FDA.reportPublic FDA data

Application 040798

Type
ANDA
Sponsor
ACCORD HLTHCARE

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001FLUOROURACILFLUOROURACILINJECTABLE;INJECTION5GM/100ML (50MG/ML)NoYes
002FLUOROURACILFLUOROURACILINJECTABLE;INJECTION2.5GM/50ML (50MG/ML)NoYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
16729-276FluorouracilFluorouracilAccord Healthcare, Inc.ANDACurrent
68001-266FluorouracilFluorouracilBluePoint LaboratoriesANDACurrent
68001-266FluorouracilFluorouracilBluePoint LaboratoriesANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
85245SUPPL 2026-03-03
85228SUPPL 2026-03-03
77992SUPPL 2024-03-27
77968SUPPL 2024-03-26