FDA — authorised 24 September 1996
- Marketing authorisation holder: FRESENIUS KABI USA
- Status: approved
🇺🇸 Naropin in United States
FDA authorised Naropin on 24 September 1996
Marketing authorisations
FDA — authorised 15 February 2018
- Application: NDA020533
- Marketing authorisation holder: FRESENIUS KABI USA
- Status: approved
FDA — authorised 14 November 2019
- Application: ANDA206166
- Marketing authorisation holder: INFORLIFE
- Indication: Labeling
- Status: approved
FDA — authorised 4 November 2022
- Application: ANDA207636
- Marketing authorisation holder: SOMERSET THERAPS LLC
- Indication: Labeling
- Status: approved
FDA — authorised 26 October 2023
- Application: ANDA206091
- Marketing authorisation holder: MYLAN LABS LTD
- Status: approved
FDA — authorised 15 August 2024
- Application: ANDA211907
- Marketing authorisation holder: HIKMA
- Status: approved
Naropin in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Pain approved in United States
Frequently asked questions
Is Naropin approved in United States?
Yes. FDA authorised it on 24 September 1996; FDA authorised it on 15 February 2018; FDA authorised it on 14 November 2019.
Who is the marketing authorisation holder for Naropin in United States?
FRESENIUS KABI USA holds the US marketing authorisation.