FDA.reportPublic FDA data

Application 214186

Type
ANDA
Sponsor
ALEOR DERMACEUTICALS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001NYSTATIN AND TRIAMCINOLONE ACETONIDENYSTATIN; TRIAMCINOLONE ACETONIDEOINTMENT;TOPICAL100,000 UNITS/GM;0.1%NoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
62332-585Nystatin and Triamcinolone AcetonideNystatin and Triamcinolone AcetonideAlembic Pharmaceuticals, Inc.ANDACurrent
62332-585Nystatin and Triamcinolone AcetonideNystatin and Triamcinolone AcetonideAlembic Pharmaceuticals, Inc.ANDACurrent
71589-016Nystatin and Triamcinolone AcetonideNystatin and Triamcinolone AcetonideAleor Dermaceuticals LimitedANDACurrent