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Serving 500+ biopharmaceutical companies globally:

Chinese Patent Office
McKesson
Cantor Fitzgerald
Citi
Daiichi Sankyo
McKinsey
Boehringer Ingelheim
Julphar
Federal Trade Commission
Mallinckrodt

Generated: June 23, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 065422

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NDA 065422 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, Roxane, 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, Glenmark Pharms Ltd, Dr Reddys Labs Ltd, Perrigo Uk Finco, Riconpharma Llc, and Teligent Pharma Inc, and is included in sixty-seven NDAs. It is available from forty-six 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. Fourteen suppliers are listed for this compound. Additional details are available on the nystatin; triamcinolone acetonide profile page.

Summary for NDA: 065422

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

Pharmacology for NDA: 065422

Ingredient-typePolyenes

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 Lehigh Valley Technologies, Inc. 64950-230 64950-230-06 1 BOTTLE, PLASTIC in 1 CARTON (64950-230-06) > 60 mL in 1 BOTTLE, PLASTIC
NYSTATIN
nystatin
SUSPENSION;ORAL 065422 ANDA Lehigh Valley Technologies, Inc. 64950-230 64950-230-48 1 BOTTLE, PLASTIC in 1 CARTON (64950-230-48) > 480 mL in 1 BOTTLE, PLASTIC

Summary 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 500+ biopharmaceutical companies globally:

Daiichi Sankyo
Express Scripts
McKesson
Boehringer Ingelheim
Chubb
UBS
Healthtrust
Moodys
Fuji
Colorcon

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