Data updated: Mar 10, 2026
PREDNISONE
PREDNISONE
Approved 1971-12-23
56
Indications
--
Phase 3 Trials
54
Years on Market
Details
- Status
- Discontinued
- First Approved
- 1971-12-23
- Routes
- ORAL
- Dosage Forms
- TABLET, TABLET, DELAYED RELEASE, SOLUTION
Companies
REXALL AIPING PHARM INC MUTUAL PHARM PVT FORM HEATHER UPSHER SMITH VANGARD WATSON LABS UDL DURAMED PHARMS BARR JUBILANT CADISTA PHOENIX LABS NY CHARTWELL MOLECULAR EVERYLIFE PHARMAVITE NYLOS AM THERAP GENEYORK PHARMS CONTRACT PHARMACAL INWOOD LABS SPERTI ROXANE STRIDES PHARMA NOVITIUM PHARMA Aurobindo Pharma IVAX SUB TEVA PHARMS WHITEWORTH TOWN PLSN Hikma BUNDY SUPERPHARM AMNEAL PHARMS NY PH HEALTH HALSEY VITARINE RISING Teva IMPAX LABS Viatris KV PHARM ELKINS SINN PUREPAC PHARM Sun Pharma POINTVIEW HLDINGS AMNEAL Dr. Reddy's SCHERER LABS XTTRIUM LABS INC VALEANT PHARM INTL MARSHALL PHARMA FERRANTE CHARTWELL RX PANRAY LEDERLE
Active Ingredient: PREDNISONE
Website: ↗
PREDNISONE Approval History
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What PREDNISONE Treats
56 FDA approvalsOriginally approved for its first indication in 1971 . Covers 56 distinct patient populations.
- Other (56)
Other
(56 approvals)- • Approved indication (Dec 1971)
- • Approved indication (Jan 1972)
- • Approved indication (Apr 1972)
- • Approved indication (Jul 1972)
- • Approved indication (Jul 1972)
- • Approved indication (Nov 1972)
- • Approved indication (Jun 1973)
- • Approved indication (Feb 1974)
- • Approved indication (Mar 1974)
- • Approved indication (Mar 1974)
- • Approved indication (May 1974)
- • Approved indication (Jun 1974)
- • Approved indication (Jun 1974)
- • Approved indication (Dec 1974)
- • Approved indication (Feb 1975)
- • Approved indication (Oct 1975)
- • Approved indication (Jun 1976)
- • Approved indication (Aug 1976)
- • Approved indication (Nov 1976)
- • Approved indication (Nov 1976)
- • Approved indication (May 1978)
- • Approved indication (Jul 1978)
- • Approved indication (Apr 1979)
- • Approved indication (Jun 1979)
- • Approved indication (Oct 1980)
- • Approved indication (Jan 1982)
- • Approved indication (Jul 1982)
- • Approved indication (Oct 1983)
- • Approved indication (Jun 1984)
- • Approved indication (Oct 1984)
- • Approved indication (Nov 1984)
- • Approved indication (Dec 1985)
- • Approved indication (Jul 1986)
- • Approved indication (Aug 1988)
- • Approved indication (Jan 1989)
- • Approved indication (Sep 1994)
- • Approved indication (Aug 2001)Letter
- • Approved indication (Jul 2002)Letter
- • Approved indication (Feb 2003)
- • Approved indication (Jan 2004)
- • Approved indication (Dec 2004)
- • Approved indication (Jun 2005)
- • Approved indication (Nov 2010)
- • Approved indication (Apr 2017)
- • Approved indication (Dec 2018)
- • Approved indication (Dec 2018)
- • Approved indication (Nov 2019)
- • Approved indication (Jun 2020)
- • Approved indication (Jun 2020)
- • Approved indication (Sep 2020)
- • Approved indication (Feb 2021)
- • Approved indication (Jul 2021)
- • Approved indication (Nov 2021)
- • Approved indication (Mar 2022)
- • Approved indication (Dec 2023)
- • Approved indication (Oct 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.
PREDNISONE FDA Label Details
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.