TheraRadar
Data updated: Jul 17, 2026

METHYLPREDNISOLONE SODIUM SUCCINATE · WATSON LABS INC

Generic · see SOLU-MEDROL
Respiratory Approved 1959-05-18

METHYLPREDNISOLONE SODIUM SUCCINATE is FDA-approved to treat 10 conditions (same as SOLU-MEDROL).

Source: FDA Label
Jump to: Indications Approvals Trials Competitors Safety Patents
13
Indications
--
Phase 3 Trials
67
Years on Market

Details

Status
Prescription
First Approved
1959-05-18
Routes
INJECTION, Injection
Dosage Forms
INJECTABLE, Injectable

Companies

WATSON LABS INC ABRAXIS PHARM ELKINS SINN Fresenius Kabi BEDFORD Teva INTL MEDICATION QUAD PHARMS EUGIA PHARMA SAGENT PHARMS INC AMNEAL Hikma TIANJIN KINGYORK
Active Ingredient: METHYLPREDNISOLONE SODIUM SUCCINATE

METHYLPREDNISOLONE SODIUM SUCCINATE Approval History

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Original
New Indication
New Form
Label Update
145 FDA actions from 1980 to 2026
Jun 2026 SUPPL
Label · Labeling
Jun 2026 SUPPL
Label · Labeling
Jul 2025 SUPPL
Label · Labeling

What METHYLPREDNISOLONE SODIUM SUCCINATE Treats

10 indications

METHYLPREDNISOLONE SODIUM SUCCINATE is approved for 10 conditions since its original approval in 1980. These indications span multiple therapeutic areas including oncology, immunology, and more.

Same approved indications as SOLU-MEDROL (same active ingredient).

Source: FDA Label
📋

Clinical Trial Registry

12 trials
Trial Sponsor ID Phase Status Title
NCT07054801 LIMSAH 23-40755 Ph 2 recruiting IA Lidocaine and Methylprednisolone for Headache Associated With Subarachnoid Hemorrhage
NCT06360458 MIRACLE MRCTA,ECFAH of FMU[2024]368-1 Ph 3 active not recruiting Methylprednisolone Adjunctive to Endovascular Thrombectomy for Stroke
NCT06462781 LIGHT 1 23-267 Ph 1 completed Localized Injection of Lidocaine and Glucocorticoid for Headache Treatment Phase 1
NCT07202143 MIRACLE-2 MRCTA, ECFAH of FMU [2025]887 Ph 3 recruiting Methylprednisolone for Stroke With Large Infarct Core and Post-stroke Lymphocytopenia
NCT07185633 20250824101854977 Ph 2 not yet recruiting Study of Gecacitinib-corticosteroid as First-line Therapy for Grade II-IV Acute Graft Versus Host Disease
NCT04377503 covid-19 hsd Ph 2 terminated Tocilizumab Versus Methylprednisolone in the Cytokine Release Syndrome of Patients With COVID-19
NCT04343729 MetCOVID CAEE: 30615920.2.0000.0005 Ph 2 completed Methylprednisolone in the Treatment of Patients With Signs of Severe Acute Respiratory Syndrome in Covid-19
NCT02779283 IRB00011766 NCI-2016-00083, IRB00011766 Ph 1 completed Personalized Kinase Inhibitor Therapy Combined With Chemotherapy in Treating Patients With Newly Diagnosed Acute Myeloid Leukemia and Acute Lymphoblastic Leukemia
NCT03082092 PISTKR Ph 4 completed Pre-operative Intravenous Steroid in Total Knee Replacement for Pain Relief and Recovery
NCT02425813 IRB00032434 NCI-2015-00548, CCCWFU 98115 Ph 2 withdrawn Methylprednisolone Sodium Succinate in Treating Patients With Acute Graft-versus-Host Disease of the Gastrointestinal Tract
NCT01977781 results posted 13-067H Ph 1 completed Safety and Efficacy of Topical Tacrolimus 0.05% in the Treatment of Ocular Graft-Versus-Host Disease
NCT02317601 2014-002492-29 2014-002492-29 Ph 4 completed Preoperative Single Glucocorticoid Hip Fracture Hip Fracture Surgery
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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.

METHYLPREDNISOLONE SODIUM SUCCINATE FDA Label Details

Indications & Usage

FDA Label (PDF)

METHYLPREDNISOLONE SODIUM SUCCINATE is FDA-approved to treat 10 conditions — same approved indications as SOLU-MEDROL.

Looking for the branded version?

SOLU-MEDROL

Full clinical data, patents, trials, and competitive landscape for methylprednisolone sodium succinate.

See SOLU-MEDROL

Data Sources

FDA Approval: ANDA087030 → Trials: ClinicalTrials.gov →

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