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Data updated: Mar 10, 2026

CORTENEMA

HYDROCORTISONE Corticosteroid Hormone Receptor Agonists
Immunology Approved 1966-01-12
Jump to: Indications Approvals Trials Competitors Similar Safety Patents
1
Indication
--
Phase 3 Trials
1
Priority Reviews
60
Years on Market

Details

Status
Prescription
First Approved
1966-01-12
Routes
RECTAL
Dosage Forms
ENEMA

Companies

ANI PHARMS
Active Ingredient: HYDROCORTISONE

CORTENEMA Approval History

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What CORTENEMA Treats

3 indications

CORTENEMA is approved for 3 conditions since its original approval in 1966. These indications span multiple therapeutic areas including oncology, immunology, and more.

  • Ulcerative Colitis
  • Ulcerative Proctitis
  • Ulcerative Proctosigmoiditis
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.

CORTENEMA FDA Label Details

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Indications & Usage

FDA Label (PDF)

CORTENEMA® is indicated as adjunctive therapy in the treatment of ulcerative colitis, especially distal forms, including ulcerative proctitis, ulcerative proctosigmoiditis, and left-sided ulcerative colitis. It has proved useful also in some cases involving the transverse and ascending colons.

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Data Sources

FDA Approval: NDA016199 → Label: DailyMed → Patents: FDA Orange Book → Trials: ClinicalTrials.gov →

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