FDA.reportPublic FDA data

Application 040334

Type
ANDA
Sponsor
TEVA PHARMS USA

Application Products#

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

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0703-3018AdrucilFluorouracilTeva Parenteral Medicines, Inc.ANDACurrent
0703-3018AdrucilFluorouracilTeva Parenteral Medicines, Inc.ANDACurrent
0703-3018AdrucilFluorouracilTeva Parenteral Medicines, Inc.ANDACurrent
0703-3018AdrucilFluorouracilTeva Parenteral Medicines, Inc.ANDACurrent
0703-3019AdrucilFluorouracilTeva Parenteral Medicines, Inc.ANDACurrent
0703-3019AdrucilFluorouracilTeva Parenteral Medicines, Inc.ANDACurrent
0703-3019AdrucilFluorouracilTeva Parenteral Medicines, Inc.ANDACurrent
0703-3019AdrucilFluorouracilTeva Parenteral Medicines, Inc.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
85243SUPPL 2026-03-03
85225SUPPL 2026-03-03
77990SUPPL 2024-03-27
77966SUPPL 2024-03-26
29931ORIG2004-06-04
17772ORIG2004-06-04
22129ORIG2003-07-31