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dexmedetomidine hydrochloride

FDA Drug Profile — Dexmedetomidine Hydrochloride, DEXMEDETOMIDINE HYDROCHLORIDE, Dexmedetomidine Hydrochloride in 0.9% Sodium Chloride

Drug Details

Generic Name
dexmedetomidine hydrochloride
Brand Names
Dexmedetomidine Hydrochloride, DEXMEDETOMIDINE HYDROCHLORIDE, Dexmedetomidine Hydrochloride in 0.9% Sodium Chloride
Application Number
ANDA201072
Sponsor
Fresenius Kabi USA, LLC
NDC Codes
11
Dosage Forms
INJECTION, SOLUTION, INJECTION, POWDER
Routes
INTRAVENOUS
Active Ingredients
DEXMEDETOMIDINE HYDROCHLORIDE

Indications and Usage

1 INDICATIONS AND USAGE Dexmedetomidine hydrochloride injection is a relatively selective alpha 2 -adrenergic agonist indicated for: • Sedation of non-intubated patients prior to and/or during surgical and other procedures. (1.2) 1.2 Procedural Sedation Dexmedetomidine hydrochloride injection is indicated for sedation of non-intubated patients prior to and/or during surgical and other procedures. 1.2 Procedural Sedation Dexmedetomidine hydrochloride injection is indicated for sedation of non-intubated patients prior to and/or during surgical and other procedures.