Last Updated: November 9, 2026

Details for New Drug Application (NDA): 061965

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NDA 061965 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, 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, Adaptis, Alpharma Us Pharms, Fougera Pharms Inc, G And W Labs Inc, Genus, Morton Grove, Pai Holdings, Pharm Assoc, Pharmaderm, Pharmafair, Pharmazone, Sciegen Pharms, 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 two 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 061965

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

Medical Subject Heading (MeSH) Categories for 061965

Anti-Bacterial Agents
Antifungal Agents
Ionophores

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;VAGINAL			Strength	100,000 UNITS
Approval Date:	Approved Prior to Jan 1, 1982	TE:		RLD:	No

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