FDA — authorised 26 November 2008
- Application: ANDA079199
- Marketing authorisation holder: MYLAN INSTITUTIONAL
- Local brand name: ROCURONIUM BROMIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
🇺🇸 Rocuronium in United States
FDA authorised Rocuronium on 26 November 2008
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 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 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 2 March 2023
- Application: ANDA216234
- Marketing authorisation holder: CAPLIN
- 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 22 July 2024
- Application: ANDA217092
- Marketing authorisation holder: STERISCIENCE
- Status: approved
FDA — authorised 29 May 2025
- Application: ANDA219674
- Marketing authorisation holder: MANKIND PHARMA
- 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 24 October 2025
- Application: NDA219108
- Marketing authorisation holder: B BRAUN MEDICAL
- Status: approved
FDA — authorised 6 January 2026
- Application: ANDA213476
- Marketing authorisation holder: KNACK
- Local brand name: ROCURONIUM BROMIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
The FDA approved Rocuronium Bromide, manufactured by KNACK, for injectable use on January 6, 2026. This approval was granted through a standard expedited pathway. Rocuronium Bromide is a non-depolarizing neuromuscular blocking agent used to facilitate tracheal intubation and to provide skeletal muscle relaxation during surgery or mechanical ventilation.
FDA — authorised 4 March 2026
- Application: ANDA220124
- Marketing authorisation holder: ASPIRO
- Local brand name: ROCURONIUM BROMIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
The FDA approved Rocuronium Bromide, manufactured by ASPIRO, for injectable use on 2026-03-04. This approval was granted through the standard expedited pathway. Rocuronium Bromide is indicated for use in adults and children for the facilitation of tracheal intubation and for the attenuation of neuromuscular blockade during surgery.
Rocuronium in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Neuroscience approved in United States
Frequently asked questions
Is Rocuronium approved in United States?
Yes. FDA authorised it on 26 November 2008; FDA authorised it on 26 November 2008; FDA authorised it on 5 December 2008.
Who is the marketing authorisation holder for Rocuronium in United States?
MYLAN INSTITUTIONAL holds the US marketing authorisation.