FDA — authorised 1 September 1966
- Application: NDA012750
- Marketing authorisation holder: BAUSCH
- Local brand name: LIBRAX
- Indication: CAPSULE — ORAL
- Status: approved
🇺🇸 Librax in United States
FDA authorised Librax on 1 September 1966
Marketing authorisations
FDA — authorised 19 July 2022
- Application: ANDA215835
- Marketing authorisation holder: MICRO LABS
- Status: approved
FDA — authorised 2 September 2022
- Application: ANDA210579
- Marketing authorisation holder: MISEMER
- Indication: Labeling
- Status: approved
FDA — authorised 23 December 2022
- Application: ANDA215555
- Marketing authorisation holder: AMNEAL
- Indication: Labeling
- Status: approved
FDA — authorised 8 July 2024
- Application: ANDA212344
- Marketing authorisation holder: WINDER LABS LLC
- Status: approved
FDA
- Marketing authorisation holder: ROCHE
- Status: approved
Librax in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Immunology approved in United States
Frequently asked questions
Is Librax approved in United States?
Yes. FDA authorised it on 1 September 1966; FDA authorised it on 19 July 2022; FDA authorised it on 2 September 2022.
Who is the marketing authorisation holder for Librax in United States?
BAUSCH holds the US marketing authorisation.