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Serving 500+ biopharmaceutical companies globally:

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Generated: September 26, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 065138

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NDA 065138 describes NYSTATIN, which is a drug marketed by Watson Labs, Teva, Mayne Pharma Inc, Quantum Pharmics, Wockhardt, Paddock Llc, Vintage, Odyssey Pharms, Fougera Pharms Inc, Pharmaderm, Nesher Pharms, Pharm Assoc, Taro, Vistapharm, Fougera Pharms, Usl Pharma, Perrigo New York, Allied Pharma Inc, Morton Grove, Gavis Pharms, Lyne, Sun Pharm Inds, Actavis Mid Atlantic, Pharmafair, Hi Tech Pharma, Vintage Pharms, G And W Labs Inc, Fougera, Sandoz, Alpharma Us Pharms, Heritage Pharms Inc, X Gen Pharms, Taro Pharm, Upsher-smith Labs, Glenmark Pharms Ltd, Akorn, Dr Reddys Labs Ltd, Perrigo Uk Finco, Riconpharma Llc, and Teligent Pharma Inc, and is included in sixty-nine NDAs. It is available from forty-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. Seventeen suppliers are listed for this compound. Additional details are available on the nystatin; triamcinolone acetonide profile page.

Summary for NDA: 065138

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:0
Therapeutic Class:Antifungals
Formulation / Manufacturing:see details

Pharmacology for NDA: 065138

Ingredient-typePolyenes

Suppliers and Packaging for NDA: 065138

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
NYSTATIN
nystatin
POWDER;TOPICAL 065138 ANDA Crown Laboratories 0316-0171 0316-0171-45 1 KIT in 1 KIT (0316-0171-45) * 3 BOTTLE, PLASTIC in 1 KIT (0316-0187-15) > 15 g in 1 BOTTLE, PLASTIC
NYSTATIN
nystatin
POWDER;TOPICAL 065138 ANDA Major Pharmaceuticals 0904-6456 0904-6456-02 60 g in 1 BOTTLE, PLASTIC (0904-6456-02)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:POWDER;TOPICALStrength100,000 UNITS/GM
Approval Date:Jul 23, 2004TE:ATRLD:No


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Serving 500+ biopharmaceutical companies globally:

Colorcon
Express Scripts
Healthtrust
QuintilesIMS
US Army
Queensland Health
Harvard Business School
Mallinckrodt
Federal Trade Commission
US Department of Justice

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