Last Updated: June 19, 2026

Details for New Drug Application (NDA): 213826

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NDA 213826 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, 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-eight 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 213826

Tradename:	NYSTATIN
Applicant:	Macleods Pharms Ltd
Ingredient:	nystatin
Patents:	0

Pharmacology for NDA: 213826

Medical Subject Heading (MeSH) Categories for 213826

Anti-Bacterial Agents
Antifungal Agents
Ionophores

Suppliers and Packaging for NDA: 213826

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
NYSTATIN	nystatin	OINTMENT;TOPICAL	213826	ANDA	Macleods Pharmaceuticals Limited	33342-481	33342-481-15	1 TUBE in 1 CARTON (33342-481-15) / 15 g in 1 TUBE
NYSTATIN	nystatin	OINTMENT;TOPICAL	213826	ANDA	Macleods Pharmaceuticals Limited	33342-481	33342-481-30	1 TUBE in 1 CARTON (33342-481-30) / 30 g in 1 TUBE

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	OINTMENT;TOPICAL			Strength	100,000 UNITS/GM
Approval Date:	Jan 14, 2021	TE:	AT	RLD:	No

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