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FDA BLA · BLA761123

SAPHNELO

anifrolumab-fnia

Sponsor: ASTRAZENECA AB

APPLICATION
BLA761123
TYPE
BLA
ORIGINAL APPROVAL
2021-07-30
LATEST ACTION
2024-08-07
ROUTE
INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription

Products

SAPHNELOPrescription
ANIFROLUMAB-FNIA 300MG/2ML(150MG/ML) · INJECTABLE · INJECTION

Approval history

2024-08-07Labeling · Supplement 5 · standard — Label ↗AP
2023-12-01Efficacy · Supplement 3 · standard — Label ↗AP
2021-07-30Type 1 - New Molecular Entity · 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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