FDA.reportPublic FDA data

fibrin sealant (thrombin 6.5 UNT/mL, human) topical solution 4 mL Prefilled Syringe, frozen

RxCUI
1305907
RxNorm name
fibrin sealant (thrombin 6.5 UNT/mL, human) topical solution 4 mL Prefilled Syringe, frozen
Display name
fibrin sealant (thrombin 6.5 UNT/mL, human) topical solution 4 mL Prefilled Syringe, frozen
Full name
fibrin sealant (thrombin 6.5 UNT/mL, human) topical solution 4 mL Prefilled Syringe, frozen
Term type
PSN
Status
DailyMed mapping
Updated
2026-06-04 23:39:08

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
125266ArtissFibrin Sealant (Human)351(a)Rx2026-08-01

RxNav Current And Historical NDCs#

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UNII Substances#

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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
92fc93e1-9695-4705-90c5-4452a80bb074fibrin sealant (thrombin 6.5 UNT/mL, human) topical solution 4 mL Prefilled Syringe, frozen [PSN] · 4 ML fibrinogen, human 106 MG/ML / thrombin, human 6.5 UNT/ML Prefilled Syringe [SCD] · fibrin sealant (thrombin 6.5 UNT/ML, human) topical solution 4 ML Prefilled Syringe, frozen [SY]312These highlights do not include all the information needed to use ARTISS safely and effectively. See full prescribing information for ARTISS. ARTISS [Fibrin Sealant (Human)] Frozen Solution for topical application Initial U.S. Approval: 200820250930