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
BICTEGRAVIR, EMTRICITABINE AND TENOFOVIR ALAFENAMIDE	218766	003	ANDA	BICTEGRAVIR, EMTRICITABINE AND TENOFOVIR ALAFENAMIDE	TABLET	25MG	No	No	2025/10/14 (TA)	--	CIPLA LTD	None (Tentative Approval)
BICTEGRAVIR, EMTRICITABINE AND TENOFOVIR ALAFENAMIDE	218766	004	ANDA	BICTEGRAVIR, EMTRICITABINE AND TENOFOVIR ALAFENAMIDE	TABLET	30MG	No	No	2025/10/14 (TA)	--	CIPLA LTD	None (Tentative Approval)
BICTEGRAVIR, EMTRICITABINE AND TENOFOVIR ALAFENAMIDE	218766	005	ANDA	BICTEGRAVIR, EMTRICITABINE AND TENOFOVIR ALAFENAMIDE	TABLET	120MG	No	No	2025/10/14 (TA)	--	CIPLA LTD	None (Tentative Approval)
BICTEGRAVIR, EMTRICITABINE AND TENOFOVIR ALAFENAMIDE	218766	006	ANDA	BICTEGRAVIR, EMTRICITABINE AND TENOFOVIR ALAFENAMIDE	TABLET	15MG	No	No	2025/10/14 (TA)	--	CIPLA LTD	None (Tentative Approval)