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Generated: August 21, 2018

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Details for New Drug Application (NDA): 062512

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NDA 062512 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, Lyne, Zydus Pharms Usa Inc, Paddock Llc, Epic Pharma Llc, Gavis Pharms, Mayne Pharma Inc, Nesher Pharms, Upsher-smith Labs, X Gen Pharms, Alpharma Us Pharms, Fougera Pharms Inc, Hi Tech Pharma, Lannett Co Inc, Morton Grove, Pharm Assoc, Pharmaderm, Pharmafair, Socorro, Taro Pharm, Teva, 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, Lupin Ltd, Perrigo Uk Finco, Akorn, Riconpharma Llc, Strides Pharma, and Teligent Pharma Inc, and is included in seventy-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. Nineteen suppliers are listed for this compound. Additional details are available on the nystatin; triamcinolone acetonide profile page.
Summary for 062512
Tradename:NYSTATIN
Applicant:Wockhardt Bio Ag
Ingredient:nystatin
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 062512
Ingredient-typePolyenes
Medical Subject Heading (MeSH) Categories for 062512
Suppliers and Packaging for NDA: 062512
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
NYSTATIN nystatin SUSPENSION;ORAL 062512 ANDA Pharmaceutical Associates, Inc. 0121-4785 N 0121-4785-05
NYSTATIN nystatin SUSPENSION;ORAL 062512 ANDA Pharmaceutical Associates, Inc. 0121-4785 N 0121-4785-35

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SUSPENSION;ORALStrength100,000 UNITS/ML
Approval Date:Oct 29, 1984TE:AARLD:No

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