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Data updated: Mar 10, 2026

CIPROFLOXACIN HYDROCHLORIDE AND HYDROCORTISONE

CIPROFLOXACIN HYDROCHLORIDE Corticosteroid Hormone Receptor Agonists
Approved 2025-11-10
1
Indication
--
Phase 3 Trials
0
Years on Market

Details

Status
Prescription
First Approved
2025-11-10
Routes
OTIC
Dosage Forms
SUSPENSION/DROPS

CIPROFLOXACIN HYDROCHLORIDE AND HYDROCORTISONE Approval History

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What CIPROFLOXACIN HYDROCHLORIDE AND HYDROCORTISONE Treats

1 indications

CIPROFLOXACIN HYDROCHLORIDE AND HYDROCORTISONE is approved for 1 conditions since its original approval in 2025. These indications span multiple therapeutic areas including oncology, immunology, and more.

  • Otitis Externa
Source: FDA Label

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Trial Timeline

Full development history with FDA approval milestones

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Understanding FDA Approval Types
Count Type What it means
- ORIG Original approval - drug first enters market
- SUPPL - Efficacy New indication (new disease/condition approved)
- SUPPL - Labeling Label text changes (warnings, dosing updates)
- SUPPL - Manufacturing Production changes (new facility)
- SUPPL - Chemistry Formulation changes (new dosage strength)

Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.

CIPROFLOXACIN HYDROCHLORIDE AND HYDROCORTISONE FDA Label Details

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Indications & Usage

Ciprofloxacin hydrochloride and hydrocortisone otic suspension is indicated for the treatment of acute otitis externa in adult and pediatric patients, one year and older, due to susceptible strains of Pseudomonas aeruginosa , Staphylococcus aureus , and Proteus mirabilis .

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Data Sources

Data sourced from official FDA and NIH databases. Click links to verify on original sources.