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Data updated: Mar 10, 2026

KENALOG-10

TRIAMCINOLONE ACETONIDE Corticosteroid Hormone Receptor Agonists
Oncology Approved 1960-01-04
Jump to: Indications Approvals Trials Competitors Similar Safety Patents
1
Indication
--
Phase 3 Trials
66
Years on Market

Details

Status
Prescription
First Approved
1960-01-04
Routes
INJECTION
Dosage Forms
INJECTABLE

Companies

APOTHECON
Active Ingredient: TRIAMCINOLONE ACETONIDE

KENALOG-10 Approval History

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What KENALOG-10 Treats

14 indications

KENALOG-10 is approved for 14 conditions since its original approval in 1960. These indications span multiple therapeutic areas including oncology, immunology, and more.

  • Gouty Arthritis
  • Bursitis
  • Tenosynovitis
  • Epicondylitis
  • Rheumatoid Arthritis
  • Synovitis of Osteoarthritis
  • Alopecia Areata
  • Discoid Lupus Erythematosus
Source: FDA Label

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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.

KENALOG-10 FDA Label Details

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Indications & Usage

FDA Label (PDF)

The intra-articular or soft tissue administration of Kenalog-10 Injection (triamcinolone acetonide injectable suspension, USP) is indicated as adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in acute gouty arthritis, acute and subacute bursitis, acute nonspecific tenosynovitis, epicondylitis, rheumatoid arthritis, synovitis of osteoarthritis. The intralesional administration of Kenalog-10 Injection is indicated for alopecia areata; discoid lupus erythematosus; keloids; localized hypertrophic, infiltrated, inflammatory lesions of gran...

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Data Sources

FDA Approval: NDA012041 → Label: DailyMed → Patents: FDA Orange Book → Trials: ClinicalTrials.gov →

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