美国FDA药品数据库（U.S. FDA Drugs Database）
检索条件:" 药品名称=DEXMEDETOMIDINE HYDROCHLORIDE"
符合检索条件的记录共 53 条
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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 WILSHIRE PHARMS INC 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 WILSHIRE PHARMS INC 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 WILSHIRE PHARMS INC 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 ENDO OPERATIONS Prescription
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