Application Information

This drug has been submitted to the FDA under the reference 021038/001.

Names and composition

"PRECEDEX" is the commercial name of a drug composed of DEXMEDETOMIDINE HYDROCHLORIDE.

Forms

ApplId/ProductId Drug name Active ingredient Form Strenght
021038/001 PRECEDEX DEXMEDETOMIDINE HYDROCHLORIDE INJECTABLE/INJECTION EQ 200MCG BASE per 2ML (EQ 100MCG BASE per ML)
021038/002 PRECEDEX DEXMEDETOMIDINE HYDROCHLORIDE INJECTABLE/INJECTION EQ 200MCG BASE per 50ML (EQ 4MCG BASE per ML)
021038/003 PRECEDEX DEXMEDETOMIDINE HYDROCHLORIDE INJECTABLE/INJECTION EQ 400MCG BASE per 100ML (EQ 4MCG BASE per ML)
021038/004 PRECEDEX DEXMEDETOMIDINE HYDROCHLORIDE INJECTABLE/INJECTION EQ 80MCG BASE per 20ML (EQ 4MCG BASE per ML)

Similar Active Ingredient

ApplId/ProductId Drug name Active ingredient Form Strenght
021038/001 PRECEDEX DEXMEDETOMIDINE HYDROCHLORIDE INJECTABLE/INJECTION EQ 200MCG BASE per 2ML (EQ 100MCG BASE per ML)
021038/002 PRECEDEX DEXMEDETOMIDINE HYDROCHLORIDE INJECTABLE/INJECTION EQ 200MCG BASE per 50ML (EQ 4MCG BASE per ML)
021038/003 PRECEDEX DEXMEDETOMIDINE HYDROCHLORIDE INJECTABLE/INJECTION EQ 400MCG BASE per 100ML (EQ 4MCG BASE per ML)
021038/004 PRECEDEX DEXMEDETOMIDINE HYDROCHLORIDE INJECTABLE/INJECTION EQ 80MCG BASE per 20ML (EQ 4MCG BASE per ML)
091465/001 DEXMEDETOMIDINE HYDROCHLORIDE DEXMEDETOMIDINE HYDROCHLORIDE INJECTABLE/INJECTION EQ 200MCG BASE per 2ML (EQ 100MCG BASE per ML)
201072/001 DEXMEDETOMIDINE HYDROCHLORIDE DEXMEDETOMIDINE HYDROCHLORIDE INJECTABLE/INJECTION EQ 200MCG BASE per 2ML (EQ 100MCG BASE per ML)
202126/001 DEXMEDETOMIDINE HYDROCHLORIDE DEXMEDETOMIDINE HYDROCHLORIDE INJECTABLE/INJECTION EQ 200MCG BASE per 2ML (EQ 100MCG BASE per ML)
202585/001 DEXMEDETOMIDINE HYDROCHLORIDE DEXMEDETOMIDINE HYDROCHLORIDE INJECTABLE/INJECTION EQ 200MCG BASE per 2ML (EQ 100MCG BASE per ML)
202881/001 DEXMEDETOMIDINE HYDROCHLORIDE DEXMEDETOMIDINE HYDROCHLORIDE INJECTABLE/INJECTION EQ 200MCG BASE per 2ML (EQ 100MCG BASE per ML)
203773/001 DEXMEDETOMIDINE HYDROCHLORIDE DEXMEDETOMIDINE HYDROCHLORIDE INJECTABLE/INJECTION EQ 200MCG BASE per 2ML (EQ 100MCG BASE per ML)
203972/001 DEXMEDETOMIDINE HYDROCHLORIDE DEXMEDETOMIDINE HYDROCHLORIDE INJECTABLE/INJECTION EQ 200MCG BASE per 2ML (EQ 100MCG BASE per ML)
204023/001 DEXMEDETOMIDINE HYDROCHLORIDE DEXMEDETOMIDINE HYDROCHLORIDE INJECTABLE/INJECTION EQ 200MCG BASE per 2ML (EQ 100MCG BASE per ML)
204686/001 DEXMEDETOMIDINE HYDROCHLORIDE DEXMEDETOMIDINE HYDROCHLORIDE INJECTABLE/INJECTION EQ 200MCG BASE per 2ML (EQ 100MCG BASE per ML)
205046/001 DEXMEDETOMIDINE HYDROCHLORIDE DEXMEDETOMIDINE HYDROCHLORIDE INJECTABLE/INJECTION EQ 200MCG BASE per 2ML (EQ 100MCG BASE per ML)
205867/001 DEXMEDETOMIDINE HYDROCHLORIDE DEXMEDETOMIDINE HYDROCHLORIDE INJECTABLE/INJECTION EQ 200MCG BASE per 2ML (EQ 100MCG BASE per ML)
206628/001 DEXMEDETOMIDINE HYDROCHLORIDE DEXMEDETOMIDINE HYDROCHLORIDE SOLUTION/IV (INFUSION) EQ 400MCG BASE per 4ML (EQ 100MCG BASE per ML)
206628/002 DEXMEDETOMIDINE HYDROCHLORIDE DEXMEDETOMIDINE HYDROCHLORIDE SOLUTION/IV (INFUSION) EQ 1MG BASE per 10ML (EQ 100MCG BASE per ML)

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