FDA — authorised 12 January 1972
- Application: NDA016851
- Marketing authorisation holder: ABBVIE
- Local brand name: FML
- Indication: SUSPENSION/DROPS — OPHTHALMIC
- Status: approved
🇺🇸 Fluorometholone 1% topical ocular steroid in United States
FDA authorised Fluorometholone 1% topical ocular steroid on 12 January 1972
Marketing authorisations
FDA — authorised 4 September 1985
- Application: NDA017760
- Marketing authorisation holder: ALLERGAN
- Local brand name: FML
- Indication: OINTMENT — OPHTHALMIC
- Status: approved
Frequently asked questions
Is Fluorometholone 1% topical ocular steroid approved in United States?
Yes. FDA authorised it on 12 January 1972; FDA authorised it on 4 September 1985.
Who is the marketing authorisation holder for Fluorometholone 1% topical ocular steroid in United States?
ABBVIE holds the US marketing authorisation.