Drug application

BLENREP (BELANTAMAB MAFODOTIN-BLMF)

Drugs@FDA BLA 761440 · GLAXOSMITHKLINE LLC

Key facts

Drug name BLENREP
Active ingredients BELANTAMAB MAFODOTIN-BLMF
Application type BLA
Application number 761440
Company GLAXOSMITHKLINE LLC
Dosage forms INJECTABLE, INJECTION
Strength 70MG
Marketing status Prescription
Reference listed drug No
Latest submission class Type 2 - New Active Ingredient
Latest submission status date Oct 23, 2025

At a glance

  • 1–9 Submissions
  • 1–9 Label versions
  • 1–9 Products
  • None Therapeutic equivalents
  • Yes FDA letters on file
  • No FDA reviews on file

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

About Drugs@FDA applications

Drugs@FDA covers FDA-approved brand-name and generic drugs and therapeutic biologics, with their applications (NDA, ANDA or BLA), products, submissions and labels.

Source: U.S. Food and Drug Administration (FDA), Drugs@FDA · Source date:

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