Product Details for: FESILTY
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Product Number
Dosage Form
Route of Administration
Strength
Product Presentation
License Type
Proprietary Name
Marketing Status
001
For Injection
Intravenous
1G/50ML
Single-Dose Vial
351(a)
FESILTY
Rx
Proper Name
fibrinogen, human–chmt
fibrinogen, human–chmt
BLA Number
125833
125833
Applicant
Grifols Therapeutics LLC
Grifols Therapeutics LLC
Original Approval Date
December 16, 2025
December 16, 2025
Date of First Licensure