FDA — authorised 28 December 1990
- Status: approved
🇺🇸 Floxin in United States
FDA authorised Floxin on 28 December 1990
Marketing authorisations
FDA — authorised 28 December 1990
- Application: NDA019735
- Marketing authorisation holder: JANSSEN PHARMS
- Local brand name: FLOXIN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 31 March 1992
- Application: NDA020087
- Marketing authorisation holder: ORTHO MCNEIL PHARM
- Local brand name: FLOXIN IN DEXTROSE 5% IN PLASTIC CONTAINER
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 30 July 1993
- Application: NDA019921
- Marketing authorisation holder: ALLERGAN
- Local brand name: OCUFLOX
- Indication: SOLUTION/DROPS — OPHTHALMIC
- Status: approved
FDA — authorised 16 January 2002
- Application: ANDA075762
- Marketing authorisation holder: BEDFORD
- Local brand name: OFLOXACIN
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 2 September 2003
- Application: ANDA076182
- Marketing authorisation holder: TEVA
- Local brand name: OFLOXACIN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 2 September 2003
- Application: ANDA076093
- Marketing authorisation holder: CHARTWELL RX
- Local brand name: OFLOXACIN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 14 May 2004
- Application: ANDA076513
- Marketing authorisation holder: APOTEX INC
- Local brand name: OFLOXACIN
- Indication: SOLUTION/DROPS — OPHTHALMIC
- Status: approved
FDA — authorised 14 May 2004
- Application: ANDA076231
- Marketing authorisation holder: SANDOZ
- Local brand name: OFLOXACIN
- Indication: SOLUTION/DROPS — OPHTHALMIC
- Status: approved
FDA — authorised 14 May 2004
- Application: ANDA076615
- Marketing authorisation holder: EPIC PHARMA LLC
- Local brand name: OFLOXACIN
- Indication: SOLUTION/DROPS — OPHTHALMIC
- Status: approved
FDA — authorised 14 May 2004
- Application: ANDA076622
- Marketing authorisation holder: BAUSCH AND LOMB
- Local brand name: OFLOXACIN
- Indication: SOLUTION/DROPS — OPHTHALMIC
- Status: approved
FDA — authorised 31 August 2004
- Application: ANDA076830
- Marketing authorisation holder: ALVOGEN
- Local brand name: OFLOXACIN
- Indication: SOLUTION/DROPS — OPHTHALMIC
- Status: approved
FDA — authorised 10 February 2006
- Application: ANDA077098
- Marketing authorisation holder: DR REDDYS LABS LTD
- Local brand name: OFLOXACIN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 28 September 2007
- Application: ANDA076527
- Marketing authorisation holder: APOTEX INC
- Local brand name: OFLOXACIN
- Indication: SOLUTION/DROPS — OTIC
- Status: approved
FDA — authorised 17 March 2008
- Application: ANDA078222
- Marketing authorisation holder: SANDOZ
- Local brand name: OFLOXACIN
- Indication: SOLUTION/DROPS — OTIC
- Status: approved
FDA — authorised 17 March 2008
- Application: ANDA076128
- Marketing authorisation holder: BAUSCH AND LOMB
- Local brand name: OFLOXACIN
- Indication: SOLUTION/DROPS — OTIC
- Status: approved
FDA — authorised 17 March 2008
- Application: ANDA076616
- Marketing authorisation holder: HIKMA
- Local brand name: OFLOXACIN
- Indication: SOLUTION/DROPS — OTIC
- Status: approved
FDA — authorised 15 April 2008
- Application: ANDA076407
- Marketing authorisation holder: SENTISS
- Local brand name: OFLOXACIN
- Indication: SOLUTION/DROPS — OPHTHALMIC
- Status: approved
FDA — authorised 25 November 2008
- Application: ANDA076848
- Marketing authorisation holder: SANDOZ
- Local brand name: OFLOXACIN
- Indication: SOLUTION/DROPS — OPHTHALMIC
- Status: approved
FDA — authorised 25 February 2009
- Application: ANDA078559
- Marketing authorisation holder: FDC LTD
- Local brand name: OFLOXACIN
- Indication: SOLUTION/DROPS — OPHTHALMIC
- Status: approved
FDA — authorised 29 April 2013
- Application: ANDA202692
- Marketing authorisation holder: ALTAIRE PHARMS INC
- Local brand name: OFLOXACIN
- Indication: SOLUTION/DROPS — OPHTHALMIC
- Status: approved
FDA — authorised 18 September 2014
- Application: ANDA091656
- Marketing authorisation holder: CADILA PHARMS LTD
- Local brand name: OFLOXACIN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 30 August 2019
- Application: ANDA211525
- Marketing authorisation holder: AMNEAL
- Local brand name: OFLOXACIN
- Indication: SOLUTION/DROPS — OTIC
- Status: approved
FDA — authorised 19 January 2022
- Application: ANDA215038
- Marketing authorisation holder: FDC LTD
- Local brand name: OFLOXACIN
- Indication: SOLUTION/DROPS — OTIC
- Status: approved
FDA — authorised 14 July 2022
- Application: ANDA216130
- Marketing authorisation holder: MANKIND PHARMA
- Local brand name: OFLOXACIN
- Indication: SOLUTION/DROPS — OTIC
- Status: approved
FDA — authorised 23 November 2022
- Application: ANDA215886
- Marketing authorisation holder: MANKIND PHARMA
- Local brand name: OFLOXACIN
- Indication: SOLUTION/DROPS — OPHTHALMIC
- Status: approved
FDA — authorised 5 January 2024
- Application: ANDA217903
- Marketing authorisation holder: CAPLIN
- Local brand name: OFLOXACIN
- Indication: SOLUTION/DROPS — OTIC
- Status: approved
FDA — authorised 1 March 2024
- Application: ANDA211524
- Marketing authorisation holder: AMNEAL
- Local brand name: OFLOXACIN
- Indication: SOLUTION/DROPS — OPHTHALMIC
- Status: approved
FDA — authorised 12 April 2024
- Application: ANDA217904
- Marketing authorisation holder: CAPLIN
- Local brand name: OFLOXACIN
- Indication: SOLUTION/DROPS — OPHTHALMIC
- Status: approved
FDA — authorised 1 August 2024
- Application: ANDA213597
- Marketing authorisation holder: SOMERSET
- Local brand name: OFLOXACIN
- Indication: SOLUTION/DROPS — OPHTHALMIC
- Status: approved
FDA — authorised 15 October 2024
- Application: ANDA216328
- Marketing authorisation holder: SOMERSET THERAPS LLC
- Local brand name: OFLOXACIN
- Indication: SOLUTION/DROPS — OTIC
- Status: approved
FDA — authorised 8 April 2026
- Application: ANDA218557
- Marketing authorisation holder: MICRO LABS
- Local brand name: OFLOXACIN
- Indication: SOLUTION/DROPS — OPHTHALMIC
- Status: approved
FDA
- Application: ANDA076220
- Marketing authorisation holder: RANBAXY LABS LTD
- Local brand name: OFLOXACIN
- Indication: TABLET — ORAL
- Status: approved
Floxin in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Metabolic approved in United States
Frequently asked questions
Is Floxin approved in United States?
Yes. FDA authorised it on 28 December 1990; FDA authorised it on 28 December 1990; FDA authorised it on 31 March 1992.
Who is the marketing authorisation holder for Floxin in United States?
Marketing authorisation holder not available in our data.