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Data updated: Mar 10, 2026

GRISEOFULVIN

GRISEOFULVIN, MICROSIZE
Infectious Disease Approved 2005-03-02
6
Indications
--
Phase 3 Trials
21
Years on Market

Details

Status
Prescription
First Approved
2005-03-02
Routes
ORAL
Dosage Forms
TABLET, SUSPENSION

GRISEOFULVIN Approval History

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What GRISEOFULVIN Treats

6 indications

GRISEOFULVIN is approved for 6 conditions since its original approval in 2005. These indications span multiple therapeutic areas including oncology, immunology, and more.

  • Tinea capitis
  • Tinea corporis
  • Tinea cruris
  • Tinea barbae
  • Tinea pedis
  • Tinea unguium
Source: FDA Label

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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.

GRISEOFULVIN FDA Label Details

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Indications & Usage

Griseofulvin is indicated for the treatment of dermatophyte infections of the skin not adequately treated by topical therapy, hair and nails, namely: Tinea corporis Tinea pedis Tinea cruris Tinea barbae Tinea capitis Tinea unguium when caused by one or more of the following species of fungi: Epidermophyton floccosum Microsporum audouinii Microsporum canis Microsporum gypseum Trichophyton crateriform Trichophyton gallinae Trichophyton interdigitalis Trichophyton megnini Trichophyton mentagrophytes Trichophyton rubrum Trichophyton schoenleini Trichophyton sulphureum Trichophyton tonsurans Tricho...

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Data Sources

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