Home Applications 761291 Application 761291
Type BLA
Sponsor JANSSEN BIOTECH Purple Book Biologic Products# BLA, Proprietary name, Proper name table BLA Proprietary name Proper name License type Status Latest source 761291 Tecvayli teclistamab-cqyv 351(a) Rx 2026-06-01
Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 TECAYLI TECLISTAMAB-CQYV INJECTABLE;INJECTION 30MG/3ML(10MG/ML) No No 002 TECAYLI TECLISTAMAB-CQYV INJECTABLE;INJECTION 153MG/1.7ML(90MG/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 · 4 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 57894-449 TECVAYLI teclistamab Janssen Biotech, Inc. BLA Current 57894-449 TECVAYLI teclistamab Janssen Biotech, Inc. BLA Current 57894-450 TECVAYLI teclistamab Janssen Biotech, Inc. BLA Current 57894-450 TECVAYLI teclistamab Janssen Biotech, Inc. BLA Current