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Data updated: Mar 10, 2026

FULVICIN-U/F

GRISEOFULVIN, MICROSIZE
Infectious Disease Approved 1971-09-09
1
Indication
--
Phase 3 Trials
54
Years on Market

Details

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

Companies

Active Ingredient: GRISEOFULVIN, MICROSIZE

FULVICIN-U/F Approval History

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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

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LACER PHARMA
Shared indications:
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MEDIMETRIKS PHARMS
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LEGACY PHARMA
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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.

FULVICIN-U/F FDA Label Details

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Indications & Usage

Major indications for Griseofulvin Oral Suspension, USP are: Tinea capitis (ringworm of the scalp) Tinea corporis (ringworm of the body) Tinea pedis (athlete's foot) Tinea unguium (onychomycosis; ringworm of the nails) Tinea cruris (ringworm of the thigh) Tinea barbae (barber’s itch) Griseofulvin Oral Suspension, USP inhibits the growth of those genera of fungi that commonly cause ringworm infections of the hair, skin, and nails, such as: Trichophyton rubrum Trichophyton tonsurans Trichophyton mentagrophytes Trichophyton interdigitalis Trichophyton verrucosum Trichophyton sulphureum Trichophyt...

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Data Sources

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