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Generated: January 15, 2019

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Details for New Drug Application (NDA): 062472

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NDA 062472 describes NYSTATIN, which is a drug marketed by Actavis Mid Atlantic, Crown Labs Inc, Fougera Pharms, G And W Labs Inc, Perrigo New York, Taro, Vintage, Lyne, Zydus Pharms Usa Inc, Paddock Llc, Epic Pharma Llc, Gavis Pharms, Mayne Pharma Inc, Nesher Pharms, Upsher Smith Labs, X Gen Pharms, Alpharma Us Pharms, Fougera Pharms Inc, Hi Tech Pharma, Lannett Co Inc, Morton Grove, Pharm Assoc, Pharmaderm, Pharmafair, Socorro, Taro Pharm, Teva, Vistapharm, Wockhardt Bio Ag, Heritage Pharms Inc, Quantum Pharmics, Sandoz, Sun Pharm Industries, Usl Pharma, Watson Labs, Fougera, Odyssey Pharms, Amneal Pharms Llc, Dr Reddys Labs Ltd, Glenmark Pharms Ltd, Lupin Ltd, Perrigo Uk Finco, Akorn, Rising Pharms, Strides Pharma, and Teligent Pharma Inc, and is included in eighty NDAs. It is available from forty-nine 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 062472
Applicant:Perrigo New York
Formulation / Manufacturing:see details
Pharmacology for NDA: 062472
Medical Subject Heading (MeSH) Categories for 062472
Suppliers and Packaging for NDA: 062472
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
NYSTATIN nystatin OINTMENT;TOPICAL 062472 ANDA Perrigo New York Inc 45802-048 45802-048-11 1 TUBE in 1 CARTON (45802-048-11) > 30 g in 1 TUBE
NYSTATIN nystatin OINTMENT;TOPICAL 062472 ANDA Perrigo New York Inc 45802-048 45802-048-35 1 TUBE in 1 CARTON (45802-048-35) > 15 g in 1 TUBE

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:OINTMENT;TOPICALStrength100,000 UNITS/GM
Approval Date:Feb 13, 1984TE:ATRLD:No

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