FDA.reportPublic FDA data

Application 208136

Type
ANDA
Sponsor
GLENMARK PHARMS LTD

Application Products#

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

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
68071-3363Nystatin and Triamcinolone AcetonideNystatin and Triamcinolone AcetonideNuCare Pharmaceuticals,Inc.ANDACurrent
68462-314Nystatin and Triamcinolone AcetonideNystatin and Triamcinolone AcetonideGlenmark Pharmaceuticals Inc., USAANDACurrent
68462-314Nystatin and Triamcinolone AcetonideNystatin and Triamcinolone AcetonideGlenmark Pharmaceuticals Inc., USAANDACurrent
68788-8245Nystatin and Triamcinolone AcetonideNystatin and Triamcinolone AcetonidePreferred Pharmaceuticals Inc., USAANDACurrent