Home Applications 761039 Application 761039
Type BLA
Sponsor COHERUS BIOSCIENCES INC Purple Book Biologic Products# BLA, Proprietary name, Proper name table BLA Proprietary name Proper name License type Status Latest source 761039 Udenyca pegfilgrastim-cbqv 351(k) Biosimilar Rx 2026-08-01
Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 UDENYCA PEGFILGRASTIM-CBQV INJECTABLE;INJECTION 6MG/0.6ML 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 · 2 matching rows.
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 7 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 70114-101 UDENYCA pegfilgrastim-cbqv Coherus BioSciences Inc BLA Current 70114-101 UDENYCA pegfilgrastim-cbqv Coherus BioSciences Inc BLA Current 70114-101 UDENYCA pegfilgrastim-cbqv Coherus BioSciences Inc BLA Current 70114-101 UDENYCA pegfilgrastim-cbqv Coherus BioSciences Inc BLA Current 70114-101 UDENYCA pegfilgrastim-cbqv Coherus BioSciences Inc BLA Current 70114-101 UDENYCA pegfilgrastim-cbqv Coherus BioSciences Inc BLA Current 70114-101 UDENYCA pegfilgrastim-cbqv Coherus BioSciences Inc BLA Current