Home Applications 125147 Application 125147
Type BLA
Sponsor AMGEN Purple Book Biologic Products# BLA, Proprietary name, Proper name table BLA Proprietary name Proper name License type Status Latest source 125147 Vectibix panitumumab 351(a) Rx 2026-06-01
Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 VECTIBIX PANITUMUMAB INJECTABLE; IV (INFUSION) 5ML/100MG No No 002 VECTIBIX PANITUMUMAB INJECTABLE; IV (INFUSION) 10ML/200MG No No 003 VECTIBIX PANITUMUMAB INJECTABLE; IV (INFUSION) 20ML/400MG 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 · 8 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 55513-954 Vectibix panitumumab Amgen Inc BLA Current 55513-954 Vectibix panitumumab Amgen Inc BLA Current 55513-954 Vectibix panitumumab Amgen Inc BLA Current 55513-954 Vectibix panitumumab Amgen Inc BLA Current 55513-956 Vectibix panitumumab Amgen Inc BLA Current 55513-956 Vectibix panitumumab Amgen Inc BLA Current 55513-956 Vectibix panitumumab Amgen Inc BLA Current 55513-956 Vectibix panitumumab Amgen Inc BLA Current