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Generated: June 23, 2018

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, Amneal Pharms Llc, Crown Labs Inc, Dr Reddys Labs Ltd, Fougera Pharms Inc, Glenmark Pharms Ltd, Lupin Ltd, Perrigo New York, Perrigo Uk Finco, Pharmafair, Taro, Akorn, Riconpharma Llc, Strides Pharma, and Teligent Pharma Inc, and is included in twenty-four 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 062364
Tradename:NYSTATIN AND TRIAMCINOLONE ACETONIDE
Applicant:Taro
Ingredient:nystatin; triamcinolone acetonide
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 Rebel Distributors Corp 21695-185 E 21695-185-15
NYSTATIN AND TRIAMCINOLONE ACETONIDE nystatin; triamcinolone acetonide CREAM;TOPICAL 062364 ANDA Rebel Distributors Corp 21695-185 E 21695-185-30

Profile 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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