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FDA BLA · BLA761086

AVSOLA

infliximab-axxq

Sponsor: AMGEN INC

APPLICATION
BLA761086
TYPE
BLA
ORIGINAL APPROVAL
2019-12-06
LATEST ACTION
2025-08-25
ROUTE
INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription

Products

AVSOLAPrescription
INFLIXIMAB-AXXQ 100MG/VIAL · INJECTABLE · INJECTION

Approval history

2025-08-25BIOSIMILAR · Supplement 13LetterAP
2021-09-09Labeling · Supplement 1 · standardLabelAP
2019-12-06Original · standardLabelAP
VIEW ON DRUGS@FDA ↗

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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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