Drug application

WEZLANA (USTEKINUMAB-AUUB)

Drugs@FDA BLA 761331 · AMGEN INC

Key facts

Drug name WEZLANA
Active ingredients USTEKINUMAB-AUUB
Application type BLA
Application number 761331
Company AMGEN INC
Dosage forms INJECTABLE, INTRAVENOUS, SUBCUTANEOUS
Strength 130MG/26ML
Marketing status Prescription
Reference listed drug No
Latest submission status date Oct 31, 2023

At a glance

  • 1–9 Submissions
  • 1–9 Supplements
  • 1–9 Label versions
  • 1–9 Products
  • None Therapeutic equivalents
  • Yes FDA letters on file
  • Yes 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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