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FDA BLA · BLA761081

TRAZIMERA

trastuzumab-qyyp

Sponsor: PFIZER INC

APPLICATION
BLA761081
TYPE
BLA
ORIGINAL APPROVAL
2019-03-11
LATEST ACTION
2025-08-21
ROUTE
INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription

Products

TRAZIMERAPrescription
TRASTUZUMAB-QYYP 420MG · INJECTABLE · INJECTION

Approval history

2025-08-21Labeling · Supplement 17 · standard — Letter ↗AP
2020-05-07Labeling · Supplement 6 · standard — Letter ↗AP
2020-01-24Labeling · Supplement 2 · standard — Letter ↗AP
2019-03-11UNKNOWN · 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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