FDA — authorised 10 February 2012
- Application: NDA202514
- Marketing authorisation holder: THEA PHARMA
- Local brand name: ZIOPTAN
- Indication: SOLUTION/DROPS — OPHTHALMIC
- Status: approved
🇺🇸 Tafluprost, timolol maleate in United States
FDA authorised Tafluprost, timolol maleate on 10 February 2012
Marketing authorisations
FDA — authorised 19 August 2019
- Application: ANDA209051
- Marketing authorisation holder: MICRO LABS
- Local brand name: TAFLUPROST
- Indication: SOLUTION/DROPS — OPHTHALMIC
- Status: approved
FDA — authorised 28 January 2022
- Application: ANDA209040
- Marketing authorisation holder: SANDOZ
- Local brand name: TAFLUPROST
- Indication: SOLUTION/DROPS — OPHTHALMIC
- Status: approved
FDA — authorised 5 April 2024
- Application: ANDA218002
- Marketing authorisation holder: INGENUS PHARMS LLC
- Local brand name: TAFLUPROST
- Indication: SOLUTION/DROPS — OPHTHALMIC
- Status: approved
Tafluprost, timolol maleate 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 Tafluprost, timolol maleate approved in United States?
Yes. FDA authorised it on 10 February 2012; FDA authorised it on 19 August 2019; FDA authorised it on 28 January 2022.
Who is the marketing authorisation holder for Tafluprost, timolol maleate in United States?
THEA PHARMA holds the US marketing authorisation.