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FDA BLA · BLA761331

WEZLANA

ustekinumab-auub

Sponsor: AMGEN INC

APPLICATION
BLA761331
TYPE
BLA
ORIGINAL APPROVAL
2023-10-31
LATEST ACTION
2026-05-12
ROUTE
INTRAVENOUS, INTRAVENOUS, SUBCUTANEOUS
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription

Products

WEZLANAPrescription
USTEKINUMAB-AUUB 130MG/26ML · INJECTABLE · INTRAVENOUS, SUBCUTANEOUS

Approval history

2026-05-12BIOSIMILAR · Supplement 6 — Letter ↗AP
2025-09-25Labeling · Supplement 4 · standard — Letter ↗AP
2024-12-26Labeling · Supplement 1 · standard — Label ↗AP
2023-10-31UNKNOWN · Original · standard — Label ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

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Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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