TheraRadar

Pharma Intelligence, Simplified

Data updated: Mar 10, 2026

BETADINE

POVIDONE-IODINE
Ophthalmology Approved 1986-12-17
Jump to: Indications Approvals Trials Competitors Safety Patents
1
Indication
--
Phase 3 Trials
39
Years on Market

Details

Status
Prescription
First Approved
1986-12-17
Routes
OPHTHALMIC
Dosage Forms
SOLUTION/DROPS

Companies

Novartis
Active Ingredient: POVIDONE-IODINE

BETADINE Approval History

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What BETADINE Treats

1 FDA approvals

Originally approved for its first indication in 1986 .

  • 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

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.

BETADINE FDA Label Details

Pro

Indications & Usage

: BETADINE* 5% Sterile Ophthalmic Prep Solution for the eye is indicated for prepping of the periocular region (lids, brow, and cheek) and irrigation of the ocular surface (cornea, conjunctiva, and palpebral fornices).

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Data Sources

FDA Approval: NDA018634 → Label: DailyMed → Patents: FDA Orange Book → Trials: ClinicalTrials.gov →

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