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Last Updated: November 24, 2024

Details for New Drug Application (NDA): 208838

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NDA 208838 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-two suppliers are listed for this compound. Additional details are available on the nystatin; triamcinolone acetonide profile page.

Summary for 208838

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

Pharmacology for NDA: 208838

Medical Subject Heading (MeSH) Categories for 208838

Anti-Bacterial Agents
Antifungal Agents
Ionophores

Suppliers and Packaging for NDA: 208838

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
NYSTATIN	nystatin	POWDER;TOPICAL	208838	ANDA	RedPharm Drug	67296-1501	67296-1501-3	30 g in 1 BOTTLE, PLASTIC (67296-1501-3)
NYSTATIN	nystatin	POWDER;TOPICAL	208838	ANDA	Leading Pharma, LLC	69315-306	69315-306-15	15 g in 1 BOTTLE, PLASTIC (69315-306-15)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	POWDER;TOPICAL			Strength	100,000 UNITS/GM
Approval Date:	May 30, 2017	TE:	AT	RLD:	No

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