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
BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE	214737	001	ANDA	BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE	TABLET;SUBLINGUAL	EQ 1.4MG BASE;EQ 0.36MG BASE	No	No	2023/08/11 (TA)	--	SUN PHARM INDUSTRIES	None (Tentative Approval)
BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE	214737	002	ANDA	BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE	TABLET;SUBLINGUAL	EQ 5.7MG BASE;EQ 1.4MG BASE	No	No	2023/08/11 (TA)	--	SUN PHARM INDUSTRIES	None (Tentative Approval)
BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE	214737	003	ANDA	BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE	TABLET;SUBLINGUAL	EQ 8.6MG BASE;EQ 2.1MG BASE	No	No	2023/08/11 (TA)	--	SUN PHARM INDUSTRIES	None (Tentative Approval)
BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE	214737	004	ANDA	BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE	TABLET;SUBLINGUAL	EQ 11.4MG BASE;EQ 2.9MG BASE	No	No	2023/08/11 (TA)	--	SUN PHARM INDUSTRIES	None (Tentative Approval)
BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE	214737	005	ANDA	BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE	TABLET;SUBLINGUAL	EQ 2.9MG BASE;EQ 0.71MG BASE	No	No	2023/08/11 (TA)	--	SUN PHARM INDUSTRIES	None (Tentative Approval)
BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE	214737	006	ANDA	BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE	TABLET;SUBLINGUAL	EQ 0.7MG BASE;EQ 0.18MG BASE	No	No	2023/08/11 (TA)	--	SUN PHARM INDUSTRIES	None (Tentative Approval)