Data updated: May 26, 2026
NYSTATIN AND TRIAMCINOLONE ACETONIDE (nystatin)
Corticosteroid Hormone Receptor Agonists
Infectious Disease
Approved 1985-10-08
Nystatin and Triamcinolone Acetonide Cream USP is indicated for the treatment of cutaneous candidiasis; it has been demonstrated that the nystatin-steroid combination provides greater benefit than the nystatin component alone during the first few days of treatment.
Source: FDA Label • ALEMBIC
25
Indications
--
Phase 3 Trials
40
Years on Market
Details
- Status
- Prescription
- First Approved
- 1985-10-08
- Routes
- TOPICAL
- Dosage Forms
- CREAM, OINTMENT
Companies
ALEMBIC RISING CHARTWELL RX CROWN LABS INC SUN PHARMA CANADA PHARMAFAIR TORRENT PERRIGO NEW YORK EPIC PHARMA LLC FOUGERA PHARMS INC GLENMARK PHARMS LTD Lupin PAI HOLDINGS PHARM MACLEODS PHARMS LTD PADAGIS ISRAEL ZYDUS LIFESCIENCES AMNEAL Dr. Reddy's STRIDES PHARMA ALPHARMA US PHARMS
Website: ↗
NYSTATIN AND TRIAMCINOLONE ACETONIDE Approval History
1986
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2021
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2023
2024
2025
2026
Original
New Indication
New Form
Label Update
71 FDA actions from 1985 to 2022
Jul 2022 ORIGINAL
Update
Mar 2022 ORIGINAL
Update
Aug 2021 ORIGINAL
Update
Mar 2021 ORIGINAL
Update
Jul 2020 ORIGINAL
Update
Nov 2019 ORIGINAL
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Nov 2018 ORIGINAL
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May 2018 ORIGINAL
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Feb 2018 ORIGINAL
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Dec 2017 ORIGINAL
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Aug 2017 ORIGINAL
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Aug 2017 ORIGINAL
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Jan 2017 ORIGINAL
Update
Dec 2016 ORIGINAL
Update
Dec 2016 ORIGINAL
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Dec 2016 ORIGINAL
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Oct 2016 ORIGINAL
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Oct 2016 ORIGINAL
Update
Jun 2016 ORIGINAL
Update
Sep 2007 SUPPL
Mfg
Sep 2002 SUPPL
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Mar 2002 SUPPL
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Mar 2002 SUPPL
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Jul 2001 SUPPL
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Mar 2001 SUPPL
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May 1997 SUPPL
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Feb 1997 SUPPL
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Feb 1997 SUPPL
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Sep 1996 SUPPL
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Apr 1996 SUPPL
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Mar 1996 SUPPL
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Aug 1995 SUPPL
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Jul 1995 SUPPL
Mfg
Oct 1994 SUPPL
Mfg
Dec 1993 SUPPL
Label
Aug 1993 SUPPL
Mfg
Jun 1993 SUPPL
Label
Apr 1993 SUPPL
Label
Apr 1993 SUPPL
Label
Mar 1993 ORIGINAL
Update
Mar 1993 SUPPL
Mfg
Nov 1992 SUPPL
Label
Oct 1992 SUPPL
Label
Feb 1992 SUPPL
Label
Dec 1991 SUPPL
Mfg
Jul 1991 SUPPL
Label
Dec 1989 SUPPL
Mfg
Jul 1989 SUPPL
Mfg
Jul 1989 SUPPL
Mfg
Jun 1989 SUPPL
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May 1989 SUPPL
Mfg
Nov 1988 SUPPL
Mfg
Sep 1988 SUPPL
Mfg
Dec 1987 ORIGINAL
Update
Mar 1987 ORIGINAL
Update
Oct 1985 ORIGINAL
Update
Oct 1985 ORIGINAL
Update
What NYSTATIN AND TRIAMCINOLONE ACETONIDE Treats
25 FDA approvalsOriginally approved for its first indication in 1985 . Covers 25 distinct patient populations.
- Other (25)
Other
(25 approvals)- • Approved indication (Oct 1985)
- • Approved indication (Oct 1985)
- • Approved indication (Mar 1987)
- • Approved indication (Dec 1987)
- • Approved indication (Mar 1993)
- • Approved indication (Jun 2016)
- • Approved indication (Oct 2016)
- • Approved indication (Oct 2016)
- • Approved indication (Dec 2016)
- • Approved indication (Dec 2016)
- • Approved indication (Dec 2016)
- • Approved indication (Jan 2017)
- • Approved indication (Aug 2017)
- • Approved indication (Aug 2017)
- • Approved indication (Dec 2017)
- • Approved indication (Jan 2018)Letter
- • Approved indication (Feb 2018)
- • Approved indication (May 2018)
- • Approved indication (Nov 2018)
- • Approved indication (Nov 2019)
- • Approved indication (Jul 2020)
- • Approved indication (Mar 2021)
- • Approved indication (Aug 2021)
- • Approved indication (Mar 2022)
- • Approved indication (Jul 2022)
📋
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 |
🔬
Pro Active Pipeline
Ongoing clinical trials by development phase
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Pro Key Completed Trials
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.
NYSTATIN AND TRIAMCINOLONE ACETONIDE FDA Label Details
Indications & Usage
Nystatin and Triamcinolone Acetonide Cream USP is indicated for the treatment of cutaneous candidiasis; it has been demonstrated that the nystatin-steroid combination provides greater benefit than the nystatin component alone during the first few days of treatment.
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.