FDA.reportPublic FDA data

Application 040279

Type
ANDA
Sponsor
FRESENIUS KABI USA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001FLUOROURACILFLUOROURACILINJECTABLE;INJECTION1GM/20ML (50MG/ML)NoYes
002FLUOROURACILFLUOROURACILINJECTABLE;INJECTION500MG/10ML (50MG/ML)NoYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
63323-117FluorouracilFLUOROURACILFresenius Kabi USA, LLCANDACurrent
63323-117FluorouracilFLUOROURACILFresenius Kabi USA, LLCANDACurrent
63323-117FluorouracilFLUOROURACILFresenius Kabi USA, LLCANDACurrent
63323-117FluorouracilFLUOROURACILFresenius Kabi USA, LLCANDACurrent
63323-117FluorouracilFLUOROURACILFresenius Kabi USA, LLCANDACurrent
63323-117FluorouracilFLUOROURACILFresenius Kabi USA, LLCANDACurrent
63323-117FluorouracilFLUOROURACILFresenius Kabi USA, LLCANDACurrent
63323-117FluorouracilFLUOROURACILFresenius Kabi USA, LLCANDACurrent
63323-117FluorouracilFLUOROURACILFresenius Kabi USA, LLCANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
85223SUPPL 2026-03-03
85222SUPPL 2026-03-03
77998SUPPL 2024-03-27
77965SUPPL 2024-03-26
29910ORIG2004-06-04
17763ORIG2004-06-04
22114ORIG2003-07-31