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Last Updated: December 22, 2024

Details for New Drug Application (NDA): 062474

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NDA 062474 describes NYSTATIN, which is a drug marketed by Actavis Mid Atlantic, Cosette, Crown Labs Inc, Fougera Pharms, Macleods Pharms Ltd, Padagis Us, Strides Pharma, Taro, Torrent, Lyne, Zydus Lifesciences, Paddock Llc, Adrastea Pharma, Dr Reddys Labs Sa, Epic Pharma Llc, Lupin, Nesher Pharms, Upsher Smith Labs, Zydus Pharms, Alpharma Us Pharms, Fougera Pharms Inc, G And W Labs Inc, Genus, Leading, MLV, Morton Grove, Pai Holdings, Pharm Assoc, Pharmaderm, Pharmafair, Teva, Vistapharm, Wockhardt Bio Ag, Chartwell Rx, Heritage, Quantum Pharmics, Sandoz, Sun Pharm Industries, Watson Labs, Fougera, Odyssey Pharms, Alembic, Amneal, Dr Reddys, Glenmark Pharms Ltd, Lupin Ltd, Padagis Israel, Perrigo New York, Pai Holdings Pharm, and Rising, and is included in ninety 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. Twenty-one suppliers are listed for this compound. Additional details are available on the nystatin; triamcinolone acetonide profile page.

Summary for 062474

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

Pharmacology for NDA: 062474

Medical Subject Heading (MeSH) Categories for 062474

Anti-Bacterial Agents
Antifungal Agents
Ionophores

Suppliers and Packaging for NDA: 062474

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
NYSTATIN	nystatin	TABLET;ORAL	062474	ANDA	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.	23155-051	23155-051-01	100 TABLET, COATED in 1 BOTTLE (23155-051-01)
NYSTATIN	nystatin	TABLET;ORAL	062474	ANDA	Chartwell RX, LLC	62135-741	62135-741-90	90 TABLET, FILM COATED in 1 BOTTLE (62135-741-90)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	500,000 UNITS
Approval Date:	Dec 22, 1983	TE:	AA	RLD:	No

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