FDA.reportPublic FDA data

Application 217295

Type
ANDA
Sponsor
ALEMBIC

Application Products#

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

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
85257SUPPL 2026-03-03
85239SUPPL 2026-03-03
77995SUPPL 2024-03-27
77978SUPPL 2024-03-26