FULVICIN P/G 165 (griseofulvin, ultramicrosize) · CHARTWELL RX
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, Trichophyto...
Details
- Status
- Prescription
- First Approved
- 1982-04-06
- Routes
- ORAL
- Dosage Forms
- TABLET
FULVICIN P/G 165 Approval History
What FULVICIN P/G 165 Treats
6 indicationsFULVICIN 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
FULVICIN P/G 165 Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
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Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
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
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.