TheraRadar

Pharma Intelligence, Simplified

Data updated: Mar 10, 2026

ALTAFLUOR BENOX

BENOXINATE HYDROCHLORIDE
Dermatology Approved 2017-12-14
1
Indication
--
Phase 3 Trials
1
Priority Reviews
8
Years on Market

Details

Status
Prescription
First Approved
2017-12-14
Routes
OPHTHALMIC
Dosage Forms
SOLUTION/DROPS

ALTAFLUOR BENOX Approval History

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What ALTAFLUOR BENOX Treats

1 FDA approvals

Originally approved for its first indication in 2017 .

  • Other (1)
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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

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.

ALTAFLUOR BENOX FDA Label Details

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Indications & Usage

FDA Label (PDF)

Fluorescein Sodium and Benoxinate Hydrochloride Ophthalmic Solution, 0.3%/0.4% is indicated for ophthalmic procedures in adult and pediatric patients requiring a disclosing agent in combination with a topical ophthalmic anesthetic agent. Fluorescein Sodium and Benoxinate Hydrochloride Ophthalmic Solution, 0.3%/0.4% is a combination of fluorescein sodium, a disclosing agent and benoxinate hydrochloride, a local ester anesthetic indicated for procedures in adult and pediatric patients requiring a disclosing agent in combination with a topical ophthalmic anesthetic.

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Data Sources

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