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Data updated: Mar 10, 2026

FULVICIN P/G 165

GRISEOFULVIN, ULTRAMICROSIZE
Infectious Disease Approved 1982-04-06
1
Indication
--
Phase 3 Trials
43
Years on Market

Details

Status
Prescription
First Approved
1982-04-06
Routes
ORAL
Dosage Forms
TABLET

Companies

Active Ingredient: GRISEOFULVIN, ULTRAMICROSIZE

FULVICIN P/G 165 Approval History

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What FULVICIN P/G 165 Treats

6 indications

FULVICIN P/G 165 is approved for 6 conditions since its original approval in 1982. These indications span multiple therapeutic areas including oncology, immunology, and more.

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

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PADAGIS ISRAEL
Shared indications:
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RESILIA PHARMS
Shared indications:
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ERTACZO
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LACER PHARMA
Shared indications:
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JUBLIA
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BAUSCH
Shared indications:
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MEDIMETRIKS PHARMS
Shared indications:
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LEGACY PHARMA
Shared indications:
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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 P/G 165 FDA Label Details

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Indications & Usage

INDICATIONS FULVICIN P/G Tablets are indicated for the treatment of ringworm infections of the skin, hair, and nails, namely: tinea corporis, tinea pedis, tinea cruris, tinea barbae, tinea capitis, tinea unguium (onychomycosis) when caused by one or more of the following genera of fungi: Trichophyton rubrum, Trichophyton tonsurans, Trichophyton mentagrophytes, Trichophyton interdigitale, Trichophyton verrucosum, Trichophyton megninii, Trichophyton gallinae, Trichophyton crateriforme, Trichophyton sulphureum, Trichophyton schoenieinii, Microsporum audouini, Microsporum canis, Microsporum gypseu...

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Data Sources

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