Home Applications 103795 Application 103795
Type BLA
Sponsor IMMUNEX Purple Book Biologic Products# BLA, Proprietary name, Proper name table BLA Proprietary name Proper name License type Status Latest source 103795 Enbrel etanercept 351(a) Disc 2026-09-01
Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 ENBREL ETANERCEPT VIAL; SUBCUTANEOUS 25MG/VIAL No No 002 ENBREL ETANERCEPT SYRINGE 50MG/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.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join ENBREL ETANERCEPT Immunex Corporation a002b40c-097d-47a5-957f-7a7b1807af7f 2026-05-11 Boxed warning, Warnings, Adverse reactions Exact identifier application number: BLA103795
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
NDC Listings For This Application# NDC listings for this application page 2 of 2 · 147 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 58406-435 ENBREL etanercept Immunex Corporation BLA Current 58406-435 ENBREL etanercept Immunex Corporation BLA Current 58406-435 ENBREL etanercept Immunex Corporation BLA Current 58406-435 ENBREL etanercept Immunex Corporation BLA Current 58406-435 ENBREL etanercept Immunex Corporation BLA Current 58406-435 ENBREL etanercept Immunex Corporation BLA Current 58406-435 ENBREL etanercept Immunex Corporation BLA Current 58406-435 ENBREL etanercept Immunex Corporation BLA Current 58406-435 ENBREL etanercept Immunex Corporation BLA Current 58406-435 ENBREL etanercept Immunex Corporation BLA Current 58406-435 ENBREL etanercept Immunex Corporation BLA Current 58406-445 ENBREL etanercept Immunex Corporation BLA Current 58406-445 ENBREL etanercept Immunex Corporation BLA Current 58406-445 ENBREL etanercept Immunex Corporation BLA Current 58406-445 ENBREL etanercept Immunex Corporation BLA Current 58406-445 ENBREL etanercept Immunex Corporation BLA Current 58406-445 ENBREL etanercept Immunex Corporation BLA Current 58406-445 ENBREL etanercept Immunex Corporation BLA Current 58406-445 ENBREL etanercept Immunex Corporation BLA Current 58406-445 ENBREL etanercept Immunex Corporation BLA Current 58406-445 ENBREL etanercept Immunex Corporation BLA Current 58406-445 ENBREL etanercept Immunex Corporation BLA Current 58406-445 ENBREL etanercept Immunex Corporation BLA Current 58406-445 ENBREL etanercept Immunex Corporation BLA Current 58406-445 ENBREL etanercept Immunex Corporation BLA Current 58406-446 ENBREL etanercept Immunex Corporation BLA Current 58406-446 ENBREL etanercept Immunex Corporation BLA Current 58406-446 ENBREL etanercept Immunex Corporation BLA Current 58406-446 ENBREL etanercept Immunex Corporation BLA Current 58406-446 ENBREL etanercept Immunex Corporation BLA Current 58406-446 ENBREL etanercept Immunex Corporation BLA Current 58406-446 ENBREL etanercept Immunex Corporation BLA Current 58406-446 ENBREL etanercept Immunex Corporation BLA Current 58406-446 ENBREL etanercept Immunex Corporation BLA Current 58406-446 ENBREL etanercept Immunex Corporation BLA Current 58406-446 ENBREL etanercept Immunex Corporation BLA Current 58406-446 ENBREL etanercept Immunex Corporation BLA Current 58406-446 ENBREL etanercept Immunex Corporation BLA Current 58406-446 ENBREL etanercept Immunex Corporation BLA Current 58406-455 ENBREL etanercept Immunex Corporation BLA Current 58406-455 ENBREL etanercept Immunex Corporation BLA Current 58406-455 ENBREL etanercept Immunex Corporation BLA Current 58406-455 ENBREL etanercept Immunex Corporation BLA Current 58406-455 ENBREL etanercept Immunex Corporation BLA Current 58406-455 ENBREL etanercept Immunex Corporation BLA Current 58406-455 ENBREL etanercept Immunex Corporation BLA Current 58406-455 ENBREL etanercept Immunex Corporation BLA Current 58406-455 ENBREL etanercept Immunex Corporation BLA Current 58406-455 ENBREL etanercept Immunex Corporation BLA Current 58406-455 ENBREL etanercept Immunex Corporation BLA Current 58406-455 ENBREL etanercept Immunex Corporation BLA Current 58406-455 ENBREL etanercept Immunex Corporation BLA Current 58406-455 ENBREL etanercept Immunex Corporation BLA Current 58406-456 ENBREL etanercept Immunex Corporation BLA Current 58406-456 ENBREL etanercept Immunex Corporation BLA Current 58406-456 ENBREL etanercept Immunex Corporation BLA Current 58406-456 ENBREL etanercept Immunex Corporation BLA Current 58406-456 ENBREL etanercept Immunex Corporation BLA Current 58406-456 ENBREL etanercept Immunex Corporation BLA Current 58406-456 ENBREL etanercept Immunex Corporation BLA Current 58406-456 ENBREL etanercept Immunex Corporation BLA Current 58406-456 ENBREL etanercept Immunex Corporation BLA Current 58406-456 ENBREL etanercept Immunex Corporation BLA Current 58406-456 ENBREL etanercept Immunex Corporation BLA Current 58406-456 ENBREL etanercept Immunex Corporation BLA Current 58406-456 ENBREL etanercept Immunex Corporation BLA Current 58406-456 ENBREL etanercept Immunex Corporation BLA Current