TheraRadar
Data updated: May 26, 2026

MONISTAT 3 (miconazole nitrate)

Infectious Disease Approved 1984-08-15

MONISTAT 3 is indicated for the treatment of Vaginal Yeast Infection.

Source: FDA Label • MEDTECH PRODUCTS
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

1985
1986
1987
1988
1989
1990
1991
1992
1993
1994
1995
1996
1997
1998
1999
2000
2001
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
32 FDA actions from 1984 to 2021
Sep 2021 SUPPL
Mfg · Manufacturing (CMC)
FDA Letter
Jan 2020 SUPPL
Label · Labeling
FDA Letter Label
Mar 2014 SUPPL
Mfg · Manufacturing (CMC)

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

MONISTAT 3 Competitive Set

Pro

Three rings of competition based on shared molecular targets and treated indications.

Indication competitors

7

Same indication, different mechanism — what else might this patient receive?

KLAYESTA
EPIC PHARMA
2018 1 indic.
GYNAZOLE-1
PADAGIS ISRAEL
2012 1 indic.
Unlock 5 more competitors across all three rings.
Upgrade to Pro

Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.

📋

Clinical Trial Registry

1 trials
Trial Sponsor ID Phase Status Title
NCT03359070 GDN 042/13 Ph 2 completed Clinical Trial Comparing Dapaconazole Versus Miconazole in Patients With Tinea Cruris
🔬

Active Pipeline

Pro

Ongoing clinical trials by development phase

Loading...
⭐

Key Completed Trials

Pro

Completed studies with published results, ranked by significance

Loading...
📊

Trial Timeline

ClinicalTrials.gov ↗ Pro

Full development history with FDA approval milestones

|
Loading...
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

Indications & Usage

FDA Label (PDF)

MONISTAT 3 is indicated for the treatment of Vaginal Yeast Infection.

Track MONISTAT 3 with TheraRadar Pro

Watchlist alerts, full database access, CSV exports across 14,000+ drugs.

Upgrade to Pro

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.