美国FDA药品数据库(U.S. FDA Drugs Database)
检索条件:" 药品名称=DEXMEDETOMIDINE HYDROCHLORIDE"
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 208266 002 ANDA DEXMEDETOMIDINE HYDROCHLORIDE INJECTABLE;INJECTION EQ 400MCG BASE/100ML (EQ 4MCG BASE/ML) No No 2020/09/15 2020/09/15 ENDO OPERATIONS Prescription
DEXMEDETOMIDINE HYDROCHLORIDE 212857 001 ANDA DEXMEDETOMIDINE HYDROCHLORIDE INJECTABLE;INJECTION EQ 80MCG BASE/20ML (EQ 4MCG BASE/ML) No No 2020/11/23 2020/11/23 TAGI Prescription
DEXMEDETOMIDINE HYDROCHLORIDE 212857 002 ANDA DEXMEDETOMIDINE HYDROCHLORIDE INJECTABLE;INJECTION EQ 200MCG BASE/50ML (EQ 4MCG BASE/ML) No No 2020/11/23 2020/11/23 TAGI Prescription
DEXMEDETOMIDINE HYDROCHLORIDE 212857 003 ANDA DEXMEDETOMIDINE HYDROCHLORIDE INJECTABLE;INJECTION EQ 400MCG BASE/100ML (EQ 4MCG BASE/ML) No No 2020/11/23 2020/11/23 TAGI Prescription
DEXMEDETOMIDINE HYDROCHLORIDE 210321 001 ANDA DEXMEDETOMIDINE HYDROCHLORIDE INJECTABLE;INJECTION EQ 200MCG BASE/50ML (EQ 4MCG BASE/ML) No No 2020/12/07 2020/12/07 EUGIA PHARMA Prescription
DEXMEDETOMIDINE HYDROCHLORIDE 210321 002 ANDA DEXMEDETOMIDINE HYDROCHLORIDE INJECTABLE;INJECTION EQ 400MCG BASE/100ML (EQ 4MCG BASE/ML) No No 2020/12/07 2020/12/07 EUGIA PHARMA Prescription
DEXMEDETOMIDINE HYDROCHLORIDE 214794 001 ANDA DEXMEDETOMIDINE HYDROCHLORIDE INJECTABLE;INJECTION EQ 200MCG BASE/2ML (EQ 100MCG BASE/ML) No No 2021/09/03 2021/09/03 PIRAMAL CRITICAL Discontinued
DEXMEDETOMIDINE HYDROCHLORIDE 216604 001 ANDA DEXMEDETOMIDINE HYDROCHLORIDE INJECTABLE;INJECTION EQ 200MCG BASE/50ML (EQ 4MCG BASE/ML) No No 2023/05/15 2023/05/15 AMNEAL Prescription
DEXMEDETOMIDINE HYDROCHLORIDE 216604 002 ANDA DEXMEDETOMIDINE HYDROCHLORIDE INJECTABLE;INJECTION EQ 400MCG BASE/100ML (EQ 4MCG BASE/ML) No No 2023/05/15 2023/05/15 AMNEAL Prescription
DEXMEDETOMIDINE HYDROCHLORIDE 217308 001 ANDA DEXMEDETOMIDINE HYDROCHLORIDE INJECTABLE;INJECTION EQ 200MCG BASE/50ML (EQ 4MCG BASE/ML) No No 2023/06/07 2023/06/07 MILLA PHARMS Prescription
DEXMEDETOMIDINE HYDROCHLORIDE 217308 002 ANDA DEXMEDETOMIDINE HYDROCHLORIDE INJECTABLE;INJECTION EQ 400MCG BASE/100ML (EQ 4MCG BASE/ML) No No 2023/06/07 2023/06/07 MILLA PHARMS Prescription
DEXMEDETOMIDINE HYDROCHLORIDE 218112 001 ANDA DEXMEDETOMIDINE HYDROCHLORIDE SOLUTION;INTRAVENOUS EQ 400MCG BASE/4ML (EQ 100MCG BASE/ML) No No 2024/09/24 2024/09/24 SOMERSET Prescription
DEXMEDETOMIDINE HYDROCHLORIDE 218112 002 ANDA DEXMEDETOMIDINE HYDROCHLORIDE SOLUTION;INTRAVENOUS EQ 1MG BASE/10ML (EQ 100MCG BASE/ML) No No 2024/09/24 2024/09/24 SOMERSET Prescription
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