Treats infections caused by susceptible isolates of the designated microorganisms in the…. Sold as Ciprodex. Every FDA application for this active ingredient: 1 branded and 6 generic.
As of Nov 15, 2026, FDA lists 7 applications for Ciprofloxacin; Dexamethasone (sold as Ciprodex), first approved Jul 18, 2003, with 0 new uses approved and 0 published complete response letters.
| Jul 18, 2003 | CiprodexNDA 21537 · New dosage form | Sandoz | 6 | Marketed |
| Aug 10, 2020 | Ciprofloxacin And DexamethasoneANDA 205548 | Dr Reddys | 1 | Marketed |
| Aug 30, 2022 | Ciprofloxacin And DexamethasoneANDA 210470 | Sun Pharm | 0 | Marketed |
| Jun 9, 2023 | Ciprofloxacin And DexamethasoneANDA 215768 | Sentiss | 0 | Marketed |
| Mar 22, 2024 | Ciprofloxacin And DexamethasoneANDA 216501 | Amneal | 0 | Marketed |
| Jan 6, 2026 | Ciprofloxacin And DexamethasoneANDA 216487 | Upsher Smith Labs | 0 | Marketed |
| Oct 15, 2026 | Ciprofloxacin And DexamethasoneANDA 217723 | Alembic | 0 | Marketed |
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
Sandoz
Alembic