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
LAMIVUDINE	078545	001	ANDA	LAMIVUDINE	TABLET;ORAL	150MG	No	No	2019/03/05	2019/03/05	MYLAN LABS LTD	Discontinued
LAMIVUDINE	078545	002	ANDA	LAMIVUDINE	TABLET;ORAL	300MG	No	No	2019/03/05	2019/03/05	MYLAN LABS LTD	Discontinued
EFAVIRENZ, LAMIVUDINE AND TENOFOVIR DISOPROXIL FUMARATE	210649	001	NDA	EFAVIRENZ; LAMIVUDINE; TENOFOVIR DISOPROXIL FUMARATE	TABLET;ORAL	400MG;300MG;300MG	No	No	2019/03/15	2019/03/15	MACLEODS PHARMS LTD	Discontinued
LAMIVUDINE	211306	001	ANDA	LAMIVUDINE	TABLET;ORAL	100MG	No	No	2019/03/21	2019/03/21	ANNORA	Prescription
DOLUTEGRAVIR; LAMIVUDINE; TENOFOVIR DISOPROXIL FUMARATE	210796	001	NDA	DOLUTEGRAVIR;LAMIVUDINE;TENOFOVIR DISOPROXIL FUMARATE	TABLET;ORAL	50MG/300MG/300MG	No	No	2019/03/25 (TA)	--	MACLEODS PHARMS LTD	None (Tentative Approval)
LAMIVUDINE	090198	001	ANDA	LAMIVUDINE	TABLET;ORAL	150MG	No	No	2019/05/01	2019/05/01	MACLEODS PHARMS LTD	Prescription
LAMIVUDINE	090198	002	ANDA	LAMIVUDINE	TABLET;ORAL	300MG	No	No	2019/05/01	2019/05/01	MACLEODS PHARMS LTD	Prescription
LAMIVUDINE AND ZIDOVUDINE	079079	001	ANDA	LAMIVUDINE; ZIDOVUDINE	TABLET;ORAL	150MG;300MG	No	No	2019/08/12	2019/08/12	MYLAN LABS LTD	Discontinued
EFAVIRENZ, LAMIVUDINE AND TENOFOVIR DISOPROXIL FUMARATE	212786	001	ANDA	EFAVIRENZ; LAMIVUDINE; TENOFOVIR DISOPROXIL FUMARATE	TABLET;ORAL	600MG;300MG;300MG	No	No	2020/05/14	2020/05/14	LAURUS	Prescription
EFAVIRENZ, LAMIVUDINE AND TENOFOVIR DISOPROXIL FUMARATE	213038	001	ANDA	EFAVIRENZ; LAMIVUDINE; TENOFOVIR DISOPROXIL FUMARATE	TABLET;ORAL	400MG;300MG;300MG	No	No	2020/05/14	2020/05/14	LAURUS	Prescription
DOLUTEGRAVIR, LAMIVUDINE AND TENOFOVIR DISOPROXIL FUMARATE	213556	001	NDA	DOLUTEGRAVIR; LAMIVUDINE; TENOFOVIR DISOPROXIL FUMARATE	TABLET;ORAL	50MG; 300MG; 300MG	No	No	2020/10/06 (TA)	--	SHANGHAI DESANA BIO-PHARMACEUTICALS CO LTD	None (Tentative Approval)
DOLUTEGRAVIR, LAMIVUDINE AND TENOFOVIR DISOPROXIL FUMARATE	212303	001	NDA	DOLUTEGRAVIR; LAMIVUDINE; TENOFOVIR DISOPROXIL FUMARATE	TABLET; ORAL	50MG/300MG/300MG	No	No	2021/06/25 (TA)	--	LUPIN PHARMS	None (Tentative Approval)
DOLUTEGRAVIR LAMIVUDINE TENOFOVIR ALAFENAMIDE	212527	001	NDA	DOLUTEGRAVIR LAMIVUDINE TENOFOVIR ALAFENAMIDE	TABLET, FOR SUSPENSION; ORAL	EQ 50MG BASE; 300MG; 25MG	No	No	2022/03/30 (TA)	--	CIPLA USA INC.	None (Tentative Approval)
ABACAVIR SULFATE AND LAMIVUDINE	216332	001	ANDA	ABACAVIR SULFATE; LAMIVUDINE	TABLET;ORAL	EQ 600MG BASE;300MG	No	No	2022/07/25	2022/07/25	LAURUS	Prescription
ABACAVIR; DOLUTEGRAVIR; LAMIVUDINE	216223	001	ANDA	ABACAVIR;DOLUTEGRAVIR;LAMIVUDINE	TABLET;ORAL	600MG;50MG;300MG	No	No	2022/08/11 (TA)	--	LAURUS LABS LTD	None (Tentative Approval)
DOLUTEGRAVIR; LAMIVUDINE; TENOFOVIR DISOPROXIL FUMARATE	211868	001	NDA	DOLUTEGRAVIR; LAMIVUDINE; TENOFOVIR DISOPROXIL FUMARATE	TABLET;ORAL	50MG/300MG/300MG	No	No	2023/07/12 (TA)	--	EMCURE PHARMS LTD	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)
ABACAVIR; DOLUTEGRAVIR; LAMIVUDINE	217070	001	NDA	ABACAVIR; DOLUTEGRAVIR; LAMIVUDINE	TABLET; ORAL	60MG;5MG;30MG	No	No	2023/08/14 (TA)	--	AUROBINDO PHARMA USA	None (Tentative Approval)
DOLUTEGRAVIR; TENOFOVIR DISOPROXIL FUMARATE; LAMIVUDINE	217016	001	NDA	DOLUTEGRAVIR; TENOFOVIR DISOPROXIL FUMARATE; LAMIVUDINE	TABLET; ORAL	50MG/300MG/300MG	No	No	2023/09/14 (TA)	--	STRIDES PHARMA	None (Tentative Approval)
LAMIVUDINE	091475	001	ANDA	LAMIVUDINE	SOLUTION;ORAL	10MG/ML	No	No	2023/10/06	2023/10/06	HETERO LABS LTD III	Prescription