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Serving leading biopharmaceutical companies globally:

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US Department of Justice
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Generated: January 22, 2018

DrugPatentWatch Database Preview

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, 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 062512
Tradename:NYSTATIN
Applicant:Wockhardt
Ingredient:nystatin
Patents:0
Therapeutic Class:Antifungals
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 0121-4785-35 10 TRAY in 1 CASE (0121-4785-35) > 10 CUP, UNIT-DOSE in 1 TRAY > 5 mL in 1 CUP, UNIT-DOSE
NYSTATIN nystatin SUSPENSION;ORAL 062512 ANDA Pharmaceutical Associates, Inc. 0121-4785 0121-4785-05 4 TRAY in 1 CASE (0121-4785-05) > 10 CUP, UNIT-DOSE in 1 TRAY > 5 mL in 1 CUP, UNIT-DOSE

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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Serving leading biopharmaceutical companies globally:

Argus Health
Federal Trade Commission
Baxter
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Novartis
Cerilliant

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