TheraRadar

Pharma Intelligence, Simplified

Data updated: Mar 10, 2026

FLAC

FLUOCINOLONE ACETONIDE Corticosteroid Hormone Receptor Agonists
Immunology Approved 2018-04-11
Jump to: Indications Approvals Trials Competitors Similar Safety Patents
1
Indication
--
Phase 3 Trials
7
Years on Market

Details

Status
Prescription
First Approved
2018-04-11
Routes
OTIC
Dosage Forms
OIL/DROPS

Companies

ANDA REPOSITORY
Active Ingredient: FLUOCINOLONE ACETONIDE

FLAC Approval History

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What FLAC Treats

1 indications

FLAC is approved for 1 conditions since its original approval in 2018. These indications span multiple therapeutic areas including oncology, immunology, and more.

  • Dermatoses
Source: FDA Label

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Key Completed Trials

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Trial Timeline

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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.

FLAC FDA Label Details

Pro

Indications & Usage

Fluocinolone Acetonide Topical Solution is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.

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Data Sources

FDA Approval: ANDA210736 → Label: DailyMed → Trials: ClinicalTrials.gov →

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