TheraRadar
Data updated: May 26, 2026

NYSTATIN

Infectious Disease Approved 1976-05-25

NYSTATIN is indicated for the treatment of Candidiasis.

Source: FDA Label • CROWN LABS INC
Jump to: Indications Approvals Trials Competitors Similar Safety Patents
48
Indications
--
Phase 3 Trials
50
Years on Market

Details

Status
Prescription
First Approved
1976-05-25
Routes
TOPICAL, VAGINAL, ORAL
Dosage Forms
CREAM, OINTMENT, TABLET, SUSPENSION, POWDER

Companies

CROWN LABS INC LYNE WATSON LABS ODYSSEY PHARMS MORTON GROVE Teva Aurobindo Pharma PADAGIS US SUN PHARMA CANADA PHARMOBEDIENT Sun Pharma COSETTE QUANTUM PHARMICS PHARMADERM GENUS UPSHER SMITH LABS MACLEODS PHARMS LTD FOUGERA PHARMS G AND W LABS INC PHARMAFAIR ALPHARMA US PHARMS ZYDUS LIFESCIENCES TORRENT HERITAGE CHARTWELL RX SCIEGEN PHARMS NESHER PHARMS Novartis PADDOCK LLC VISTAPHARM LLC PHARM ASSOC FOUGERA FOUGERA PHARMS INC TARO PAI HOLDINGS SENORES PHARMS ZYDUS PHARMS STERANCO HLTHCARE Dr. Reddy's Lupin
Active Ingredient: NYSTATIN

NYSTATIN Approval History

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Original
New Indication
New Form
Label Update
287 FDA actions from 1976 to 2026
Feb 2026 ORIGINAL
Update
Mar 2025 ORIGINAL
Update
Mar 2024 SUPPL
Label · Labeling

What NYSTATIN Treats

1 indications

NYSTATIN is approved for 1 conditions since its original approval in 1976. These indications span multiple therapeutic areas including oncology, immunology, and more.

  • Candidiasis
Source: FDA Label

NYSTATIN Competitive Set

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

Indication competitors

10

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

MICAFUNGIN IN SODIUM CHLORIDE 0.9%
Baxter
2023 6 indic.
VIVJOA
MYCOVIA PHARMS
2022 1 indic.
Unlock 8 more competitors across all three rings.
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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.

Drugs Similar to NYSTATIN

3 of 10

FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.

ANCOBON
FLUCYTOSINE
1 shared
BAUSCH
Shared indications:
Candidiasis
CLOTRIMAZOLE
CLOTRIMAZOLE
1 shared
Hikma
Shared indications:
Candidiasis
DIFLUCAN
FLUCONAZOLE
1 shared
Pfizer
Shared indications:
Candidiasis
View all 10 similar drugs Pro
📋

Clinical Trial Registry

6 trials
Trial Sponsor ID Phase Status Title
NCT03178149 7317-CL-0003 Ph 1 recruiting A Study of the Safety and Tolerability of ASP7317 in Senior Adults Who Are Losing Their Clear, Sharp Central Vision Due to Geographic Atrophy Secondary to Dry Age-related Macular Degeneration
NCT04550546 STUDY00004638 Ph 1 completed Effects of Nystatin Suspension Oral Application on Oral Microbial Community
NCT04532060 FoAr Ph 2 completed Clinical Trial Evaluating Chlorine e6 Derivative-mediated Antimicrobial Photodynamic Therapy as a Treatment for Denture Stomatitis
NCT03862079 2017-0466 NCI-2019-01045, 2017-0466 Ph 2 withdrawn Fecal Transplant +/- Gut Decontamination in Preventing Acute Graft Versus Host Disease in Patients Given Broad-Spectrum Antibiotics
NCT01495039 Nista 1 Ph 4 completed Antifungal Prophylaxis in Intensive Care Unit (ICU) Patients
NCT01531192 ZTB630301 Ph 4 completed Comparison of Lactobacillus Reuteri and Nystatin Prophylaxis on Candida Colonization and Infection in Very Low Birth Weight Infants
🔬

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.

NYSTATIN FDA Label Details

Indications & Usage

FDA Label (PDF)

NYSTATIN is indicated for the treatment of Candidiasis.

Looking for the branded version?

NYSTATIN AND TRIAMCINOLONE ACETONIDE

Full clinical data, patents, trials, and competitive landscape for nystatin.

See NYSTATIN AND TRIAMCINOLONE ACETONIDE

Data Sources

FDA Approval: ANDA207733 → Label: DailyMed → Trials: ClinicalTrials.gov →

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