TheraRadar
Data updated: May 26, 2026

CIPROFLOXACIN HYDROCHLORIDE AND HYDROCORTISONE (ciprofloxacin hydrochloride)

Corticosteroid Hormone Receptor Agonists
Infectious Disease Approved 2025-11-10

CIPROFLOXACIN HYDROCHLORIDE AND HYDROCORTISONE is indicated for the treatment of Otitis Externa.

Source: FDA Label • COSETTE PHARMS NC
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

2026
Original
New Indication
New Form
Label Update
1 FDA actions from 2025 to 2025
Nov 2025 ORIGINAL
Update

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

CIPROFLOXACIN HYDROCHLORIDE AND HYDROCORTISONE Competitive Set

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Indication competitors

1

Same indication, different mechanism — what else might this patient receive?

Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.

Drugs Similar to CIPROFLOXACIN HYDROCHLORIDE AND HYDROCORTISONE

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CIPROFLOXACIN HYDROCHLORIDE
1 shared
Novartis
Shared indications:
Otitis Externa
OFLOXACIN
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Novartis
Shared indications:
Otitis Externa
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Clinical Trial Registry

1 trials
Trial Sponsor ID Phase Status Title
NCT00596453 results posted NA_00010549 Ph 4 terminated Impact of Antibiotic Treatment on Prostate-Specific Antigen (PSA) Variability
🔬

Active Pipeline

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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.

CIPROFLOXACIN HYDROCHLORIDE AND HYDROCORTISONE FDA Label Details

Indications & Usage

CIPROFLOXACIN HYDROCHLORIDE AND HYDROCORTISONE is indicated for the treatment of Otitis Externa.

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Data Sources

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