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Generated: December 11, 2018

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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 two suppliers. 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. Twenty-one 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
Pharmacology for NDA: 062367
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 0472-0150-15 1 TUBE in 1 CARTON (0472-0150-15) > 15 g in 1 TUBE
MYKACET nystatin; triamcinolone acetonide CREAM;TOPICAL 062367 ANDA Actavis Pharma, Inc. 0472-0150 0472-0150-30 1 TUBE in 1 CARTON (0472-0150-30) > 30 g in 1 TUBE

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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