FDA — authorised 26 November 2008
- Application: ANDA078717
- Marketing authorisation holder: TEVA PHARMS
- Local brand name: ROCURONIUM BROMIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
🇺🇸 ROCURONIUM BROMIDE in United States
FDA authorised ROCURONIUM BROMIDE on 26 November 2008 · 3,626 US adverse-event reports
Marketing authorisations
FDA — authorised 26 November 2008
- Application: ANDA078519
- Marketing authorisation holder: HOSPIRA
- Local brand name: ROCURONIUM BROMIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 26 November 2008
- Application: ANDA079199
- Marketing authorisation holder: MYLAN INSTITUTIONAL
- Local brand name: ROCURONIUM BROMIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 5 December 2008
- Application: ANDA079195
- Marketing authorisation holder: SANDOZ
- Local brand name: ROCURONIUM BROMIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 29 December 2008
- Application: ANDA078651
- Marketing authorisation holder: FRESENIUS KABI USA
- Local brand name: ROCURONIUM BROMIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 28 July 2010
- Application: ANDA091458
- Marketing authorisation holder: SAGENT PHARMS INC
- Local brand name: ROCURONIUM BROMIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 27 August 2012
- Application: ANDA091115
- Marketing authorisation holder: TAMARANG
- Local brand name: ROCURONIUM BROMIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 28 February 2017
- Application: ANDA204679
- Marketing authorisation holder: WEST WARD PHARM CORP
- Local brand name: ROCURONIUM BROMIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 12 April 2017
- Application: ANDA206206
- Marketing authorisation holder: EUGIA PHARMA
- Status: supplemented
FDA — authorised 4 April 2018
- Application: ANDA205656
- Marketing authorisation holder: GLAND
- Local brand name: ROCURONIUM BROMIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 13 August 2019
- Application: ANDA210437
- Marketing authorisation holder: PIRAMAL CRITICAL
- Local brand name: ROCURONIUM BROMIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 26 May 2022
- Application: ANDA212668
- Marketing authorisation holder: PRINSTON INC
- Status: approved
FDA — authorised 2 March 2023
- Application: ANDA216234
- Marketing authorisation holder: CAPLIN
- Local brand name: ROCURONIUM BROMIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 8 May 2023
- Application: ANDA213453
- Marketing authorisation holder: MEITHEAL
- Status: approved
FDA — authorised 24 May 2023
- Application: ANDA217034
- Marketing authorisation holder: HIKMA
- Local brand name: ROCURONIUM BROMIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 12 July 2024
- Application: ANDA215684
- Marketing authorisation holder: SHANDONG
- Local brand name: ROCURONIUM BROMIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 12 July 2024
- Application: ANDA204918
- Marketing authorisation holder: RISING
- Local brand name: ROCURONIUM BROMIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 22 July 2024
- Application: ANDA217092
- Marketing authorisation holder: STERISCIENCE
- Local brand name: ROCURONIUM BROMIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 29 May 2025
- Application: ANDA219674
- Marketing authorisation holder: MANKIND PHARMA
- Local brand name: ROCURONIUM BROMIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 9 June 2025
- Application: NDA217472
- Marketing authorisation holder: FRESENIUS KABI USA
- Local brand name: ROCURONIUM BROMIDE
- Indication: SOLUTION — INTRAVENOUS
- Status: approved
FDA — authorised 6 January 2026
- Application: ANDA213476
- Marketing authorisation holder: KNACK
- Local brand name: ROCURONIUM BROMIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 4 March 2026
- Application: ANDA220124
- Marketing authorisation holder: ASPIRO
- Local brand name: ROCURONIUM BROMIDE
- 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: 3,626
Most-reported reactions
- Drug Ineffective — 676 reports (18.64%)
- Anaphylactic Shock — 588 reports (16.22%)
- Anaphylactic Reaction — 575 reports (15.86%)
- Hypotension — 498 reports (13.73%)
- Cardiac Arrest — 346 reports (9.54%)
- Tachycardia — 204 reports (5.63%)
- Bradycardia — 202 reports (5.57%)
- Bronchospasm — 197 reports (5.43%)
- Rash — 172 reports (4.74%)
- Drug Interaction — 168 reports (4.63%)
ROCURONIUM BROMIDE 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 ROCURONIUM BROMIDE approved in United States?
Yes. FDA authorised it on 26 November 2008; FDA authorised it on 26 November 2008; FDA authorised it on 26 November 2008.
Who is the marketing authorisation holder for ROCURONIUM BROMIDE in United States?
TEVA PHARMS holds the US marketing authorisation.