TheraRadar

Pharma Intelligence, Simplified

Data updated: Mar 10, 2026

PROCTOFOAM HC

HYDROCORTISONE ACETATE
Immunology Approved 1978-07-26
Jump to: Indications Approvals Trials Competitors Similar Safety Patents
1
Indication
--
Phase 3 Trials
47
Years on Market

Details

Status
Prescription
First Approved
1978-07-26
Routes
TOPICAL
Dosage Forms
AEROSOL, METERED

Companies

Viatris
Active Ingredient: HYDROCORTISONE ACETATE , PRAMOXINE HYDROCHLORIDE

PROCTOFOAM HC Approval History

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What PROCTOFOAM HC Treats

1 indications

PROCTOFOAM HC is approved for 1 conditions since its original approval in 1978. These indications span multiple therapeutic areas including oncology, immunology, and more.

  • Dermatoses
Source: FDA Label

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Active Pipeline

Pro

Ongoing clinical trials by development phase

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Key Completed Trials

Pro

Completed studies with published results, ranked by significance

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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.

PROCTOFOAM HC FDA Label Details

Pro

Indications & Usage

Proctofoam ® HC is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses of the anal region.

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Data Sources

FDA Approval: ANDA086195 → Label: DailyMed → Trials: ClinicalTrials.gov →

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