🇺🇸 Decadron in United States

FDA authorised Decadron on 6 October 1959

Marketing authorisations

FDA — authorised 6 October 1959

  • Application: NDA012071
  • Marketing authorisation holder: MERCK
  • Local brand name: DECADRON
  • Indication: INJECTABLE — INJECTION
  • Status: approved

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FDA — authorised 7 July 1960

  • Application: NDA012376
  • Marketing authorisation holder: MERCK
  • Local brand name: DECADRON
  • Indication: ELIXIR — ORAL
  • Status: approved

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FDA — authorised 20 June 1962

  • Application: NDA013422
  • Marketing authorisation holder: HARROW EYE
  • Local brand name: MAXIDEX
  • Indication: SUSPENSION/DROPS — OPHTHALMIC
  • Status: approved

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FDA — authorised 23 October 1973

  • Application: ANDA083342
  • Marketing authorisation holder: ALCON
  • Local brand name: MAXIDEX
  • Indication: OINTMENT — OPHTHALMIC
  • Status: approved

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FDA

  • Status: approved

Decadron in other countries

Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.

Other Other approved in United States

Frequently asked questions

Is Decadron approved in United States?

Yes. FDA authorised it on 6 October 1959; FDA authorised it on 7 July 1960; FDA authorised it on 20 June 1962.

Who is the marketing authorisation holder for Decadron in United States?

MERCK holds the US marketing authorisation.