Data updated: Mar 10, 2026
PREDNISOLONE
PREDNISOLONE
Approved 1971-11-24
30
Indications
--
Phase 3 Trials
54
Years on Market
Details
- Status
- Discontinued
- First Approved
- 1971-11-24
- Routes
- ORAL
- Dosage Forms
- TABLET, SOLUTION, SYRUP
Companies
HEATHER WATSON LABS TP ANDA HOLDINGS CHARTWELL RX LANNETT CO INC PUREPAC PHARM FERRANTE IMPAX LABS SUPERPHARM PHARM ASSOC PVT FORM VALEANT PHARM INTL Hikma VITARINE PHARMOBEDIENT CNSLTG NESHER PHARMS WHITEWORTH TOWN PLSN WE PHARMS Teva PANRAY INWOOD LABS PHOENIX LABS NY FOSUN PHARMA UDL CHARTWELL MOLECULAR MARSHALL PHARMA SPERTI BUNDY TABLICAPS ZHEJIANG XIANJU IVAX SUB TEVA PHARMS ROXANE ELKINS SINN EVERYLIFE RISING Aurobindo Pharma
Active Ingredient: PREDNISOLONE
Website: ↗
PREDNISOLONE Approval History
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What PREDNISOLONE Treats
30 FDA approvalsOriginally approved for its first indication in 1971 . Covers 30 distinct patient populations.
- Other (30)
Other
(30 approvals)- • Approved indication (Nov 1971)
- • Approved indication (Jan 1972)
- • Approved indication (Mar 1972)
- • Approved indication (May 1972)
- • Approved indication (Sep 1972)
- • Approved indication (May 1973)
- • Approved indication (Jun 1973)
- • Approved indication (Jul 1973)
- • Approved indication (May 1974)
- • Approved indication (May 1975)
- • Approved indication (Jun 1975)
- • Approved indication (Jun 1976)
- • Approved indication (Mar 1977)
- • Approved indication (Mar 1977)
- • Approved indication (Feb 1985)
- • Approved indication (Sep 1994)
- • Approved indication (May 1998)Letter
- • Approved indication (May 1999)Label Letter
- • Approved indication (May 1999)Label Letter
- • Approved indication (Jan 2000)Letter
- • Approved indication (Oct 2001)Letter
- • Approved indication (Apr 2002)Letter
- • Approved indication (Feb 2003)
- • Approved indication (Mar 2003)
- • Approved indication (Sep 2003)
- • Approved indication (Aug 2005)
- • Approved indication (Sep 2007)
- • Approved indication (Mar 2023)
- • Approved indication (May 2024)
- • Approved indication (Jun 2025) New
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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 FDA Label Details
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.