Home Applications 761342 Application 761342
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 761342 Talvey talquetamab-tgvs 351(a) Rx 2026-06-01
Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 TALVEY TALQUETAMAB-TGVS INJECTABLE;INJECTION 3MG/1.5ML(2MG/ML) No No 002 TALVEY TALQUETAMAB-TGVS INJECTABLE;INJECTION 40MG/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 ยท 1 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join TALVEY TALQUETAMAB Janssen Biotech, Inc. 9001355e-003d-4d4e-b4ce-337e0fd14952 2025-10-08 Boxed warning, Warnings, Adverse reactions Exact identifier application number: BLA761342
Documents# Document, Submission type, Date table Document Submission type Date 85851 SUPPL 2026-05-08 85293 SUPPL 2026-03-09 83658 SUPPL 2025-10-03 83654 SUPPL 2025-10-03 83653 SUPPL 2025-10-03 83161 SUPPL 2025-08-20 80486 SUPPL 2024-12-03 78979 SUPPL 2024-07-05 77589 SUPPL 2024-02-21 76656 SUPPL 2023-11-24 75589 ORIG 2023-09-28 75357 ORIG 2023-09-07 75026 ORIG 2023-08-10 75025 ORIG 2023-08-10