FDA — authorised 22 March 1996
- Application: ANDA074524
- Marketing authorisation holder: HIKMA
- Local brand name: KETAMINE HYDROCHLORIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
🇺🇸 IV Ketamine in United States
FDA authorised IV Ketamine on 22 March 1996 · 20 US adverse-event reports
Marketing authorisations
FDA — authorised 27 June 1996
- Application: ANDA074549
- Marketing authorisation holder: HOSPIRA
- Local brand name: KETAMINE HYDROCHLORIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 28 December 2001
- Application: ANDA076092
- Marketing authorisation holder: EUGIA PHARMA
- Local brand name: KETAMINE HYDROCHLORIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 13 January 2023
- Application: ANDA215808
- Marketing authorisation holder: FRESENIUS KABI USA
- Local brand name: KETAMINE HYDROCHLORIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 7 August 2025
- Application: ANDA217858
- Marketing authorisation holder: CAPLIN
- Local brand name: KETAMINE HYDROCHLORIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 17 September 2025
- Application: ANDA219684
- Marketing authorisation holder: BAXTER HLTHCARE CORP
- Local brand name: KETAMINE HYDROCHLORIDE
- Indication: SOLUTION — INTRAMUSCULAR, INTRAVENOUS
- Status: approved
FDA
- Application: ANDA071951
- Marketing authorisation holder: QUAD PHARMS
- Local brand name: KETAMINE HCL
- Indication: Injectable — Injection
- Status: approved
FDA
- Application: ANDA071950
- Marketing authorisation holder: QUAD PHARMS
- Local brand name: KETAMINE HCL
- Indication: Injectable — Injection
- Status: approved
FDA
- Application: ANDA071949
- Marketing authorisation holder: QUAD PHARMS
- Local brand name: KETAMINE HCL
- 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: 23 April 2025 – 23 April 2026
- Total reports: 20
Most-reported reactions
- Nausea — 4 reports (20%)
- Post Lumbar Puncture Syndrome — 3 reports (15%)
- Dizziness — 2 reports (10%)
- Euphoric Mood — 2 reports (10%)
- Headache — 2 reports (10%)
- Malaise — 2 reports (10%)
- Pyrexia — 2 reports (10%)
- Abdominal Pain — 1 report (5%)
- Anaemia Postoperative — 1 report (5%)
- Arthralgia — 1 report (5%)
Other Psychiatry / Pain Management approved in United States
Frequently asked questions
Is IV 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 IV Ketamine in United States?
HIKMA holds the US marketing authorisation.