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Data updated: Mar 10, 2026

DEXAMETHASONE INTENSOL

DEXAMETHASONE Corticosteroid Hormone Receptor Agonists
Oncology Approved 1983-09-01
Jump to: Indications Approvals Trials Competitors Similar Safety Patents
1
Indication
--
Phase 3 Trials
42
Years on Market

Details

Status
Prescription
First Approved
1983-09-01
Routes
ORAL
Dosage Forms
CONCENTRATE

Companies

Hikma
Active Ingredient: DEXAMETHASONE

DEXAMETHASONE INTENSOL Approval History

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What DEXAMETHASONE INTENSOL Treats

10 indications

DEXAMETHASONE INTENSOL is approved for 10 conditions since its original approval in 1983. These indications span multiple therapeutic areas including oncology, immunology, and more.

  • Asthma
  • Atopic Dermatitis
  • Contact Dermatitis
  • Drug Hypersensitivity
  • Allergic Rhinitis
  • Serum Sickness
  • Dermatitis Herpetiformis
  • Exfoliative Erythroderma
Source: FDA Label

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Key Completed Trials

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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.

DEXAMETHASONE INTENSOL FDA Label Details

Pro

Indications & Usage

Allergic States Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment in asthma, atopic dermatitis, contact dermatitis, drug hypersensitivity reactions, perennial or seasonal allergic rhinitis, and serum sickness. Dermatologic Diseases Bullous dermatitis herpetiformis, exfoliative erythroderma, mycosis fungoides, pemphigus, and severe erythema multiforme (Stevens-Johnson syndrome). Endocrine Disorders Primary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the drug of choice; may be used in conjunction with sy...

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Data Sources

FDA Approval: ANDA088252 → Label: DailyMed → Trials: ClinicalTrials.gov →

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