FDA — authorised 8 October 2015
- Application: ANDA201043
- Marketing authorisation holder: AUROBINDO PHARMA LTD
- Indication: Labeling
- Status: approved
🇺🇸 Levaquin in United States
FDA authorised Levaquin on 8 October 2015
Marketing authorisations
FDA — authorised 15 October 2018
- Application: ANDA206919
- Marketing authorisation holder: EUGIA PHARMA
- Indication: Labeling
- Status: approved
FDA — authorised 24 April 2019
- Application: ANDA076890
- Marketing authorisation holder: CHARTWELL MOLECULAR
- Indication: Labeling
- Status: approved
FDA — authorised 20 September 2024
- Application: ANDA206908
- Marketing authorisation holder: GLAND
- Indication: Labeling
- Status: approved
The FDA approved Levaquin for its labelled indication on 20 September 2024. The approval was granted to GLAND, the marketing authorisation holder, under the standard expedited pathway. The application number for this approval is ANDA206908.
FDA — authorised 26 September 2024
- Application: ANDA090343
- Marketing authorisation holder: INFORLIFE
- Indication: Labeling
- Status: approved
The FDA approved Levaquin for its labelled indications. This approval was granted to INFORLIFE on 2024-09-26 under the standard expedited pathway. The application number for this approval is ANDA090343.
Levaquin 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 Levaquin approved in United States?
Yes. FDA authorised it on 8 October 2015; FDA authorised it on 15 October 2018; FDA authorised it on 24 April 2019.
Who is the marketing authorisation holder for Levaquin in United States?
AUROBINDO PHARMA LTD holds the US marketing authorisation.