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Last Updated: December 27, 2024

Details for New Drug Application (NDA): 210532

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NDA 210532 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 210532

Tradename:	NYSTATIN
Applicant:	Epic Pharma Llc
Ingredient:	nystatin
Patents:	0

Pharmacology for NDA: 210532

Medical Subject Heading (MeSH) Categories for 210532

Anti-Bacterial Agents
Antifungal Agents
Ionophores

Suppliers and Packaging for NDA: 210532

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
NYSTATIN	nystatin	POWDER;TOPICAL	210532	ANDA	Epic Pharma, LLC	42806-178	42806-178-15	15 g in 1 BOTTLE (42806-178-15)
NYSTATIN	nystatin	POWDER;TOPICAL	210532	ANDA	Epic Pharma, LLC	42806-178	42806-178-30	30 g in 1 BOTTLE (42806-178-30)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	POWDER;TOPICAL			Strength	100,000 UNITS/GM
Approval Date:	Apr 30, 2018	TE:	AT	RLD:	No

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