TheraRadar
Data updated: Jun 17, 2026

HYDROCORTISONE VALERATE

Dermatology Approved 1998-08-12

HYDROCORTISONE VALERATE is indicated for the treatment of Dermatitis.

Source: FDA Label • GLENMARK PHARMS LTD
10
Indications
--
Phase 3 Trials
27
Years on Market

Details

Status
Discontinued
First Approved
1998-08-12
Routes
TOPICAL
Dosage Forms
OINTMENT, CREAM

HYDROCORTISONE VALERATE Approval History

1999
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2026
Original
New Indication
New Form
Label Update
27 FDA actions from 1998 to 2021
Nov 2021 ORIGINAL
Update
Feb 2021 ORIGINAL
Update
Mar 2020 ORIGINAL
Update

What HYDROCORTISONE VALERATE Treats

1 indications

HYDROCORTISONE VALERATE is approved for 1 conditions since its original approval in 1998. These indications span multiple therapeutic areas including oncology, immunology, and more.

  • Dermatitis
Source: FDA Label

HYDROCORTISONE VALERATE Competitive Set

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Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.

What's emerging in HYDROCORTISONE VALERATE's indications

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Phase 3 candidates targeting molecules with no FDA-approved drug, in indications HYDROCORTISONE VALERATE treats. First-in-class if their pivotal trials read out positive.

Drugs Similar to HYDROCORTISONE VALERATE

FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.

CORDRAN
FLURANDRENOLIDE
1 shared
ALMIRALL
Shared indications:
Dermatitis
🔬

Active Pipeline

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Key Completed Trials

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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 VALERATE FDA Label Details

Indications & Usage

FDA Label (PDF)

HYDROCORTISONE VALERATE is indicated for the treatment of Dermatitis.

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Data Sources

Data sourced from official FDA and NIH databases. Click links to verify on original sources.