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Medicines · US (FDA)

FDA 2020

FDA

Dexmedetomidine Hydrochloride

Approved 23 Nov 2020InjectionInjectable

The FDA lists this product in 58 strengths and forms.

Official labelAsk Osler about it

On this page

Composition
Strengths and forms
Official product information

The table holds no label text for this product yet, only the facts beside it. The official product information has the full text.

Composition

Active ingredients: DEXMEDETOMIDINE HYDROCHLORIDE EQ 200MCG BASE/50ML (EQ 4MCG BASE/ML)

Strengths and forms

The FDA lists each strength of a product separately; these pages share one label.

DEXMEDETOMIDINE HYDROCHLORIDE EQ 200MCG BASE/2ML (EQ 100MCG BASE/ML) · InjectableANDA202126-001 · Prescription
DEXMEDETOMIDINE HYDROCHLORIDE EQ 200MCG BASE/2ML (EQ 100MCG BASE/ML) · InjectableANDA203773-001 · Discontinued
DEXMEDETOMIDINE HYDROCHLORIDE EQ 200MCG BASE/2ML (EQ 100MCG BASE/ML) · InjectableANDA203972-001 · Prescription
DEXMEDETOMIDINE HYDROCHLORIDE EQ 200MCG BASE/50ML (EQ 4MCG BASE/ML) · InjectableANDA210321-001 · Prescription
DEXMEDETOMIDINE HYDROCHLORIDE EQ 400MCG BASE/100ML (EQ 4MCG BASE/ML) · InjectableANDA210321-002 · Prescription
DEXMEDETOMIDINE HYDROCHLORIDE EQ 200MCG BASE/50ML (EQ 4MCG BASE/ML) · InjectableANDA212571-001 · Prescription
DEXMEDETOMIDINE HYDROCHLORIDE EQ 400MCG BASE/100ML (EQ 4MCG BASE/ML) · InjectableANDA212571-002 · Prescription
DEXMEDETOMIDINE HYDROCHLORIDE EQ 400MCG BASE/100ML (EQ 4MCG BASE/ML) · Injectable

Two medicines in one question?

Name two or more medicines and Osler runs an interaction check. A severe interaction is stated at the very top of the answer.

ANDA212791-002 · Prescription

DEXMEDETOMIDINE HYDROCHLORIDE EQ 80MCG BASE/20ML (EQ 4MCG BASE/ML) · InjectableANDA212791-003 · Discontinued

DEXMEDETOMIDINE HYDROCHLORIDE EQ 200MCG BASE/50ML (EQ 4MCG BASE/ML) · InjectableANDA212791-001 · Prescription

DEXMEDETOMIDINE HYDROCHLORIDE EQ 200MCG BASE/50ML (EQ 4MCG BASE/ML) · InjectableANDA216604-001 · Prescription

DEXMEDETOMIDINE HYDROCHLORIDE EQ 400MCG BASE/100ML (EQ 4MCG BASE/ML) · InjectableANDA216604-002 · Prescription

DEXMEDETOMIDINE HYDROCHLORIDE EQ 400MCG BASE/100ML (EQ 4MCG BASE/ML) · InjectableANDA217308-002 · Prescription

DEXMEDETOMIDINE HYDROCHLORIDE EQ 200MCG BASE/50ML (EQ 4MCG BASE/ML) · InjectableANDA217308-001 · Prescription

DEXMEDETOMIDINE HYDROCHLORIDE EQ 200MCG BASE/2ML (EQ 100MCG BASE/ML) · InjectableANDA091465-001 · Discontinued

DEXMEDETOMIDINE HYDROCHLORIDE EQ 400MCG BASE/100ML (EQ 4MCG BASE/ML) · SolutionNDA206628-004 · Prescription

DEXMEDETOMIDINE HYDROCHLORIDE EQ 1MG BASE/10ML (EQ 100MCG BASE/ML) · SolutionNDA206628-002 · Prescription

