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Serving hundreds of leading biopharmaceutical companies globally:

Cerilliant
Harvard Business School
Merck
McKesson
Deloitte
McKinsey
Federal Trade Commission
Express Scripts
Cipla

Generated: April 21, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 062474

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NDA 062474 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, Paddock Llc, Gavis Pharms, Lyne, Mayne Pharma Inc, Nesher Pharms, Upsher-smith Labs, X Gen Pharms, Allied Pharma Inc, Alpharma Us Pharms, Fougera Pharms Inc, Hi Tech Pharma, Morton Grove, Pharm Assoc, Pharmaderm, Pharmafair, Taro Pharm, Teva, Vintage Pharms, 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, Perrigo Uk Finco, Akorn, Riconpharma Llc, Strides Pharma, and Teligent Pharma Inc, and is included in seventy-five NDAs. It is available from thirty-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. Sixteen suppliers are listed for this compound. Additional details are available on the nystatin; triamcinolone acetonide profile page.
Summary for 062474
Tradename:NYSTATIN
Applicant:Heritage Pharms Inc
Ingredient:nystatin
Patents:0
Therapeutic Class:Antifungals
Formulation / Manufacturing:see details
Pharmacology for NDA: 062474
Ingredient-typePolyenes
Medical Subject Heading (MeSH) Categories for 062474
Suppliers and Packaging for NDA: 062474
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
NYSTATIN nystatin TABLET;ORAL 062474 ANDA Heritage Pharmaceuticals Inc 23155-051 N 23155-051-01
NYSTATIN nystatin TABLET;ORAL 062474 ANDA Avera McKennan Hospital 69189-0587 N 69189-0587-1

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength500,000 UNITS
Approval Date:Dec 22, 1983TE:AARLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

Mallinckrodt
Baxter
Colorcon
Chinese Patent Office
Accenture
Fish and Richardson
Daiichi Sankyo
UBS
Teva

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