03/21	APOTEX	Discontinued
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; TENOFOVIR ALAFENAMIDE	215071	001	ANDA	EMTRICITABINE;TENOFOVIR ALAFENAMIDE	TABLET;ORAL	200MG;25MG	No	No	2024/07/29 (TA)	--	LUPIN LTD	None (Tentative Approval)