Home Applications 761310 Application 761310
Type BLA
Sponsor IMMUNOGEN INC Purple Book Biologic Products# BLA, Proprietary name, Proper name table BLA Proprietary name Proper name License type Status Latest source 761310 Elahere mirvetuximab soravtansine-gynx 351(a) Rx 2026-06-01
Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 MIRVETUXIMAB SORAVTANSINE MIRVETUXIMAB SORAVTANSINE INJECTABLE;INJECTION 100mg/20mL single-dose vial No No
openFDA label cross-check# Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated 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 ELAHERE MIRVETUXIMAB SORAVTANSINE ImmunoGen, Inc. 00c424b5-6ccd-48ab-9e88-1986451120e2 2025-07-14 Boxed warning, Warnings, Adverse reactions Exact identifier application number: BLA761310 ndc (product): 72903-853
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 1 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 72903-853 ELAHERE mirvetuximab soravtansine ImmunoGen, Inc. BLA Current
Documents# Document, Submission type, Date table Document Submission type Date 77947 SUPPL 2024-03-25 77921 SUPPL 2024-03-22 72801 ORIG 2022-12-07 72617 ORIG 2022-11-15 72616 ORIG 2022-11-14