TheraRadar
Data updated: May 26, 2026

GRISEOFULVIN (griseofulvin, microsize)

Infectious Disease Approved 2005-03-02

GRISEOFULVIN is indicated for the treatment of Tinea capitis; Tinea corporis; Tinea cruris; Tinea barbae; Tinea pedis; Tinea unguium.

Source: FDA Label • CHARTWELL RX
6
Indications
--
Phase 3 Trials
21
Years on Market

Details

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

GRISEOFULVIN Approval History

2006
2007
2008
2009
2010
2011
2012
2013
2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
8 FDA actions from 2005 to 2013
Aug 2013 ORIGINAL
Update · Not Applicable
Oct 2012 ORIGINAL
Update
Oct 2010 ORIGINAL
Update

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

GRISEOFULVIN 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.

Drugs Similar to GRISEOFULVIN

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FULVICIN P/G
GRISEOFULVIN, ULTRAMICROSIZE
5 shared
CHARTWELL RX
Shared indications:
FULVICIN P/G 165
GRISEOFULVIN, ULTRAMICROSIZE
5 shared
CHARTWELL RX
Shared indications:
FULVICIN-U/F
GRISEOFULVIN, MICROSIZE
5 shared
CHARTWELL RX
Shared indications:
Tinea CapitisTinea CorporisTinea Pedis +2 more
🔬

Active Pipeline

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Ongoing clinical trials by development phase

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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.

GRISEOFULVIN FDA Label Details

Indications & Usage

GRISEOFULVIN is indicated for the treatment of Tinea capitis; Tinea corporis; Tinea cruris; Tinea barbae; Tinea pedis; Tinea unguium.

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Data Sources

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