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Data updated: May 26, 2026

CILOXAN (ciprofloxacin hydrochloride)

Ophthalmology Approved 1990-12-31

CILOXAN is indicated for the treatment of Bacterial Conjunctivitis.

Source: FDA Label • Novartis
Jump to: Indications Approvals Trials Competitors Similar Safety Patents
3
Indications
--
Phase 3 Trials
35
Years on Market

Details

Status
Prescription
First Approved
1990-12-31
Routes
OPHTHALMIC
Dosage Forms
OINTMENT, SOLUTION/DROPS

Companies

Novartis
Active Ingredient: CIPROFLOXACIN HYDROCHLORIDE

CILOXAN Approval History

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Original
New Indication
New Form
Label Update
33 FDA actions from 1990 to 2017 · 1 indication expansions
Mar 2017 SUPPL
Label · Labeling
FDA Letter Label
Feb 2017 SUPPL
Label · Labeling
FDA Letter Label
Aug 2016 SUPPL
Mfg · Manufacturing (CMC)

What CILOXAN Treats

1 indications

CILOXAN is approved for 1 conditions since its original approval in 1990. These indications span multiple therapeutic areas including oncology, immunology, and more.

  • Bacterial Conjunctivitis
Source: FDA Label

CILOXAN Competitive Set

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

Indication competitors

6

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

GATIFLOXACIN
HI-TECH PHARMACAL
2011 1 indic.
ZYMAXID
AbbVie
2010 1 indic.
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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 CILOXAN

3 of 7

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

AZASITE
AZITHROMYCIN
1 shared
THEA PHARMA
Shared indications:
Bacterial Conjunctivitis
BESIVANCE
BESIFLOXACIN HYDROCHLORIDE
1 shared
BAUSCH AND LOMB
Shared indications:
Bacterial Conjunctivitis
CETRAXAL
CIPROFLOXACIN HYDROCHLORIDE
1 shared
LAB SALVAT
Shared indications:
Bacterial Conjunctivitis
View all 7 similar drugs Pro
📋

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
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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.

CILOXAN FDA Label Details

Indications & Usage

FDA Label (PDF)

CILOXAN is indicated for the treatment of Bacterial Conjunctivitis.

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Data Sources

FDA Approval: NDA020369 → Label: DailyMed → Patents: FDA Orange Book → Trials: ClinicalTrials.gov →

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