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Last Updated: March 26, 2026

Details for New Drug Application (NDA): 065148

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NDA 065148 describes NYSTATIN, which is a drug marketed by Actavis Mid Atlantic, Aurobindo Pharma, Chartwell Rx, Cosette, Crown Labs Inc, Fougera Pharms, Macleods Pharms Ltd, Padagis Us, Sun Pharma Canada, Torrent, 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, Lupin 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 forty 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 065148

Tradename:	NYSTATIN
Applicant:	Genus
Ingredient:	nystatin
Patents:	0

Pharmacology for NDA: 065148

Medical Subject Heading (MeSH) Categories for 065148

Anti-Bacterial Agents
Antifungal Agents
Ionophores

Suppliers and Packaging for NDA: 065148

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
NYSTATIN	nystatin	SUSPENSION;ORAL	065148	ANDA	Genus Lifesciences Inc.	64950-372	64950-372-47	473 mL in 1 BOTTLE (64950-372-47)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SUSPENSION;ORAL			Strength	100,000 UNITS/ML
Approval Date:	Jun 28, 2005	TE:	AA	RLD:	No

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