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Last Updated: August 12, 2020

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Details for New Drug Application (NDA): 209082

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NDA 209082 describes NYSTATIN, which is a drug marketed by Actavis Mid Atlantic, Cosette, Crown Labs Inc, Fougera Pharms, Perrigo New York, Taro, Torrent, Vintage, Cadila, Lyne, Paddock Llc, Epic Pharma Llc, Lupin, Mayne Pharma Inc, Nesher Pharms, Upsher Smith Labs, Xgen 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, Rising, Strides Pharma, Teligent Pharma Inc, and Vitruvias Therap, and is included in eighty-three NDAs. It is available from thirty-seven 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. Nineteen suppliers are listed for this compound. Additional details are available on the nystatin; triamcinolone acetonide profile page.
Summary for 209082
Tradename:NYSTATIN
Applicant:Lyne
Ingredient:nystatin
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 209082
Medical Subject Heading (MeSH) Categories for 209082
Suppliers and Packaging for NDA: 209082
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
NYSTATIN nystatin OINTMENT;TOPICAL 209082 ANDA Leading Pharma, LLC 69315-307 69315-307-15 1 TUBE in 1 CARTON (69315-307-15) > 15 g in 1 TUBE
NYSTATIN nystatin OINTMENT;TOPICAL 209082 ANDA Leading Pharma, LLC 69315-307 69315-307-30 1 TUBE in 1 CARTON (69315-307-30) > 30 g in 1 TUBE

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:OINTMENT;TOPICALStrength100,000 UNITS/GM
Approval Date:May 21, 2018TE:ATRLD:No

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