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Data updated: Mar 10, 2026

CORTEF

HYDROCORTISONE Corticosteroid Hormone Receptor Agonists
Oncology Approved 1952-12-15
2
Indications
--
Phase 3 Trials
73
Years on Market

Details

Status
Prescription
First Approved
1952-12-15
Routes
ORAL, INJECTION
Dosage Forms
TABLET, INJECTABLE, SUSPENSION

Companies

Active Ingredient: HYDROCORTISONE

CORTEF Approval History

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What CORTEF Treats

10 indications

CORTEF is approved for 10 conditions since its original approval in 1952. These indications span multiple therapeutic areas including oncology, immunology, and more.

  • Adrenocortical Insufficiency
  • Congenital Adrenal Hyperplasia
  • Thyroiditis
  • Hypercalcemia
  • Psoriatic Arthritis
  • Rheumatoid Arthritis
  • Ankylosing Spondylitis
  • Bursitis
Source: FDA Label

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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

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.

CORTEF FDA Label Details

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Indications & Usage

FDA Label (PDF)

CORTEF Tablets are indicated in the following conditions. 1. Endocrine Disorders Primary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the first choice; synthetic analogs may be used in conjunction with mineralocorticoids where applicable; in infancy mineralocorticoid supplementation is of particular importance) Congenital adrenal hyperplasia Non suppurative thyroiditis Hypercalcemia associated with cancer 2. Rheumatic Disorders As adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in: Psoriatic arthritis Rhe...

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Data Sources

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