FDA.reportPublic FDA data

antihemophilic factor, human recombinant residues 743-1636 deleted 1 UNT Prefilled Syringe

RxCUI
1720165
RxNorm name
antihemophilic factor, human recombinant residues 743-1636 deleted 1 UNT Prefilled Syringe
Display name
antihemophilic factor, human recombinant residues 743-1636 deleted 1 UNT Prefilled Syringe
Full name
antihemophilic factor, human recombinant residues 743-1636 deleted 1 UNT Prefilled Syringe
Term type
PSN
Status
DailyMed mapping
Updated
2026-06-04 23:38:50

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
125264Xyntha, Xyntha SolofuseAntihemophilic Factor (Recombinant), Plasma/Albumin Free351(a)Rx2026-06-01

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.

DailyMed RxNorm Mappings#

Set ID, RxNorm string, TTY table
Set IDRxNorm stringTTYSPL versionLabelEffective
25ea1c3c-14a2-ef11-302e-012bd683924fantihemophilic factor, human recombinant residues 743-1636 deleted 1 UNT Prefilled SyringePSN35These highlights do not include all the information needed to use XYNTHA safely and effectively. See full prescribing information for XYNTHA. XYNTHA ® SOLOFUSE ® (antihemophilic factor [recombinant]) lyophilized powder for solution in prefilled dual-chamber syringe, for intravenous injection Initial U.S. Approval: 200820260316
25ea1c3c-14a2-ef11-302e-012bd683924ffactor VIII, human recombinant residues 743-1636 deleted 1 UNT Prefilled SyringeSY35These highlights do not include all the information needed to use XYNTHA safely and effectively. See full prescribing information for XYNTHA. XYNTHA ® SOLOFUSE ® (antihemophilic factor [recombinant]) lyophilized powder for solution in prefilled dual-chamber syringe, for intravenous injection Initial U.S. Approval: 200820260316
25ea1c3c-14a2-ef11-302e-012bd683924fantihemophilic factor, human recombinant residues 743-1636 deleted 1 UNT Prefilled SyringeSCD35These highlights do not include all the information needed to use XYNTHA safely and effectively. See full prescribing information for XYNTHA. XYNTHA ® SOLOFUSE ® (antihemophilic factor [recombinant]) lyophilized powder for solution in prefilled dual-chamber syringe, for intravenous injection Initial U.S. Approval: 200820260316