FDA — authorised 7 September 1982
- Application: NDA018227
- Marketing authorisation holder: HOSPIRA
- Local brand name: AMIDATE
- Indication: INJECTABLE — INJECTION
- Status: approved
🇺🇸 Amidate in United States
FDA authorised Amidate on 7 September 1982 · 201 US adverse-event reports
Marketing authorisations
FDA — authorised 4 November 1996
- Application: ANDA074593
- Marketing authorisation holder: HIKMA
- Local brand name: ETOMIDATE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 2 January 2009
- Application: ANDA078289
- Marketing authorisation holder: RISING
- Local brand name: ETOMIDATE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 22 December 2009
- Application: ANDA078867
- Marketing authorisation holder: LUITPOLD
- Local brand name: ETOMIDATE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 20 June 2012
- Application: ANDA091297
- Marketing authorisation holder: PH HEALTH
- Local brand name: ETOMIDATE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 18 July 2014
- Application: ANDA202360
- Marketing authorisation holder: ZYDUS PHARMS
- Local brand name: ETOMIDATE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 13 August 2014
- Application: ANDA204618
- Marketing authorisation holder: AVET LIFESCIENCES
- Local brand name: ETOMIDATE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 25 February 2016
- Application: ANDA202354
- Marketing authorisation holder: HIKMA
- Local brand name: ETOMIDATE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 7 February 2017
- Application: ANDA201044
- Marketing authorisation holder: MYLAN LABS LTD
- Local brand name: ETOMIDATE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 24 February 2017
- Application: ANDA206126
- Marketing authorisation holder: EUGIA PHARMA
- Local brand name: ETOMIDATE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 18 April 2017
- Application: ANDA209058
- Marketing authorisation holder: GLAND
- Local brand name: ETOMIDATE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 18 December 2020
- Application: ANDA215028
- Marketing authorisation holder: CAPLIN
- Local brand name: ETOMIDATE
- Indication: INJECTABLE — INJECTION
- Status: approved
Safety signals — FAERS
Adverse reaction reports describe suspected side effects. A report does not mean the drug caused the event — co-medications, underlying disease and coincidence all contribute.
- Window: 19 April 2025 – 19 April 2026
- Total reports: 201
Most-reported reactions
- Renal Failure — 28 reports (13.93%)
- Pain — 26 reports (12.94%)
- Anxiety — 22 reports (10.95%)
- Injury — 21 reports (10.45%)
- Fear — 20 reports (9.95%)
- Unevaluable Event — 20 reports (9.95%)
- Emotional Distress — 19 reports (9.45%)
- Renal Injury — 17 reports (8.46%)
- Anhedonia — 14 reports (6.97%)
- Stress — 14 reports (6.97%)
Amidate in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Metabolic approved in United States
Frequently asked questions
Is Amidate approved in United States?
Yes. FDA authorised it on 7 September 1982; FDA authorised it on 4 November 1996; FDA authorised it on 2 January 2009.
Who is the marketing authorisation holder for Amidate in United States?
HOSPIRA holds the US marketing authorisation.