Home Applications 125553 Application 125553
Type BLA
Sponsor SANDOZ INC Purple Book Biologic Products# BLA, Proprietary name, Proper name table BLA Proprietary name Proper name License type Status Latest source 125553 Zarxio filgrastim-sndz 351(k) Biosimilar Rx 2026-08-01
Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 ZARXIO FILGRASTIM-SNDZ INJECTABLE;INJECTION 300 mcg/0.5 mL No No 002 ZARXIO FILGRASTIM-SNDZ INJECTABLE;INJECTION 480 mcg/0.8 mL 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 · 14 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 61314-304 ZARXIO filgrastim-sndz Sandoz Inc BLA Current 61314-304 ZARXIO filgrastim-sndz Sandoz Inc. BLA Current 61314-304 ZARXIO filgrastim-sndz Sandoz Inc. BLA Current 61314-312 ZARXIO filgrastim-sndz Sandoz Inc BLA Current 61314-312 ZARXIO filgrastim-sndz Sandoz Inc. BLA Current 61314-312 ZARXIO filgrastim-sndz Sandoz Inc. BLA Current 61314-318 ZARXIO filgrastim-sndz Sandoz Inc. BLA Current 61314-318 ZARXIO filgrastim-sndz Sandoz Inc. BLA Current 61314-318 ZARXIO filgrastim-sndz Sandoz Inc. BLA Current 61314-318 ZARXIO filgrastim-sndz Sandoz Inc. BLA Current 61314-326 ZARXIO filgrastim-sndz Sandoz Inc. BLA Current 61314-326 ZARXIO filgrastim-sndz Sandoz Inc. BLA Current 61314-326 ZARXIO filgrastim-sndz Sandoz Inc. BLA Current 61314-326 ZARXIO filgrastim-sndz Sandoz Inc. BLA Current