FDA — authorised 23 June 2008
- Marketing authorisation holder: ALCON PHARMS LTD
- Status: approved
🇺🇸 Durezol in United States
FDA authorised Durezol on 23 June 2008
Marketing authorisations
FDA — authorised 23 June 2008
- Application: NDA022212
- Marketing authorisation holder: SANDOZ
- Local brand name: DUREZOL
- Indication: EMULSION — OPHTHALMIC
- Status: approved
FDA — authorised 17 November 2021
- Application: ANDA211526
- Marketing authorisation holder: AMNEAL
- Status: approved
FDA — authorised 11 February 2025
- Application: ANDA218191
- Marketing authorisation holder: UPSHER SMITH LABS
- Status: approved
FDA — authorised 20 March 2025
- Application: ANDA212566
- Marketing authorisation holder: MYLAN LABS LTD
- Status: approved
FDA — authorised 26 January 2026
- Application: ANDA213774
- Marketing authorisation holder: ALEMBIC
- Status: approved
Durezol in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Metabolic approved in United States
Frequently asked questions
Is Durezol approved in United States?
Yes. FDA authorised it on 23 June 2008; FDA authorised it on 23 June 2008; FDA authorised it on 17 November 2021.
Who is the marketing authorisation holder for Durezol in United States?
ALCON PHARMS LTD holds the US marketing authorisation.