FDA.reportPublic FDA data

Application 076526

Type
ANDA
Sponsor
TARO

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001FLUOROURACILFLUOROURACILSOLUTION;TOPICAL2%NoNo
002FLUOROURACILFLUOROURACILSOLUTION;TOPICAL5%NoYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
51672-4062FluorouracilFluorouracilTaro Pharmaceuticals U.S.A., Inc.ANDACurrent
51672-4062FluorouracilFluorouracilTaro Pharmaceuticals U.S.A., Inc.ANDACurrent
51672-4062FluorouracilFluorouracilTaro Pharmaceuticals U.S.A., Inc.ANDACurrent
51672-4062FluorouracilFluorouracilTaro Pharmaceuticals U.S.A., Inc.ANDACurrent
51672-4063FluorouracilFluorouracilTaro Pharmaceuticals U.S.A., Inc.ANDACurrent
51672-4063FluorouracilFluorouracilTaro Pharmaceuticals U.S.A., Inc.ANDACurrent
51672-4063FluorouracilFluorouracilTaro Pharmaceuticals U.S.A., Inc.ANDACurrent
51672-4063FluorouracilFluorouracilTaro Pharmaceuticals U.S.A., Inc.ANDACurrent