Data updated: Mar 10, 2026
HYDROCORTISONE
HYDROCORTISONE
Approved 1955-01-19
48
Indications
--
Phase 3 Trials
71
Years on Market
Details
- Status
- Discontinued
- First Approved
- 1955-01-19
- Routes
- ORAL, TOPICAL, FOR RX COMPOUNDING, RECTAL
- Dosage Forms
- TABLET, CREAM, OINTMENT, POWDER, LOTION, ENEMA
Companies
PUREPAC PHARM FOUGERA PHARMS INC PERRIGO NEW YORK AMBIX USL PHARMA NASKA TARO PADDOCK LLC Teva ENCUBE SUN PHARMA CANADA PADAGIS US PHARMADERM ALPHARMA US PHARMS STRIDES PHARMA INTL FERRANTE PARKE DAVIS SYOSSET CHARTWELL MOLECULAR WHITEWORTH TOWN PLSN ALTANA Novartis STIEFEL TOPIDERM Aurobindo Pharma HIBROW HLTHCARE FOUGERA PHARMS RISING INGRAM PHARM NEXGEN PHARMA INC Hikma MERICON ROXANE EVERYLIFE IMPAX LABS IVAX PHARMS PANRAY WATSON LABS ELKINS SINN STRIDES PHARMA NOVITIUM PHARMA IMPAX LABS INC INWOOD LABS G AND W LABS PHARMAFAIR
Active Ingredient: HYDROCORTISONE
Website: ↗
HYDROCORTISONE Approval History
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What HYDROCORTISONE Treats
48 FDA approvalsOriginally approved for its first indication in 1955 . Covers 48 distinct patient populations.
- Other (48)
Other
(48 approvals)- • Approved indication (Jan 1955)
- • Approved indication (May 1972)
- • Approved indication (Jun 1972)
- • Approved indication (Sep 1972)
- • Approved indication (Mar 1973)
- • Approved indication (May 1973)
- • Approved indication (Jun 1973)
- • Approved indication (Jul 1973)
- • Approved indication (Mar 1974)
- • Approved indication (May 1974)
- • Approved indication (Apr 1975)
- • Approved indication (Apr 1976)
- • Approved indication (May 1976)
- • Approved indication (Nov 1977)
- • Approved indication (Apr 1978)
- • Approved indication (May 1978)
- • Approved indication (Jun 1978)
- • Approved indication (Jul 1978)
- • Approved indication (Nov 1978)
- • Approved indication (Jun 1982)
- • Approved indication (Oct 1982)
- • Approved indication (Apr 1983)
- • Approved indication (Apr 1983)
- • Approved indication (May 1983)
- • Approved indication (Sep 1983)
- • Approved indication (Nov 1984)
- • Approved indication (Feb 1986)
- • Approved indication (Dec 1986)
- • Approved indication (Feb 1987)
- • Approved indication (Mar 1988)
- • Approved indication (Apr 1988)
- • Approved indication (Feb 1989)
- • Approved indication (May 1993)
- • Approved indication (May 1994)
- • Approved indication (Jul 1999)Letter
- • Approved indication (Jul 2000)Letter
- • Approved indication (Dec 2000)Label Letter
- • Approved indication (Jul 2003)
- • Approved indication (Mar 2004)
- • Approved indication (Mar 2007)
- • Approved indication (Jul 2007)
- • Approved indication (Aug 2010)
- • Approved indication (Apr 2017)
- • Approved indication (Jul 2018)
- • Approved indication (Jul 2018)
- • Approved indication (Jul 2023)
- • Approved indication (Nov 2024)
- • Approved indication (May 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.
HYDROCORTISONE FDA Label Details
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.