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
ABACAVIR; DOLUTEGRAVIR; LAMIVUDINE	218383	003	ANDA	ABACAVIR;DOLUTEGRAVIR;LAMIVUDINE	TABLET;ORAL	60MG	No	No	2024/12/03 (TA)	--	LUPIN LTD	None (Tentative Approval)
ABACAVIR \|\| DOLUTEGRAVIR \|\| LAMIVUDINE	212181	001	ANDA	ABACAVIR \|\| DOLUTEGRAVIR \|\| LAMIVUDINE	TABLET	50MG	No	No	2024/12/05 (TA)	--	EMCURE PHARMS LTD	None (Tentative Approval)
ABACAVIR \|\| DOLUTEGRAVIR \|\| LAMIVUDINE	212181	002	ANDA	ABACAVIR \|\| DOLUTEGRAVIR \|\| LAMIVUDINE	TABLET	300MG	No	No	2024/12/05 (TA)	--	EMCURE PHARMS LTD	None (Tentative Approval)
ABACAVIR \|\| DOLUTEGRAVIR \|\| LAMIVUDINE	212181	003	ANDA	ABACAVIR \|\| DOLUTEGRAVIR \|\| LAMIVUDINE	TABLET	600MG	No	No	2024/12/05 (TA)	--	EMCURE PHARMS LTD	None (Tentative Approval)
LAMIVUDINE	200406	001	ANDA	LAMIVUDINE	TABLET; ORAL	150MG	No	No	2024/12/19 (TA)	--	MICRO LABS LTD	None (Tentative Approval)
LAMIVUDINE	200406	002	ANDA	LAMIVUDINE	TABLET; ORAL	300MG	No	No	2024/12/19 (TA)	--	MICRO LABS LTD	None (Tentative Approval)
ABACAVIR SULFATE AND LAMIVUDINE	212663	001	ANDA	ABACAVIR SULFATE; LAMIVUDINE	TABLET;ORAL	EQ 600MG BASE;300MG	No	No	2024/12/19	2024/12/19	MACLEODS PHARMS LTD	Discontinued
ABACAVIR SULFATE AND LAMIVUDINE	205412	001	ANDA	ABACAVIR SULFATE; LAMIVUDINE	TABLET;ORAL	EQ 600MG BASE;300MG	No	No	2025/04/16	2025/04/16	HETERO LABS LTD V	Prescription
DOLUTEGRAVIR SODIUM AND ABACAVIR SULFATE AND LAMIVUDINE	210811	002	ANDA	ABACAVIR \|\| DOLUTEGRAVIR \|\| LAMIVUDINE	TABLET	300MG	No	No	2025/06/12 (TA)	--	CIPLA LIMITED	None (Tentative Approval)
DOLUTEGRAVIR SODIUM AND ABACAVIR SULFATE AND LAMIVUDINE	210811	003	ANDA	ABACAVIR \|\| DOLUTEGRAVIR \|\| LAMIVUDINE	TABLET	600MG	No	No	2025/06/12 (TA)	--	CIPLA LIMITED	None (Tentative Approval)
DOLUTEGRAVIR AND LAMIVUDINE	219623	002	ANDA	DOLUTEGRAVIR AND LAMIVUDINE	TABLET	300MG	No	No	2025/06/12 (TA)	--	EMCURE PHARMS LTD	None (Tentative Approval)
ABACAVIR, DOLUTEGRAVIR, LAMIVUDINE	210391	002	ANDA	ABACAVIR, DOLUTEGRAVIR, LAMIVUDINE	TABLET	50MG	No	No	2025/06/30 (TA)	--	CIPLA LIMITED	None (Tentative Approval)
ABACAVIR, DOLUTEGRAVIR, LAMIVUDINE	210391	003	ANDA	ABACAVIR, DOLUTEGRAVIR, LAMIVUDINE	TABLET	300MG	No	No	2025/06/30 (TA)	--	CIPLA LIMITED	None (Tentative Approval)
ABACAVIR, DOLUTEGRAVIR AND LAMIVUDINE	217830	002	ANDA	ABACAVIR, DOLUTEGRAVIR, LAMIVUDINE	TABLET	5MG	No	No	2025/09/17 (TA)	--	MACLEODS PHARMACEUTICALS LTD	None (Tentative Approval)
ABACAVIR, DOLUTEGRAVIR AND LAMIVUDINE	217830	003	ANDA	ABACAVIR, DOLUTEGRAVIR, LAMIVUDINE	TABLET	30MG	No	No	2025/09/17 (TA)	--	MACLEODS PHARMACEUTICALS LTD	None (Tentative Approval)