FDA — authorised 19 September 2000
- Application: ANDA075392
- Marketing authorisation holder: TEVA PARENTERAL
- Local brand name: PROPOFOL
- Indication: INJECTABLE — INJECTION
- Status: approved
🇺🇸 Propofol Fresenius in United States
FDA authorised Propofol Fresenius on 19 September 2000 · 200 US adverse-event reports
Marketing authorisations
FDA — authorised 19 April 2005
- Application: ANDA074848
- Marketing authorisation holder: HIKMA
- Local brand name: PROPOFOL
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 22 December 2015
- Application: ANDA205307
- Marketing authorisation holder: WATSON LABS INC
- Local brand name: PROPOFOL
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 15 November 2018
- Application: ANDA205067
- Marketing authorisation holder: DR REDDYS
- Local brand name: PROPOFOL
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 16 September 2020
- Application: ANDA205576
- Marketing authorisation holder: INNOPHARMA
- Local brand name: PROPOFOL
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 12 October 2021
- Application: ANDA206408
- Marketing authorisation holder: AVET LIFESCIENCES
- Local brand name: PROPOFOL
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 20 June 2024
- Application: ANDA217013
- Marketing authorisation holder: ASPIRO
- Local brand name: PROPOFOL
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 15 August 2024
- Application: ANDA217525
- Marketing authorisation holder: AMNEAL
- Local brand name: PROPOFOL
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 2 December 2025
- Application: ANDA217945
- Marketing authorisation holder: NANJING KING FRIEND
- Local brand name: PROPOFOL
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA
- Application: ANDA075040
- Marketing authorisation holder: ESI LEDERLE
- Local brand name: PROPOFOL
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA
- Application: ANDA074719
- Marketing authorisation holder: BAXTER HLTHCARE
- Local brand name: PROPOFOL
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA
- 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: 20 April 2025 – 20 April 2026
- Total reports: 200
Most-reported reactions
- Anaphylactic Shock — 82 reports (41%)
- Bronchospasm — 23 reports (11.5%)
- Hypotension — 19 reports (9.5%)
- Anaphylactic Reaction — 14 reports (7%)
- Cardio-Respiratory Arrest — 14 reports (7%)
- Cardiac Arrest — 11 reports (5.5%)
- Rash — 11 reports (5.5%)
- Tachycardia — 10 reports (5%)
- Nausea — 8 reports (4%)
- Renal Failure Acute — 8 reports (4%)
Propofol Fresenius 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 Propofol Fresenius approved in United States?
Yes. FDA authorised it on 19 September 2000; FDA authorised it on 19 April 2005; FDA authorised it on 22 December 2015.
Who is the marketing authorisation holder for Propofol Fresenius in United States?
TEVA PARENTERAL holds the US marketing authorisation.