FDA.reportPublic FDA data

Application 062364

Type
ANDA
Sponsor
TARO

Application Products#

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

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
21695-185Nystatin and TriamcinoloneNystatin and Triamcinolone AcetonideRebel Distributors CorpANDACurrent
51672-1263Nystatin and Triamcinolone AcetonideNystatin and Triamcinolone AcetonideTaro Pharmaceuticals U.S.A., Inc.ANDACurrent
51672-1263Nystatin and Triamcinolone AcetonideNystatin and Triamcinolone AcetonideTaro Pharmaceuticals U.S.A., Inc.ANDACurrent
52959-558Nystatin and Triamcinolone AcetonideNystatin and Triamcinolone AcetonideH.J. Harkins Company, Inc.ANDACurrent
53002-9360Nystatin and Triamcinolone AcetonideNystatin and Triamcinolone AcetonideRPK Pharmaceuticals, Inc.ANDACurrent
68071-5037Nystatin and Triamcinolone AcetonideNystatin and Triamcinolone AcetonideNuCare Pharmaceuticals,Inc.ANDACurrent
68071-5037Nystatin and Triamcinolone AcetonideNystatin and Triamcinolone AcetonideNuCare Pharmaceuticals,Inc.ANDACurrent
70518-1114Nystatin and Triamcinolone AcetonideNystatin and Triamcinolone AcetonideREMEDYREPACK INC.ANDACurrent
70518-1114Nystatin and Triamcinolone AcetonideNystatin and Triamcinolone AcetonideREMEDYREPACK INC.ANDACurrent
71085-009Nystatin and Triamcinolone AcetonideNystatin and Triamcinolone AcetonideIPG PHARMACEUTICALS, INC.ANDACurrent
76413-120Nystatin and Triamcinolone AcetonideNystatin and Triamcinolone AcetonideCentral Texas Community Health CentersANDACurrent