FDA.reportPublic FDA data

Application 077524

Type
ANDA
Sponsor
MAYNE PHARMA

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
21695-829FLUOROURACILfluorouracilRebel Distributors CorpANDACurrent
51862-362FLUOROURACILFLUOROURACILMayne Pharma Inc.ANDACurrent
51862-362FLUOROURACILFLUOROURACILMayne Pharma Inc.ANDACurrent
51862-362FLUOROURACILFLUOROURACILMayne Pharma Inc.ANDACurrent
66530-249FLUOROURACILfluorouracilSpear Dermatology ProductsANDACurrent
66530-249FLUOROURACILfluorouracilSpear Dermatology ProductsANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
43124ORIG2011-02-15
9056ORIG2008-04-15