Home Applications 761080 Application 761080
Type BLA
Sponsor HOSPIRA INC Purple Book Biologic Products# BLA, Proprietary name, Proper name table BLA Proprietary name Proper name License type Status Latest source 761080 Nivestym filgrastim-aafi 351(k) Biosimilar Rx 2026-06-01
Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 NIVESTYM FILGRASTIM-AAFI VIAL;SINGLE-DOSE 300MCG/ML No No 002 NIVESTYM FILGRASTIM-AAFI VIAL;SINGLE-DOSE 480MCG/1.6ML No No 003 NIVESTYM FILGRASTIM-AAFI INJECTABLE;INJECTION 300MCG/0.5ML No No 004 NIVESTYM FILGRASTIM-AAFI INJECTABLE;INJECTION 480MCG/0.8ML No No
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 36 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 0069-0291 Nivestym filgrastim-aafi Pfizer Laboratories Div Pfizer Inc BLA Current 0069-0291 Nivestym filgrastim-aafi Pfizer Laboratories Div Pfizer Inc BLA Current 0069-0291 Nivestym filgrastim-aafi Pfizer Laboratories Div Pfizer Inc BLA Current 0069-0291 Nivestym filgrastim-aafi Pfizer Laboratories Div Pfizer Inc BLA Current 0069-0291 Nivestym filgrastim-aafi Pfizer Laboratories Div Pfizer Inc BLA Current 0069-0291 Nivestym filgrastim-aafi Pfizer Laboratories Div Pfizer Inc BLA Current 0069-0291 Nivestym filgrastim-aafi Pfizer Laboratories Div Pfizer Inc BLA Current 0069-0291 Nivestym filgrastim-aafi Pfizer Laboratories Div Pfizer Inc BLA Current 0069-0291 Nivestym filgrastim-aafi Pfizer Laboratories Div Pfizer Inc BLA Current 0069-0292 Nivestym filgrastim-aafi Pfizer Laboratories Div Pfizer Inc BLA Current 0069-0292 Nivestym filgrastim-aafi Pfizer Laboratories Div Pfizer Inc BLA Current 0069-0292 Nivestym filgrastim-aafi Pfizer Laboratories Div Pfizer Inc BLA Current 0069-0292 Nivestym filgrastim-aafi Pfizer Laboratories Div Pfizer Inc BLA Current 0069-0292 Nivestym filgrastim-aafi Pfizer Laboratories Div Pfizer Inc BLA Current 0069-0292 Nivestym filgrastim-aafi Pfizer Laboratories Div Pfizer Inc BLA Current 0069-0292 Nivestym filgrastim-aafi Pfizer Laboratories Div Pfizer Inc BLA Current 0069-0292 Nivestym filgrastim-aafi Pfizer Laboratories Div Pfizer Inc BLA Current 0069-0292 Nivestym filgrastim-aafi Pfizer Laboratories Div Pfizer Inc BLA Current 0069-0293 Nivestym filgrastim-aafi Pfizer Laboratories Div Pfizer Inc BLA Current 0069-0293 Nivestym filgrastim-aafi Pfizer Laboratories Div Pfizer Inc BLA Current 0069-0293 Nivestym filgrastim-aafi Pfizer Laboratories Div Pfizer Inc BLA Current 0069-0293 Nivestym filgrastim-aafi Pfizer Laboratories Div Pfizer Inc BLA Current 0069-0293 Nivestym filgrastim-aafi Pfizer Laboratories Div Pfizer Inc BLA Current 0069-0293 Nivestym filgrastim-aafi Pfizer Laboratories Div Pfizer Inc BLA Current 0069-0293 Nivestym filgrastim-aafi Pfizer Laboratories Div Pfizer Inc BLA Current 0069-0293 Nivestym filgrastim-aafi Pfizer Laboratories Div Pfizer Inc BLA Current 0069-0293 Nivestym filgrastim-aafi Pfizer Laboratories Div Pfizer Inc BLA Current 0069-0294 Nivestym filgrastim-aafi Pfizer Laboratories Div Pfizer Inc BLA Current 0069-0294 Nivestym filgrastim-aafi Pfizer Laboratories Div Pfizer Inc BLA Current 0069-0294 Nivestym filgrastim-aafi Pfizer Laboratories Div Pfizer Inc BLA Current 0069-0294 Nivestym filgrastim-aafi Pfizer Laboratories Div Pfizer Inc BLA Current 0069-0294 Nivestym filgrastim-aafi Pfizer Laboratories Div Pfizer Inc BLA Current 0069-0294 Nivestym filgrastim-aafi Pfizer Laboratories Div Pfizer Inc BLA Current 0069-0294 Nivestym filgrastim-aafi Pfizer Laboratories Div Pfizer Inc BLA Current 0069-0294 Nivestym filgrastim-aafi Pfizer Laboratories Div Pfizer Inc BLA Current 0069-0294 Nivestym filgrastim-aafi Pfizer Laboratories Div Pfizer Inc BLA Current