Home Applications 125294 Application 125294
Type BLA
Sponsor SICOR BIOTECH Purple Book Biologic Products# BLA, Proprietary name, Proper name table BLA Proprietary name Proper name License type Status Latest source 125294 Granix tbo-filgrastim 351(a) Rx 2026-08-01
Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 GRANIX TBO-FILGRASTIM INJECTABLE; INJECTION 300MCG/0.5ML No No 002 GRANIX TBO-FILGRASTIM 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 · 24 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 63459-910 GRANIX tbo-filgrastim Cephalon, Inc. BLA Current 63459-910 GRANIX tbo-filgrastim Cephalon, Inc. BLA Current 63459-910 GRANIX tbo-filgrastim Cephalon, LLC BLA Current 63459-910 GRANIX tbo-filgrastim Cephalon, Inc. BLA Current 63459-910 GRANIX tbo-filgrastim Cephalon, LLC BLA Current 63459-910 GRANIX tbo-filgrastim Cephalon, Inc. BLA Current 63459-912 GRANIX tbo-filgrastim Cephalon, Inc. BLA Current 63459-912 GRANIX tbo-filgrastim Cephalon, Inc. BLA Current 63459-912 GRANIX tbo-filgrastim Cephalon, LLC BLA Current 63459-912 GRANIX tbo-filgrastim Cephalon, Inc. BLA Current 63459-912 GRANIX tbo-filgrastim Cephalon, LLC BLA Current 63459-912 GRANIX tbo-filgrastim Cephalon, Inc. BLA Current 63459-918 GRANIX tbo-filgrastim Cephalon, Inc. BLA Current 63459-918 GRANIX tbo-filgrastim Cephalon, Inc. BLA Current 63459-918 GRANIX tbo-filgrastim Cephalon, LLC BLA Current 63459-918 GRANIX tbo-filgrastim Cephalon, Inc. BLA Current 63459-918 GRANIX tbo-filgrastim Cephalon, LLC BLA Current 63459-918 GRANIX tbo-filgrastim Cephalon, Inc. BLA Current 63459-920 GRANIX tbo-filgrastim Cephalon, Inc. BLA Current 63459-920 GRANIX tbo-filgrastim Cephalon, Inc. BLA Current 63459-920 GRANIX tbo-filgrastim Cephalon, LLC BLA Current 63459-920 GRANIX tbo-filgrastim Cephalon, Inc. BLA Current 63459-920 GRANIX tbo-filgrastim Cephalon, LLC BLA Current 63459-920 GRANIX tbo-filgrastim Cephalon, Inc. BLA Current