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FDA BLA · BLA761072

IXIFI

Sponsor: PFIZER INC

APPLICATION
BLA761072
TYPE
BLA
ORIGINAL APPROVAL
2017-12-13
LATEST ACTION
2025-10-09
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription

Products

IXIFIPrescription
INFLIXIMAB-QBTX 100MG/VIAL · INJECTABLE · INJECTION

Approval history

2025-10-09BIOSIMILAR · Supplement 14 — Label ↗AP
2023-12-26Labeling · Supplement 9 · standard — Label ↗AP
2020-01-16Efficacy · Supplement 6 · standard — Letter ↗AP
2017-12-13Type 5 - New Formulation or New Manufacturer · 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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