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Last Updated: December 25, 2024

Details for New Drug Application (NDA): 062512

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NDA 062512 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 062512

Tradename:	NYSTATIN
Applicant:	Wockhardt Bio Ag
Ingredient:	nystatin
Patents:	0

Pharmacology for NDA: 062512

Medical Subject Heading (MeSH) Categories for 062512

Anti-Bacterial Agents
Antifungal Agents
Ionophores

Suppliers and Packaging for NDA: 062512

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
NYSTATIN	nystatin	SUSPENSION;ORAL	062512	ANDA	ATLANTIC BIOLOGICALS CORP.	17856-0538	17856-0538-1	72 CUP, UNIT-DOSE in 1 BOX, UNIT-DOSE (17856-0538-1) / 5 mL in 1 CUP, UNIT-DOSE
NYSTATIN	nystatin	SUSPENSION;ORAL	062512	ANDA	ATLANTIC BIOLOGICALS CORP.	17856-0538	17856-0538-5	5 mL in 1 SYRINGE (17856-0538-5)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SUSPENSION;ORAL			Strength	100,000 UNITS/ML
Approval Date:	Oct 29, 1984	TE:	AA	RLD:	No

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