🇺🇸 Dexamethasone (IV) in United States

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

FDA authorised Dexamethasone (IV) on 1 September 1983

Marketing authorisation

FDA — authorised 1 September 1983

Application: ANDA088252
Marketing authorisation holder: HIKMA
Local brand name: DEXAMETHASONE INTENSOL
Indication: CONCENTRATE — ORAL
Status: approved

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Frequently asked questions

Is Dexamethasone (IV) approved in United States?

Yes. FDA authorised it on 1 September 1983.

Who is the marketing authorisation holder for Dexamethasone (IV) in United States?

HIKMA holds the US marketing authorisation.