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Infasurf
calfactant
351(a) Standalone BLA
Overview
Source: Purple BookProprietary name
Infasurf
Proper name
calfactant
Licence type
351(a)
BLA number
020521
Applicant
ONY Biotech Inc.
Center
CDER
Presentations
2
First licensure
—
Presentations
Source: Purple Book| Strength | Dosage form | Route | Presentation | Status | Licensed |
|---|---|---|---|---|---|
| 105MG/3ML (35MG/ML) | Suspension | Intratracheal | Single-Dose Vial | Rx | December 12, 2002 |
| 210MG/6ML (35MG/ML) | Suspension | Intratracheal | Single-Dose Vial | Rx | July 1, 1998 |
Sources for this page
| Purple Book | FDA | Licence type, presentations, reference product, exclusivity |