Home Applications 761384 Application 761384
Type BLA
Sponsor ABBVIE INC Purple Book Biologic Products# BLA, Proprietary name, Proper name table BLA Proprietary name Proper name License type Status Latest source 761384 Emrelis telisotuzumab vedotin-tllv 351(a) Rx 2026-06-01
Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 EMRELIS TELISOTUZUMAB VEDOTIN-TLLV VIAL;SINGLE-DOSE 20MG No No 002 EMRELIS TELISOTUZUMAB VEDOTIN-TLLV VIAL;SINGLE-DOSE 100MG 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 EMRELIS TELISOTUZUMAB VEDOTIN AbbVie Inc. bc04f980-3957-4e35-ab81-8ec2ffe87215 2025-05-25 Warnings, Adverse reactions Exact identifier application number: BLA761384
Documents# Document, Submission type, Date table Document Submission type Date 82576 ORIG 2025-06-16 82307 ORIG 2025-05-23 82294 ORIG 2025-05-15 82293 ORIG 2025-05-15