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Serving leading biopharmaceutical companies globally:

Express Scripts
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Generated: January 23, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 065175

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NDA 065175 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, Heritage Pharms Inc, Quantum Pharmics, Sandoz, Sun Pharm Industries, Usl Pharma, Watson Labs, Fougera, Odyssey Pharms, Dr Reddys Labs Ltd, Glenmark Pharms Ltd, Perrigo Uk Finco, Akorn, Riconpharma Llc, and Teligent Pharma Inc, and is included in seventy-one NDAs. It is available from forty-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. Seventeen suppliers are listed for this compound. Additional details are available on the nystatin; triamcinolone acetonide profile page.
Summary for 065175
Tradename:NYSTATIN
Applicant:X Gen Pharms
Ingredient:nystatin
Patents:0
Therapeutic Class:Antifungals
Formulation / Manufacturing:see details
Pharmacology for NDA: 065175
Ingredient-typePolyenes
Medical Subject Heading (MeSH) Categories for 065175
Suppliers and Packaging for NDA: 065175
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
NYSTATIN nystatin POWDER;TOPICAL 065175 ANDA X-GEN Pharmaceuticals, Inc. 39822-3015 39822-3015-1 15 g in 1 BOTTLE, PLASTIC (39822-3015-1)
NYSTATIN nystatin POWDER;TOPICAL 065175 ANDA X-GEN Pharmaceuticals, Inc. 39822-3015 39822-3015-3 30 g in 1 BOTTLE, PLASTIC (39822-3015-3)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:POWDER;TOPICALStrength100,000 UNITS/GM
Approval Date:Dec 17, 2004TE:ATRLD:No

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Serving leading biopharmaceutical companies globally:

Moodys
Colorcon
Merck
Queensland Health
Accenture
McKesson
Fish and Richardson
Federal Trade Commission
Daiichi Sankyo

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