Data updated: Mar 10, 2026
METHYLPREDNISOLONE SODIUM SUCCINATE
METHYLPREDNISOLONE SODIUM SUCCINATE
Approved 1980-02-15
13
Indications
--
Phase 3 Trials
46
Years on Market
Details
- Status
- Discontinued
- First Approved
- 1980-02-15
- Routes
- INJECTION, Injection
- Dosage Forms
- INJECTABLE, Injectable
Companies
WATSON LABS Hikma AMNEAL SAGENT PHARMS INC Teva ELKINS SINN ABRAXIS PHARM QUAD PHARMS INTL MEDICATION Fresenius Kabi TIANJIN KINGYORK BEDFORD LABS EUGIA PHARMA
Active Ingredient: METHYLPREDNISOLONE SODIUM SUCCINATE
Website: ↗
METHYLPREDNISOLONE SODIUM SUCCINATE Approval History
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What METHYLPREDNISOLONE SODIUM SUCCINATE Treats
13 FDA approvalsOriginally approved for its first indication in 1980 . Covers 13 distinct patient populations.
- Other (13)
Other
(13 approvals)- • Approved indication (Feb 1980)
- • Approved indication (Jun 1984)
- • Approved indication (Mar 1986)
- • Approved indication (Nov 1992)
- • Approved indication (Jul 2004)Letter
- • Approved indication (Aug 2004)Letter
- • Approved indication (Feb 2007)
- • Approved indication (Jul 2011)
- • Approved indication (Dec 2015)
- • Approved indication (Feb 2016)
- • Approved indication (Nov 2016)Label Letter
- • Approved indication (Apr 2021)
- • Approved indication (Sep 2022)
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Pro Active Pipeline
Ongoing clinical trials by development phase
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Pro Key Completed Trials
Completed studies with published results, ranked by significance
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Trial Timeline
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
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.