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FDA Drug information

DEXMEDETOMIDINE HYDROCHLORIDE

Read time: 1 mins
Marketing start date: 23 Dec 2024
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Summary of product characteristics


Effective Time

20221017

Version

3

Spl Product Data Elements

DEXMEDETOMIDINE HYDROCHLORIDE dexmedetomidine hydrochloride DEXMEDETOMIDINE HYDROCHLORIDE DEXMEDETOMIDINE SODIUM CHLORIDE WATER

Application Number

ANDA206798

Brand Name

DEXMEDETOMIDINE HYDROCHLORIDE

Generic Name

dexmedetomidine hydrochloride

Product Ndc

70771-1319

Product Type

HUMAN PRESCRIPTION DRUG

Route

INTRAVENOUS

Package Label Principal Display Panel

PRINCIPAL DISPLAY PANEL 200 MCG/2 ML CONTAINER LABEL NDC 70771-1319-1 Dexmedetomidine Hydrochloride Injection 200 mcg/2 mL (100 mcg/mL) For Intravenous Infusion Use MUST BE DILUTED 2 mL Single-Dose Vial Rx only Zydus Pharmaceuticals PRINCIPAL DISPLAY PANEL - 200 MCG/2 ML CARTON LABEL NDC 70771-1319-7 Dexmedetomidine Hydrochloride Injection 200 mcg/2 mL (100 mcg/mL) For Intravenous Infusion Use MUST BE DILUTED 25 X 2 mL Single-Dose Vials Rx only Zydus Pharmaceuticals Dexmedetomidine Hydrochloride Injection - Container Label Dexmedetomidine Hydrochloride Injection - Carton Label

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