FDA — authorised 10 August 2020
- Application: ANDA205548
- Marketing authorisation holder: DR REDDYS
- Local brand name: CIPROFLOXACIN AND DEXAMETHASONE
- Indication: SUSPENSION/DROPS — OTIC
- Status: approved
🇺🇸 Ciprodex in United States
FDA authorised Ciprodex on 10 August 2020
Marketing authorisations
FDA — authorised 30 August 2022
- Application: ANDA210470
- Marketing authorisation holder: SUN PHARM
- Local brand name: CIPROFLOXACIN AND DEXAMETHASONE
- Indication: SUSPENSION/DROPS — OTIC
- Status: approved
FDA — authorised 9 June 2023
- Application: ANDA215768
- Marketing authorisation holder: SENTISS
- Local brand name: CIPROFLOXACIN AND DEXAMETHASONE
- Indication: SUSPENSION/DROPS — OTIC
- Status: approved
FDA — authorised 22 March 2024
- Application: ANDA216501
- Marketing authorisation holder: AMNEAL
- Local brand name: CIPROFLOXACIN AND DEXAMETHASONE
- Indication: SUSPENSION/DROPS — OTIC
- Status: approved
FDA — authorised 6 January 2026
- Application: ANDA216487
- Marketing authorisation holder: UPSHER SMITH LABS
- Local brand name: CIPROFLOXACIN AND DEXAMETHASONE
- Indication: SUSPENSION/DROPS — OTIC
- Status: approved
FDA
- Status: approved
Ciprodex in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Other approved in United States
Frequently asked questions
Is Ciprodex approved in United States?
Yes. FDA authorised it on 10 August 2020; FDA authorised it on 30 August 2022; FDA authorised it on 9 June 2023.
Who is the marketing authorisation holder for Ciprodex in United States?
DR REDDYS holds the US marketing authorisation.