TheraRadar

Pharma Intelligence, Simplified

Data updated: Mar 10, 2026

MONISTAT 3

MICONAZOLE NITRATE
Infectious Disease Approved 1984-08-15
Jump to: Indications Approvals Trials Competitors Safety Patents
2
Indications
--
Phase 3 Trials
41
Years on Market

Details

Status
Prescription
First Approved
1984-08-15
Routes
VAGINAL
Dosage Forms
SUPPOSITORY, CREAM

Companies

MEDTECH PRODUCTS
Active Ingredient: MICONAZOLE NITRATE

MONISTAT 3 Approval History

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What MONISTAT 3 Treats

1 indications

MONISTAT 3 is approved for 1 conditions since its original approval in 1984. These indications span multiple therapeutic areas including oncology, immunology, and more.

  • Vaginal Yeast Infection
Source: FDA Label
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Active Pipeline

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Ongoing clinical trials by development phase

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Key Completed Trials

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Completed studies with published results, ranked by significance

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Trial Timeline

ClinicalTrials.gov ↗ Pro

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.

MONISTAT 3 FDA Label Details

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Indications & Usage

FDA Label (PDF)

Uses treats vaginal yeast infections relieves external itching and irritation due to a vaginal yeast infection

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Data Sources

FDA Approval: NDA018888 → Label: DailyMed → Patents: FDA Orange Book → Trials: ClinicalTrials.gov →

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