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Generated: June 21, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 062124

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NDA 062124 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, Allied Pharma Inc, Alpharma Us Pharms, Fougera Pharms Inc, Hi Tech Pharma, Lannett Co Inc, Morton Grove, Pharm Assoc, Pharmaderm, Pharmafair, 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, Riconpharma Llc, Strides Pharma, and Teligent Pharma Inc, and is included in seventy-nine NDAs. It is available from forty-eight 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 062124
Tradename:NYSTATIN
Applicant:Fougera Pharms
Ingredient:nystatin
Patents:0
Therapeutic Class:Antifungals
Formulation / Manufacturing:see details
Pharmacology for NDA: 062124
Ingredient-typePolyenes
Medical Subject Heading (MeSH) Categories for 062124
Suppliers and Packaging for NDA: 062124
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
NYSTATIN nystatin OINTMENT;TOPICAL 062124 ANDA E. FOUGERA & CO., A division of Fougera Pharmaceuticals Inc. 0168-0007 N 0168-0007-15
NYSTATIN nystatin OINTMENT;TOPICAL 062124 ANDA E. FOUGERA & CO., A division of Fougera Pharmaceuticals Inc. 0168-0007 N 0168-0007-30

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:OINTMENT;TOPICALStrength100,000 UNITS/GM
Approval Date:Sep 23, 1982TE:ATRLD:No

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