FDA — authorised 31 December 1986
- Application: NDA019404
- Marketing authorisation holder: ALLERGAN
- Local brand name: OCUFEN
- Indication: SOLUTION/DROPS — OPHTHALMIC
- Status: approved
🇺🇸 Ocufen in United States
FDA authorised Ocufen on 31 December 1986
Marketing authorisations
FDA — authorised 31 December 1986
- Marketing authorisation holder: ALLERGAN
- Status: approved
FDA — authorised 20 June 1994
- Application: ANDA074358
- Marketing authorisation holder: NATCO PHARMA
- Local brand name: FLURBIPROFEN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 24 May 1995
- Application: ANDA074405
- Marketing authorisation holder: TEVA
- Local brand name: FLURBIPROFEN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 31 May 1995
- Application: ANDA074411
- Marketing authorisation holder: IVAX SUB TEVA PHARMS
- Local brand name: FLURBIPROFEN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 31 May 1995
- Application: ANDA074431
- Marketing authorisation holder: NEW HEIGHTSRX
- Local brand name: FLURBIPROFEN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 28 July 1995
- Application: ANDA074448
- Marketing authorisation holder: RISING
- Local brand name: FLURBIPROFEN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 1 April 1997
- Application: ANDA074647
- Marketing authorisation holder: PLIVA
- Local brand name: FLURBIPROFEN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 16 May 1997
- Application: ANDA074560
- Marketing authorisation holder: THERAGEN
- Local brand name: FLURBIPROFEN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 27 June 2000
- Application: ANDA074447
- Marketing authorisation holder: BAUSCH AND LOMB
- Indication: Manufacturing (CMC)
- Status: approved
FDA — authorised 27 April 2001
- Application: ANDA075058
- Marketing authorisation holder: SUN PHARM INDS INC
- Local brand name: FLURBIPROFEN
- Indication: TABLET — ORAL
- Status: approved
Ocufen 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 Ocufen approved in United States?
Yes. FDA authorised it on 31 December 1986; FDA authorised it on 31 December 1986; FDA authorised it on 20 June 1994.
Who is the marketing authorisation holder for Ocufen in United States?
ALLERGAN holds the US marketing authorisation.