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FDA BLA · BLA761100

ONTRUZANT

trastuzumab

Sponsor: SAMSUNG BIOEPIS CO LTD

APPLICATION
BLA761100
TYPE
BLA
ORIGINAL APPROVAL
2019-01-18
LATEST ACTION
2026-04-15
ROUTE
INTRAVENOUS, IV (INFUSION)
DOSAGE FORM
POWDER
MARKETING STATUS
Prescription

Products

ONTRUZANTPrescription
TRASTUZUMAB-DTTB 150MG · POWDER · IV (INFUSION)
ONTRUZANTPrescription
TRASTUZUMAB-DTTB 420MG · POWDER · IV (INFUSION)

Approval history

2026-04-15Labeling · Supplement 30 · standardAP
2025-12-05Labeling · Supplement 28 · standard — Letter ↗AP
2025-02-28Bioequivalence · Supplement 25 — Letter ↗AP
2020-03-19Manufacturing (CMC) · Supplement 5 — Letter ↗AP
2019-01-18UNKNOWN · Original · standard — Label ↗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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