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Last Updated: December 12, 2025

Details for New Drug Application (NDA): 219527

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NDA 219527 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, MLV, Morton Grove, Pai Holdings, Pharm Assoc, Pharmaderm, Pharmafair, Senores Pharms, 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 NDAs. It is available from thirty-nine 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 219527

Tradename:	NYSTATIN
Applicant:	Aurobindo Pharma
Ingredient:	nystatin
Patents:	0

Pharmacology for NDA: 219527

Medical Subject Heading (MeSH) Categories for 219527

Anti-Bacterial Agents
Antifungal Agents
Ionophores

Suppliers and Packaging for NDA: 219527

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
NYSTATIN	nystatin	CREAM;TOPICAL	219527	ANDA	Aurobindo Pharma Limited	59651-907	59651-907-14	1 TUBE in 1 CARTON (59651-907-14) / 15 g in 1 TUBE
NYSTATIN	nystatin	CREAM;TOPICAL	219527	ANDA	Aurobindo Pharma Limited	59651-907	59651-907-30	1 TUBE in 1 CARTON (59651-907-30) / 30 g in 1 TUBE

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	CREAM;TOPICAL			Strength	100,000 UNITS/GM
Approval Date:	Mar 21, 2025	TE:	AT	RLD:	No

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