TheraRadar
Data updated: May 26, 2026

CIPRO HC (ciprofloxacin hydrochloride)

Corticosteroid Hormone Receptor Agonists
Infectious Disease Approved 1998-02-10

CIPRO HC is indicated for the treatment of Otitis Externa.

Source: FDA Label • Novartis
Jump to: Indications Approvals Trials Competitors Similar Safety Patents
1
Indication
--
Phase 3 Trials
28
Years on Market

Details

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

Companies

Novartis
Active Ingredient: CIPROFLOXACIN HYDROCHLORIDE , HYDROCORTISONE

CIPRO HC Approval History

1999
2000
2001
2002
2003
2004
2005
2006
2007
2008
2009
2010
2011
2012
2013
2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
9 FDA actions from 1998 to 2017
Mar 2017 SUPPL
Label · Labeling
FDA Letter Label
Jul 2013 SUPPL
Mfg · Manufacturing (CMC)
Mar 2002 SUPPL
Mfg · Manufacturing (CMC)

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

CIPRO HC Competitive Set

Pro

Three rings of competition based on shared molecular targets and treated indications.

Indication competitors

1

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

CIPROFLOXACIN AND DEXAMETHASONE
UPSHER SMITH
2020 2 indic.

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 CIPRO HC

FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.

CIPROFLOXACIN HYDROCHLORIDE AND HYDROCORTISONE
CIPROFLOXACIN HYDROCHLORIDE
1 shared
COSETTE PHARMS NC
Shared indications:
Otitis Externa
OFLOXACIN
OFLOXACIN
1 shared
Novartis
Shared indications:
Otitis Externa
📋

Clinical Trial Registry

2 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
NCT00980876 STPh 09/08 Ph 3 completed A Comparative Study Between Two Formulations of the Ciprofloxacin Hydrochloride + Hydrocortisone Otic Suspension
🔬

Active Pipeline

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Ongoing clinical trials by development phase

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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

ClinicalTrials.gov ↗ Pro

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

Indications & Usage

FDA Label (PDF)

CIPRO HC is indicated for the treatment of Otitis Externa.

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Data Sources

FDA Approval: NDA020805 → Label: DailyMed → Patents: FDA Orange Book → Trials: ClinicalTrials.gov →

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