TheraRadar

Pharma Intelligence, Simplified

Data updated: Mar 10, 2026

CIPRO HC

CIPROFLOXACIN HYDROCHLORIDE Corticosteroid Hormone Receptor Agonists
Approved 1998-02-10
1
Indication
--
Phase 3 Trials
28
Years on Market

Details

Status
Prescription
First Approved
1998-02-10
Routes
OTIC
Dosage Forms
SUSPENSION/DROPS

Companies

CIPRO HC Approval History

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What CIPRO HC Treats

1 indications

CIPRO HC is approved for 1 conditions since its original approval in 1998. These indications span multiple therapeutic areas including oncology, immunology, and more.

  • Otitis Externa
Source: FDA Label

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Key Completed Trials

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Completed studies with published results, ranked by significance

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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.

CIPRO HC FDA Label Details

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Indications & Usage

FDA Label (PDF)

CIPRO ® HC OTIC 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.