FDA — authorised 10 December 1999
- Application: NDA021085
- Marketing authorisation holder: BAYER HLTHCARE
- Local brand name: AVELOX
- Indication: TABLET — ORAL
- Status: approved
🇺🇸 Avelox in United States
FDA authorised Avelox on 10 December 1999
Marketing authorisations
FDA — authorised 27 April 2001
- Application: NDA021334
- Marketing authorisation holder: BAYER PHARMS
- Local brand name: AVELOX
- Indication: Tablet — Oral
- Status: approved
FDA — authorised 12 April 2004
- Application: NDA021598
- Marketing authorisation holder: HARROW EYE
- Indication: Labeling
- Status: approved
FDA — authorised 5 December 2019
- Application: ANDA202632
- Marketing authorisation holder: AUROBINDO PHARMA LTD
- Indication: Labeling
- Status: approved
FDA — authorised 19 July 2021
- Application: ANDA209469
- Marketing authorisation holder: ALEMBIC
- Indication: Labeling
- Status: approved
FDA — authorised 2 May 2023
- Application: ANDA208778
- Marketing authorisation holder: GLAND
- Indication: Labeling
- Status: approved
FDA — authorised 27 January 2025
- Application: ANDA217988
- Marketing authorisation holder: MANKIND PHARMA
- Status: approved
Avelox in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Infectious Disease approved in United States
Frequently asked questions
Is Avelox approved in United States?
Yes. FDA authorised it on 10 December 1999; FDA authorised it on 27 April 2001; FDA authorised it on 12 April 2004.
Who is the marketing authorisation holder for Avelox in United States?
BAYER HLTHCARE holds the US marketing authorisation.