TheraRadar

Pharma Intelligence, Simplified

Data updated: Mar 10, 2026

PEDIAPRED

PREDNISOLONE SODIUM PHOSPHATE
Oncology Approved 1986-05-28
Jump to: Indications Approvals Trials Competitors Similar Safety Patents
2
Indications
--
Phase 3 Trials
39
Years on Market

Details

Status
Prescription
First Approved
1986-05-28
Routes
ORAL
Dosage Forms
SOLUTION

Companies

SETON PHARM
Active Ingredient: PREDNISOLONE SODIUM PHOSPHATE

PEDIAPRED Approval History

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What PEDIAPRED Treats

10 indications

PEDIAPRED is approved for 10 conditions since its original approval in 1986. These indications span multiple therapeutic areas including oncology, immunology, and more.

  • Allergic Rhinitis
  • Asthma
  • Contact Dermatitis
  • Atopic Dermatitis
  • Serum Sickness
  • Drug Hypersensitivity
  • Pemphigus
  • Bullous Dermatitis Herpetiformis
Source: FDA Label

Drugs Similar to PEDIAPRED

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Shared indications:
AsthmaAtopic DermatitisContact Dermatitis +5 more
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Shared indications:
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METHYLPREDNISOLONE ACETATE
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ORAPRED ODT
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ADVANZ PHARMA
Shared indications:
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DUPIXENT
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Shared indications:
Atopic DermatitisAsthma
HYDROXYZINE PAMOATE
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Shared indications:
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SINGULAIR
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Shared indications:
AsthmaAllergic Rhinitis
ACCOLATE
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STRIDES PHARMA INTL
Shared indications:
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ADBRY
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LEO PHARMA AS
Shared indications:
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ADVAIR HFA
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AIRDUO RESPICLICK
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Shared indications:
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AIRSUPRA
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Shared indications:
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COVIS
Shared indications:
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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.

PEDIAPRED FDA Label Details

Pro

Indications & Usage

FDA Label (PDF)

Prednisolone Sodium Phosphate Oral Solution (15 mg Prednisolone per 5 mL) is indicated in the following conditions: 1. Allergic States Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment in adult and pediatric populations with: seasonal or perennial allergic rhinitis; asthma; contact dermatitis; atopic dermatitis; serum sickness; drug hypersensitivity reactions. 2. Dermatologic Diseases Pemphigus; bullous dermatitis herpetiformis; severe erythema multiforme (Stevens-Johnson syndrome); exfoliative erythroderma; mycosis fungoides. 3. E...

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Data Sources

FDA Approval: NDA019157 → Label: DailyMed → Patents: FDA Orange Book → Trials: ClinicalTrials.gov →

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