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Data updated: Mar 10, 2026

FLURBIPROFEN SODIUM

FLURBIPROFEN SODIUM
Ophthalmology Approved 1995-01-04
1
Indication
--
Phase 3 Trials
31
Years on Market

Details

Status
Prescription
First Approved
1995-01-04
Routes
OPHTHALMIC
Dosage Forms
SOLUTION/DROPS

Companies

Active Ingredient: FLURBIPROFEN SODIUM

FLURBIPROFEN SODIUM Approval History

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What FLURBIPROFEN SODIUM Treats

1 indications

FLURBIPROFEN SODIUM is approved for 1 conditions since its original approval in 1995. These indications span multiple therapeutic areas including oncology, immunology, and more.

  • Miosis
Source: FDA Label

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Key Completed Trials

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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.

FLURBIPROFEN SODIUM FDA Label Details

Pro

Indications & Usage

Flurbiprofen sodium ophthalmic solution is indicated for the inhibition of intraoperative miosis.

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Data Sources

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