Application 202668

Type
ANDA
Sponsor
MYLAN LABS LTD

Application Products#

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

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
85246SUPPL 2026-03-03
85229SUPPL 2026-03-03
77997SUPPL 2024-03-27
77970SUPPL 2024-03-26