TheraRadar

Pharma Intelligence, Simplified

Data updated: Mar 10, 2026

METHYLPREDNISOLONE

METHYLPREDNISOLONE
Approved 1980-02-15
Jump to: Indications Approvals Trials Competitors Safety Patents
15
Indications
--
Phase 3 Trials
46
Years on Market

Details

Status
Discontinued
First Approved
1980-02-15
Routes
ORAL, INJECTION
Dosage Forms
TABLET, INJECTABLE

Companies

PAR PHARM JUBILANT CADISTA WATSON LABS ELKINS SINN AMNEAL PRAXGEN TIANJIN TIANYAO ZYDUS PHARMS CHARTWELL RX INGENUS PHARMS LLC RISING HEATHER DURAMED PHARMS BARR Merck PH HEALTH Novartis
Active Ingredient: METHYLPREDNISOLONE

METHYLPREDNISOLONE Approval History

Loading approval history...

What METHYLPREDNISOLONE Treats

15 FDA approvals

Originally approved for its first indication in 1980 . Covers 15 distinct patient populations.

  • Other (15)
🔬

Active Pipeline

Pro

Ongoing clinical trials by development phase

Loading...
⭐

Key Completed Trials

Pro

Completed studies with published results, ranked by significance

Loading...
📊

Trial Timeline

ClinicalTrials.gov ↗ Pro

Full development history with FDA approval milestones

Loading...
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.

METHYLPREDNISOLONE FDA Label Details

Pro

Want competitive intelligence?

See who's developing similar drugs and track their progress

View Pipeline Dashboard

Data Sources

FDA Approval: ANDA089207 → Trials: ClinicalTrials.gov →

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