TheraRadar

Pharma Intelligence, Simplified

Data updated: Mar 10, 2026

NYSTOP

NYSTATIN
Infectious Disease Approved 1996-08-16
1
Indication
--
Phase 3 Trials
29
Years on Market

Details

Status
Prescription
First Approved
1996-08-16
Routes
TOPICAL
Dosage Forms
POWDER

Companies

Active Ingredient: NYSTATIN

NYSTOP Approval History

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What NYSTOP Treats

2 indications

NYSTOP is approved for 2 conditions since its original approval in 1996. These indications span multiple therapeutic areas including oncology, immunology, and more.

  • Cutaneous Mycotic Infection
  • Mucocutaneous Mycotic Infection
Source: FDA Label
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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

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.

NYSTOP FDA Label Details

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Indications & Usage

Nystatin Topical Powder is indicated in the treatment of cutaneous or mucocutaneous mycotic infections caused by Candida albicans and other susceptible Candida species. This preparation is not indicated for systemic, oral, intravaginal or ophthalmic use.

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Data Sources

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