TheraRadar
Data updated: May 26, 2026

CETRAXAL (ciprofloxacin hydrochloride)

Ophthalmology Approved 2009-05-01

CETRAXAL is indicated for the treatment of Bacterial Conjunctivitis.

Source: FDA Label • LAB SALVAT
1
Indication
--
Phase 3 Trials
17
Years on Market

Details

Status
Prescription
First Approved
2009-05-01
Routes
OTIC
Dosage Forms
SOLUTION/DROPS

Companies

Active Ingredient: CIPROFLOXACIN HYDROCHLORIDE

CETRAXAL Approval History

2010
2011
2012
2013
2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
1 FDA actions from 2009 to 2009
May 2009 ORIGINAL
New Form · Type 3 - New Dosage Form

What CETRAXAL Treats

1 indications

CETRAXAL is approved for 1 conditions since its original approval in 2009. These indications span multiple therapeutic areas including oncology, immunology, and more.

  • Bacterial Conjunctivitis
Source: FDA Label

CETRAXAL Competitive Set

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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 CETRAXAL

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
CILOXAN
CIPROFLOXACIN HYDROCHLORIDE
1 shared
Novartis
Shared indications:
Bacterial Conjunctivitis
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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.

CETRAXAL FDA Label Details

Indications & Usage

FDA Label (PDF)

CETRAXAL is indicated for the treatment of Bacterial Conjunctivitis.

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Data Sources

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