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Serving hundreds of leading biopharmaceutical companies globally:

US Army
US Department of Justice
Express Scripts

Generated: March 24, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 065422

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NDA 065422 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 forty-five 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. Eighteen suppliers are listed for this compound. Additional details are available on the nystatin; triamcinolone acetonide profile page.
Summary for 065422
Therapeutic Class:Antifungals
Formulation / Manufacturing:see details
Pharmacology for NDA: 065422
Medical Subject Heading (MeSH) Categories for 065422
Suppliers and Packaging for NDA: 065422
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
NYSTATIN nystatin SUSPENSION;ORAL 065422 ANDA Genus Lifescience Inc. 64950-230 N 64950-230-06
NYSTATIN nystatin SUSPENSION;ORAL 065422 ANDA Genus Lifescience Inc. 64950-230 N 64950-230-48

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SUSPENSION;ORALStrength100,000 UNITS/ML
Approval Date:Mar 7, 2011TE:AARLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

Fish and Richardson
Federal Trade Commission
Boehringer Ingelheim
Johnson and Johnson
Daiichi Sankyo

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