DEXMEDETOMIDINE HYDROCHLORIDE EQ 200MCG BASE/50ML (EQ 4MCG BASE/ML) · SolutionNDA206628-003 · Prescription

DEXMEDETOMIDINE HYDROCHLORIDE EQ 400MCG BASE/4ML (EQ 100MCG BASE/ML) · SolutionNDA206628-001 · Prescription

DEXMEDETOMIDINE HYDROCHLORIDE EQ 400MCG BASE/100ML (EQ 4MCG BASE/ML) · InjectableANDA209065-004 · Prescription

DEXMEDETOMIDINE HYDROCHLORIDE EQ 80MCG BASE/20ML (EQ 4MCG BASE/ML) · InjectableANDA209065-002 · Prescription

DEXMEDETOMIDINE HYDROCHLORIDE EQ 200MCG BASE/50ML (EQ 4MCG BASE/ML) · InjectableANDA209065-003 · Prescription

DEXMEDETOMIDINE HYDROCHLORIDE EQ 200MCG BASE/2ML (EQ 100MCG BASE/ML) · InjectableANDA209065-001 · Prescription

DEXMEDETOMIDINE HYDROCHLORIDE EQ 200MCG BASE/50ML (EQ 4MCG BASE/ML) · InjectableThis page

DEXMEDETOMIDINE HYDROCHLORIDE EQ 400MCG BASE/100ML (EQ 4MCG BASE/ML) · InjectableANDA212857-003 · Prescription

DEXMEDETOMIDINE HYDROCHLORIDE EQ 80MCG BASE/20ML (EQ 4MCG BASE/ML) · InjectableANDA212857-001 · Prescription

DEXMEDETOMIDINE HYDROCHLORIDE EQ 200MCG BASE/2ML (EQ 100MCG BASE/ML) · InjectableANDA214794-001 · Discontinued

DEXMEDETOMIDINE HYDROCHLORIDE EQ 200MCG BASE/2ML (EQ 100MCG BASE/ML) · InjectableANDA202585-001 · Prescription

DEXMEDETOMIDINE HYDROCHLORIDE EQ 200MCG BASE/2ML (EQ 100MCG BASE/ML) · InjectableANDA202881-001 · Prescription

DEXMEDETOMIDINE HYDROCHLORIDE EQ 200MCG BASE/2ML (EQ 100MCG BASE/ML) · InjectableANDA204843-001 · Prescription

DEXMEDETOMIDINE HYDROCHLORIDE EQ 400MCG BASE/100ML (EQ 4MCG BASE/ML) · InjectableANDA206407-002 · Prescription

DEXMEDETOMIDINE HYDROCHLORIDE EQ 1MG BASE/250ML (EQ 4MCG BASE/ML) · InjectableANDA206407-003 · Prescription

DEXMEDETOMIDINE HYDROCHLORIDE EQ 200MCG BASE/50ML (EQ 4MCG BASE/ML) · InjectableANDA206407-001 · Prescription

DEXMEDETOMIDINE HYDROCHLORIDE EQ 200MCG BASE/2ML (EQ 100MCG BASE/ML) · InjectableANDA208103-001 · Prescription

DEXMEDETOMIDINE HYDROCHLORIDE EQ 200MCG BASE/50ML (EQ 4MCG BASE/ML) · InjectableANDA208532-001 · Prescription

DEXMEDETOMIDINE HYDROCHLORIDE EQ 400MCG BASE/100ML (EQ 4MCG BASE/ML) · InjectableANDA208532-002 · Prescription

DEXMEDETOMIDINE HYDROCHLORIDE EQ 200MCG BASE/2ML (EQ 100MCG BASE/ML) · InjectableANDA205046-001 · Prescription

DEXMEDETOMIDINE HYDROCHLORIDE EQ 400MCG BASE/100ML (EQ 4MCG BASE/ML) · InjectableANDA208266-002 · Prescription

DEXMEDETOMIDINE HYDROCHLORIDE EQ 200MCG BASE/50ML (EQ 4MCG BASE/ML) · InjectableANDA208266-001 · Prescription

