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Serving hundreds of leading biopharmaceutical companies globally:

McKesson
AstraZeneca
Chubb
Daiichi Sankyo
Fuji
Cerilliant
US Department of Justice
Mallinckrodt
Cantor Fitzgerald

Generated: April 21, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 062367

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NDA 062367 describes MYKACET, which is a drug marketed by G And W Labs Inc and is included in two NDAs. It is available from one supplier. Additional details are available on the MYKACET profile page.

The generic ingredient in MYKACET is nystatin; triamcinolone acetonide. There are eight drug master file entries for this compound. Sixteen suppliers are listed for this compound. Additional details are available on the nystatin; triamcinolone acetonide profile page.
Summary for 062367
Tradename:MYKACET
Applicant:G And W Labs Inc
Ingredient:nystatin; triamcinolone acetonide
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 062367
Ingredient-typePolyenes
Mechanism of ActionCorticosteroid Hormone Receptor Agonists
Suppliers and Packaging for NDA: 062367
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
MYKACET nystatin; triamcinolone acetonide CREAM;TOPICAL 062367 ANDA Actavis Pharma, Inc. 0472-0150 N 0472-0150-15
MYKACET nystatin; triamcinolone acetonide CREAM;TOPICAL 062367 ANDA Actavis Pharma, Inc. 0472-0150 N 0472-0150-30

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CREAM;TOPICALStrength100,000 UNITS/GM;0.1%
Approval Date:May 28, 1985TE:ATRLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

Merck
Cantor Fitzgerald
Mallinckrodt
AstraZeneca
Chubb
Healthtrust
UBS
Farmers Insurance
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