TheraRadar
Data updated: May 26, 2026

PRAMOSONE (hydrocortisone acetate)

Dermatology Approved 1973-11-13

PRAMOSONE is indicated for the treatment of Dermatoses.

Source: FDA Label • LEGACY PHARMA
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4
Indications
--
Phase 3 Trials
52
Years on Market

Details

Status
Prescription
First Approved
1973-11-13
Routes
TOPICAL
Dosage Forms
LOTION, CREAM

Companies

LEGACY PHARMA FERNDALE LABS
Active Ingredient: HYDROCORTISONE ACETATE , PRAMOXINE HYDROCHLORIDE

PRAMOSONE Approval History

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Original
New Indication
New Form
Label Update
38 FDA actions from 1973 to 2002
Jan 2002 SUPPL
Mfg · Manufacturing (CMC)
Dec 2001 SUPPL
Mfg · Manufacturing (CMC)
Nov 2001 SUPPL
Mfg · Manufacturing (CMC)

What PRAMOSONE Treats

1 indications

PRAMOSONE is approved for 1 conditions since its original approval in 1973. These indications span multiple therapeutic areas including oncology, immunology, and more.

  • Dermatoses
Source: FDA Label

PRAMOSONE Competitive Set

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Three rings of competition based on shared molecular targets and treated indications.

Indication competitors

10

Same indication, different mechanism — what else might this patient receive?

HALOBETASOL PROPIONATE AND TAZAROTENE
SUN PHARMA
2025 1 indic.
CLOCORTOLONE PIVALATE
TARO
2020 1 indic.
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Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.

Drugs Similar to PRAMOSONE

3 of 20

FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.

ALA-SCALP
HYDROCORTISONE
1 shared
LEGACY PHARMA
Shared indications:
Dermatoses
ALCLOMETASONE DIPROPIONATE
ALCLOMETASONE DIPROPIONATE
1 shared
SUN PHARMA CANADA
Shared indications:
Dermatoses
AMCINONIDE
AMCINONIDE
1 shared
TARO PHARM INDS
Shared indications:
Dermatoses
View all 20 similar drugs Pro
📋

Clinical Trial Registry

2 trials
Trial Sponsor ID Phase Status Title
NCT02671058 CINC-2015-BA Ph 1 completed Pharmacokinetics and Bioavailability of Hydrocortisone Acetate Suppositories
NCT02689856 Hydro/Lido 143-6151-201 Ph 2 completed Safety and Efficacy of Hydrocortisone and Lidocaine Treatment of Grade I and II Hemorrhoids
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Active Pipeline

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Ongoing clinical trials by development phase

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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

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.

PRAMOSONE FDA Label Details

Indications & Usage

PRAMOSONE is indicated for the treatment of Dermatoses.

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Data Sources

FDA Approval: ANDA085979 → Label: DailyMed → Trials: ClinicalTrials.gov →

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