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FDA BLA · BLA761099

ZIRABEV

bevacizumab-bvzr

Sponsor: PFIZER INC

APPLICATION
BLA761099
TYPE
BLA
ORIGINAL APPROVAL
2019-06-27
LATEST ACTION
2024-08-28
ROUTE
INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription

Products

ZIRABEVPrescription
BEVACIZUMAB-BVZR 400MG/16ML · INJECTABLE · INJECTION
ZIRABEVPrescription
BEVACIZUMAB-BVZR 100MG/4ML · INJECTABLE · INJECTION

Approval history

2024-08-28Labeling · Supplement 12 · standard — Letter ↗AP
2023-02-17Bioequivalence · Supplement 10 · unknown — Letter ↗AP
2021-02-09Labeling · Supplement 6 · standard — Label ↗AP
2021-02-09Efficacy · Supplement 4 · standard — Letter ↗AP
2019-06-27Type 5 - New Formulation or New Manufacturer · 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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