FDA — authorised 11 April 1977
- Application: NDA011748
- Marketing authorisation holder: PHARMACIA AND UPJOHN
- Local brand name: OXYLONE
- Indication: CREAM — TOPICAL
- Status: approved
🇺🇸 FLUCON® in United States
FDA authorised FLUCON® on 11 April 1977
Marketing authorisations
FDA — authorised 23 April 1986
- Application: NDA019216
- Marketing authorisation holder: ABBVIE
- Local brand name: FML FORTE
- Indication: SUSPENSION/DROPS — OPHTHALMIC
- Status: approved
FDA — authorised 29 September 1989
- Application: NDA019525
- Marketing authorisation holder: ALLERGAN
- Local brand name: FML-S
- Indication: SUSPENSION/DROPS — OPHTHALMIC
- Status: approved
FDA — authorised 12 February 2026
- Application: ANDA218819
- Marketing authorisation holder: DIFGEN PHARMS
- Local brand name: FLUOROMETHOLONE
- Indication: SUSPENSION/DROPS — OPHTHALMIC
- Status: approved
Other Infectious Disease approved in United States
Frequently asked questions
Is FLUCON® approved in United States?
Yes. FDA authorised it on 11 April 1977; FDA authorised it on 23 April 1986; FDA authorised it on 29 September 1989.
Who is the marketing authorisation holder for FLUCON® in United States?
PHARMACIA AND UPJOHN holds the US marketing authorisation.