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Serving leading biopharmaceutical companies globally:

Queensland Health
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Generated: January 17, 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, Dr Reddys Labs Ltd, Fougera Pharms Inc, Glenmark Pharms Ltd, Perrigo New York, Perrigo Uk Finco, Pharmafair, Taro, Akorn, Riconpharma Llc, and Teligent Pharma Inc, and is included in nineteen NDAs. It is available from sixteen 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. Seventeen 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 68462-799-65 1 TUBE in 1 CARTON (68462-799-65) > 60 g in 1 TUBE
NYSTATIN AND TRIAMCINOLONE ACETONIDE nystatin; triamcinolone acetonide OINTMENT;TOPICAL 208300 ANDA Glenmark Pharmaceuticals Inc., USA 68462-799 68462-799-17 1 TUBE in 1 CARTON (68462-799-17) > 15 g in 1 TUBE

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 leading biopharmaceutical companies globally:

Medtronic
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Colorcon
Mallinckrodt
Express Scripts
McKesson
Dow
Citi
Covington

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