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Generated: December 12, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 062364

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NDA 062364 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 seventeen 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. Eighteen suppliers are listed for this compound. Additional details are available on the nystatin; triamcinolone acetonide profile page.

Summary for 062364

Tradename:1
Applicant:1
Ingredient:1
Patents:0
Formulation / Manufacturing:see details

Pharmacology for NDA: 062364

Ingredient-typePolyenes
Mechanism of ActionCorticosteroid Hormone Receptor Agonists

Suppliers and Packaging for NDA: 062364

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
NYSTATIN AND TRIAMCINOLONE ACETONIDE nystatin; triamcinolone acetonide CREAM;TOPICAL 062364 ANDA STAT RX LLC USA 16590-173 16590-173-15 15 g in 1 TUBE (16590-173-15)
NYSTATIN AND TRIAMCINOLONE ACETONIDE nystatin; triamcinolone acetonide CREAM;TOPICAL 062364 ANDA Rebel Distributors Corp 21695-185 21695-185-60 60 g in 1 TUBE (21695-185-60)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:CREAM;TOPICALStrength100,000 UNITS/GM;0.1%
Approval Date:Dec 22, 1987TE:ATRLD:No


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