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Survanta
beractant
351(a) Standalone BLA
Overview
Source: Purple BookProprietary name
Survanta
Proper name
beractant
Licence type
351(a)
BLA number
020032
Applicant
AbbVie Inc.
Center
CDER
Presentations
2
First licensure
—
Presentations
Source: Purple Book| Strength | Dosage form | Route | Presentation | Status | Licensed |
|---|---|---|---|---|---|
| 100MG/4ML (25MG/ML) | Suspension | Intratracheal | Single-Dose Vial | Rx | July 1, 1991 |
| 200MG/8ML (25MG/ML) | Suspension | Intratracheal | Single-Dose Vial | Rx | July 1, 1991 |
Exclusivity
Source: Purple Book| Kind | Expires |
|---|---|
| Orphan exclusivity | July 2, 1998 |
Sources for this page
| Purple Book | FDA | Licence type, presentations, reference product, exclusivity |