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Curosurf
poractant alfa
351(a) Standalone BLA
Overview
Source: Purple BookProprietary name
Curosurf
Proper name
poractant alfa
Licence type
351(a)
BLA number
020744
Applicant
Chiesi USA, Inc.
Center
CDER
Presentations
2
First licensure
—
Presentations
Source: Purple Book| Strength | Dosage form | Route | Presentation | Status | Licensed |
|---|---|---|---|---|---|
| 120MG/1.5ML (80MG/ML) | Suspension | Intratracheal | Single-Dose Vial | Rx | November 18, 1999 |
| 240MG/3ML (80MG/ML) | Suspension | Intratracheal | Single-Dose Vial | Rx | November 18, 1999 |
Sources for this page
| Purple Book | FDA | Licence type, presentations, reference product, exclusivity |