FDA — authorised 12 January 1972
- Marketing authorisation holder: ALLERGAN
- Status: approved
🇺🇸 Fml in United States
FDA authorised Fml on 12 January 1972
Marketing authorisations
FDA — authorised 5 November 1986
- Application: NDA019216
- Marketing authorisation holder: ABBVIE
- Indication: Manufacturing (CMC)
- Status: approved
FDA — authorised 8 June 1993
- Application: NDA016851
- Marketing authorisation holder: ABBVIE
- Indication: Manufacturing (CMC)
- Status: approved
FDA — authorised 21 April 1997
- Application: NDA019079
- Marketing authorisation holder: HARROW EYE
- Indication: Manufacturing (CMC)
- Status: approved
FDA — authorised 9 January 2024
- Application: ANDA216348
- Marketing authorisation holder: AMNEAL
- Status: approved
FDA — authorised 12 February 2026
- Application: ANDA218819
- Marketing authorisation holder: DIFGEN PHARMS
- Status: approved
Fml in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Immunology approved in United States
Frequently asked questions
Is Fml approved in United States?
Yes. FDA authorised it on 12 January 1972; FDA authorised it on 5 November 1986; FDA authorised it on 8 June 1993.
Who is the marketing authorisation holder for Fml in United States?
ALLERGAN holds the US marketing authorisation.