Data updated: Mar 10, 2026
PREDNISOLONE SODIUM PHOSPHATE
PREDNISOLONE SODIUM PHOSPHATE
Approved 1974-01-29
25
Indications
--
Phase 3 Trials
52
Years on Market
Details
- Status
- Discontinued
- First Approved
- 1974-01-29
- Routes
- INJECTION, OPHTHALMIC, ORAL
- Dosage Forms
- INJECTABLE, SOLUTION/DROPS, SOLUTION, TABLET, ORALLY DISINTEGRATING
Companies
WATSON LABS SOLA BARNES HIND BAUSCH AND LOMB VINTAGE PHARMS EDENBRIDGE PHARMS PHARM ASSOC CHARTWELL RX EPIC PHARMA LLC WE PHARMS Hikma PHARMOBEDIENT AMNEAL PHARMS MISSION PHARMA NESHER PHARMS PH HEALTH Novartis BAUSCH RISING AMNEAL PHARMOBEDIENT CNSLTG
Active Ingredient: PREDNISOLONE SODIUM PHOSPHATE
Website: ↗
PREDNISOLONE SODIUM PHOSPHATE Approval History
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What PREDNISOLONE SODIUM PHOSPHATE Treats
25 FDA approvalsOriginally approved for its first indication in 1974 . Covers 25 distinct patient populations.
- Other (25)
Other
(25 approvals)- • Approved indication (Jan 1974)
- • Approved indication (Aug 1974)
- • Approved indication (Nov 1974)
- • Approved indication (Nov 1974)
- • Approved indication (Dec 1974)
- • Approved indication (Oct 1991)
- • Approved indication (Jul 1994)
- • Approved indication (Jun 2002)Letter
- • Approved indication (Jul 2002)Letter
- • Approved indication (Dec 2002)Letter
- • Approved indication (Mar 2003)
- • Approved indication (May 2004)
- • Approved indication (Oct 2004)
- • Approved indication (Apr 2005)
- • Approved indication (May 2005)
- • Approved indication (Oct 2007)
- • Approved indication (Mar 2008)
- • Approved indication (Jun 2008)
- • Approved indication (Mar 2009)
- • Approved indication (May 2009)
- • Approved indication (Sep 2010)
- • Approved indication (Apr 2013)
- • Approved indication (Dec 2016)Letter
- • Approved indication (Mar 2020)Letter
- • Approved indication (Oct 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.
PREDNISOLONE SODIUM PHOSPHATE FDA Label Details
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.