Sold as Floxin, Ocuflox, Floxin In Dextrose 5%, Floxin In Dextrose 5% In Plastic Container, Floxin Otic. Every FDA application for this active ingredient: 4 branded and 30 generic.
As of Nov 15, 2026, FDA lists 34 applications for Ofloxacin (sold as Floxin, Ocuflox, Floxin In Dextrose 5% and others), first approved Dec 28, 1990, with 4 new uses approved and 0 published complete response letters.
| Ofloxacin | Part D | $24.3M | -11% | 1,092,318 |
| Ocuflox | Part D | $5K | -24% | 47 |
| Randomized, Multicenter, Non-inferiority Trial Comparing the Efficacy of Fosfomycin Versus Fluoroquinolones or Cotrimoxazole as Oral Follow-up Treatment in Febrile Urinary Tract Infections in Men Caused by Susceptible EnterobacteriaProstatitis, Escherichia Coli Infection · Assistance Publique - Hôpitaux de Paris | Phase 3 | Not yet recruiting | Nov 12, 2026 |
| All-Oral Fluoroquinolone-Based Triple Therapies for Adults With Imaging-Confirmed Osteoarticular BrucellosisBrucellosis, Osteoarticular Brucellosis · The First Affiliated Hospital of Shihezi University | Not applicable | Not yet recruiting | Oct 21, 2026 |
| Fluoroquinolone-Doxycycline Oral Treatments for Adults With Uncomplicated BrucellosisBrucellosis · The First Affiliated Hospital of Shihezi University | Not applicable | Not yet recruiting | Oct 21, 2026 |
| Efficacy and Safety of Piclosept in the Complex Treatment of Neonatal DacryocystitisNeonatal Dacryocystitis, Congenital Nasolacrimal Duct Obstruction · Kazakh Eye Research Institute | Phase 4 | Active, not recruiting | Oct 15, 2026 |
| European Implementation Study on Simultaneous Screening for Gastric and Colorectal CancersHelicobacter Pylori Infection, Colorectal Cancer · University of Latvia | — | Not yet recruiting | Oct 14, 2026 |
| A Phase 2b Study to Evaluate the Efficacy, Safety, and PK Profiles of TNP-2092 Administered Via IA Injection in PJI ParticipantsProsthetic Joint Infection (PJI) · TenNor Therapeutics (Zhongshan) Limited | Phase 2 | Recruiting | Oct 5, 2026 |
| Intracameral Levofloxacin Versus Moxifloxacin After Cataract SurgeryCataract, Postoperative Endophthalmitis · Assiut University | Not applicable | Not yet recruiting | Sep 30, 2026 |
| Inhaled Lexofloxacin vs Usual Care for Treatment of Community-Acquired PneumoniaCommunity-acquired Pneumonia, CAP · Copenhagen Respiratory Research | Phase 2 / Phase 3 | Active, not recruiting | Sep 25, 2026 |
| Dec 28, 1990 | FloxinNDA 19735 · New molecular entity | Janssen Pharms | 42 | Discontinued |
| Mar 31, 1992 | Floxin In Dextrose 5%, FloxinNDA 20087 · New dosage form | Ortho Mcneil Pharm | 15 | Discontinued |
| Jul 30, 1993 | OcufloxNDA 19921 · New dosage form | Allergan | 15 | Marketed |
| Dec 16, 1997 | Floxin OticNDA 20799 · New dosage form | Daiichi | 11 | Discontinued |
| Jan 16, 2002 | OfloxacinANDA 75762 | Bedford | 0 | Discontinued |
| Sep 2, 2003 | OfloxacinANDA 76093 | Chartwell Rx | 10 | Marketed |
| Sep 2, 2003 | OfloxacinANDA 76182 | Teva | 18 | Marketed |
| May 14, 2004 | OfloxacinANDA 76231 | Sandoz | 0 | Discontinued |
| May 14, 2004 | OfloxacinANDA 76513 | Apotex Inc | 4 | Marketed |
| May 14, 2004 | OfloxacinANDA 76615 | Epic Pharma LLC | 0 | Discontinued |
| May 14, 2004 | OfloxacinANDA 76622 | Bausch And Lomb | 1 | Marketed |
| Aug 31, 2004 | OfloxacinANDA 76830 | Alvogen | 2 | Discontinued |
| Feb 10, 2006 | OfloxacinANDA 77098 | Dr Reddys Labs Ltd | 12 | Marketed |
| Sep 28, 2007 | OfloxacinANDA 76527 | Apotex Inc | 1 | Marketed |
| Mar 17, 2008 | OfloxacinANDA 76128 | Bausch And Lomb Inc | 0 | Marketed |
| Mar 17, 2008 | OfloxacinANDA 76616 | Hikma | 2 | Discontinued |
| Mar 17, 2008 | OfloxacinANDA 78222 | Sandoz | 0 | Discontinued |
| Apr 15, 2008 | OfloxacinANDA 76407 | Sentiss | 1 | Marketed |
| Nov 25, 2008 | OfloxacinANDA 76848 | Sandoz | 1 | Discontinued |
| Feb 25, 2009 | OfloxacinANDA 78559 | Fdc Ltd | 2 | Marketed |
| Aug 11, 2009 | OfloxacinANDA 90395 | Alvogen | 0 | Discontinued |
| Apr 29, 2013 | OfloxacinANDA 202692 | Altaire Pharms Inc | 0 | Marketed |
| Sep 18, 2014 | OfloxacinANDA 91656 | Cadila Pharms Ltd | 3 | Marketed |
| Aug 30, 2019 | OfloxacinANDA 211525 | Amneal | 0 | Marketed |
| Jan 19, 2022 | OfloxacinANDA 215038 | Fdc Ltd | 0 | Marketed |
| Jul 14, 2022 | OfloxacinANDA 216130 | Mankind Pharma | 0 | Marketed |
| Nov 23, 2022 | OfloxacinANDA 215886 | Mankind Pharma | 1 | Marketed |
| Jan 5, 2024 | OfloxacinANDA 217903 | Caplin | 0 | Marketed |
| Mar 1, 2024 | OfloxacinANDA 211524 | Amneal | 0 | Discontinued |
| Apr 12, 2024 | OfloxacinANDA 217904 | Caplin | 0 | Marketed |
| Aug 1, 2024 | OfloxacinANDA 213597 | Somerset | 0 | Marketed |
| Oct 15, 2024 | OfloxacinANDA 216328 | Somerset Theraps LLC | 0 | Marketed |
| Apr 8, 2026 | OfloxacinANDA 218557 | Micro Labs | 0 | Marketed |
| — | OfloxacinANDA 76220 | Ranbaxy Labs Ltd | 0 | Discontinued |
Applications, approvals and products come from FDA's Drugs@FDA data files, refreshed weekly, grouped by active ingredient as FDA spells it. Complete response letters are FDA's published letters. Medicare spending is CMS's Part D and Part B dashboard, matched to this ingredient by generic name; shortages are FDA's shortage list, matched by application number; clinical trials are ClinicalTrials.gov studies naming the ingredient as an intervention, refreshed daily; safety programs are FDA's REMS list, matched by application number or, for shared programs, by ingredient. Drugs@FDA
Allergan
Teva
Sandoz
Hikma