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Serving hundreds of leading biopharmaceutical companies globally:

Cipla
Covington
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Medtronic
Farmers Insurance
Fuji
Fish and Richardson
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Generated: May 20, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 208300

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NDA 208300 describes NYSTATIN AND TRIAMCINOLONE ACETONIDE, which is a drug marketed by Alpharma Us Pharms, Amneal Pharms Llc, Crown Labs Inc, Dr Reddys Labs Ltd, Fougera Pharms Inc, Glenmark Pharms Ltd, Perrigo New York, Perrigo Uk Finco, Pharmafair, Taro, Akorn, Riconpharma Llc, Strides Pharma, and Teligent Pharma Inc, and is included in twenty-three NDAs. It is available from eighteen suppliers. Additional details are available on the NYSTATIN AND TRIAMCINOLONE ACETONIDE profile page.

The generic ingredient in NYSTATIN AND TRIAMCINOLONE ACETONIDE 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 208300
Tradename:NYSTATIN AND TRIAMCINOLONE ACETONIDE
Applicant:Glenmark Pharms Ltd
Ingredient:nystatin; triamcinolone acetonide
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 208300
Ingredient-typePolyenes
Mechanism of ActionCorticosteroid Hormone Receptor Agonists
Suppliers and Packaging for NDA: 208300
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
NYSTATIN AND TRIAMCINOLONE ACETONIDE nystatin; triamcinolone acetonide OINTMENT;TOPICAL 208300 ANDA Glenmark Pharmaceuticals Inc., USA 68462-799 N 68462-799-17
NYSTATIN AND TRIAMCINOLONE ACETONIDE nystatin; triamcinolone acetonide OINTMENT;TOPICAL 208300 ANDA Glenmark Pharmaceuticals Inc., USA 68462-799 N 68462-799-35

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:OINTMENT;TOPICALStrength100,000 UNITS/GM;0.1%
Approval Date:Jun 23, 2016TE:ATRLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

US Army
Julphar
Accenture
Cantor Fitzgerald
Dow
Queensland Health
Covington
Deloitte
Merck

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