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Data updated: May 26, 2026

CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE (betamethasone dipropionate)

Dermatology Approved 2001-05-29

CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE is indicated for the treatment of Tinea Pedis; Tinea Cruris; Tinea Corporis.

Source: FDA Label • GLENMARK SPECLT • Azole Antifungal

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.

Source: FDA Label
6
Indications
--
Phase 3 Trials
24
Years on Market

Details

Status
Discontinued
First Approved
2001-05-29
Routes
TOPICAL
Dosage Forms
CREAM, LOTION

CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE Approval History

2002
2003
2004
2005
2006
2007
2008
2009
2010
2011
2012
2013
2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
28 FDA actions from 2001 to 2020
Jul 2020 SUPPL
Label · Labeling
May 2020 SUPPL
Label · Labeling
Jan 2017 SUPPL
Label · Labeling

What CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE Treats

3 indications

CLOTRIMAZOLE 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
Source: FDA Label

CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE Competitive Set

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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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Active Pipeline

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Key Completed Trials

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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.

CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE FDA Label Details

Indications & Usage

CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE is indicated for the treatment of Tinea Pedis; Tinea Cruris; Tinea Corporis.

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Data Sources

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