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Last Updated: April 9, 2025

Details for New Drug Application (NDA): 064142

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NDA 064142 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, Medley Pharms, MLV, Morton Grove, Pai Holdings, Pharm Assoc, Pharmaderm, Pharmafair, Teva, Vistapharm Llc, Xttrium Labs Inc, 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 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. Nineteen suppliers are listed for this compound. Additional details are available on the nystatin; triamcinolone acetonide profile page.

Summary for 064142

Tradename:	NYSTATIN
Applicant:	Vistapharm Llc
Ingredient:	nystatin
Patents:	0

Medical Subject Heading (MeSH) Categories for 064142

Anti-Bacterial Agents
Antifungal Agents
Ionophores

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	SUSPENSION;ORAL			Strength	100,000 UNITS/ML
Approval Date:	Jun 25, 1998	TE:		RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	SUSPENSION;ORAL			Strength	100,000 UNITS/ML
Approval Date:	Mar 7, 2011	TE:		RLD:	No

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