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Last Updated: December 11, 2019

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Details for New Drug Application (NDA): 062571

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NDA 062571 describes NYSTATIN, which is a drug marketed by Acp Nimble, Actavis Mid Atlantic, Crown Labs Inc, Fougera Pharms, Perrigo New York, Taro, Torrent, Vintage, Lyne, Zydus Pharms, Paddock Llc, Epic Pharma Llc, Lupin, Mayne Pharma Inc, Nesher Pharms, Upsher Smith Labs, X Gen Pharms, Alpharma Us Pharms, Fougera Pharms Inc, G And W Labs Inc, Hi Tech Pharma, Lannett Co Inc, Morton Grove, Pharm Assoc, Pharmaderm, Pharmafair, Socorro, Teva, Vistapharm, Wockhardt Bio Ag, Heritage Pharms Inc, Quantum Pharmics, Sandoz, Sun Pharm Industries, Watson Labs, Fougera, Odyssey Pharms, Amneal Pharms Llc, Dr Reddys, Glenmark Pharms Ltd, Lupin Ltd, Perrigo Uk Finco, Akorn, Anda Repository, Strides Pharma, and Teligent Pharma Inc, and is included in eighty-two NDAs. It is available from forty-one 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 suppliers are listed for this compound. Additional details are available on the nystatin; triamcinolone acetonide profile page.
Summary for 062571
Tradename:NYSTATIN
Applicant:Alpharma Us Pharms
Ingredient:nystatin
Patents:0
Formulation / Manufacturing:see details
Medical Subject Heading (MeSH) Categories for 062571

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:SUSPENSION;ORALStrength100,000 UNITS/ML
Approval Date:Oct 29, 1985TE:RLD:No

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