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FDA BLA · BLA761143

TEPEZZA

teprotumumab

Sponsor: HORIZON THERAPEUTICS IRELAND

APPLICATION
BLA761143
TYPE
BLA
ORIGINAL APPROVAL
2020-01-21
LATEST ACTION
2025-11-24
ROUTE
INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription

Products

TEPEZZAPrescription
TEPROTUMUMAB-TRBW 500MG · INJECTABLE · INJECTION

Approval history

2025-11-24Labeling · Supplement 32 · standard — Letter ↗AP
2025-09-09Labeling · Supplement 30 · standard — Label ↗AP
2025-08-26Labeling · Supplement 31 · standard — Letter ↗AP
2023-07-17Labeling · Supplement 23 · standard — Letter ↗AP
2023-04-13Labeling · Supplement 24 · standard — Letter ↗AP
2022-12-06Labeling · Supplement 21 · standard — Label ↗AP
2021-10-26Labeling · Supplement 14 · standard — Letter ↗AP
2020-01-21Type 1 - New Molecular Entity · Original · priority — Letter ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Biologics industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

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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