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
DEXMEDETOMIDINE HYDROCHLORIDE	206798	001	ANDA	DEXMEDETOMIDINE HYDROCHLORIDE	INJECTABLE;INJECTION	EQ 200MCG BASE/2ML (EQ 100MCG BASE/ML)	No	No	2018/02/27	2018/02/27	ZYDUS PHARMS	Prescription
DEXMEDETOMIDINE HYDROCHLORIDE	208532	001	ANDA	DEXMEDETOMIDINE HYDROCHLORIDE	INJECTABLE;INJECTION	EQ 200MCG BASE/50ML (EQ 4MCG BASE/ML)	No	No	2018/08/21	2018/08/21	BAXTER HLTHCARE CORP	Prescription
DEXMEDETOMIDINE HYDROCHLORIDE	208532	002	ANDA	DEXMEDETOMIDINE HYDROCHLORIDE	INJECTABLE;INJECTION	EQ 400MCG BASE/100ML (EQ 4MCG BASE/ML)	No	No	2018/08/21	2018/08/21	BAXTER HLTHCARE CORP	Prescription
DEXMEDETOMIDINE HYDROCHLORIDE	208129	001	ANDA	DEXMEDETOMIDINE HYDROCHLORIDE	INJECTABLE;INJECTION	EQ 80MCG BASE/20ML (EQ 4MCG BASE/ML)	No	No	2018/11/29	2018/11/29	FRESENIUS KABI USA	Prescription
DEXMEDETOMIDINE HYDROCHLORIDE	208129	002	ANDA	DEXMEDETOMIDINE HYDROCHLORIDE	INJECTABLE;INJECTION	EQ 200MCG BASE/50ML (EQ 4MCG BASE/ML)	No	No	2018/11/29	2018/11/29	FRESENIUS KABI USA	Prescription
DEXMEDETOMIDINE HYDROCHLORIDE	208129	003	ANDA	DEXMEDETOMIDINE HYDROCHLORIDE	INJECTABLE;INJECTION	EQ 400MCG BASE/100ML (EQ 4MCG BASE/ML)	No	No	2018/11/29	2018/11/29	FRESENIUS KABI USA	Prescription
DEXMEDETOMIDINE HYDROCHLORIDE	208129	004	ANDA	DEXMEDETOMIDINE HYDROCHLORIDE	INJECTABLE;INJECTION	EQ 80MCG BASE/20ML (EQ 4MCG BASE/ML)	No	No	2018/11/29	--	FRESENIUS KABI USA	None (Tentative Approval)
DEXMEDETOMIDINE HYDROCHLORIDE	204843	001	ANDA	DEXMEDETOMIDINE HYDROCHLORIDE	INJECTABLE;INJECTION	EQ 200MCG BASE/2ML (EQ 100MCG BASE/ML)	No	No	2019/01/18	2019/01/18	MEITHEAL	Prescription
DEXMEDETOMIDINE HYDROCHLORIDE	212791	001	ANDA	DEXMEDETOMIDINE HYDROCHLORIDE	INJECTABLE;INJECTION	EQ 200MCG BASE/50ML (EQ 4MCG BASE/ML)	No	No	2019/12/04	2019/12/04	SLAYBACK PHARMA LLC	Prescription
DEXMEDETOMIDINE HYDROCHLORIDE	212791	002	ANDA	DEXMEDETOMIDINE HYDROCHLORIDE	INJECTABLE;INJECTION	EQ 400MCG BASE/100ML (EQ 4MCG BASE/ML)	No	No	2019/12/04	2019/12/04	SLAYBACK PHARMA LLC	Prescription
DEXMEDETOMIDINE HYDROCHLORIDE	212791	003	ANDA	DEXMEDETOMIDINE HYDROCHLORIDE	INJECTABLE;INJECTION	EQ 80MCG BASE/20ML (EQ 4MCG BASE/ML)	No	No	2019/12/04	2020/05/08	SLAYBACK PHARMA LLC	Discontinued
DEXMEDETOMIDINE HYDROCHLORIDE	206407	001	ANDA	DEXMEDETOMIDINE HYDROCHLORIDE	INJECTABLE;INJECTION	EQ 200MCG BASE/50ML (EQ 4MCG BASE/ML)	No	No	2020/01/30	2020/01/30	HIKMA	Prescription
DEXMEDETOMIDINE HYDROCHLORIDE	206407	002	ANDA	DEXMEDETOMIDINE HYDROCHLORIDE	INJECTABLE;INJECTION	EQ 400MCG BASE/100ML (EQ 4MCG BASE/ML)	No	No	2020/01/30	2020/01/30	HIKMA	Prescription
DEXMEDETOMIDINE HYDROCHLORIDE	207551	001	ANDA	DEXMEDETOMIDINE HYDROCHLORIDE	INJECTABLE;INJECTION	EQ 200MCG BASE/50ML (EQ 4MCG BASE/ML)	No	No	2020/05/20	2020/05/20	AMNEAL PHARMS CO	Prescription
DEXMEDETOMIDINE HYDROCHLORIDE	207551	002	ANDA	DEXMEDETOMIDINE HYDROCHLORIDE	INJECTABLE;INJECTION	EQ 400MCG BASE/100ML (EQ 4MCG BASE/ML)	No	No	2020/05/20	2020/05/20	AMNEAL PHARMS CO	Prescription
DEXMEDETOMIDINE HYDROCHLORIDE	209307	001	ANDA	DEXMEDETOMIDINE HYDROCHLORIDE	INJECTABLE;INJECTION	EQ 200MCG BASE/50ML (EQ 4MCG BASE/ML)	No	No	2020/06/03	2020/06/03	GLAND PHARMA LTD	Prescription
DEXMEDETOMIDINE HYDROCHLORIDE	209307	002	ANDA	DEXMEDETOMIDINE HYDROCHLORIDE	INJECTABLE;INJECTION	EQ 400MCG BASE/100ML (EQ 4MCG BASE/ML)	No	No	2020/06/03	2020/06/03	GLAND PHARMA LTD	Prescription
DEXMEDETOMIDINE HYDROCHLORIDE	212571	001	ANDA	DEXMEDETOMIDINE HYDROCHLORIDE	INJECTABLE;INJECTION	EQ 200MCG BASE/50ML (EQ 4MCG BASE/ML)	No	No	2020/08/27	2020/08/27	MYLAN LABS LTD	Prescription
DEXMEDETOMIDINE HYDROCHLORIDE	212571	002	ANDA	DEXMEDETOMIDINE HYDROCHLORIDE	INJECTABLE;INJECTION	EQ 400MCG BASE/100ML (EQ 4MCG BASE/ML)	No	No	2020/08/27	2020/08/27	MYLAN LABS LTD	Prescription
DEXMEDETOMIDINE HYDROCHLORIDE	208266	001	ANDA	DEXMEDETOMIDINE HYDROCHLORIDE	INJECTABLE;INJECTION	EQ 200MCG BASE/50ML (EQ 4MCG BASE/ML)	No	No	2020/09/15	2020/09/15	PAR STERILE PRODUCTS	Prescription