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BioPharmaceutical Business Intelligence

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Serving leading biopharmaceutical companies globally:

Cipla
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Federal Trade Commission
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Farmers Insurance
Harvard Business School
Express Scripts
Queensland Health
Argus Health
US Army

Generated: December 16, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 062838

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NDA 062838 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-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. Eighteen suppliers are listed for this compound. Additional details are available on the nystatin; triamcinolone acetonide profile page.

Summary for 062838

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

Pharmacology for NDA: 062838

Ingredient-typePolyenes

Suppliers and Packaging for NDA: 062838

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
NYSTATIN nystatin TABLET;ORAL 062838 ANDA Aidarex Pharmaceuticals LLC 33261-896 33261-896-30 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (33261-896-30)
NYSTATIN nystatin TABLET;ORAL 062838 ANDA Sun Pharmaceutical Industries, Inc. 53489-400 53489-400-02 50 TABLET, FILM COATED in 1 BOTTLE (53489-400-02)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength500,000 UNITS
Approval Date:Dec 22, 1988TE:AARLD:No


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Serving leading biopharmaceutical companies globally:

US Department of Justice
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Moodys
Accenture

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