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NILSTAT

NDA

NYSTATIN | N050299 | CHARTWELL MOLECULES LLC

1 strength0 unique patents0 unique exclusivities

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

No ANDA patent litigation cases (NOS 835) matched from PACER

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

31 trials from ClinicalTrials.gov — 1 recruiting, 24 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
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 NCT03178149	Phase 1	Recruiting	Astellas Institute for Regenerative Medicine	42	2018-07-13 → 2027-12-31
Study of Epidermal Growth Factor on Oral Mucositis Induced by Intensive Chemotherapy for Hematologic Malignancies NCT00845819	Phase 2	Completed	Seoul National University Hospital	138	2009-02 → 2014-10
Effect of Aqueous Extract of Garlic and Nystatin Mouthwash in Denture Stomatitis NCT01198223	Phase 2	Completed	Qazvin University Of Medical Sciences	40	2010-07 → 2010-10
Open Study of the Efficacy of the Local Treatment With Polygynax of Bacterial and/or Mycotic Vaginitis NCT02444481	Phase 4	Completed	Laboratoire Innotech International	169	2009-04 → 2009-11
Comparative Randomized Study of the Efficacy, Safety, and Toleration of Fluconazole Oral Suspension or Nystatin Oral Suspension in the Treatment of Patients With Oropharyngeal Candidiasis in Association With the Acquired Immunodeficiency Syndrome NCT00002112	N/A	Completed	Pfizer	—	—
Periodontal Disease Treatment of a Physically Challenged Population NCT01718912	N/A	Completed	Oravital Inc	11	2013-11 → 2014-10
Nystatin Pastilles for the Prevention of Oral Candidiasis in Patients With AIDS or ARC NCT00002057	N/A	Completed	Bristol-Myers Squibb	—	—
Selective Decontamination of the Digestive Tract in Intensive Care Unit Patients NCT02389036	Phase 3	Completed	The George Institute	20,010	2017-05-01 → 2023-04-26
Efficacy of 1% Nanochitosan Solution in the Treatment of Denture Stomatitis NCT07694024	Phase 2	Completed	Kerman University of Medical Sciences	30	2016-01-17 → 2016-05-04
Efficacy of 5% Nanochitosan Paste in the Treatment of Oral Candidosis NCT07793331	Phase 2	Completed	Kerman University of Medical Sciences	30	2016-01-01 → 2016-12-01

Source: ClinicalTrials.gov. Trials matched by ingredient name.

Drug Pricing (NADAC)

National Average Drug Acquisition Cost — Week of 2026-10-21 | 2 NDCs

Highest NADAC/Unit

$0.1430

per ml

Lowest NADAC/Unit

$0.0554

per ml

Brand NDCs

Generic NDCs

NDC Description	NADAC/Unit	Unit	Type	Generic NADAC	Effective
62135081346NYSTATIN 100,000 UNIT/ML SUSP	$0.1430	ML	Generic	—	2026-10-21
62135081347NYSTATIN 100,000 UNIT/ML SUSP	$0.0554	ML	Generic	—	2026-10-21

Source: NADAC (data.medicaid.gov). Prices reflect national average acquisition costs for retail community pharmacies.

VA Federal Supply Schedule

Government-negotiated contract prices | 1 NDC (1 FSS)

Lowest Price

$499.99

Highest Price

$499.99

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
62135-0813-47NYSTATIN 100000UNT/ML SUSP,ORAL	$499.99	FSS	Chartwell RX LLC	02/28/2027

Source: VA Federal Supply Schedule (va.gov). Prices are government-negotiated contract prices.

API Supply Chain4 active DMFs5 inactive

4 active API suppliers hold Drug Master Files for this ingredient.

CENTRIENT PHARMACEUTICALS NETHERLANDS BVNYSTATIN

DMF 135231998

VUAB PHARMA ASNYSTATIN USP

DMF 140561999

ANTIBIOTICE SANYSTATIN

DMF 148132000

CONCORD BIOTECH LTDNYSTATIN USP

DMF 417912025

SHAOXING PHARMACEUTICAL FACTORYInactiveNYSTATIN

DMF 125571997

ER SQUIBB AND SONS INCInactiveNYSTATIN

DMF 132981998

BRISTOL MYERS SQUIBB COInactiveNYSTATIN

DMF 134411998

LEDERLE LABORATORIESInactiveNYSTATIN BULK POWDER

DMF 150282000

OLON SPAInactiveNYSTATIN

DMF 352252020

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Products (1)

#001 — 100,000 UNITS/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLDAA

0 patents0 exclusivities▴

SUSPENSION;ORAL | Approved: Approved Prior to Jan 1, 1982

No patent or exclusivity listings for this strength.