Last Updated: August 3, 2026

Details for New Drug Application (NDA): 065183

✉ Email this page to a colleague

« Back to Dashboard

NDA 065183 describes NYSTATIN, which is a drug marketed by Actavis Mid Atlantic, Aurobindo Pharma, Chartwell Rx, Cosette Pharms Nc, Crown Labs Inc, Fougera Pharms, Macleods Pharms Ltd, Padagis Us, Sun Pharma Canada, Torrent, Cosette, Lyne, Zydus Lifesciences, Paddock Llc, Dr Reddys Labs Sa, Lupin, Nesher Pharms, Pharmobedient, Upsher Smith Labs, Zydus Pharms, Alpharma Us Pharms, Fougera Pharms Inc, G And W Labs Inc, Genus, Morton Grove, Pai Holdings, Pharm Assoc, Pharmaderm, Pharmafair, Sciegen Pharms, Senores Pharms, Steranco Hlthcare, Taro, Teva, Vistapharm Llc, Heritage, Quantum Pharmics, Sandoz, Sun Pharm Industries, Watson Labs, Fougera, Odyssey Pharms, Alembic, Amneal, Glenmark Pharms Ltd, Padagis Israel, Perrigo New York, Dr Reddys, Epic Pharma Llc, Pai Holdings Pharm, Rising, and Strides Pharma, and is included in ninety-one NDAs. It is available from thirty-seven suppliers. Additional details are available on the NYSTATIN profile page.

The generic ingredient in NYSTATIN is nystatin; triamcinolone acetonide. There are eight drug master file entries for this compound. Eighteen suppliers are listed for this compound. Additional details are available on the nystatin; triamcinolone acetonide profile page.

Summary for 065183

Tradename:	NYSTATIN
Applicant:	Upsher Smith Labs
Ingredient:	nystatin
Patents:	0

Pharmacology for NDA: 065183

Medical Subject Heading (MeSH) Categories for 065183

Anti-Bacterial Agents
Antifungal Agents
Ionophores

Suppliers and Packaging for NDA: 065183

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
NYSTATIN	nystatin	POWDER;TOPICAL	065183	ANDA	Upsher-Smith Laboratories, LLC	0832-0465	0832-0465-15	1 BOTTLE, PLASTIC in 1 CARTON (0832-0465-15) / 15 g in 1 BOTTLE, PLASTIC
NYSTATIN	nystatin	POWDER;TOPICAL	065183	ANDA	Upsher-Smith Laboratories, LLC	0832-0465	0832-0465-30	1 BOTTLE, PLASTIC in 1 CARTON (0832-0465-30) / 30 g in 1 BOTTLE, PLASTIC

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	POWDER;TOPICAL			Strength	100,000 UNITS/GM
Approval Date:	May 3, 2005	TE:	AT	RLD:	No

Complete Access Available with Subscription

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. We do not provide individual investment advice. This service is not registered with any financial regulatory agency. The information we publish is educational only and based on our opinions plus our models. By using DrugPatentWatch you acknowledge that we do not provide personalized recommendations or advice. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.