FDA.reportPublic FDA data

Application 090368

Type
ANDA
Sponsor
TARO

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001FLUOROURACILFLUOROURACILCREAM;TOPICAL5%NoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
16714-178FluorouracilFluorouracilNORTHSTAR RX LLCANDACurrent
50090-4264FluorouracilFluorouracilA-S Medication SolutionsANDACurrent
50090-4264FluorouracilFluorouracilA-S Medication SolutionsANDACurrent
50090-4264FluorouracilFluorouracilA-S Medication SolutionsANDACurrent
51672-4118FluorouracilFluorouracilTaro Pharmaceuticals U.S.A., Inc.ANDACurrent
51672-4118FluorouracilFluorouracilTaro Pharmaceuticals U.S.A., Inc.ANDACurrent
51672-4118FluorouracilFluorouracilTaro Pharmaceuticals U.S.A., Inc.ANDACurrent
51672-4118FluorouracilFluorouracilTaro Pharmaceuticals U.S.A., Inc.ANDACurrent
52549-4118FluorouracilFluorouracilTaro Pharmaceutical Industries Ltd.ANDACurrent