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Last Updated: March 18, 2024

Details for New Drug Application (NDA): 065175


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NDA 065175 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, Beowulf Asset, Dr Reddys Labs Sa, Epic Pharma Llc, Lupin, Nesher Pharms, Upsher Smith Labs, Zydus Pharms, Akorn, Alpharma Us Pharms, Fougera Pharms Inc, G And W Labs Inc, Genus, Leading, MLV, Morton Grove, Pharm Assoc, Pharmaderm, Pharmafair, Teva, Vistapharm, Wockhardt Bio Ag, Chartwell Rx, Heritage Pharms, 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-four 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 065175
Tradename:NYSTATIN
Applicant:Beowulf Asset
Ingredient:nystatin
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 065175
Medical Subject Heading (MeSH) Categories for 065175
Suppliers and Packaging for NDA: 065175
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
NYSTATIN nystatin POWDER;TOPICAL 065175 ANDA XGen Pharmaceuticals DJB, Inc. 39822-3015 39822-3015-1 15 g in 1 BOTTLE, PLASTIC (39822-3015-1)
NYSTATIN nystatin POWDER;TOPICAL 065175 ANDA XGen Pharmaceuticals DJB, Inc. 39822-3015 39822-3015-3 30 g in 1 BOTTLE, PLASTIC (39822-3015-3)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:POWDER;TOPICALStrength100,000 UNITS/GM
Approval Date:Dec 17, 2004TE:ATRLD:No

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