FDA — authorised 21 October 2004
- Application: NDA021721
- Marketing authorisation holder: JANSSEN PHARMS
- Local brand name: LEVAQUIN
- Indication: SOLUTION — ORAL
- Status: approved
🇺🇸 Levaquin in United States
FDA authorised Levaquin on 21 October 2004
Marketing authorisations
FDA — authorised 7 July 2011
- Application: ANDA090343
- Marketing authorisation holder: INFORLIFE
- Local brand name: LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER
- Indication: INJECTABLE — INJECTION
- Status: approved
The FDA approved Levaquin for its labelled indications. This approval was granted to INFORLIFE on 2024-09-26. The application number for this approval is ANDA090343.
FDA — authorised 19 June 2013
- Application: ANDA200674
- Marketing authorisation holder: FRESENIUS KABI USA
- Local brand name: LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 3 September 2015
- Application: ANDA078579
- Marketing authorisation holder: HOSPIRA
- Local brand name: LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 8 October 2015
- Application: ANDA201043
- Marketing authorisation holder: AUROBINDO PHARMA LTD
- Indication: Labeling
- Status: approved
FDA — authorised 10 February 2016
- Application: ANDA206919
- Marketing authorisation holder: EUGIA PHARMA
- Local brand name: LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 24 April 2019
- Application: ANDA076890
- Marketing authorisation holder: CHARTWELL MOLECULAR
- Indication: Labeling
- Status: approved
FDA — authorised 30 December 2020
- Application: ANDA206908
- Marketing authorisation holder: GLAND
- Local brand name: LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER
- Indication: INJECTABLE — INJECTION
- Status: approved
The FDA approved Levaquin for its labelled indications on 2024-09-20. The marketing authorisation holder is GLAND. The approval was granted through a standard pathway.
FDA — authorised 29 January 2024
- Application: ANDA216164
- Marketing authorisation holder: KNACK
- Local brand name: LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER
- Indication: INJECTABLE — INJECTION
- Status: approved
Levaquin 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 Levaquin approved in United States?
Yes. FDA authorised it on 21 October 2004; FDA authorised it on 7 July 2011; FDA authorised it on 19 June 2013.
Who is the marketing authorisation holder for Levaquin in United States?
JANSSEN PHARMS holds the US marketing authorisation.