TheraRadar
Data updated: May 26, 2026

FULVICIN-U/F (griseofulvin, microsize)

Infectious Disease Approved 1971-09-09

FULVICIN-U/F is indicated for the treatment of Tinea Capitis; Tinea Corporis; Tinea Pedis; Onychomycosis; Tinea Cruris; Tinea Barbae; Ringworm.

Source: FDA Label • CHARTWELL RX
Jump to: Indications Approvals Trials Competitors Similar Safety Patents
1
Indication
--
Phase 3 Trials
54
Years on Market

Details

Status
Prescription
First Approved
1971-09-09
Routes
ORAL
Dosage Forms
TABLET

Companies

CHARTWELL RX
Active Ingredient: GRISEOFULVIN, MICROSIZE

FULVICIN-U/F Approval History

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Original
New Indication
New Form
Label Update
4 FDA actions from 1971 to 2001
Jan 2001 SUPPL
Mfg · Manufacturing (CMC)
Sep 1971 ORIGINAL
Update

What FULVICIN-U/F Treats

7 indications

FULVICIN-U/F is approved for 7 conditions since its original approval in 1971. These indications span multiple therapeutic areas including oncology, immunology, and more.

  • Tinea Capitis
  • Tinea Corporis
  • Tinea Pedis
  • Onychomycosis
  • Tinea Cruris
  • Tinea Barbae
  • Ringworm
Source: FDA Label

FULVICIN-U/F Competitive Set

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Three rings of competition based on shared molecular targets and treated indications.

Indication competitors

8

Same indication, different mechanism — what else might this patient receive?

TOLSURA
MAYNE PHARMA
2018 4 indic.
STERITALC
NOVATECH SA
2017 2 indic.
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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 FULVICIN-U/F

3 of 20

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

FULVICIN P/G
GRISEOFULVIN, ULTRAMICROSIZE
6 shared
CHARTWELL RX
Shared indications:
Tinea CorporisTinea PedisTinea Cruris +3 more
FULVICIN P/G 165
GRISEOFULVIN, ULTRAMICROSIZE
6 shared
CHARTWELL RX
Shared indications:
Tinea CorporisTinea PedisTinea Cruris +3 more
GRISEOFULVIN
GRISEOFULVIN, MICROSIZE
5 shared
CHARTWELL RX
Shared indications:
Tinea capitisTinea corporisTinea cruris +2 more
View all 20 similar drugs Pro
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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

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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.

FULVICIN-U/F FDA Label Details

Indications & Usage

FULVICIN-U/F is indicated for the treatment of Tinea Capitis; Tinea Corporis; Tinea Pedis; Onychomycosis; Tinea Cruris; Tinea Barbae; Ringworm.

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Data Sources

FDA Approval: ANDA060569 → Label: DailyMed → Trials: ClinicalTrials.gov →

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