🇺🇸 KETAMINE in United States

FDA authorised KETAMINE on 22 March 1996

Marketing authorisations

FDA — authorised 22 March 1996

  • Application: ANDA074524
  • Marketing authorisation holder: HIKMA
  • Status: supplemented

FDA — authorised 27 June 1996

  • Application: ANDA074549
  • Marketing authorisation holder: HOSPIRA
  • Status: supplemented

FDA — authorised 28 December 2001

  • Application: ANDA076092
  • Marketing authorisation holder: EUGIA PHARMA
  • Status: supplemented

FDA — authorised 24 January 2023

  • Application: ANDA216809
  • Marketing authorisation holder: GLAND
  • Status: approved

FDA — authorised 17 September 2025

  • Application: ANDA219684
  • Marketing authorisation holder: BAXTER HLTHCARE CORP
  • Status: approved

FDA

  • Status: approved

KETAMINE in other countries

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

Frequently asked questions

Is KETAMINE approved in United States?

Yes. FDA authorised it on 22 March 1996; FDA authorised it on 27 June 1996; FDA authorised it on 28 December 2001.

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

HIKMA holds the US marketing authorisation.