DEXMEDETOMIDINE HYDROCHLORIDE EQ 400MCG BASE/100ML (EQ 4MCG BASE/ML) · InjectableANDA209307-002 · Prescription

DEXMEDETOMIDINE HYDROCHLORIDE EQ 200MCG BASE/50ML (EQ 4MCG BASE/ML) · InjectableANDA209307-001 · Prescription

DEXMEDETOMIDINE HYDROCHLORIDE EQ 200MCG BASE/2ML (EQ 100MCG BASE/ML) · InjectableANDA204686-001 · Prescription

DEXMEDETOMIDINE HYDROCHLORIDE EQ 200MCG BASE/2ML (EQ 100MCG BASE/ML) · InjectableANDA205272-001 · Prescription

DEXMEDETOMIDINE HYDROCHLORIDE EQ 200MCG BASE/2ML (EQ 100MCG BASE/ML) · InjectableANDA205867-001 · Prescription

DEXMEDETOMIDINE HYDROCHLORIDE EQ 200MCG BASE/2ML (EQ 100MCG BASE/ML) · InjectableANDA206798-001 · Prescription

DEXMEDETOMIDINE HYDROCHLORIDE EQ 400MCG BASE/4ML (EQ 100MCG BASE/ML) · SolutionANDA218112-001 · Prescription

DEXMEDETOMIDINE HYDROCHLORIDE EQ 1MG BASE/10ML (EQ 100MCG BASE/ML) · SolutionANDA218112-002 · Prescription

DEXMEDETOMIDINE HYDROCHLORIDE EQ 400MCG BASE/100ML (EQ 4MCG BASE/ML) · InjectableANDA220315-002 · Prescription

DEXMEDETOMIDINE HYDROCHLORIDE EQ 200MCG BASE/50ML (EQ 4MCG BASE/ML) · InjectableANDA220315-001 · Prescription

DEXMEDETOMIDINE HYDROCHLORIDE EQ 200MCG BASE/2ML (EQ 100MCG BASE/ML) · InjectableANDA201072-001 · Prescription

DEXMEDETOMIDINE HYDROCHLORIDE EQ 200MCG BASE/2ML (EQ 100MCG BASE/ML) · InjectableANDA204023-001 · Prescription

DEXMEDETOMIDINE HYDROCHLORIDE EQ 80MCG BASE/20ML (EQ 4MCG BASE/ML) · InjectableANDA208129-004 · Tentative approval

DEXMEDETOMIDINE HYDROCHLORIDE EQ 200MCG BASE/50ML (EQ 4MCG BASE/ML) · InjectableANDA208129-002 · Prescription

DEXMEDETOMIDINE HYDROCHLORIDE EQ 400MCG BASE/100ML (EQ 4MCG BASE/ML) · InjectableANDA208129-003 · Prescription

DEXMEDETOMIDINE HYDROCHLORIDE EQ 80MCG BASE/20ML (EQ 4MCG BASE/ML) · InjectableANDA208129-001 · Prescription

DEXMEDETOMIDINE HYDROCHLORIDE EQ 400MCG BASE/100ML (EQ 4MCG BASE/ML) · InjectableANDA207551-002 · Prescription

DEXMEDETOMIDINE HYDROCHLORIDE EQ 200MCG BASE/50ML (EQ 4MCG BASE/ML) · InjectableANDA207551-001 · Prescription

DEXMEDETOMIDINE HYDROCHLORIDE EQ 200MCG BASE/2ML (EQ 100MCG BASE/ML) · InjectableANDA218675-001 · Prescription

Official product information

Drugs@FDA lists the approved labels, letters and reviews for application ANDA212857.

Prognia shows this product information for reference and learning. It is not treatment advice and can lag behind the official text. Always check the current product information and local protocols before prescribing.

At a glance

Brand name: Dexmedetomidine Hydrochloride
Route: Injection
Dosage form: Injectable
Applicant: Tagi
Status: Prescription
FDA approval: 23 Nov 2020
Application: ANDA212857-002