TheraRadar

Pharma Intelligence, Simplified

Data updated: Mar 10, 2026

COLOCORT

HYDROCORTISONE Corticosteroid Hormone Receptor Agonists
Immunology Approved 1999-12-03
1
Indication
--
Phase 3 Trials
26
Years on Market

Details

Status
Prescription
First Approved
1999-12-03
Routes
RECTAL
Dosage Forms
ENEMA

Companies

Active Ingredient: HYDROCORTISONE

COLOCORT Approval History

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What COLOCORT Treats

10 indications

COLOCORT is approved for 10 conditions since its original approval in 1999. These indications span multiple therapeutic areas including oncology, immunology, and more.

  • Skin Irritation
  • Inflammation
  • Eczema
  • Psoriasis
  • Poison Ivy
  • Poison Oak
  • Poison Sumac
  • Insect Bites
Source: FDA Label

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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.

COLOCORT FDA Label Details

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Indications & Usage

Uses • temporarily relieves itching associated with minor skin irritations, inflammation, and rashes due to: • eczema • psoriasis • poison ivy, oak, sumac • insect bites • detergents • jewelry • cosmetics • soaps • seborrheic dermatitis • temporarily relieves external anal and genital itching • other uses of this product should only be under the advice and supervision of a doctor

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Data Sources

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