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
PRECEDEX	021038	001	NDA	DEXMEDETOMIDINE HYDROCHLORIDE	INJECTABLE;INJECTION	EQ 200MCG BASE/2ML (EQ 100MCG BASE/ML)	Yes	Yes	1999/12/17	1999/12/17	HOSPIRA	Prescription
PRECEDEX	021038	002	NDA	DEXMEDETOMIDINE HYDROCHLORIDE	INJECTABLE;INJECTION	EQ 200MCG BASE/50ML (EQ 4MCG BASE/ML)	Yes	Yes	1999/12/17	2013/03/13	HOSPIRA	Prescription
PRECEDEX	021038	003	NDA	DEXMEDETOMIDINE HYDROCHLORIDE	INJECTABLE;INJECTION	EQ 400MCG BASE/100ML (EQ 4MCG BASE/ML)	Yes	Yes	1999/12/17	2013/03/13	HOSPIRA	Prescription
PRECEDEX	021038	004	NDA	DEXMEDETOMIDINE HYDROCHLORIDE	INJECTABLE;INJECTION	EQ 80MCG BASE/20ML (EQ 4MCG BASE/ML)	Yes	Yes	1999/12/17	2014/11/14	HOSPIRA	Prescription
PRECEDEX	021038	005	NDA	DEXMEDETOMIDINE HYDROCHLORIDE	INJECTABLE;INJECTION	EQ 1MG BASE/250ML (EQ 4MCG BASE/ML)	Yes	Yes	1999/12/17	2020/01/31	HOSPIRA	Prescription