FDA — authorised 17 July 2014
- Application: ANDA078601
- Marketing authorisation holder: NAVINTA LLC
- Local brand name: ROPIVACAINE HYDROCHLORIDE
- Indication: SOLUTION — INJECTION
- Status: approved
🇺🇸 ROPIVACAINE HYDROCHLORIDE in United States
FDA authorised ROPIVACAINE HYDROCHLORIDE on 17 July 2014
Marketing authorisations
FDA — authorised 23 September 2014
- Application: ANDA090318
- Marketing authorisation holder: RISING
- Local brand name: ROPIVACAINE HYDROCHLORIDE
- Indication: SOLUTION — INJECTION
- Status: approved
FDA — authorised 23 September 2014
- Application: ANDA090194
- Marketing authorisation holder: HOSPIRA
- Local brand name: ROPIVACAINE HYDROCHLORIDE
- Indication: SOLUTION — INJECTION
- Status: approved
FDA — authorised 11 April 2016
- Application: ANDA203955
- Marketing authorisation holder: RISING
- Local brand name: ROPIVACAINE HYDROCHLORIDE
- Indication: SOLUTION — INJECTION
- Status: approved
FDA — authorised 13 July 2016
- Application: ANDA205612
- Marketing authorisation holder: EUGIA PHARMA
- Local brand name: ROPIVACAINE HYDROCHLORIDE
- Indication: SOLUTION — INJECTION
- Status: approved
FDA — authorised 11 June 2018
- Application: ANDA206166
- Marketing authorisation holder: INFORLIFE
- Local brand name: ROPIVACAINE HYDROCHLORIDE
- Indication: SOLUTION — INJECTION
- Status: approved
FDA — authorised 15 June 2018
- Application: ANDA207636
- Marketing authorisation holder: SOMERSET THERAPS LLC
- Local brand name: ROPIVACAINE HYDROCHLORIDE
- Indication: SOLUTION — INJECTION
- Status: approved
FDA — authorised 9 April 2020
- Application: ANDA212808
- Marketing authorisation holder: CAPLIN
- Local brand name: ROPIVACAINE HYDROCHLORIDE
- Indication: SOLUTION — INJECTION
- Status: approved
FDA — authorised 20 July 2020
- Application: ANDA214074
- Marketing authorisation holder: HIKMA
- Local brand name: ROPIVACAINE HYDROCHLORIDE
- Indication: SOLUTION — INJECTION
- Status: approved
FDA — authorised 18 August 2022
- Application: ANDA210102
- Marketing authorisation holder: GLAND
- Local brand name: ROPIVACAINE HYDROCHLORIDE
- Indication: SOLUTION — INJECTION
- Status: approved
FDA — authorised 8 March 2023
- Application: ANDA216605
- Marketing authorisation holder: AMNEAL
- Local brand name: ROPIVACAINE HYDROCHLORIDE
- Indication: SOLUTION — INJECTION
- Status: approved
FDA — authorised 26 October 2023
- Application: ANDA206091
- Marketing authorisation holder: MYLAN LABS LTD
- Local brand name: ROPIVACAINE HYDROCHLORIDE
- Indication: SOLUTION — INJECTION
- Status: approved
FDA — authorised 30 July 2024
- Application: ANDA218713
- Marketing authorisation holder: KINDOS
- Local brand name: ROPIVACAINE HYDROCHLORIDE
- Indication: SOLUTION — INJECTION
- Status: approved
FDA — authorised 15 August 2024
- Application: ANDA211907
- Marketing authorisation holder: HIKMA
- Local brand name: ROPIVACAINE HYDROCHLORIDE
- Indication: SOLUTION — INJECTION
- Status: approved
FDA — authorised 21 March 2025
- Application: ANDA219883
- Marketing authorisation holder: ANTHEA PHARMA
- Local brand name: ROPIVACAINE HYDROCHLORIDE
- Indication: SOLUTION — INJECTION
- Status: approved
FDA
- Status: approved
ROPIVACAINE HYDROCHLORIDE 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 ROPIVACAINE HYDROCHLORIDE approved in United States?
Yes. FDA authorised it on 17 July 2014; FDA authorised it on 23 September 2014; FDA authorised it on 23 September 2014.
Who is the marketing authorisation holder for ROPIVACAINE HYDROCHLORIDE in United States?
NAVINTA LLC holds the US marketing authorisation.