FDA.reportPublic FDA data

Saphnelo 300 MG per 2 ML Injection

RxCUI
2565286
RxNorm name
Saphnelo 300 MG per 2 ML Injection
Display name
Saphnelo 300 MG per 2 ML Injection
Full name
Saphnelo 300 MG per 2 ML Injection
Term type
SY
Status
DailyMed mapping
Updated
2026-06-04 23:39:23

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
761123Saphneloanifrolumab-fnia351(a)Rx2026-09-01
761451Saphneloanifrolumab-fnia351(a)Rx2026-09-01

RxNav Current And Historical NDCs#

RxNav current and historical NDC rows page 1 of 1 · 0 matching rows.

No records found.

UNII Substances#

UNII substance links page 1 of 1 · 0 matching rows.

No records found.

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed RxNorm Mappings#

unique DailyMed labels mapped to this RxNorm concept page 1 of 1 · 1 matching rows.

Set ID, RxNorm mappings, Terms table
Set IDRxNorm mappingsTermsSPL versionLabelEffective
d6203302-2128-41a7-b0b4-0e6c0704d4dcSaphnelo 300 MG in 2 ML Injection [PSN] · 2 ML anifrolumab-fnia 150 MG/ML Injection [Saphnelo] [SBD] · 2 ML Saphnelo 150 MG/ML Injection [SY] · Saphnelo 300 MG per 2 ML Injection [SY]415These highlights do not include all the information needed to use SAPHNELO ® safely and effectively. See full prescribing information for SAPHNELO. SAPHNELO (anifrolumab-fnia) injection, for intravenous, or subcutaneous use Initial U.S. Approval: 202120260424