Product Details for: Infasurf

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Product Number
Dosage Form
Route of Administration
Strength
Product Presentation
License Type
Proprietary Name
Marketing Status
001
Suspension
Intratracheal
210MG/6ML (35MG/ML)
Single-Dose Vial
351(a)
Infasurf
Rx
002
Suspension
Intratracheal
105MG/3ML (35MG/ML)
Single-Dose Vial
351(a)
Infasurf
Rx
Proper Name
calfactant
BLA Number
020521
Applicant
ONY Biotech Inc.
Original Approval Date
July 1, 1998
Date of First Licensure
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