FDA — authorised 16 November 2022
- Application: ANDA214894
- Marketing authorisation holder: DR REDDYS
- Status: approved
🇺🇸 Difluprednate Ophthalmic Emulsion in United States
FDA authorised Difluprednate Ophthalmic Emulsion on 16 November 2022
Marketing authorisations
FDA
- Status: approved
Difluprednate Ophthalmic Emulsion 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 Difluprednate Ophthalmic Emulsion approved in United States?
Yes. FDA authorised it on 16 November 2022; FDA has authorised it.
Who is the marketing authorisation holder for Difluprednate Ophthalmic Emulsion in United States?
DR REDDYS holds the US marketing authorisation.