FDA.reportPublic FDA data

Application 214845

Type
ANDA
Sponsor
ACCORD HLTHCARE

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
16729-542FluorouracilFluorouracilAccord Healthcare Inc.ANDACurrent
16729-542FluorouracilFluorouracilAccord Healthcare Inc.ANDACurrent
16729-542FluorouracilFluorouracilAccord Healthcare Inc.ANDACurrent