CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE (betamethasone dipropionate) · Teva
This topical cream is indicated for the treatment of symptomatic inflammatory tinea pedis (athlete's foot), tinea cruris (jock itch), and tinea corporis (ringworm) in patients 17 years and older. It is specifically indicated for infections caused by *Epidermophyton floccosum*, *Trichophyton mentagrophytes*, and *Trichophyton rubrum*. The medication combines an azole antifungal with a corticosteroid to treat the underlying fungal infection while managing associated inflammatory symptoms.
How CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE Works
Clotrimazole is an azole antifungal agent. Betamethasone dipropionate is a corticosteroid that plays a role in cellular signaling, immune function, and protein regulation to manage inflammation; however, the precise mechanism of action for the treatment of tinea pedis, tinea cruris, and tinea corporis is unknown.
Details
- Status
- Prescription
- First Approved
- 2001-05-29
- Routes
- TOPICAL
- Dosage Forms
- CREAM, LOTION
Companies
CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE Approval History
What CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE Treats
3 indicationsCLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE is approved for 3 conditions since its original approval in 2001. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Tinea Pedis
- Tinea Cruris
- Tinea Corporis
CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE Competitive Set
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Indication competitors
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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.
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Clinical Trial Registry
1 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT06332612 MROSF | 8420224AROM | Ph 1, Ph 2 | completed | Metformin Repurposing in Oral Submucous Fibrosis: Unveiling In Vitro Signaling Pathways, Progressing to Clinical Trial |
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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.
CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE FDA Label Details
Indications & Usage
Clotrimazole and betamethasone dipropionate cream is a combination of an azole antifungal and corticosteroid and is indicated for the topical treatment of symptomatic inflammatory tinea pedis, tinea cruris, and tinea corporis due to Epidermophyton floccosum, Trichophyton mentagrophytes, and Trichophyton rubrum in patients 17 years and older. Clotrimazole and betamethasone dipropionate cream contains a combination of clotrimazole, an azole antifungal, and betamethasone dipropionate, a corticosteroid, and is indicated for the topical treatment of symptomatic inflammatory tinea pedis, tinea cruri...
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.