FDA.reportPublic FDA data

Application 761027

Type
BLA
Sponsor
ACCORD BIOPHARMA INC.

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001FILKRIFILGRASTIM-LAHAINJECTABLE;INJECTION300MCG/0.5MLNoNo
002FILKRIFILGRASTIM-LAHAINJECTABLE;INJECTION480MCG/0.8MLNoNo

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
84806ORIG 2026-01-21
84779ORIG 2026-01-20